kerala medical services corporation ltd.kmscl.kerala.gov.in/media/qcmanual.pdf · kerala medical...

KERALA MEDICAL SERVICES CORPORATION LTD.

QUALITY CONTROL MANUAL

FOR DRUGS AND SUPPLIES

PREFACE

Kerala Medical Services Corporation has been designated as the central procurement agency in place of the erstwhile Central Purchase Committee for procurement of drugs and is operational with effect from 1st April 2008. Government has later entrusted the centralized procurement of equipments also with KMSCL. The Corporation has procured drugs worth Rs.150.17 crores in 2008-09, Rs.147.29 crores in 2009-10 and Rs. 44.49 crores in 2010-11. The procurement cost of equipments is estimated as Rs. 41 crores. The Quality Control policy of Kerala Medical Services Corporation has been defined by the Managing Director as appropriate to the long term vision, commitment to quality, people’s perception of KMSCL procured items and other aspects of Health and Family welfare. In order to assure that the best possible medicines and other medical supplies to be made available to the consumers, it is imperative that it fulfills the following parameters 1) Right quality 2) Right quantity and 3) Right price For assuring the safety and efficacy of various drugs and supplies that are made available by KMSCL, this Quality Control Manual has been introduced. All procedures, instructions, and directions set forth in this manual are in accordance with and confirm to the requirement of standards like IP, BP, USP, BPC, NF, IS ,ISO and as per the KMSCL`S specifications. The manual shall provide in-depth understanding of the need of quality system, including prescribing the tests required to be conducted for the drugs and supplies procured by the KMSCL. And moreover this document will also be a part of the tender document. The manual will be revised as needed to incorporate improvements so as to strengthen the quality control parameters.

Sd/- BIJU PRABHAKAR.IAS MANAGING DIRECTOR

KKEERRAALLAA MMEEDDIICCAALL SSEERRVVIICCEESS CCOORRPPOORRAATTIIOONN LLTTDD QUALITY CONTROL MANUAL FOR DRUGS AND SUPPLIES

Title : Current Index For Drugs and Supplies Page 1 of 13

Sl. No. Drug Name Drug Code Page No.

TABLETS 1

1 Acetyl Salicylic acid Tablets I.P D01018&D13024 2

2 Acyclovir Tablets IP D09002 3

3 Albendazole Tablets IP D08001 4

4 Allopurinol Tablets I.P D01013 5

5 Alprazolam Tablets IP D17007 6

6 Aluminium Hydroxide Tablets IP D20003 7

7 Amitriptyline Tablets IP D17005 8

8 Amlodipine Tablets IP D13012&D13031 9

9 Amoxycillin Dispersible Tablets I.P D02003 10

10 Atenolol Tablets IP D13008 11

11 Atorvastatin Tablets IP D13013 12

12 Azithromycin Tablets D02031 13

13 Bisacodyl Tablets IP D20012 14

14 Calcium lactate Tablets IP D22001 15

15 Carbamazepine Tablets IP D07005 16

16 Carbidopa+Levodopa Tablets IP D11002 17

17 Cetirizine Tablets 18

18 Chlordiazepoxide Tablets IP D17009 19

19 Chloroquine phosphate Tablets IP D08009 20

20 Chlorpheneramine maleate Tablets IP D05006 21

21 Chlorpromazine Tablets IP D17002&D17003 22

22 Ciprofloxacin Tablets I.P D02011 23

23 Clobazam Tablets D07009 24

24 Clomiphene citrate Tablets D16009 25

25 Clopidogrel Tablets IP D13023 26

26 Clotrimazole vaginal Tablets IP D08008 27

27 Clozapine Tablets D17014&D17015 28

28 Co-trimoxazole Tablets I.P D02001 29



29 Dexamethasone Tablets IP D05003 30

30 Diazepam Tablets IP D17001 31 Sl. No.

Drug Name Drug Code Page No.

31 Diclofenac sodium Tablets I.P D01004 32

32 Dicyclomine Hcl Tablets IP D20008 33

33 Diethyl carbamazine Tablets IP D08003 34

34 Digoxin Tablets IP D13014 35

35 Diltiazem Tablets IP D13004 36

36 Domperidone Tablets IP D200007 37

37 Enalapril Maleate Tablets IP D13009D13032 38

38 Erythromycin stearate Tablets I.P D02015 39

39 Ferrous sulphate Tablets D22006 40

40 Fluconozole Tablets D08014 41

41 Folic acid Tablets IP D12002 42

42 Frusemide Tablets IP D19001 43

43 Glibenclamide Tablets IP D21001&D21002 44

44 Glipizide Tablets D21004 45

45 Griseofulvin Tablets IP D08005 46

46 HaloperidolTablets IP D17010 47

47 Ibuprofen Tablets I.P(Film coated) D01006 48

48 Imipramine Tablets IP D17004 49

49 Isosorbide dinitrate Tablets IP D13001&D13002 50

50 Isosorbide-5 mononitrate Tablets IP D13003 51

51 Ketoconozole Tablets IP D08006 52

52 Lithium carbonate Tablets IP D17025&D17026 53

53 Lorazepam D17033 54

54 Losartan potassium D13011 55

55 Mefanamic Acid Tablets I.P D01014 56

56 Metformin Tablets IP D21003 57

57 Methylergometrin maleate Tablets IP D16003 58

58 Metoclopramide Tablets IP D200006 59



59 Metoprolol Tablets IP D13020D13033 60

60 Metronidazole Tablets I.P D02023 61

61 Nicotinic acid Tablets IP D13021 62

Sl. No.


62 Nifedipine Tablets IP D13005 63

63 Nitrazepam Tablets IP D17006 64

64 Norfloxacin Tablets I.P D02016 65

65 Ofloxacin Tablets D02017 66

66 Olanzapine Tablets D17016&D17020 67

67 Paracetamol Tablets I.P D01002 68

68 Pheneramine maleate Tablets IP D05007 69

69 Phenobarbitone Tablets IP D07002 70

70 Phenytoin sodium Tablets IP D07004 71

71 Prednisolone Tablets IP D05011 72

72 Proponolol Tablets IP D13029&D13030 73

73 Ranitidine Tablets IP D20002 74

74 Risperidone Tablets D17017 75

75 Salbutamol sulphate Tablets IP D03004 76

76 SertalineTablets D17019 77

77 Sodium valproate Tablets IP D07006&D07010 78

78 Spiranolactone Tablets IP D19003&D19004 79

79 Sulfasalazine Tablets B.P D01015 80

80 Tamoxifen Tablets IP D24027 81

81 Theophylline and Etophylline Tablets D03002 82

82 Thyroxine Tablets IP D21019 83

83 Tramadol Tablets I.P D01012 84

84 Trihexyphenidyl Tablets IP D11001 85

85 Verapamil Tablets IP D13007 86

86 Vitamin B complex Tablets NFI(strong) D22002&D22004 87

CAPSULES 88

87 Amoxycillin Capsules IP D02004&D02005 89



88 Ampicillin Capsules IP D02007 90

89 Clofazimine Capsules IP D10002 91

90 Cloxacillin Capsules IP D02006 92

91 Doxycycline Capsules IP D02014 93

Sl. No.


92 Fluoxetine Capsules D17008 94

93 Hydroxy urea Capsules USP D24023 95

94 Nifedipine soft gelatin Capsules D13006 96

95 Omeprazole Capsules D20004 97

96 Vitamin A & D soft gelatin Capsules D22005 98

ORAL LIQUIDS, SOLUTIONS AND POWDERS 99

97 Amoxycillin dry syrup IP D2032&D02033 100

98 Benedicts Reagent D26001 101

99 Cephalexin oral suspension(dry) IP D02022 102

100 Chlorhexidine with Ethyl alcohol solution D25010 103

101 Chlorhexidine/Cetrimide solution D25001 104

102 Chloroxylenol solution BP D250057D25006 105

103 Cotrimoxazole Oral suspension IP D02002 106

104 Dicyclomine oral solution IP D20010 107

105 Diethyl carbamazine citrate suspension D08004 108

106 Formaldehyde solution D25014 109

107 Gamma benzene hexachloride solution USP D14010 110

108 Gluteraldehyde solution BP D25007 111

109 Glycerin IP D14021 112

110 Halothane USP liquid D04002 113

111 Hydrogen peroxide solution IP D25003&D25016 114

112 Mixture carminative concentrate D20013 115

113 Non oxylenol surfactant based Iodine Solution D25009 116

114 ORS powder IP D20011 117

115 Orthothaladehyde solution D25008 118

116 Paracetamol syrup D01003 119



117 Piperazine citrate syrup IP D08016 120

118 Povidone-Iodine solution IP D14011&D14019 121

119 Salbutamol Nebuliser solution BP D03006 122

120 Salbutamol syrup IP D03005 123

121 Syrup Lactulose USP D20015 124

Sl. No.


GELS, CREAMS, OINTMENTS, LINIMENTS, LOTIONS, PESSERIES

125

122 Acyclovir cream BP D09003 126

123 Benzyl benzoate application IP D14006 127

124 Betamethasone valerate cream USP D14009 128

125 Calamine lotion IP D14014 129

126 Chloramphenicol Applicaps D15010 130

127 Ciprofloxacin eye ointment USP D15003 131

128 Clotrimazole cream IP D08007 132

129 Glycerin magsulf BPC D14007 133

130 Lignocaine Hcl gel IP D04003 134

131 Povidone-Iodine ointment USP D14008 135

132 Povidone-Iodine vaginal pesseries D16006 136

133 Salicylic acid ointment BP D14004 137

134 Silversulphadiazine cream USP D14001 138

135 Turpentine liniment IP D14013 139

136 Whitfields ointment IP D14005 140

EAR DROPS / EYE DROPS 141

137 Betamethasone Eye drops IP D15007 142

138 Ciprofloxacin Eye/Ear drops IP D15002 143

139 Timolol maleate eye drops IP D15005 144

140 Tropicamide eye drops IP D15006 145

141 Saline nasal drops D15011 146

142 Sodium bicarbonate ear drops BPC D15008 147

143 Xylometazoline Nasal drops IP D15009 148

PARENTERALS 149



144 Aciclovir Injection IP D09001 150

145 Adrenaline bitartrate Injection IP D05005 151

146 Amikasin Sulphate Injection IP D02021 152

147 Aminophylline Injection IP D03003 153

148 Anti Snake venom(Freeze dried) D21012 154

149 Ampicillin Injection IP D02008 155 Sl. No.


150 Atropine Injection IP D04007 156

151 Benzyl Penicillin Injection IP D02009 157

152 Betamethasone sodium Injection IP D05004 158

153 Bleomycin Injection IP D24009 159

154 Bupivacaine HCl in Dextrose injection USP D04017 160

155 Calcium Gluconate Injection IP D22003 161

156 Carboprost Injection IP D06008 162

157 Cefotaxime Injection IP D02026 163

158 Cefotaxime Sodium Injection IP D02010 164

159 Cefuroxime Injection IP D02019 165

160 Chlorpheniramine maleate Injection IP D05008 166

161 Ciprofloxacin Injection IP D02012 167

162 Cisplastin Injection IP D24012&D24013 168

163 Cloxacillin Injection IP D02025 169

164 Cyclophosphamide Injection IP D24003&D24004 170

165 Cynocobalamin Injection IP D12001 171

166 Cytosine Arabinoside Injection IP D24021 172

167 Desferrioxamine Injection BP D06006 173

168 Dexamethasone sodium Injection IP D05001 174

169 Dextran 40 with Sodiumchloride 0.9% IP D12007 175

170 Dextrose Injection IP D18003, D18004, D18005, D18006

176

171 Diazepam Injection IP D07007 177

172 Diclofenac sodium Injection IP D01005 178

173 Dicyclomine Hcl Injection IP D20009 179



174 Digoxin Injection IP D13015 180

175 Dimercaprol Injection IP D06009 181

176 Dobutamine Hydrochloride Injection USP D13017 182

177 Dopamine Hydrochloride Injection USP D13016 183

178 Doxurubicin Hcl Injection IP D24024 184

179 Electrolyte M Injection (Maintenance)

D18008 185

180 Electrolyte P Injection (Pediatric)) D18007 186

Sl. No.


181 Etoposide Injection IP D24014 187

182 Fluoro uracil Injection IP D24028 188

183 Fluphenazine Decanoate Injection IP D17013 189

184 Frusemide Injection IP D19002 190

185 Gamma globulin (I.V) IP D21020 191

186 Gentamycin Injection IP D02013 192

187 Glycopyrrolate USP D04019 193

188 Haloperidol Injection IP D17012 194

189 Heparin sodium Injection IP D12003 195

190 Human Anti-D Immunoglobulin IP D21011 196

191 Hydrocortisone sodium succinate Injection IP D05002 197

192 Hydroxy Ethyl Starch I.V Infusion D12006 198

193 Iohexol Injection USP D23001 199

194 Ketamine Injection IP D04001 200

195 Leucovorin calcium Injection USP D24015 201

196 Lignocaine 2 % with Adrenaline Injection IP D04018 202

197 Lignocaine Hcl Injection Heavy IP D04005 203

198 Lignocaine Hcl Injection IP D04004 204

199 Lorazepam Injection USP D17034 205

200 Magnesium Sulphate Injection BP D16007 206

201 Mannitol Injection IP D18010 207

202 Methotrexate Injection IP D24010 208

203 Methyl Ergometrin Maleate Injection IP D16004 209



204 Methyl prednisolone sodium succinate Injection D05012 210

205 Metoclopramide Injection IP D20005 211

206 Metoprolol Injection BP D13019 212

207 Metronidazole Injection IP D02025 213

208 N-Acetyl Cysteine Injection BP D06007 214

209 Naloxone Injection BP D06003 215

210 Neostigmine methylsulphate Injection IP D04008 216

211 Nitroglycerin Injection USP D13028 217

Sl. No.


212 Ofloxacin Injection D02018 218

213 Ondansetron Injection USP D20014 219

214 Oxytocin Injection IP D16001 220

215 Paclitaxel Injection USP D24019 221

216 Pancuronium bromide Injection B.P D04009 222

217 Paracetamol Injection D01009 223

218 Pentazocine lactate Injection IP D01008 224

219 Phenobarbitone sodium Injection IP D07003 225

220 Phenytoin sodium Injection D07008 226

221 Phytomenadione Injection BP D12005 227

222 Potassium chloride for Injection Concentrate USP D18012 228

223 Pralidoxime Chloride Injection IP D06004 229

224 Promethazine Injection IP D05009 230

225 Propofol Injection BP D04010 231

226 Protamine Sulphate Injection IP D12012 233

227 Quinine Injection IP D08010 234

228 Ranitidine Injection IP D20001 235

229 Ringer Lactate Injection IP D18009 236

230 Sodium Calcium Edetate Injection BP D22002&D22004 237

231 Sodium chloride 0.9% & Dextrose 5.0% w/v IP D18002 238

232 Sodium chloride Injection IP 0.9%w/v D18001 239

233 Sodium Nitro Prusside Injection USP D13025 240



234 Sodium thiosulphate Injection BP D06012 241

235 Sterile Water for Injection IP D18011 242

236 Streptokinase Injection IP D13022 243

237 Succinyl choline Injection IP D04013 244

238 Terbutaline Injection IP D03007 245

239 Tetanus Toxoid Injection IP D21009 246

240 Theophylline and Etophylline Injection D03001 247

241 Thiopentone sodium Injection IP D04014 248

242 Tramadol Injection IP D01011 249

Sl. No.


243 Vancomycin Hydrochloride Injection D02027 250

244 Vecuronium Bromide Injection D04020 251

245 Vincristine Sulphate Injection IP D24002 252

MEDICAL DEVICES 253

246 Absorbable cotton Gauze S27008 254

247 Absorbent Cotton Wool IP S27007 255

248 Adhesive Tape U.S.P. S27002 256

249 Black Braided Silk 1-25 M (Reels) S27104 to S27107 257

250 Black Silk 5-0 ½ C 17mm Needle Taper cut 76 cm S27108 258

251 Blood collection single bag S27010 259

252 BP Blade S27014 to S27021 260

253 Braided Poly Glycolic Acid Suture 1 150cm without Needle

S27184 261

254 Braided Poly Glycolic Acid Suture 1-0 150cm without Needle

S27183 262

255 Braided Poly Glycolic Acid Suture 1-0 90cm ½ Circle Taper Cut

S27179 263

256 Braided Poly Glycolic Acid Suture 190 cm ½ Circle Taper Cut (Heavy) 40mm

S27177 264

257 Braided Poly Glycolic Acid Suture 2-0 150cm without Needle

S27182 265

258 Braided Poly Glycolic Acid Suture 2-0 90cm ½ Circle Reverse Cutting 40mm

S27178 266

259 Braided Poly Glycolic Acid Suture 3-0 45cm 3/8 Circle Reverse Cutting 12mm

S27180 267

260 Catgut Atraumatic No. IRB 63 mm Blunt Needle S27109 268



261 Catgut Atromatic No. 1, RB, 63 mm S27120&S27121 269

262 Catgut Chromic 1 – 0, RB, 3/8 circle 76 cm, 45mm S27122 270

263 Catgut Chromic 1-0 152 cm Null S27110& S27111 271

264 Catgut Chromic 2-0 ½ CRB 30mm Needle 76 cm S27112 272

265 Catgut Chromic 3-0 ½ 12mm Needle Reverse cut 76 cm

S27113 to S27115 273

266 Catgut No. 1 with Needle S27116 & S27117 274

267 Catgut Plain BP 1-0 152 cm S27118 &S27119 275

268 Disposable Needle S27025 to S27030 276

269 Disposable Surgeon`s mask (Double Layer) S27100 277

Sl. No.


270 Disposable syringe without needle S27031 to S27033 278

271 Endo Tracheal Tube S27045 to S27053 279

272 Endotracheal Tube 5.5 with cuff S27054 to S27061 280

273 Folley’s Catheter S27062 to S27065 281

274 Infant Feeding Tube S27069 to S27074 282

275 Infusion set 283

276 Insulin Syringe with Fixed Needle S27211 284

277 Monofilament Poly Amide 10/0 CS – Ultima ½ Circle Double Needle 6mm

S27167 285

278 Monofilament Poly Amide 10/0 CS – Ultima 3/8 Circle Double Needle 6mm

S27168 286

279 Monofilament Poly Propylene Blue 3-0 70cm 3/8 Circle Cutting 22mm

S27176 287

280 Monofilament Poly Propylene Blue 170cm ½ CRB (Heavy)

S27175 288

281 Monofilament Poly Propylene Blue 1-0 70cm ½ CRB 30mm

S27174 289

282 Monofilament Polyamide 8/0 ½ Circle Reverse Cutting Micro point 8mm

S27169 290

283 Non- Adherent Sterile Rayon Dressing Impregnated with 10 povidone Iodine size 10 x 10cm

S27172 291

284 Oxygen Catheter S27203 to S27205 292

285 Paediatric Bag S27012 293

286 Plaster of Paris Bandages BP S27001 294



287 Poliglecarpone 25 (Dyed) Size 1/0 with round body

needle for Anastamosis S27128 295

288 Poliglecarpone 25 (Dyed) Size 2/0 with black JB shaped round body needle for Anastamosis

S27130 296

289 Poliglecarpone 25 (Dyed) Size 2/0 with round body needle for Anastamosis

S27129 297

290 Poliglecarpone 25 (Dyed) Size 3/0 with black JB shaped for Anastamosis

S27132 298

291 Poliglecarpone 25 (Dyed) size 3/0 with cutting needle for sub cuticular suturing

S27131 299

292 Poliglecarpone 25 Size 1/0 with round body needle for Anastamosis

S27125 300

293 Poliglecarpone 25 Size 3/0 with visi black JB shaped round body needle For Anastamosis

S27126 301

Sl. No. Drug Name Drug Code Page No.

294 Poly dioxanone of size 1 with ½ Circle RB, Heavy 50mm needle suture length 1.5m, for sheath closure

S27187 302

295 Polyglactin 910 of Size 1, ½ Circle 36mm OB needle made of special grade steel 420 with ribbed body for secure Grip

S27186 303

296 Polyglactin 910 of Size 1, ½ Circle 40mm CT needle made of special grade steal for 420 with ribbed body for secure Grip

S27188 304

297 Polyglacten 910 of Size 1-0, ½ Circle 36mm OB needle made of special grade steel 420 with ribbed body for secure Grip

S27189 305

298 Polyglacten 910 rapid Size 2/0 with taper needle for Episiotomy Repair S27185 306

299 Polyglycolic acid 1-0, 150 cm with out needle S27156 307

300 Polyglycolic acid 1-0, round body, ½ Circle, 40mm, 150cm S27157 308

301 Polyglycolic acid 2-0, taper cut, ½ circle, 30mm, 90cm S27158 309

302 Polyglycolic acid No. 1, ½ circle, 40mm, 90cm S27155 310

303 Polyglycolic acid Size 2/0 with double armed needle for Episiotomy S27124 311

304 Polyglycolic acid with Calcium Stearate size 01 with 36mm reverse cutting ortho special (O.S) needle S27164 312

305 Polyglycolic acid with Calcium Stearate size 5/0 with Ethiprime cutting 12mm S27162 313



306 Polyglycolic acid with Calcium Stearate size 6/0 with micropoint spatulate 8 mm S27161 314

307 Poly propylene 1, ½ CRB 30 mm needle S27136 to S27141 315

308 Quadraple Bag with SAGM Platelet storage S27011 316

309 Ryle’s Tube S27076 to S27079 317

310 Sics Blade (Sharp Edge) cresant Blade 2.8mm S27201 318

311 Sics Blade (Sharp Edge) Keratomo Blade (2.8mm) S27200 319

312 Sics Blade (Sharp Edge) Side port S27202 320

313 Suction catheter S27089 to S27093 321

314 Surgical silk 2-0 St. RB 50 mm needle 76 cm S27142 to S27149 322

315 Suture pack silk No. 1 S27150 to S27154 323

316 Virgin Silk 8/0 3/8 Circle micropoint spatulated 6mm needle S27165 324

Sl. No.


317 Virgin Silk 8/0 3/8 Circle micropoint spatulated double needle

S27166 325

MISCELLANEOUS 326

318 Activated Charcoal Powder IP. D06002 327

319 Black Disinfectant Fluid Grade-III D25012 328

320 Bleaching Powder 30 % IP D25011 329

321 Gentian Violet Paint BPC D14017 330

322 Liquid Paraffin IP D14003 331

323 Nitrous oxide IP D04015 332

324 Oxygen IP D04016 333

325 Purified Talc IP D14016 334

326 Surgical Spirit 70.0%v/v BP D25002 335

327 Washing soda D25013 336

328 White Soft Paraffin IP D14015 337

GENERAL TESTS 338

329 General test 339

330 General test for Tablets 340,341

331 General test for Capsules 342

332 General test for Oral liquids 343



333 General test for Powders 344

334 General test for Gels 345

335 General test for Creams 346

336 General test for Ointments 347

337 General test for Pesseries 348

338 General test for Suppositories 349

339 General test for Ear drops/Eye drops 350

340 General test for Eye ointment 351

341 General test for Nasal Drops 352

342 General test for Parenterals as per IP 353 to356

343 General test for Parenterals as per BP 357 to364

344 General test for Parenterals as per USP 365 to368

345 General test for Sutures 369to372

Sl. No

Drug Name Drug Code Page No

346

References 373

347

Abbreviations 374

KKEE

RRAA

LLAA

MM

EEDD

II CCAA

LL

SSEE

RRVV

II CCEE

SS

CCOO

RRPP

OORR

AATT

II OONN

LL

TTDD

TTAABBLLEETTSS

QQuuaalliittyy CCoonnttrrooll MMaannuuaall FFoorr

DDrruuggss AAnndd SSuupppplliieess

KKMMSSCCLL QUALITY CONTROL MANUAL FOR

DRUGS AND SUPPLIES Drug Code : D01018

Quality Control Department

Drug Name : Acetyl Salicylic Acid Tablets IP Page 1 of 1

Synonym : Aspirin Copy No. 1

Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 694-695

Prepared By:

Date:

Name:

(Asst. Manager - QC)

Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

2

TESTS AS PER OFFICIAL MONOGRAPH

1. Description. 2. Identification. 3. Salicylic acid 4. Uniformity of weight- Refer-G-TAB-002 5. Disintegration- Refer- G-TAB-004 6. Assay: limit-95.0-105.0% of the stated amount of Aspirin.

ADDITIONAL TESTS

1. Friability - Not more than 1.0% 2. Hardness - Minimum 3 kg/cm square.

LIMITS

For test 1 to 6, limit as per IP-2007.

LABELLING

Nil

QUANTITY REQUIRED FOR ANALYSIS

100 Numbers.

SHELF LIFE

Minimum 2 years.



Quality Control Department Drug Name :

Acyclovir Tablets IP Page 1 of 1 Synonym :

Copy No. 1 Official Standards :

Indian Pharmacopoeia 2007, Volume 2, Page No. 687-688

Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

3


1. Description. 2. Identification. 3. Guanine 4. Related substances. 5. Uniformity of weight – Refer G-TAB -002 6. Disintegration – Refer G-TAB -004 7. Assay: -95.0% to 105.0% of the stated amount of Acyclovir.

ADDITIONAL TESTS


LIMITS


LABELLING

Nil


100 Numbers.

SHELF LIFE Minimum 18 months.




Drug Name : Albendazole Tablets IP Page 1 of 1

Synonym : Copy No. 1


Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

4


1. Description. 2. Identification. 3. Uniformity of Weight- Refer-G-TAB-002. 4. Disintegration – Refer G-TAB-004 5. Assay: Limit- 92.5 to 107.5% of the stated amount of Albendazole.

ADDITIONAL TESTS


LIMITS


LABELLING

Nil


100 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Allopurinol Tablets IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

5


1. Description. 2. Identification. 3. Related substances. 4. Uniformity of weight- refer-G-TAB-002 5. Disintegration- refer- G-TAB-004 6. Assay: limit- 92.5-107.5% of the stated amount of Allopurinol.

ADDITIONAL TESTS


LIMITS


LABELLING

Nil


100 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Aluminium Hydroxide Tablets IP Page 1 of 1

Synonym : Copy No.

Official Standards : Indian Pharmacopoeia 1985

Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

6


1. Description. 2. Identification. 3. Uniformity of content -Refer- G-TAB-001 4. Disintegration – Refer G-TAB -004 5. Assay: - 90.0% to 110.0% of the stated amount of Alprazolam.

ADDITIONAL TESTS

Friability - Not more than 1.0%.

LIMITS


LABELLING

Nil


100 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Aluminium Hydroxide Tablets IP Page 1 of 1

Synonym : Copy No.

Official Standards : Indian Pharmacopoeia 1985

Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

7


1. Description. 2. Identification. 3. Uniformity of weight Refer- G-TAB-002 4. Disintegration – Refer-G-TAB-004 (not applicable to chewable tablets) 5. Neutralizing capacity- NLT 230 ml of 0.1 M Hydrochloric Acid for each gram

of Dried Aluminium hydroxide Gel. 6. Assay: - Limit as per IP 1985.

ADDITIONAL TESTS


LIMITS


LABELLING

Nil


100 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Amitriptylline Tablets IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

8


1. Description. 2. Identification. 3. Related substances-HPLC 4. Uniformity of weight - Refer- G-TAB-001 5. Dissolution – D value 75.0% Refer- G-TAB-003 6. Assay:- 90.0% to 110.0% of the stated amount of Amitriptylline.

ADDITIONAL TESTS

Friability - Not more than 1.0%

LIMITS


LABELLING

Nil


100 Numbers.

SHELF LIFE

Minimum 2 years.


DRUGS AND SUPPLIES Drug Code : D13012 & D13031 Quality Control Department

Drug Name : Amlodipine Tablets IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

9


1. Description. 2. Identification- HPLC 3. Related substances- HPLC 4. Uniformity of content - Refer- G-TAB-001 5. Dissolution – D value 70.0% Refer- G-TAB-003 6. Assay:- 90.0% to 110.0% of the stated amount of Amlodipine.

ADDITIONAL TESTS


LIMITS


LABELLING

The label states the strength in terms of the equivalent amount of Amlodipine.


100 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Amoxycillin Dispersible Tablets IP Page 1 of 1


Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 723

Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

10


1. Description. 2. Identification. 3. Uniformity of weight- Refer-G-TAB-002 4. Disintegration- limit-30 minutes, Refer- G-TAB-004 5. Uniformity of dispersion-Refer-G-TAB-005 6. Assay: limit-90.0-120.0% of the stated amount of Amoxicillin

ADDITIONAL TESTS


LIMITS


LABELLING

Nil


100 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Atenolol Tablets IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

11


1. Description. 2. Identification. 3. Related substances 4. Uniformity of weight. Refer- G-TAB-002 5. Disintegration- Refer-G-TAB-004 6. Assay: - limit not less than 92.5% and not more than 107.5% of stated

amount of Atenolol.

ADDITIONAL TESTS


LIMITS


LABELLING

Nil


100 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Atorvastatin Tablets IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

12


1. Description. 2. Identification. 3. Related substances-HPLC 4. Dissolution – Refer G-TAB -004 5. Uniformity of weight -Refer- G-TAB-002 6. Assay: - 90.0% to 110.0% of the stated amount of Atorvastatin.

ADDITIONAL TESTS


LIMITS


LABELLING

The label states the strength in terms of the equivalent amount of Atorvastatin.


100 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Azithromycin Tablets IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

13


1. Description. 2. Identification. 3. Related substances- HPLC 4. Water- NMT 6.0 % 5. Dissolution – D –value NLT 75.0%. Refer G-TAB -004 6. Uniformity of weight -Refer- G-TAB-002 7. Assay:- 90.0% to 110.0% of the stated amount of Azithromycin.

ADDITIONAL TESTS


LIMITS


LABELLING

Nil


100 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Bisacodyl Tablets IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

14


1. Description. 2. Identification- HPLC 3. Uniformity of content- Refer -G-TAB-001 4. Disintegration – Refer G-TAB-004 5. Assay: - Limit 95.0% to 105.0% of the stated amount of Bisacodyl.

ADDITIONAL TESTS

Nil

LIMITS


LABELLING

Nil


100 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Calcium Lactate Tablets IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

15


1. Description. 2. Identification. 3. Uniformity of weight- Refer- G-TAB-002 4. Disintegration – Refer-G-TAB-004 (Limit not more than 30 minutes) 5. Assay: - Limit not less than 95.0% and not more than 105.0% of stated

amount of Calcium Lactate Pentahydrate.

ADDITIONAL TESTS


LIMITS


LABELLING

The label states the strength in terms of the equivalent amount of Calcium Lactate Pentahydrate.


100 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Carbamazepine Tablets IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

16


1. Description. 2. Identification. 3. Related substances - HPLC 4. Uniformity of weight – Refer- G-TAB 002 5. Disintegration – Refer - G-TAB-004 6. Assay: limit- 95.0-105.0% of the stated amount of Carbamazepine.

ADDITIONAL TESTS


LIMITS


LABELLING

Nil


100 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Carbidopa and Levodopa Tablets IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

17


1. Description. 2. Identification. 3. Uniformity of Content- Refer-G-TAB-001 4. Disintegration- Refer- G-TAB-004 5. Assay: limit- 90.0-110.0% of the stated amount of anhydrous Carbidopa

and 95.0 to 105.0 % of the stated amount of Levodopa.

ADDITIONAL TESTS

Nil

LIMITS


LABELLING

The label states the quantity of Carbidopa in terms of the equivalent amount of anhydrous Carbidopa and the quantity of Levodopa in each tablet.


100 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Cetirizine Tablet IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

18


1. Description. 2. Identification. 3. Related substances 4. Uniformity of content -Refer- G-TAB-001 5. Dissolution – D –value NLT 75.0% Refer G-TAB -003 6. Assay:- 90.0% to 110.0% of the stated amount of Cetirizine Hydrochloride.

ADDITIONAL TESTS


LIMITS


LABELLING

Nil


100 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Chlordiazepoxide Tablets IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

19


1. Description. 2. Identification. 3. Related substances 4. Uniformity of content -Refer- G-TAB-001 5. Disintegration – Refer G-TAB -004 6. Assay: - 90.0% to 110.0% of the stated amount of Chlordiazepoxide.

ADDITIONAL TESTS


LIMITS


LABELLING

Nil


100 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Chloroquine Phosphate Tablets IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

20


1. Description. 2. Identification. 3. Related substances. 4. Dissolution - D value 70.0% , Refer G-TAB - 003 5. Uniformity of weight – Refer G-TAB- 002 6. Disintegration Refer - G-TAB- 004 7. Assay: - 92.5% to 107.5% of the stated amount of Chloroquine Phosphate.

ADDITIONAL TESTS


LIMITS For test 1 to 7, limit as per IP-2007.

LABELLING Nil QUANTITY REQUIRED FOR ANALYSIS 100 Numbers.

SHELF LIFE Minimum 2 years.




Drug Name : Chlorpheniramine Maleate Tablets IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

22


1. Description. 2. Identification. 3. Related substances 4. Uniformity of content- Refer-G-TAB-001 5. Disintegration- Refer- G-TAB-004 6. Assay: limit- 95.0-105.0% of the stated amount of Chlorpheniramine

Maleate.

ADDITIONAL TESTS

Nil

LIMITS


LABELLING

Nil


100 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Chlorpromazine Tablets IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

22


1. Description. 2. Identification. 3. Related substances. 4. Uniformity of content -Refer- G-TAB-001 5. Disintegration – Refer G-TAB -004 6. Assay: - 92.5% to 110.0% of the stated amount of Chlorpromazine.

ADDITIONAL TESTS


LIMITS


LABELLING

Nil


100 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Ciprofloxacin Tablets IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

23


1. Description. 2. Identification. 3. Uniformity of Weight- Refer-G-TAB-002. 4. Dissolution- D-value- 80.0%. Refer- G-TAB-003. 5. Assay: Limit- 90.0-110.0% of the stated amount of Ciprofloxacin.

ADDITIONAL TESTS


LIMITS


LABELLING

The label states the strength in terms of the equivalent amount of Ciprofloxacin.


100 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Clobazam Tablets Page 1 of 1


Official Standards :

Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

24


1. Description. 2. Identification. 3. Uniformity of Weight- Refer-G-TAB-002. 4. Disintegration –Refer-G-TAB-004 5. Assay: -HPLC - Limit not less than 90.0% and not more than 110.0% of the

stated amount of Clobazam.

ADDITIONAL TESTS


LIMITS

For test 3 and 4, limit as per IP-2007.

LABELLING

Nil


100 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Clomifene Tablets IP Page 1 of 1

Synonym : Clomifene Citrate Copy No. 1


Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

25


1. Description. 2. Identification. 3. Z-isomer- HPLC 4. Dissolution – D –value NLT 80.0%. Refer G-TAB -004 5. Uniformity of weight -Refer- G-TAB-002 6. Assay: -92.5% to 107.5% of the stated amount of Clomifene citrate.

ADDITIONAL TESTS


LIMITS


LABELLING

Nil


100 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Clopidogrel Tablets IP Page 1 of 1


Official Standards : Indian Pharmacopoeia 2007, Addendum, Page No.

Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

26


1. Description. 2. Identification. 3. Related substances 4. Uniformity of content -Refer- G-TAB-001 5. Dissolution – D value NLT 80.0% Refer G-TAB -003 6. Assay: - 90.0% to 110.0% of the stated amount of Clopidogrel.

ADDITIONAL TESTS


LIMITS


LABELLING

The label states the strength in terms of the equivalent amount of Clopidogrel.


100 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Clotrimazole Vaginal Tablets IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

27


1. Description. 2. Identification. 3. Related substances - HPLC 4. Uniformity of content - Refer G-PES- 001 5. Uniformity of weight – Refer G-PES- 002 6. Disintegration - G-PES -003 7. Assay: - 95.0% - 105.0% of the stated amount of Clotrimazole.

ADDITIONAL TESTS

Nil

LIMITS


LABELLING

Nil


100 Numbers.

SHELF LIFE

Minimum 18 months.




Drug Name : Clozapine Tablets USP Page 1 of 1


Official Standards : US Pharmacopoeia 2008, Volume 2, Page No. 1833

Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

28


1. Description. 2. Identification. 3. Dissolution – D value 85.0% (Q) of the labelled amount of Clozapine. 4. Chromatographic purity. 5. Uniformity of dosage units. 6. Assay: - 90.0% to 110.0% of the labelled amount of Clozapine.

ADDITIONAL TESTS


LIMITS

For test 1 to 6, limit as per USP-2008.

LABELLING

Nil


120 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Co-trimoxazole Tablets IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

29


1. Description. 2. Identification. 3. Uniformity of weight- Refer-G-TAB-002 4. Disintegration-D-value-80.0%- Refer- G-TAB-004 5. Assay: limit- 92.5%-107.5% of the stated amount of Trimethoprim and

Sulphamethoxazole.

ADDITIONAL TESTS


LIMITS


LABELLING

Nil


100 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Dexamethasone Tablets IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

30


1. Description. 2. Identification. 3. Related substances-HPLC 4. Uniformity of content- Refer-G-TAB-001 5. Disintegration- Refer- G-TAB-004 6. Assay: limit- 90.0-110.0% of the stated amount of Dexamethasone.

ADDITIONAL TESTS

Nil

LIMITS


LABELLING

Nil


100 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Diazepam Tablets IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

31


1. Description. 2. Identification. 3. Related substances and Decomposition product. 4. Dissolution – D value-85.0%,Refer G-TAB -004 5. Uniformity of content -Refer- G-TAB-001 6. Assay:- 92.5% to 107.5% of the stated amount of Diazepam.

ADDITIONAL TESTS


LIMITS


LABELLING

Nil


100 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Diclofenac Sodium Tablets IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

32


1. Description. 2. Identification. 3. Salicylic acid 4. Uniformity of weight- Refer-G-TAB-002 5. Disintegration- Refer- G-TAB-004 6. Assay: limit-95.0-105.0% of the stated amount of Diclofenac sodium.

ADDITIONAL TESTS

1. Friability-not more than 1.0% 2. Hardness- minimum 3 kg/cm square.

LIMITS


LABELLING

Nil


100 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Dicyclomine Hydrochloride Tablets IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

33


1. Description. 2. Identification. 3. Related substances 4. Dissolution – Refer G-TAB -004 5. Uniformity of content - Refer- G-TAB-001 6. Assay:- 90.0% to 110.0% of the stated amount of Dicyclomine Hydrochloride.

ADDITIONAL TESTS


LIMITS


LABELLING

Nil


100 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Digoxin Tablets IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

34


1. Description. 2. Identification. 3. N1 N1 Diethyl piperazine and N-methyl piperazine 4. Dissolution - D value 75.0%, Refer G-TAB-003 5. Uniformity of weight – Refer G-TAB-002 6. Assay: Limit- 92.5 to 107.5 % of the stated amount of Diethylcarbamazine.

ADDITIONAL TESTS


LIMITS


LABELLING

Nil


100 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Digoxin Tablets IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

35


1. Description. 2. Identification. 3. Dissolution – Refer G-TAB -004 4. Uniformity of weight -Refer- G-TAB-002 5. Assay:- 90.0% to 110.0% of the stated amount of Digoxin.

ADDITIONAL TESTS


LIMITS


LABELLING

Nil


100 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Diltiazem Tablets IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

36


1. Description. 2. Identification. 3. Dissolution- Limit- NLT 60.0% of the stated amount of Diltiazem HCl is

dissolved in 30.0 minutes and NLT 80.0% in 3.0 hours. Refer- G-TAB-003 4. Uniformity of weight- Refer-G-TAB-002 5. Assay: limit-90.0-110.0% of the stated amount of Diltiazem HCl.

ADDITIONAL TESTS


LIMITS


LABELLING

Nil


100 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Domperidone Tablets IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

37


1. Description. 2. Identification. 3. Dissolution – Refer G-TAB -003 4. Related substances - HPLC 5. Uniformity of content - Refer- G-TAB-001 6. Assay:- 95.0% to 105.0% of the stated amount of Domperidone.

ADDITIONAL TESTS


LIMITS


LABELLING

The label states the strength in terms of the equivalent amount of Domperidone.


100 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Enalapril Maleate Tablets IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

38


1. Description. 2. Identification. 3. Uniformity of content -Refer- G-TAB-001 4. Disintegration – Refer G-TAB -004 5. Assay: -90.0% to 110.0% of the stated amount of Enalapril Maleate.

ADDITIONAL TESTS


LIMITS


LABELLING

Nil


100 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Erythromycin Stearate Tablets IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

39


1. Description. 2. Identification. 3. Uniformity of Weight- Refer-G-TAB-002. 4. Disintegration- Refer- G-TAB-004 5. Assay: limit- 90.0-115.0% of the stated amount of Erythromycin.

ADDITIONAL TESTS


LIMITS


LABELLING

The label states the strength in terms of the equivalent amount of Erythromycin.


100 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Ferrous Sulphate Tablets IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

40


1. Description. 2. Identification. 3. Uniformity of weight – Refer- GTAB-002 4. Disintegration- Refer- GTAB-004 5. Assay:- Limit- 80.0 to 90.0% of the stated amount of Ferrous Sulphate.

ADDITIONAL TESTS


LIMITS


LABELLING

The label states the quantity of the active ingredient both as the amount of dried ferrous sulphate and in terms of the equivalent amount of ferrous ions in each tablet.


100 Numbers.

SHELF LIFE

Minimum 18 months.




Drug Name : Fluconazole Tablets Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

41


1. Description. 2. Identification. 3. Uniformity of Weight- Refer-G-TAB-002. 4. Disintegration –Refer-G-TAB-004 5. Assay: - HPLC - Limit not less than 90.0% and not more than 110.0% of

stated amount of Fluconazole.

ADDITIONAL TESTS


LIMITS


LABELLING

Nil


160 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Folic Acid Tablets IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

42


1. Description. 2. Identification- HPLC 3. Hydrolysis product -HLPC 4. Uniformity of content -Refer- G-TAB-001 5. Disintegration – Refer -G-TAB -004 6. Assay: -95.0% to 115.0% of the stated amount of Folic acid.

ADDITIONAL TESTS

1. Friability - Not more than 1.0% 2. Hardness - Not more than 1.0%

LIMITS


LABELLING

Nil


100 Numbers.

SHELF LIFE

Minimum 18 months.




Drug Name : Frusemide Tablets IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

43


1. Description. 2. Identification- HPLC 3. Free amines. 4. Uniformity of weight – Refer G-TAB-002 5. Disintegration – Refer G-TAB-004 6. Assay: - Limit 90.0% to 110.0% of the stated amount of Frusemide

ADDITIONAL TESTS


LIMITS


LABELLING

Nil


100 Numbers.

SHELF LIFE

Minimum 2 years.



Drug Name : Glibenclamide Tablets IP Page 1 of 1

Synonym : Copy No.


Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

44


1. Description. 2. Identification. 3. Related substances. 4. Uniformity of content - Refer- G-TAB-001 5. Disintegration – Refer- G-TAB-004 6. Assay: - 90.0% to 110.0% of the stated amount of Glibenclamide.

ADDITIONAL TESTS


LIMITS


LABELLING

Nil


100 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Glipizide Tablets IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

45


1. Description. 2. Identification. 3. Related substances 4. Uniformity of content - Refer- G-TAB-001 5. Disintegration – Refer G-TAB -004 6. Assay:- 90.0% to 110.0% of the stated amount of Glipizide.

ADDITIONAL TESTS


LIMITS


LABELLING

Nil


100 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Griseofulvin Tablets IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

46


1. Description. 2. Identification. 3. Related substance – gas chromatography 4. Dissolution- D value 70.0%. Refer-G-TAB-003 5. Uniformity of weight – Refer G-TAB-002 6. Disintegration – Refer G-TAB-004 7. Assay: limit-95.0% - 105.0% of the stated amount of Griseofulivin.

ADDITIONAL TESTS


LIMITS


LABELLING

Nil


100 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Haloperidol Tablets IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

47


1. Description. 2. Identification. 3. Related substance – gas chromatography 4. Dissolution- D value 70.0%. Refer-G-TAB-003 5. Uniformity of weight – Refer G-TAB-002 6. Disintegration – Refer G-TAB-004 7. Assay: limit-95.0% - 105.0% of the stated amount of Griseofulivin.

ADDITIONAL TESTS


LIMITS


LABELLING

Nil


100 Numbers.

SHELF LIFE

Minimum 2 years.



Drug Name : Ibuprofen Tablets IP (Film Coated) Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

48


1. Description. 2. Identification. 3. Related substance 4. Uniformity of weight- Refer-G-TAB-002 5. Dissolution- Refer- D-value-50.0%G-TAB-003 6. Assay: Limit-95.0-105.0% of the stated amount of Ibuprofen.

ADDITIONAL TESTS

Nil

LIMITS


LABELLING

Nil


100 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Imipramine Tablets IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

49


1. Description. 2. Identification. 3. Related Substances. 4. Uniformity of weight -Refer- G-TAB-002 5. Disintegration – Refer -G-TAB -004 6. Assay: - 92.5% to 107.5% of the stated amount of Imipramine

Hydrochloride.

ADDITIONAL TESTS


LIMITS


LABELLING

Nil


100 Numbers.

SHELF LIFE

Minimum 2 years.



Drug Name : Isosorbide Dinitrate Tablets IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

50


1. Description. 2. Identification- HPLC 3. Inorganic nitrate. 4. Related substances. 5. Uniformity of content - Refer- G-TAB-001 6. Dissolution – D value 80.0% Refer- G-TAB-003 7. Assay: -90.0% to 110.0% of the stated amount of Isosorbide Dinitrate.

ADDITIONAL TESTS


LIMITS


LABELLING

The label states whether the tablets are to be swallowed whole, chewed before swallowing for allowing to dissolve in the mouth.


100 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Isosorbide 5 Mononitrate Tablets BP Page 1 of 1


Official Standards : British Pharmacopoeia 2009, Volume 3, Page No. 2703

Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

51


1. Description. 2. Identification. 3. Inorganic nitrates 4. Isosorbide Dinitrate and Isosorbide 2 -nitrate 5. Uniformity of weight Refer- G-TAB-002 6. Disintegration –Refer-G-TAB-004 (not applicable to chewable tablets) 7. Assay:- 95.0 to 105.0 % of the stated amount of Isosorbide Mononitrate.

ADDITIONAL TESTS


LIMITS

For test 1 to 6, limit as per BP-2009.

LABELLING

Nil


100 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Ketoconazole Tablets IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

52


1. Description. 2. Identification. 3. Uniformity of Weight- Refer-G-TAB-002. 4. Disintegration – Refer- G-TAB-004 5. Assay: Limit- 95.0% - 105.0% of the stated amount of Ketoconazole.

ADDITIONAL TESTS


LIMITS


LABELLING

Nil


100 Numbers.

SHELF LIFE

Minimum 2 years.



Drug Name : Lithium Carbonate Tablets IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

53


1. Description. 2. Identification. 3. Dissolution – D value-60.0%, Refer G-TAB -004 4. Uniformity of weight - Refer- G-TAB-002 5. Assay: - 95.0% to 105.0% of the stated amount of Lithium Carbonate.

ADDITIONAL TESTS


LIMITS


LABELLING

Nil


100 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Lorazepam Tablets BP Page 1 of 1


Official Standards : British Pharmacopoeia 2009, Volume 3, Page No. 2734-2725

Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

54


1. Description. 2. Identification. 3. Dissolution – D value 75.0% (Q) of the stated amount of Lorazepam. 4. Related substances 5. Uniformity of content 6. Assay:- 90.0% to 110.0% of the stated amount of Lorazepam.

ADDITIONAL TESTS


LIMITS


LABELLING

Nil


100 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Losartan Potassium Tablets IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

55


1. Description. 2. Identification. 3. Related substances- HPLC 4. Dissolution – D –value NLT 75.0%. Refer G-TAB -004 5. Uniformity of weight -Refer- G-TAB-002 6. Assay:- 90.0% to 110.0% of the stated amount of Losartan Potassium.

ADDITIONAL TESTS


LIMITS


LABELLING

Nil


100 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Mefenamic Acid Tablets BP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

56


1. Description. 2. Identification. 3. 2,3-dimethyl aniline. 4. Related substances. 5. Uniformity of content- Refer-Page-2257 BP 6. Disintegration- Refer- G-TAB-004 7. Assay: limit- 95.0-110.0% of the stated amount of Mefenamic acid.

ADDITIONAL TESTS


LIMITS For test 1 to 7, limit as per BP-2009. LABELLING Nil QUANTITY REQUIRED FOR ANALYSIS 100 Numbers. SHELF LIFE Minimum 2 years.




Drug Name : Metformin Tablets IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

57


1. Description. 2. Identification. 3. Related substances 4. Dissolution – D value not less than 70.0% of the stated amount of Metformin

Hydrochloride - Refer-G-TAB-003 5. Uniformity of weight. Refer- G-TAB-002 6. Assay: - HPLC - limit not less than 95.0% and not more than 105.0% of

stated amount of Metformin Hydrochloride.

ADDITIONAL TESTS


LIMITS


LABELLING

Nil


100 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Methyl Ergometrine Tablets IP Page 1 of 1

Synonym : Methyl Ergonovin Copy No. 1


Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

58


1. Description. 2. Identification. 3. Related substances. 4. Uniformity of content -Refer- G-TAB-001 5. Disintegration – Refer G-TAB -004 6. Assay: - 90.0% to 110.0% of the stated amount of Methyl Ergometrine

Maleate.

ADDITIONAL TESTS


LIMITS


LABELLING

Nil


100 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Metoclopramide Tablets IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

59


1. Description. 2. Identification. 3. Related substances 4. Uniformity of content -Refer- G-TAB-001 5. Disintegration – Refer G-TAB -004 6. Assay:- 90.0% to 110.0% of the stated amount of Anhydrous Metoclopramide

Hydrochloride.

ADDITIONAL TESTS


LIMITS


LABELLING

The label states the strength in terms of the equivalent amount of anhydrous Metoclopramide Hydrochloride.


100 Numbers.

SHELF LIFE

Minimum 2 years.



Drug Name : Metoprolol Tablets IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

60


1. Description. 2. Identification. 3. Dissolution – D value not less than 80.0% of the stated amount of

Metoprolol Tartrate, Refer-G-TAB-003 4. Uniformity of weight Refer- G-TAB-002 5. Assay: - HPLC - limit not less than 90.0% and not more than 110.0% of

stated amount of Metoprolol Tartrate.

ADDITIONAL TESTS


LIMITS


LABELLING

Nil


100 Numbers.

SHELF LIFE

Minimum 2 years.



Drug Name : Metronidazole Tablets IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

61


1. Description. 2. Identification. 3. Related substances 4. Uniformity of Weight- Refer-G-TAB-002 5. Dissolution- D-value- 85.0%- Refer- G-TAB-003 6. Assay: limit- 95.0-105.0% of the stated amount of Metronidazole.

ADDITIONAL TESTS


LIMITS


LABELLING

Nil


100 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Nicotinic Acid Tablets IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

62


1. Description. 2. Identification. 3. Uniformity of Weight- Refer-G-TAB-002. 4. Disintegration –Refer-G-TAB-004 5. Assay: - Limit not less than 92.5% and not more than 107.5% of stated

amount of Nicotinic acid.

ADDITIONAL TESTS


LIMITS


LABELLING

Nil


100 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Nifedipine Tablets IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

63


1. Description. 2. Identification. 3. Uniformity of content - Refer- G-TAB-001 4. Uniformity of weight- Refer- G-TAB-002, if the tablet is sustained release. 5. Disintegration – Refer G-TAB -004 6. Dissolution – If the tablet is sustained release.Refer-G-TAB-003

Limits- (1) In acid, D value is NLT 25.0% and NMT 45.0% of the stated amount of Nifedipine, (2) In buffer D value is NLT 60.0% of the stated amount of Nifedipine.

7. Assay: - Limit not less than 90.0% and not more than 110.0% of stated amount of Nifedipine.

ADDITIONAL TESTS

Nil

LIMITS


LABELLING

Nil


100 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Nitrazepam Tablets IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

64


1. Description. 2. Identification. 3. Related substances 4. Uniformity of content -Refer- G-TAB-001 5. Disintegration – Refer G-TAB -004 6. Assay:- 90.0% to 110.0% of the stated amount of Nitrazepam.

ADDITIONAL TESTS


LIMITS


LABELLING

Nil


100 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Norfloxacin Tablets IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

65


1. Description. 2. Identification. 3. Dissolution-D-value- NLT-70.0%- REFER- G-TAB-003 4. Uniformity of weight- Refer-G-TAB-002 5. Assay: limit-95.0-105.0% of the stated amount of Norfloxacin.

ADDITIONAL TESTS


LIMITS


LABELLING

Nil


100 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Ofloxacin Tablets IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

66


1. Description. 2. Identification. 3. Uniformity of Weight- Refer-G-TAB-002. 4. Dissolution-D-value-75.0%-Refer-TAB-003 5. Related substances. 6. Assay: limit-90.0 to 110.0% of the stated amount of Ofloxacin.

ADDITIONAL TESTS


LIMITS


LABELLING

Nil


100 Numbers.

SHELF LIFE

Minimum 2 years.



Drug Name : Olanzepine Tablets IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

67


1. Description. 2. Identification. 3. Dissolution – D value not less than 70.0% of the labelled amount of

Olanazepine. Refer-G-TAB-003 4. Uniformity of weight Refer- G-TAB-002 5. Assay: -HPLC -limit not less than 90.0% and not more than 110.0% of stated

amount of Olanzepine.

ADDITIONAL TESTS


LIMITS


LABELLING

Nil


100 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Tramadol Tablets Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

68


1. Description. 2. Identification. 3. Uniformity of weight - Refer- G-TAB-002 4. Disintegration –Refer-G-TAB-004 5. Assay: - HPLC - Limit not less than 90.0% and not more than 110.0% of

stated amount of Tramadol hydrochloride.

ADDITIONAL TESTS

1. Friability - not more than 1.0% 2. Hardness - minimum 3 kg/cm square.

LIMITS

For test 3 & 4, limit as per IP-2007.

LABELLING

Nil


160 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Pheneramine Maleate Tablets IP Page 1 of 1

Synonym : Pheneramine Copy No. 1


Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

69


1. Description. 2. Identification. 3. Related substances. 4. Uniformity of weight – Refer- G-TAB-002 5. Disintegration-Refer- G-TAB-004 6. Assay: limit-92.5-107.5% of the stated amount Pheneramine Maleate.

ADDITIONAL TESTS


LIMITS


LABELLING

Nil


100 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Phenobarbitone Tablet IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

70


1. Description. 2. Identification. 3. Uniformity of Weight- Refer-G-TAB-002. 4. Disintegration- limit-30 minutes, Refer- G-TAB-004 5. Assay: limit- 92.5-107.5% of the stated amount of Phenobarbitone.

ADDITIONAL TESTS


LIMITS


LABELLING

Nil


100 Numbers.

SHELF LIFE

Minimum 2 years.



Quality Control Department Drug Name : Phenytoin Sodium Tablets IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

71


1. Description. 2. Identification. 3. Related substances 4. Uniformity of weight – Refer- G-TAB-002 5. Disintegration-Refer- G-TAB-004 6. Assay: limit- 90.0-110.0% of the stated amount Phenytoin sodium.

ADDITIONAL TESTS


LIMITS


LABELLING

Nil


100 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Prednisolone Tablets IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

72


1. Description. 2. Identification. 3. Dissolution – Refer G-TAB -003 4. Related substances-HPLC 5. Uniformity of content -Refer- G-TAB-001 6. Assay: -90.0% to 110.0% of the stated amount of Prednisolone

ADDITIONAL TESTS


LIMITS


LABELLING

Nil


100 Numbers.

SHELF LIFE

Minimum 2 years.



Drug Name : Propranolol Tablets IP Page 1 of 1

Synonym : Propranolol Hydrochloride Copy No. 1


Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

73


1. Description. 2. Identification. 3. Uniformity of Weight- Refer-G-TAB-002. 4. Dissolution – D value not less than 75.0% of the stated amount of

Propranolol Hydrochloride, Refer-G-TAB-003 5. Assay: - HPLC - limit not less than 92.5% and not more than 107.5% of

stated amount of Propranolol Hydrochloride.

ADDITIONAL TESTS


LIMITS


LABELLING

Nil


100 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Ranitidine Hydrochloride Tablets IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

74


1. Description. 2. Identification- HPLC 3. Related substance-HPLC 4. Uniformity of weight – Refer -G-TAB-002 5. Disintegration Refer G-TAB-004 6. Assay: - limit 90.0% to 110.0% of the stated amount of Ranitidine.

ADDITIONAL TESTS

Leak test for strips - limit not more than 2%

LIMITS


LABELLING

The label states the strength in terms of the equivalent amount of Ranitidine.


100 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Risperidone Tablets USP Page 1 of 1


Official Standards : US Pharmacopoeia 2008, Volume 3, Page No. 3197-3198

Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

75


1. Description. 2. Identification- HPLC 3. Dissolution – NLT -75% (Q) of the labelled amount of Risperidone.

Refer- P-267 4. Uniformity of dosage units Refer P. No. 363 5. Related compounds - HPLC 6. Assay: - limit 90.0% to 110.0% of the labelled amount of Risperidone.

ADDITIONAL TESTS


LIMITS

For test 1 to 6, limit as per USP-2008

LABELLING

Nil


160 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Salbutamol Sulphate Tablet IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

76


1. Description. 2. Identification. 3. Related substances. 4. Uniformity of Content- Refer-G-TAB-001 5. Disintegration- Refer- G-TAB-004 6. Assay: limit- 90.0-110.0% of the stated amount of Salbutamol.

ADDITIONAL TESTS


LIMITS


LABELLING

The label states the strength in terms of the equivalent amount of Salbutamol.


100 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Sertraline Tablets Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

77


1. Description. 2. Identification. 3. Uniformity of Weight- Refer- G-TAB-002. 4. Disintegration .Refer-G-TAB-004 5. Assay: - HPLC - Limit not less than 90.0% and not more than 110.0% of

stated amount of Sertraline.

ADDITIONAL TESTS


LIMITS


LABELLING

Nil


120 Numbers.

SHELF LIFE

Minimum 2 years.



Drug Name : Sodium Valporate Tablets IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

78


1. Description. 2. Identification. 3. Uniformity of Weight- Refer-G-TAB-002. 4. Disintegration – Refer G-TAB-004 5. Related substance – Gas chromatography 6. Assay: Limit-95.0-105.0% of the stated amount of Sodium Valporate.

ADDITIONAL TESTS


LIMITS


LABELLING

Nil


100 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Spironolactone Tablets IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

79


1. Description. 2. Identification. 3. Dissolution – D value not less than 70.0% of the stated amount of

Spironolactone. Refer-G-TAB-003 4. Uniformity of weight Refer- G-TAB-002 5. Assay: - HPLC - limit not less than 95.0% and not more than 105.0% of

stated amount of Spironolactone.

ADDITIONAL TESTS


LIMITS


LABELLING

Nil


100 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Sulfasalazine Tablets BP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

80


1. Description. 2. Identification. 3. Salicylic acid and sulfa pyridine-HPLC 4. Related substance-HPLC-Refer Page No-2985 5. Uniformity of content- Refer-Page-2257 BP 6. Dissolution- Refer- Not less than 70% 7. Assay: limit- 95.0-105.0% of the stated amount of Sulfasalazine.

ADDITIONAL TESTS


LIMITS


LABELLING

Nil


100 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Tamoxifen Tablets IP Page 1 of 1

Synonym : Tamoxifen Citrate Copy No. 1


Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

81


1. Description. 2. Identification. 3. E-isomer and Related substances 4. Uniformity of content - Refer- G-TAB-001 5. Disintegration – Refer G-TAB -004 6. Assay: - 90.0% to 110.0% of the stated amount of Tamoxifen.

ADDITIONAL TESTS


LIMITS


LABELLING

The label states the strength in terms of the equivalent amount of Tamoxifen.


100 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Theophylline and Etophylline Tablets Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

82


1. Description. 2. Identification. 3. Uniformity of Weight- Refer-G-TAB-002 4. Disintegration- Refer- G-TAB-004 5. Assay: limit- 90.0-110.0% of the stated amount of Theophylline and

Etophylline.

ADDITIONAL TESTS


LIMITS


LABELLING

Nil


100 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Thyroxine Sodium Tablets IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

83


1. Description. 2. Identification. 3. Uniformity of content - Refer- G-TAB-001 4. Disintegration – Refer G-TAB -004 5. Assay: - 90.0% to 110.0% of the stated amount of Thyroxine Sodium.

ADDITIONAL TESTS


LIMITS


LABELLING

The label states the strength in terms of the equivalent amount of anhydrous Thyroxine sodium.


100 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Tramadol Tablets Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

84


1. Description. 2. Identification. 3. Uniformity of weight - Refer- G-TAB-002 4. Disintegration –Refer-G-TAB-004 5. Assay: - HPLC - Limit not less than 90.0% and not more than 110.0% of

stated amount of Tramadol hydrochloride.

ADDITIONAL TESTS

1. Friability - not more than 1.0% 2. Hardness - minimum 3 kg/cm square.

LIMITS

For test 3 & 4, limit as per IP-2007.

LABELLING

Nil


160 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Trihexyphenidyl Tablets IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

85


1. Description. 2. Identification - HPLC. 3. Uniformity of Content -Refer- G-TAB-001 4. Disintegration – Refer G-TAB -004 5. Assay: - 90.0% to 110.0% of the stated amount of Trihexyphenidyl

Hydrochloride.

ADDITIONAL TESTS


LIMITS


LABELLING

Nil


100 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Verapamil Tablets IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

86


1. Description. 2. Identification. 3. Related substances 4. Uniformity of weight Refer- G-TAB-002 5. Disintegration –Refer-G-TAB-004 6. Assay: - Limit not less than 92.5% and not more than 107.5% of stated

amount of Verapamil Hydrochloride.

ADDITIONAL TESTS


LIMITS


LABELLING

Nil


100 Numbers.

SHELF LIFE

Minimum 2 years.



Drug Name : Vitamin B Complex Tablets NFI (Strong) Page 1 of 1


Official Standards : NFI

Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

87


1. Description. 2. Identification- HPLC 3. Uniformity of weight – Refer G-TAB-002 4. Disintegration – Refer G-TAB-004 5. Assay: - Limits 90.0% to 110.0% of the stated amount.

ADDITIONAL TESTS


LIMITS

IP-2007 & NFI

LABELLING

Nil


100 Numbers.

SHELF LIFE

Minimum 2 years.

88

KKEE

RRAA

LLAA

MM

EEDD

II CCAA

LL

SSEE

RRVV

II CCEE

SS

CCOO

RRPP

OORR

AATT

II OONN

LL

TTDD

CCAAPPSSUULLEESS





Drug Name : Amoxicillin Capsules IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

89


1. Description 2. Identification 3. Uniformity of weight- Refer-G-CAP-001 4. Dissolution- Refer- G-CAP-004 5. Assay: limit-90.0-110.0% of the stated amount of Amoxicillin

ADDITIONAL TESTS

Leak test

LIMITS

For test 1 to 5. Limit as per IP-2007

LABELLING

The label states the quantity of the active ingredient in terms of the equivalent amount of Amoxicillin


100 numbers

SHELF LIFE

Minimum 2 year




Drug Name : Ampicillin Capsules IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

90


1. Description 2. Identification 3. Uniformity of weight- Refer-G-CAP-001 4. Dissolution-Refer- G-CAP-004 5. Assay: limit-92.5-107.5% of the stated amount of

Ampicillin ADDITIONAL TESTS Leak test LIMITS For tests 1 to 5, Limit as per IP-2007 LABELLING

The label states the strength in terms of the equivalent amount of Ampicillin (when Ampicillin trihydrate is used)

QUANTITY REQUIRED FOR ANALYSIS 100 numbers SHELF LIFE Minimum 2 year




Drug Name : Clofazimine Capsules IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

91


1. Description 2. Identification 3. Uniformity of weight- Refer-G-CAP-001 4. Disintegration-Refer- G-CAP-003 5. Assay: limit-95.0-105.0% of the stated amount of Clofazimine.

ADDITIONAL TESTS

Leak test

LIMITS

For tests 1 to 5, Limit as per IP-2007.

LABELLING


100 numbers

SHELF LIFE

Minimum 2 year




Drug Name : Cloxacillin Capsules IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

92


1. Description 2. Identification 3. Uniformity of weight- Refer-G-CAP-001 4. Dissolution-Refer- G-CAP-004 5. Assay: limit-92.5-107.5% of the stated amount of Cloxacillin

ADDITIONAL TESTS

Leak test

LIMITS

For tests 1 to 5, Limit as per IP-2007

LABELLING

The label states the quantity of the active ingredient in terms of the equivalent amount of Cloxacillin.


100 numbers

SHELF LIFE

Minimum 2 year




Drug Name : Doxycycline Capsules IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

93


1. Description 2. Identification 3. Light absorbing impurities-absorbance of the filtrate at about 490nm is not

greater than 0.2 when calculated with the reference to the dried contents of the capsule.

4. Related substance-HPLC 5. Loss on drying-not more than 8.5% determined on 0.5grams of the

contents of the capsules by drying in an oven at 105°c for 2 hours. 6. Uniformity of weight- refer-G-CAP001 7. Disintegration-,refer- G-CAP-003 8. Assay: limit-90.0-120.0% of the stated amount of Doxycycline.

ADDITIONAL TESTS

Leak test

LIMITS


LABELLING

The label states the strength in terms of the equivalent amount of Doxycycline.


100 numbers

SHELF LIFE

Minimum 2 year




Drug Name : Fluoxetine Capsules USP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

94


1. Description 2. Identification 3. Uniformity of dosage units 4. Dissolution- Q- value NLT 80.0% of the labeled amount of Fluoxetine

Note: For delayed release capsules-Acid stage-NMT 10.0% of the labeled amount of Fluoxetine; Buffer stage-NLT 75.0% (Q) of the labeled amount of Fluoxetine.

5. Chromatographic purity 6. Assay: limit-90.0-110.0% of the labeled amount of Fluoxetine

ADDITIONAL TESTS

Leak test

LIMITS

For tests 1 to 6, Limit as per USP-2008.

LABELLING


200 numbers

SHELF LIFE

Minimum 2 year




Drug Name : Hydroxy urea Capsules USP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

95


1. Description 2. Identification 3. Dissolution – D value 80.0% (Q) of the labeled amount of Hydroxy urea. 4. Uniformity of dosage units 5. Assay: -90.0% to 110.0% of the stated amount of Hydroxy urea.

ADDITIONAL TESTS

Leak test

LIMITS


LABELLING


120 numbers

SHELF LIFE

Minimum 2 year




Drug Name : Nifedipine Capsules IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

96


1. Description 2. Identification 3. Uniformity of content- Refer-G-CAP-002 4. Disintegration- Limit- NMT 30 minutes, Refer- G-CAP-003 5. Assay: limit-90.0-110.0% of the stated amount of Nifedipine.

ADDITIONAL TESTS

Leak test

LIMITS


LABELLING


100 numbers

SHELF LIFE

Minimum 2 year




Drug Name : Omeprazole Capsules IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

97


1. Description 2. Identification 3. Uniformity of weight- Refer-G-CAP-001 4. Dissolution- D- value NLT 70.0%.Refer- G-CAP-004 5. Loss on drying- Limit-NMT 3.0% 6. Assay: limit-90.0-110.0% of the stated amount of Omeprazole

ADDITIONAL TESTS

Leak test

LIMITS


LABELLING


200 numbers

SHELF LIFE

Minimum 2 year




Drug Name : Vitamin A and D Capsules IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

98


1. Description 2. Identification 3. Uniformity of weight- Refer-G-CAP-001 4. Disintegration-Refer-G-CAP-003 5. Assay: limit-90.0-110.0% of the stated number of units of Vitamin A and D

ADDITIONAL TESTS

Leak test

LIMITS


LABELLING

The label states the number of units of Vitamin A and Vitamin D per capsules.


100 numbers

SHELF LIFE

Minimum 2 year

99

KKEE

RRAA

LLAA

MM

EEDD

II CCAA

LL

SSEE

RRVV

II CCEE

SS

CCOO

RRPP

OORR

AATT

II OONN

LL

TTDD

OORRAALL LLIIQQUUIIDDSS,,SSOOLLUUTTIIOONNSS&&

PPOOWWDDEERRSS





Drug Name : Amoxycillin Dry Syrup IP Page 1 of 1

Synonym : Amoxycillin oral suspension Copy No. 1


Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

100


1. Description 2. Identification 3. pH-limit-4.0 to 7.0 4. Uniformity of weight- Refer-G-ORP-002 5. Assay: limit-90.0%-120.0% of the stated amount of Amoxycillin.

When stored at the temperature and for the period stated on the label during which the constituted suspension may be expected to be satisfactory for use, it contains NLT 80.0 % of the stated amount of Amoxycillin.

ADDITIONAL TESTS

Nil

LIMITS


LABELLING

The label states 1) the quantity of active ingredient in terms of the equivalent amount of Amoxycillin; 2) the temperature of storage and the period during which the constituted suspension may be expected to be satisfactory for use.


50 numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Benedicts Reagent Page 1 of 1


Official Standards : KMSCL In-house Method.

Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

101


1. Description - Blue solution 2. Identification - Gives positive results for the presence of Sodium, Copper and

Sulphate. Qualitative Analysis

Standard Benedicts Reagent:- Solution-1:- Dissolve 173 gram of sodium citrate and 100 gram sodium carbonate in about 800 ml water. Heat to dissolve the salts and filter if necessary. Solution -2:- Dissolve17.3 gram copper sulphate in about 100 ml water. Mix solutions 1 and 2 with stirring and make up the volume to 1000 ml with water. Benedicts Test. (Qualitative):- Standard Benedicts solution: - To 2ml of standard Benedict’s reagent, add 5 drops (about 1 ml) of the test solution and add 3 drops of Methylene Blue indicator. Boil for 10 minutes in a water bath. Cool the solution. Observation: - Red or green colored precipitate / solution is formed. Sample Benedicts solution: - To 2 ml of Benedict’s reagent, add 5 drops (about 1ml) of the test solution and add 3 drops of Methylene Blue indicator. Boil for 10 minutes in a water bath. Cool the solution Observation: - Red or green colored precipitate / solution is formed. (Note: - Test solution: 1 gram of Dextrose anhydrous dissolved in 100 ml water.)

Quantitative Analysis

Standard Benedicts solution: - To 20 ml of standard Benedicts reagent, add three drops of Methylene Blue solution. Boil and titrate with 1.0% w/v solution of anhydrous Dextrose. End point - Brick red color. Sample Benedict’s solution: - To 20 ml of sample Benedict’s reagent, add three drops of Methylene Blue solution. Boil and titrate with 1.0% w/v solution of anhydrous Dextrose. End point - Brick red color.

QUANTITY REQUIRED FOR ANALYSIS 2 x 500ml. SHELF LIFE Minimum 2 years.




Drug Name : Cephalexin Oral Suspension (Dry) IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

102


1. Description 2. Identification 3. Uniformity of weight- Refer-G-ORP-002 4. Assay: limit-90.0-120.0% of the stated amount of Cephalexin.

ADDITIONAL TESTS

Nil

LIMITS


LABELLING

The label states the strength in terms of the equivalent amount of anhydrous Cephalaxin.


100 numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Chlorhexidine Gluconate 2.5% v/v with Ethyl Alcohol 70.0% v/v Solution Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

103


1. Description 2. Identification 3. Ethanol content 4. Weight/ml 5. Assay: -90.0% - 110.0% of the stated amount.

ADDITIONAL TESTS

Nil

LIMITS

LABELLING

Nil


2 Numbers.

SHELF LIFE

Minimum 18 months.




Drug Name : Chlorhexidine / Cetrimide Solution Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

104


1. Description 2. Identification 3. Weight/ml 4. Assay: -90.0% - 110.0% of the stated amount.

ADDITIONAL TESTS

Nil

LIMITS

LABELLING

Nil


2 Numbers.

SHELF LIFE

Minimum 18 months.



Drug Name : Chloroxylenol solution BP Page 1 of 1

Synonym : Copy No.


Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

105


1. Description 2. Identification 3. Ethanol content-Limit16.0 to 21.0%v/v 4. Organic stabilizers. 5. Non-volatile matter 6. Assay: - GC- 4.75 to 5.25%w/v of Chloroxylenol.

ADDITIONAL TESTS

LIMITS

For tests 1 to 6, limit as per BP-2009.

LABELLING

1. The label states the names of any added anti-microbial preservatives (p.2222) 2. The date after which the solution is not intended to be used. 3. The conditions under which it should be stored. 4. The label indicates the pharmaceutical form as ‘cutaneous solution’.


2 Numbers.

SHELF LIFE

Minimum 18 months.




Drug Name : Co-trimoxazole Oral Suspension IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

106


1. Description 2. Identification 3. Uniformity of volume- Refer-G-ORA-002 4. pH-limit-5.0 to 6.5 5. Assay: limit 90.0%-110.0% of the stated amount of Trimethoprim and

Sulphamethoxazole

ADDITIONAL TESTS

Nil

LIMITS


LABELLING

The label states 1) the content of Trimethoprim and of Sulphamethoxazole in each 5 ml of the suspension 2) that the contents should be shaken before use; 3) that a suspension containing 40 mg of Trimethoprim and 200mg of Sulphamethoxazole in 5ml is meant for pediatric use.


100 numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Dicyclomine Oral Solution IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

107


1. Description 2. Identification 3. Uniformity of volume- Refer-G-ORA-002 4. Assay: limit-90.0-110.0% of the stated amount of Dicyclomine

Hydrochloride.

ADDITIONAL TESTS

Nil

LIMITS


LABELLING


50 numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Diethylcarbamazine Citrate Suspension Page 1 of 1


Official Standards : KMSCL In-house Method

Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

108


1. Description 2. Identification 3. Uniformity of volume- Refer-G-ORA-002 4. Microbial limits-(as per IP -2007)-Total Bacterial counts-NMT 100 CFU/ML

Pseudomonas aeuruginosa-should be absent. Total yeast and mould count-NMT 100 CFU/MG Escherichia coli-should be absent. Staphylococcus aureus-should be absent Salmonella species-should be absent

5. Assay: limit-90.0-110.0% of the stated amount of Diethylcarbamazine citrate.

ADDITIONAL TESTS

Nil

LIMITS

For test 1 to 5, limit as per IP-2007 & KMSCL In-house method.

LABELLING


50 numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Formaldehyde Solution IP Page 1 of 1


Official Standards : Indian Pharmacopoeia.

Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

109


1. Description 2. Weight per ml at 25°c 3. Assay-Limit 34.0 to 37.0 % w/v of Formaldehyde.

ADDITIONAL TESTS

LIMITS

For test 1 to 3, limit as per IP.

LABELLING


2 x 500 ml.

SHELF LIFE

Minimum 2 years.




Drug Name : Gamma Benzene Hexachloride Solution USP Page 1 of 1

Synonym : Lindane Lotion Copy No. 1

Official Standards : US Pharmacopeia.

Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

110


1. Description 2. Identification 3. pH- Limit 6.5 to 8.5 4. Weight/ml 5. Uniformity of Volume- Refer-G-ORA-002 6. Assay: - Limits 0.9 %w/v to 1.1 % w/v of Gamma Benzene Hexachloride.

ADDITIONAL TESTS

Nil

LIMITS

For tests 1 to 6, limit as per USP.

LABELLING


4 numbers.

SHELF LIFE

Minimum 18 months.




Drug Name : Glutaraldehyde Solution BP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

111


1. Description 2. Identification 3. Ethanol content- 50.0 to 60.0% v/v. 4. Assay: - 9.2 to 10.5 %w/v of Glutaraldehyde.

ADDITIONAL TESTS

Particulate matter -sample should be clear and free from particles when observed on visual inspection

LIMITS

For tests 1 to 4, limit as per BP-2009.

LABELLING

The label states (1) the date after which the solution is not intended to be used. (2) the condition under which it should be stored.


2 Numbers.

SHELF LIFE

Minimum 18 months.




Drug Name : Glycerin IP Page 1 of 1

Synonym : Glycerol Copy No. 1


Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

112


1. Description 2. Identification 3. Appearance of solution 4. Acidity or Alkalinity 5. Heavy metals 6. Iron 7. Chlorides 8. Sulphates 9. Aldehydes and reducing substances 10. Ester 11. Ethylene glycol, diethylene glycol and related substances 12. Sugars 13. Sulphated ash 14. Water 15. Assay-Limit 98.0 to 110.0% of Glycerin calculated on the anhydrous basis.

ADDITIONAL TESTS Nil

LIMITS


LABELLING


2 Numbers.

SHELF LIFE

Minimum 18 months.




Drug Name : Halothane USP Liquid Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

113


1. Description 2. Identification-IR 3. Specific gravity-1.872 TO 1.877 AT 20°C - p.no-351 of USP vol-1 4. Distilling range-p.no-274 of USP vol-1 5. Refractive index-1.369 and 1.371 at 20°c- p.no-351 of USPvol-1 6. Acidity or alkalinity 7. Water-not more than 0.03 %- p.no-370 of USP vol-1 8. Limit of non volatile residue-not exceeding 1.0 mg 9. Chlorides and bromides- 10. Thymol content 11. Chromatographic purity-GC –Halothane contains not less than 0.008% and

not more than 0.0121 % of Thymol, by weight as a stabilizer.


LIMITS


LABELLING

The label states the strength in terms of the equivalent amount of anhydrous Cephalaxin.


10 numbers.

SHELF LIFE

Minimum 18 months.



Drug Name : Hydrogen peroxide Solution IP 20.0%w/v Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

114


1. Description 2. Identification 3. Acidity 4. Organic stabilizers. 5. Non-volatile matter 6. Assay - Limit5.0%w/v to 7.0%w/v of Hydrogen peroxide, corresponding to

about 20 times its volume of available oxygen.

ADDITIONAL TESTS

Nil

LIMITS


LABELLING

The label states whether or not the solution contains a stabilizing agent.


4 Numbers.

SHELF LIFE

Minimum 18 months.




Drug Name : Mixture Carminative Concentrate Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

115


1. Description 2. Identification 3. Alcohol content-Limit, 20.0 to 26.0%v/v as per label claim. 4. Assay: limit-90.0-110.0% of the stated amount of Sodium bicarbonate.

ADDITIONAL TESTS

LIMITS

LABELLING

Dilution should be stated.


2 x 500 ml.

SHELF LIFE

Minimum 2 years.




Drug Name : Non Oxylenol Surfactant Based Iodine Solution Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

116


1. Description 2. Identification–for Iodine 3. pH-Limit 2.5 to 3.5 4. Assay: limit-85.0-120.0% of the stated amount of available Iodine.

ADDITIONAL TESTS

LIMITS

For test 1 to 4, limit as per KMSCL In-house method.

LABELLING


2x 500 ml.

SHELF LIFE

Minimum 2 years.




Drug Name : ORS Powder IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

117


1. Description 2. Identification 3. Uniformity of weight-Refer, G-ORP-002 4. Seal test-(only for sachets). 5. Assay-ORS contains NLT 90.0% and NMT 110.0% of the stated amount of

Dextrose (anhydrous) or Dextrose monohydrate as appropriate and of the requisite amounts of sodium, potassium, chloride and citrate calculated from the stated amount of the relevant constituents.

ADDITIONAL TESTS

Nil

LIMITS


LABELLING

The Label should meet the requirements as stated in IP (1 to 7)


100 numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Orthothaladehyde Solution Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

118


1. Description 2. Identification 3. pH-Limit 7.0 to 8.0 4. Assay: limit-90.0-110.0% of the stated amount of Orthothaladehyde.

ADDITIONAL TESTS

Nil

LIMITS

For test 1 to 4, limit as per KMSCL In-house method

LABELLING


1x 5 litre.

SHELF LIFE

Minimum 2 years.




Drug Name : Paracetamol Syrup IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

119


1. Description 2. Identification 3. 4-amino phenol 4. Uniformity of volume- refer-G-ORA-002 5. Particulate matter -sample should be clear and free from particles when

observed on visual inspection 6. Assay: limit 95.0-105.0% of the stated amount of Paracetamol.

ADDITIONAL TESTS

Nil

LIMITS

For test 1, 2, 3 and 6, limit as per IP-2007

LABELLING

Nil.


50 numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Piperazine Citrate Syrup IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

120


1. Description 2. Identification 3. Uniformity of volume- Refer-G-ORA-002 4. Assay: limit-92.5-107.5% of the stated amount of Piperazine hydrate.

ADDITIONAL TESTS

Particulate matter -sample should be clear and free from particles when observed on visual inspection

LIMITS


LABELLING

The label states the strength in terms of the equivalent amount of Piperazine hydrate.


50 numbers.

SHELF LIFE

Minimum 2 years.



Drug Name : Povidone Iodine Solution IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

121


1. Description 2. Identification 3. pH-Limit-3.0 to 6.5 4. Ethanol (if present)-Limit, 90.0 to 110.0 % of the stated amount of Ethanol. 5. Assay-Limit, NLT 85.0 % and NMT 120.0 % of the stated amount of Iodine.

ADDITIONAL TESTS

Nil

LIMITS


LABELLING

The label states the quantities of Iodine and Ethanol (if present) as % w/v.


2 x 500 ml.

SHELF LIFE

Minimum 2 years.




Drug Name : Salbutamol Nebuliser Solution BP Page 1 of 1

Synonym : Salbutamol Copy No. 1


Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

122


1. Description 2. Identification 3. Acidity (pH-3 to 5)-refer P.A225 4. Related substance-HPLC 5. Salbutamol ketone-HPLC 6. Assay: limit-95.0-105.0% of the stated amount of Salbutamol.

ADDITIONAL TESTS

Nil

LIMITS


LABELLING

1. Not to be taken by mouth 2. Label states the quantity of active ingredients in terms of the equivalent

amount of Salbutamol. 3. The date after which the solution for nebulisation is not intended to be

used.


30 numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Salbutamol Syrup IP Page 1 of 1

Synonym : Salbutamol Copy No. 1


Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

123


1. Description 2. Identification 3. pH-3.4 to4.5 4. Uniformity of volume- Refer-G-ORA-002 5. Assay: limit-90.0-110.0% of the stated amount of Salbutamol.

ADDITIONAL TESTS

Nil

LIMITS


LABELLING

The label states the strength in terms of the equivalent amount of Salbutamol.


240 numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Syrup Lactulose USP Page 1 of 1

Synonym : Lactulose Solution Copy No. 1

Official Standards : US Pharmacopeia 2008, Volume 2, Page No. 2497

124


1. Description 2. Identification 3. Microbial limits- Total bacterial count does not exceed 100 CFU/gram of

Lactulose and the test for Salmonella species and Escherichia coli are negative.

4. pH-Limit-2.5 to 6.5 5. Related compounds. 6. Volume in container. 7. Assay: NLT 90.0% and NMT 110.0%w/w of the labeled amount of

Lactulose.

ADDITIONAL TESTS

Nil

LIMITS


LABELLING


50 numbers.

SHELF LIFE

Minimum 18 months.

125

KKEE

RRAA

LLAA

MM

EEDD

II CCAA

LL

SSEE

RRVV

II CCEE

SS

CCOO

RRPP

OORR

AATT

II OONN

LL

TTDD

GGEELLSS,,CCRREEAAMMSS,,OOIINNTTMMEENNTTSS,,LLIINNIIMMEENNTTSS,,LLOOTTIIOONNSS,,

PPEESSSSEERRIIEESS






Drug Name : Acyclovir Cream BP 5 %w/w Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

126


1. Description 2. Identification 3. Guanine 4. Assay: NLT 95.0% and NMT 105.0%w/w of the stated amount of Acyclovir.

ADDITIONAL TESTS

Uniformity of weight.

LIMITS

For tests 1 to 4, Limit as per BP-2009.

LABELLING

The label states (1) the date after which the cream is not intended to be used; (2) the conditions under which the cream should be stored.


40 x 5 grams

SHELF LIFE

Minimum 18 months.




Drug Name : Benzyl Benzoate Application IP 25% w/v Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

127


1. Description 2. Identification 3. Assay: NLT 22.5% and NMT 27.5%w/w of Benzyl benzoate.

ADDITIONAL TESTS

Nil

LIMITS


LABELLING

The label states that the contents should be shaken before use.


2x 500 ml

SHELF LIFE

Minimum 2 years.




Drug Name : Betamethasone Valerate Cream USP 1%w/w Page 1 of 1


Official Standards : US Pharmacopeia 2008, Volume 1 & 2, Page No. 1524-1525

Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

128


1. Description 2. Identification 3. Microbial limits-refer page no-71 4. Minimum fill-Refer page no-298 5. Assay: NLT 90.0% and NMT 110.0%w/w of the labeled amount of

Betamethasone.

ADDITIONAL TESTS

Nil

LIMITS


LABELLING


60 x 5 gram tubes.

SHELF LIFE

Minimum 18 months.




Drug Name : Calamine Lotion IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

129


1. Description 2. Identification 3. Microbial contamination

ADDITIONAL TESTS

Nil

LIMITS


LABELLING

The label states (1) the concentration of Calamine and Zinc oxide in the preparation; (2) that the preparation is intended for external use only; (3) that the contents should be shaken before use; (4)the conditions under which the preparation should be stored.


2X500 ml.

SHELF LIFE

Minimum 2 years.




Drug Name : Chloramphenicol Applicaps Page 1 of 1


Official Standards : KMSCL In-house Method & Indian Pharmacopoeia 2007

Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

130


1. Description 2. Identification 3. Uniformity of weight-Refer-G-EYO-001 4. Sterility-Refer-G-EYO-003 5. Particle size-Refer-G-EYO-002 6. Assay: NLT 90.0% and NMT 120.0% of the stated amount of

Chloramphenicol

ADDITIONAL TESTS

Nil

LIMITS

For tests 1 to 6, Limit as per KMSCL In-house method and IP-2007.

LABELLING


100 Numbers

SHELF LIFE

Minimum 18 months.




Drug Name : Ciprofloxacin Eye Ointment USP Page 1 of 1

Synonym : Ciprofloxacin Ophthalmic Ointment Copy No. 1


Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

131


1. Description 2. Identification 3. Sterility 4. Minimum fill-Refer page no-298 5. Metal particles 6. Assay: NLT 90.0% and NMT 110.0%w/w of the labeled amount of

Ciprofloxacin.

ADDITIONAL TESTS

Nil

LIMITS


LABELLING


60 tubes.

SHELF LIFE

Minimum 18 months.




Drug Name : Clotrimazole Cream IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

132


1. Description 2. Identification 3. Chlorotritanol 4. Uniformity of weight – Refer- G-CRE-001 5. Sterility (when the cream is labeled as ‘sterile’) Refer-G-CRE-002 6. Assay: -95.0% - 105.0% of the stated amount of Clotrimazole

ADDITIONAL TESTS

Nil

LIMITS


LABELLING

The label state (1) that the cream is sterile, where necessary, (2) the name and concentration of any antimicrobial preservative (3) The storage conditions.


40 numbers

SHELF LIFE

Minimum 18 months.




Drug Name : Glycerin Magsulf BPC Page 1 of 1


Official Standards : BPC 1963

Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

133


1. Description 2. Identification 3. Assay: -Limits:-magnesium sulphate-36.0 to 41.0% w/w Phenol-0.45 to 0.55 %w/w

ADDITIONAL TESTS

Nil

LIMITS

LABELLING

Nil


50 numbers

SHELF LIFE

Minimum 2 years.




Drug Name : Lignocaine HCl Gel IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

134


1. Description 2. Identification 3. Uniformity of weight-Refer- G-GEL-001 4. pH- limit 6.0 to 7.0 5. 2, 6, dimethyl aniline. 6. Sterility- Refer-G-INJ-005 7. Assay: limit-95.0-105.0% of the stated amount of Lignocaine Hcl.

ADDITIONAL TESTS

Nil

LIMITS


LABELLING

The label states (1) that the content are sterile (2) the strength in terms of the equivalent amount of anhydrous Lignocaine HCl (3) that any of the gel not used in a single application should be discarded


100 numbers

SHELF LIFE

Minimum 18 months.




Drug Name : Povidone Iodine Ointment USP Page 1 of 1


Official Standards : US Pharmacopeia 2008, Volume 1 & 3, Page No. 3050

Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

135


1. Description 2. Identification 3. Minimum fill-Refer page no-298 4. pH-Limit-1.5 to 6.5 5. Assay: NLT 85.0% and NMT 120.0%w/w of the labeled amount of Iodine.

ADDITIONAL TESTS

Nil

LIMITS


LABELLING


60 tubes.

SHELF LIFE

Minimum 18 months.




Drug Name : Povidone Iodine Vaginal Pesseries Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

136


1. Description 2. Identification- HPLC 3. Uniformity of weight – Refer G-PES-002 4. Disintegration – Refer G-PES-003 5. Assay: -Limits 85.0% to 120.0% of the stated amount of available Iodine.

ADDITIONAL TESTS

Nil

LIMITS

For tests 1 to 5, Limit as per KMSCL In-house method.

LABELLING

Nil


100 Numbers

SHELF LIFE

Minimum 2 years.




Drug Name : Salicylic acid Ointment BP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

137


1. Description 2. Identification 3. Assay: NLT 1.9% and NMT 2.1%w/w of Salicylic acid.

ADDITIONAL TESTS

LIMITS

For tests 1 to 3, Limit as per BP-2009.

LABELLING

The label states (1) the date after which the ointment is not intended to be used; (2) the conditions under which the ointment should be stored.


40 x 5 grams

SHELF LIFE

Minimum 18 months.




Drug Name : Silversulphadiazine Cream USP Page 1 of 1


Official Standards : US Pharmacopeia 2008, Volume 1 & 3, Page No. 3292

Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

138


1. Description 2. Identification 3. Microbial limits. -Total count does not exceed 23 CFU per gram.-Refer

page no-71 4. Minimum fill-Refer page no-298

pH-Limit-4.0 to 7.0 5. Assay: NLT 90.0% and NMT 110.0%w/w of the labeled amount of Silver

sulphadiazine.

ADDITIONAL TESTS

Nil

LIMITS


LABELLING


60 tubes.

SHELF LIFE

Minimum 18 months.




Drug Name : Turpentine Liniment IP Page 1 of 1


Official Standards : Indian Pharmacopoeia 1966.

Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

139


1. Description 2. Refractive index-Limit 1.4710 to 1.4714 3. Assay: 63.0 to 70.0 % v/w of Volatile oil and Camphor.

ADDITIONAL TESTS

Nil

LIMITS


LABELLING


2 x 500 ml.

SHELF LIFE

Minimum 2 years.




Drug Name : Whitfield’s Ointment IP Page 1 of 1

Synonym : Compound Benzoic acid Copy No. 1


Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

140


1. Description 2. Identification 3. Uniformity of weight-Refer- G-OIN-001 4. Assay: NLT 5.7% and NMT 6.3%w/w of Benzoic acid and NLT 2.85% and

NMT 3.15 %w/w of Salicylic acid.

ADDITIONAL TESTS

Nil

LIMITS


LABELLING


40 x 15 grams

SHELF LIFE

Minimum 18 months.

141

KKEE

RRAA

LLAA

MM

EEDD

II CCAA

LL

SSEE

RRVV

II CCEE

SS

CCOO

RRPP

OORR

AATT

II OONN

LL

TTDD

EEYYEE//EEAARR//NNAASSAALL DDRROOPPSS






Drug Name : Betamethasone Eye Drops IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

142


1. Description 2. Identification 3. pH-Limit, 7.0 to 8.5 4. Uniformity of volume. Refer-G-EAR-001. 5. Particle size (applicable to eye drops that are suspension). Refer-G-EAR-002. 6. Sterility.Refer-G-EAR-003 7. Assay: limit-90.0-110.0% of the stated amount of Betamethasone Sodium

Phosphate.

ADDITIONAL TESTS

Nil

LIMITS


LABELLING

The label states; 1. the names and concentrations in % or weight or volume/ml of the active

ingredients, 2. the names and concentrations of any added anti-microbial preservatives, 3. that for multiple application containers, the contents should not be used for more

than one months after opening the container, 4. that for multiple application containers care should be taken to avoid

contaminations of the contents during use, 5. that the preparation is” NOT FOR INJECTION” and 6. the conditions under which the preparation should be stored.


100 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Ciprofloxacin Eye / Ear Drops 0.3%w/v IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

143


1. Description 2. Identification 3. pH-Limit, 3.5 to 5.5 4. Uniformity of volume. Refer-G-EAR-001. 5. Particle size (applicable to eye drops that are suspension). Refer-G-EAR-

002. 6. Sterility.Refer-G-EAR-003 7. Assay: limit-90.0-110.0% of the stated amount of Ciprofloxacin.

ADDITIONAL TESTS

Nil

LIMITS


LABELLING

The label states; 7. the names and concentrations in % or weight or volume/ml of the active

ingredients, 8. the names and concentrations of any added anti-microbial preservatives, 9. that for multiple application containers, the contents should not be used for

more than one months after opening the container, 10. that for multiple application containers care should be taken to avoid

contaminations of the contents during use, 11. that the preparation is” NOT FOR INJECTION” and 12. the conditions under which the preparation should be stored.


100 Numbers. SHELF LIFE Minimum 2 years.




Drug Name : Timolol Maleate Eye Drops IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

144


4. Description 5. Identification 6. pH-Limit, 6.5 to 7.5 7. Related substances-GC 8. Uniformity of volume. Refer-G-EAR-001. 9. Sterility.Refer-G-EAR-003 10. Assay: limit-90.0-110.0% of the stated amount of Timolol.

ADDITIONAL TESTS

Nil

LIMITS


LABELLING

The label states; 1. the strength in terms of the equivalent amount of Timolol. 2. the name and concentration of any added anti-microbial preservatives


100 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Tropicamide Eye Drops IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

145


1. Description 2. Identification 3. pH-Limit, 4.0 to 5.8 4. Related substances 5. Uniformity of volume. Refer-G-EAR-001. 6. Sterility.Refer-G-EAR-003 7. Assay: limit-95.0-110.0% of the stated amount of Tropicamide.

ADDITIONAL TESTS

Nil

LIMITS


LABELLING

The label states; 3. the strength in terms of the equivalent amount of Tropicamide. 4. the name and concentration of any added anti-microbial preservatives


100 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Saline Nasal Drops Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

146


1. Description 2. Identification 3. Uniformity of volume- Refer-G-NAS-002 4. pH-Limit 6.0 to 7 5. Microbial limits - Total Bacterial counts - NMT 100 CFU/ML

Total yeast and mould count - NMT 100 CFU/MG Escherichia coli - should be absent. Salmonella species - should be absent. Staphylococcus aureus - should be absent. Pseudomonas aeuruginosa - should be absent.

6. Assay: Limit 90.0-110.0% of the stated amount of Sodium chloride.

ADDITIONAL TESTS

Nil

LIMITS

For test 1 to 6, limit as per KMSCL In -house method.

LABELLING


100 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Sodium Bicarbonate Ear drops BPC. Page 1 of 1


Official Standards : British Pharmaceutical Codex 1963, Page No. 1050-1051

Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

147


1. Description 2. Identification 3. Assay: limit-4.07to5.08%w/v of Sodium Bicarbonate.

ADDITIONAL TESTS

Nil

LIMITS

For test 1 to 3, limit as per BPC-1963.

LABELLING

Containers should be labeled “FOR EXTERNAL USE ONLY”.


50 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Xylometazoline Nasal Drops IP Page 1 of 1

Synonym : Xylometazoline Hydrochloride Copy No. 1


Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

148


1. Description 2. Identification 3. pH-Limit, 5.6 to 6.6 4. N(2-Aminoethyl) 4-tert-butyl-2,6-xylylacetamide 5. Assay: limit-90.0-110.0% of the stated amount of Xylometazoline Hcl.

ADDITIONAL TESTS

Nil

LIMITS


LABELLING


50 Numbers.

SHELF LIFE

Minimum 2 years.

149

KKEE

RRAA

LLAA

MM

EEDD

II CCAA

LL

SSEE

RRVV

II CCEE

SS

CCOO

RRPP

OORR

AATT

II OONN

LL

TTDD

PPAARREENNTTEERRAALLSS






Drug Name : Aciclovir Injection IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

150


1. Description. 2. Identification. 3. Appearance of the solution 4. pH- limit 10.7 to 11.7 5. Guanine 6. Related substance 7. BET- not more than 0.174 EU/MG of Acyclovir. 8. Clarity of solution-Refer-G-POW-003 9. Particulate matter- Refer- G-POW-005 10. Uniformity of weight-Refer-G-POW-002 11. Sterility- Refer-G-POW-004 12. Assay: Limit-90.0-110.0% of the stated amount of Aciclovir.

ADDITIONAL TESTS Nil.

LIMITS


LABELLING

The label states; 1. the quantity of acyclovir sodium in the sealed container in terms of the

equivalent amount of Aciclovir, 2. the strength of the constituted solution in terms of the equivalent amount of

Acyclovir in a suitable dose volume


100 Numbers.





Drug Name : Adrenaline bitartrate Injection IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

151


1. Description. 2. Identification. 3. Appearance of the solution 4. pH- limit 2.8 to 3.6, 5. Nor adrenaline-HPLC 6. Sterility- Refer-G-INJ-005 7. Extractable volume- Refer- G-INJ-004 8. Water-not more than 2.0 % determined on 0.3grams. 9. Particulate matter- refer- G-INJ-001 10. Assay: limit-0.09% to 0.11% wt/v of Adrenaline

ADDITIONAL TESTS

Nil.

LIMITS


LABELLING

The label states; 1. the quantity of active ingredients in parts per thousand (or) mg/ml in terms of

equivalent amount of adrenaline, 2. that the injection should not be used if it is pinkish (or) darker than slightly

yellow.


200 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Amikasin Sulphate Injection IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

152


1. Description. 2. Identification. 3. Uniformity of weight-refer- G-POW-002 4. pH- limit 3.5 to 5.5. 5. BET- not more than 0.33 EU/MG of Amikacin. 6. Sterility- Refer-G-INJ-005 7. Extractable volume-Refer-G-INJ-004 8. Particulate matter- Refer- G-INJ-001(of the constituted solution) 9. Clarity of solution-Refer-G-POW-003(of the constituted solution) 10. Assay: limit - 90.0-120.0% of the stated amount of Amikacin.

ADDITIONAL TESTS

Nil

LIMITS


LABELLING

The label states the quantity of Amikacin sulphate contained in the sealed containers in terms of the equivalent amount of Amikacin.


100 Numbers.

SHELF LIFE

Minimum 18 months.




Drug Name : Aminophylline Injection IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

153


1. Description. 2. Identification. 3. Uniformity of weight-refer G-POW-002 4. Absorbance of the solution-at 430 nm is not more than 0.15 5. pH- limit 8.8 to 10.0,determined in 10 %wt/v solution. 6. BET- not more than 0.15 EU/MG of Ampicillin. 7. Sterility- Refer-G-INJ-005 8. Water-not more than 2.0 % determined on 0.3grams. 9. Particulate matter- Refer- G-INJ-001 10. Clarity of solution-Refer-G-POW-003 11. Assay: contains Theophylline equivalent to not less than 73.25% and not

more than 88.25% of the stated amount of Aminophylline and not more than 0.295 gm of the ethylene diamine for each gram of anhydrous Theophylline determined in the assay for Theophylline.



LABELLING

The label states the (1) strength in terms of the equivalent amount of anhydrous Aminophylline in suitable dose volume; (2) the route of injection; (3) that the injections not to be used if crystals have separated.


100 Numbers.





Drug Name : Anti Snake Venom (Freeze Dried) Polyvalent 10ml Vial Page 1 of 1


Official Standards : Indian Pharmacopoeia

Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

154


1. Description 2. Identification Tests 3. Sterility 4. Assay

ADDITIONAL TESTS

Nil.

LIMITS

For test 1 to 4, limit as per IP.

LABELLING

The label states; 1. The number of mouse units per container 2. The volume of water for injection to be used for reconstitution


100 Numbers.

SHELF LIFE




Drug Name : Ampicillin Injection IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

155


1. Description. 2. Identification. 3. Uniformity of weight- Refer G-POW-002 4. Absorbance of the solution- at 430nm is not more than 0.15 5. pH - Limit 8.0 to 10.0, determined in10 minutes after dissolving in 10%w/v

solution. 6. Specific optical rotation- +258° to +287° determined in a 0.25%w/v solution of

potassium hydrogen phthalate. 7. N,N-dimethyl aniline- Not more than 20 ppm 8. Dichloromethane- Not more than 0.2%w/v 9. Heavy metals 10. BET- Not more than 0.15 EU/MG of Ampicillin. 11. Sterility- Refer-G-INJ-005 12. Water-not more than 2.0 % determined on 0.3grams. 13. Particulate matter- Refer- G-INJ-001(of the constituted solution) 14. Clarity of solution- Refer-G-POW-003(of the constituted solution) 15. Assay: limit - 95.0-105.0% of the stated amount of Ampicillin

ADDITIONAL TESTS Nil LIMITS For test 1 to 15, limit as per IP-2007.

LABELLING

The label states the quantity of Ampicillin sodium contains in the sealed containers in terms of the equivalent amount of anhydrous Ampicillin.

QUANTITY REQUIRED FOR ANALYSIS 100 Numbers.



DRUGS AND SUPPLIES Drug Code : D06001& D04007 Quality Control Department

Drug Name : Atropine Sulphate Injection IP Page 1 of 1

Synonym : Atropine Injection Copy No. 1


Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

156


1. Description. 2. Identification. 3. pH- limit 3.0 to 5.5 4. Sterility- Refer-G-INJ-005 5. Particulate matter- Refer- G-INJ-001 6. Particulate Contamination- Refer- G-INJ-002 7. Extractable Volume- Refer- G-INJ-004 8. Assay: Limit-90.0-110.0% of the stated amount of Atropine Sulphate.

ADDITIONAL TESTS

Nil.

LIMITS


LABELLING

Nil.


100 Numbers.

SHELF LIFE

Minimum 18 months.




Drug Name : Benzyl Penicillin Injection IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

157


1. Description. 2. Identification. 3. Uniformity of weight - Refer- G-POW-002 4. Absorbance of the solution - at 430nm is not more than 0.15 5. pH - Limit 5.5 to 7.5, determined in 10%w/v solution. 6. Related substance-HPLC 7. BET- Not more than 0.16 EU/MG. 8. Sterility- Refer-G-INJ-005 9. Loss on drying- Not more than 1.0% determined on 1.0 gram at 105°C 10. Particulate matter- Refer- G-INJ-001(of the constituted solution) 11. Clarity of solution-Refer-G-POW-003(of the constituted solution) 12. Assay: limit-95.0-105.0% of the stated amount of Benzyl Penicillin.

ADDITIONAL TESTS

Nil

LIMITS


LABELLING

The label states (1) whether the content are Benzyl Penicillin Potassium or Benzyl Penicillin Sodium; (2) the name of any added buffering agents.


200 Numbers.





Drug Name : Betamethasone Sodium Injection IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

158


1. Description. 2. Identification. 3. pH- limit 2.8 to 3.6, 4. Sterility- Refer-G-INJ-005 5. Extractable volume- Refer- G-INJ-004 6. Particulate matter- Refer- G-INJ-001 7. Assay: limit-92.5% to 107.5% of the stated amount of Betamethasone.

ADDITIONAL TESTS

Nil.

LIMITS


LABELLING

The label states the strength in terms of the equivalent amount of Betamethasone in a suitable dose-volume.


200 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Bleomycin Injection IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

159


1. Description. 2. Identification. 3. pH- limit 4.5 to 6.0 determined in a solution containing 10 units/ml. 4. Copper-NMT0.02% 5. Content of Bleomycins 6. BET-NMT 10.0EU/unit of Bleomycin. 7. Loss on drying - NMT 6.0% determined by drying the combined contents of

2 containers in an oven at 60°C at a pressure not exceeding 0.7kPa for 3 hrs.

8. Uniformity of weight- Refer-G-POW-002 9. Clarity of the constituted solution Refer-G-POW-003 10. Particulate matter- Refer- G-INJ-001 11. Sterility- Refer-G-INJ-005 12. Assay: limit-90.0-120.0% of the stated amount of Bleomycin. And the

content of Bleomycins is:- Bleomycin A2, between 55.0% and 70.0%; Bleomycin B2, between 25.0 % and 32.0%; sum of Bleomycin A2 and Bleomycin B2, 85.0%; Di-methyl Bleomycin A2, NMT 5.5%; other related substances NMT 9.5%.

ADDITIONAL TESTS Nil. LIMITS For test 1 to 12, limit as per IP-2007. LABELLING The label states the total number of units contained in a sealed container. QUANTITY REQUIRED FOR ANALYSIS 200 Numbers. SHELF LIFE Minimum 18 months.




Drug Name : Bupivacaine Hydrochloride in Dextrose Injection USP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

160


1. Description. 2. Identification. 3. BET- Not more than 1.8 USP EU/MG of Bupivacaine Hydrochloride 4. pH- Limit 4.0 to 6.5. 5. Volume in container 6. Particulate matter 7. Sterility 8. Assay: limit - 93.0 to 107.0 % of the labelled amount of Bupivacaine

Hydrochloride and Dextrose

ADDITIONAL TESTS

Nil.

LIMITS


LABELLING

Nil.


200 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Calcium Gluconate Injection IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

161


1. Description. 2. Identification. 3. Appearance of solution 4. pH-Limit 6.0 to 8.2 5. BET-NMT 0.17 EU/mg of Calcium Gluconate. 6. Extractable volume- Refer- G-INJ-004 7. Particulate matter-Refer-G-INJ-001 8. Sterility- Refer- G-INJ-005. 9. Assay: limit-contains a quantity of calcium equivalent to NLT 8.5% and NMT

9.4% of the stated amount of Calcium Gluconate.

ADDITIONAL TESTS

Nil.

LIMITS


LABELLING

The label states; 1. the strength as a percentage w/v of Calcium Gluconate equivalent to the total

amount of Calcium present, 2. that solutions containing visible solid particles must not be used, 3. the percentage of any added stabilizing agent.


200 Numbers.

SHELF LIFE

Minimum 18 months.




Drug Name : Carboprost Injection IP Page 1 of 1

Synonym : Carboprost Tromethamine Injection Copy No. 1


Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

162


1. Description. 2. Identification. 3. pH-Limit 7.0 to 8.0 4. BET- NMT 714.3 EU/MG of Carboprost Tromethamine. 5. Refractive index-Limit-1.481 to 1.486 determined at 20°C 6. Particulate matter-Refer-G-INJ-001 7. Sterility- Refer- G-INJ-005. 8. Extractable volume- Refer- G-INJ-004. 9. Assay: limit - 90.0-110.0% of the stated amount of Carboprast

Tromethamine. ADDITIONAL TESTS Nil. LIMITS


LABELLING

The label states the strength in terms of the equivalent amount of Carboprost in a suitable dose – volume.


200 Numbers.





Drug Name : Cefotaxime Injection IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

163


1. Description. 2. Identification. 3. pH- Limit 4.5 to 6.5,determined in a 10.0%w/v solution. 4. BET- Not more than 0.2 EU/MG of Cefotaxime 5. Sterility- Refer-G-INJ-005 6. Water- Not more than 6.0% determined on 0.15grams. 7. Particulate Matter- Refer- G-INJ-001(of the constituted solution) 8. Clarity of solution- Refer-G-POW-003(of the constituted solution) 9. Assay: Limit - 90.0-115.0% of the stated amount of Cefotaxime.

ADDITIONAL TESTS

Nil

LIMITS


LABELLING

Nil


100 Numbers.

SHELF LIFE

Minimum 18 months.




Drug Name : Cefotaxime Sodium Injection IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

164


1. Description. 2. Identification. 3. Uniformity of weight- Refer G-POW-002 4. pH - limit 4.5 to 6.5,determined in 10 %wt/v solution. 5. BET- Not more than 0.20 EU/MG. 6. Sterility- Refer-G-INJ-005 7. Water- Not more than 6.0% determined on 0.15 gram. 8. Particulate matter- Refer- G-INJ-001 (of the constituted solution) 9. Clarity of solution- Refer-G-POW-003 (of the constituted solution) 10. Assay: limit - 90.0-115.0% of the stated amount of Cefotaxime.

ADDITIONAL TESTS

Nil

LIMITS


LABELLING


200 Numbers.

SHELF LIFE

Minimum 2 years.



Drug Name : Cefuroxime Injection IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

165


1. Description. 2. Identification. 3. Uniformity of weight - Refer- G-POW-002 4. pH - limit 6.0 to 8.5,determined in a 10 %wt/v solution. 5. BET - not more than 0.10 EU/MG of Cefuroxime. 6. Sterility - Refer-G-INJ-005 7. Water - not more than 3.5 % determined on 0.15grams. 8. Particulate matter - Refer- G-INJ-001(of the constituted solution) 9. Clarity of solution - Refer-G-POW-003(of the constituted solution) 10. Assay:- Limit - 90.0-120.0% of the stated amount of Cefuroxime.

ADDITIONAL TESTS Nil LIMITS


LABELLING

The label states the quantity of Ampicillin sodium contains in the sealed containers in terms of the equivalent amount of anhydrous Ampicillin.






Drug Name : Chlorpheniramine Maleate Injection IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

166


1. Description. 2. Identification. 3. pH- limit 4.0 to 5.2, 4. Related substances 5. Sterility- Refer-G-INJ-005 6. Extractable volume-Refer- G-INJ-004 7. Particulate matter- Refer- G-INJ-001 8. Clarity of solution-Refer-G-POW-003 9. Assay: limit-90.0-110.0% of the stated amount of Chlorpheniramine Maleate.

ADDITIONAL TESTS

Nil.

LIMITS


STORAGE

Store protected from light.

LABELLING

Nil.


100 Numbers.

SHELF LIFE

Minimum 18 months.




Drug Name : Ciprofloxacin Injection IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

167


1. Description. 2. Identification. 3. pH- limit 3.5 to 4.6. 4. Ciprofloxacin ethylene diamine analog - Not more than 0.5% determined by

the method described in the assay. 5. Lactic acid- Limit 0.288 mg to 0.352 mg for each mg of ciprofloxacin stated

on the label. 6. Dextrose (if present) - 4.75 to 5.25%wt/v 7. Sodium Chloride (If Present) - 0.855 To 0.945 % 8. BET- Not more than 0.25 EU/MG of Ciprofloxacin. 9. Sterility- Refer-G-INJ-005 10. Particulate matter- Refer- G-INJ-001 11. Clarity and colour of solution- Refer-G-POW-003 12. Extractable volume- Refer-INJ-004 13. Assay: limit - 90.0-110.0% of the stated amount of Ciprofloxacin

ADDITIONAL TESTS Nil LIMITS For test 1 to 13, limit as per IP-2007.

LABELLING

The label states whether dextrose or sodium chloride has been used for preparing the injection.


SHELF LIFE

Minimum 2 years.



Drug Name : Cisplastin Injection IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

168


1. Description. 2. Identification. 3. pH-Limit 3.5o 6.5,determined in a solution constituted as directed in the

label,in water for injections 4. Related substances 5. BET-Limit NMT 2.0EU/mg of Cisplastin 6. Uniformity of weight- Refer-G-POW-002 7. Clarity of the constituted solution Refer-G-POW-003 8. Particulate matter-Refer-G-INJ-001 9. Sterility- Refer- G-INJ-005. 10. Assay: limit-90.0-110.0% of the stated amount of Cisplastin.

ADDITIONAL TESTS

Nil.

LIMITS


LABELLING

Nil.


200 Numbers.

SHELF LIFE

Minimum 18 months.




Drug Name : Cloxacillin Injection IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

169


1. Description. 2. Identification. 3. pH- limit 5.0 to 7.0. 4. BET- not more than 0.40 EU/MG of Cloxacillin. 5. Clarity of solution-Refer-G-POW-001 6. Water-NMT 4.5% 7. Particulate matter- Refer- G-INJ-001 8. Sterility- Refer-G-INJ-005 9. Assay: Limit-90.0-110.0% of the stated amount of Cloxacillin.

ADDITIONAL TESTS

Nil

LIMITS


STORAGE

Store protected from moisture at a temperature not exceeding 30°C

LABELLING

The label states the quantity of Cloxacillin Sodium contained in the sealed container in terms of the equivalent amount of Cloxacillin.


100 Numbers.

SHELF LIFE

Minimum 18 months.



Drug Name : Cyclophosphamide Injection IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

170


1. Description. 2. Identification. 3. pH-Limit 4.0 to 6.0,determined in a 2.0% w/v solution immediately after

preparation 4. Related substances 5. BET-Limit NMT 0.2EU/mg of Cyclophosphamide. 6. Uniformity of weight- Refer-G-POW-002 7. Clarity of the constituted solution Refer-G-POW-003 8. Particulate matter-Refer-G-INJ-001 9. Sterility- Refer- G-INJ-005. 10. Assay: limit-92.5-107.5% of the stated amount of Cyclophosphamide

ADDITIONAL TESTS Nil. LIMITS For test 1 to 10, limit as per IP-2007.

LABELLING

The label states; 1. the quantity of cyclophosphamide in terms of the equivalent amount of

anhydrous Cyclophosphamide, 2. the volume of water for injection to be added, 3. that the solution should be used immediately after preparation.






Drug Name : Cyanocobalamin Injection IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

171


1. Description. 2. Identification. 3. pH- limit 3.8 to 5.5 4. Related substance. 5. Particulate matter- Refer- G-INJ-001 6. Extractable volume-Refer-G-INJ-004 7. Sterility- Refer-G-INJ-005 8. Assay: Limit-95.0-105.0% of the stated amount of Cyanocobalamin.

ADDITIONAL TESTS

Nil.

LIMITS


LABELLING

The label states the strength in terms of the equivalent amount of anhydrous Cyanocobalamin in a suitable volume.


100 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Cytosine Arabinoside Injection IP Page 1 of 1

Synonym : Cytarabine, B-Ctosine Arabinoside Injection Copy No. 1


Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

172


1. Description. 2. Identification. 3. pH-Limit 4.0 to 6.0 4. Related substances 5. Water 6. BET-NMT 0.07EU/MG 7. Clarity of solution-Refer-G-POW-003 8. Particulate matter-Refer-G-INJ-001 9. Uniformity of weight-Refer-G-pow-002 10. Sterility- Refer- G-INJ-005. 11. Assay: limit- 95.0-105.0% of the stated amount of Cytarabine.


LIMITS


LABELLING

The constituted solution should be used immediately after preparation but, in any case, within the period recommended by the manufacturer.


200 Numbers.

SHELF LIFE

Minimum 18 months.




Drug Name : Desferrioxamine Injection BP Page 1 of 1

Synonym : Desferrioxamine Mesilate Copy No. 1


Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

173


1. Description. 2. Identification. 3. Related substances-HPLC 4. Uniformity of weight 5. Sterility 6. Particulate Contamination-sub visible particles 7. Assay: limit-94.0-110.0% of the stated amount of Desferrioxamine Mesilate.

ADDITIONAL TESTS

Nil.

LIMITS

For test 1 to7, limit as per BP-2009.

LABELLING

Amount of active ingredients contained in the sealed container. Direction for the preparation of the injection.


100 Numbers.

SHELF LIFE

Minimum 18 months.




Drug Name : Dexamethasone Sodium Injection IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

174


1. Description. 2. Identification. 3. pH- limit 7.0 to 8.5, 4. Free Dexamethasone 5. Sterility- Refer-G-INJ-005 6. Extractable volume. Refer- G-INJ-004 7. Particulate matter- Refer- G-INJ-001 8. Clarity of solution-Refer-G-POW-003 9. Assay: limit - 95.0-105.0% of the stated amount of Dexamethasone

Phosphate.

ADDITIONAL TESTS

Nil.

LIMITS


LABELLING

The label states the strength in terms of the equivalent amount of Dexamethasone Phosphate in a suitable dose volume.


100 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Dextran 40 with Sodium Chloride 0.9% IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

175


1. Description. 2. Identification. 3. pH- limit 4.0 to 7.0 4. Molecular size 5. Acetone 6. Ethanol 7. Heavy metals 8. Nitrogen 9. Sulphated ash 10. Foreign proteins 11. BET-NMT1.25EU/ML 12. Particulate contamination- Refer- G-INF-001 13. Sterility- Refer-G-INF-002 14. Assay: Limit-contains NLT 9.0 % and NMT 11.0 %w/v of Dextran.



LABELLING

The label states; (1) the strength as the percentage w/v of Dextran, (2) the name of the solvent, (3) the strength of leuconostoc mesenteroids used, (4) that the infusion should not be used if it is cloudy or if a deposit is present.




DRUGS AND SUPPLIES Drug Code :

D18003, D18004, D18005 & D18006 Quality Control Department

Drug Name : Dextrose Injection IP Page 1 of 1

Synonym : Dextrose I.V Infusion, Glucose I.V Infusion Copy No. 1


Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

176


1. Description. 2. Identification. 3. pH-Limit 3.5 to 6.5 4. 5-Hydroxy methyl furfural and Related substances 5. Heavy metals-Limit 0.3ppm 6. Particulate Contamination-Refer-G-INF-002 7. BET-NMT 0.5EU/ML. 8. Sterility- Refer- G-INF-002. 9. Assay: 95.0 to 105.0 % of the stated amount of anhydrous Dextrose.

ADDITIONAL TESTS

Nil.

LIMITS


LABELLING

The label states; 1. The strength as a percentage w/v of anhydrous Dextrose. 2. That the injection should not be used if it contains visible solid particles.


50 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Diazepam Injection IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

177


1. Description. 2. Identification. 3. pH : 6.2 to 6.9 4. BET : not more than 11.6 EU /MG of Diazepam 5. Sterility - Refer- G-INJ-005 6. Particulate matter - Refer- G-INJ-001 7. Extractable volume -Refer-G-INJ-004 8. Clarity of solution - Refer-G-POW-003 9. Assay: limit - 90.0-110.0% of the stated amount of Diazepam

ADDITIONAL TESTS

Nil.

LIMITS


LABELLING

Nil.


200 Numbers.

SHELF LIFE

Minimum 18 months.




Drug Name : Diclofenac Sodium Injection IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

178


1. Description. 2. Identification. 3. pH – limit 8.1 to 9.0 4. Sterility- Refer-G-INJ-005 5. Particulate matter- Refer- G-INJ-001 6. Extractable volume- Refer-G-INJ-004 7. Clarity of solution- Refer-G-pow-003 8. Assay: limit- 95.0-105.0% of the stated amount of Diclofenac sodium.

ADDITIONAL TESTS

Nil

LIMITS


LABELLING

Nil


100 Numbers.

SHELF LIFE

Minimum 18 months.




Drug Name : Dicyclomine Hydrochloride Injection IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

179


1. Description. 2. Identification. 3. BET-NMT 17.2EU/mg of Dicyclomine Hydrochloride. 4. Particulate matter- Refer- G-INJ-001 5. Extractable volume- Refer- G-INJ-004 6. Sterility- Refer-G-INJ-005 7. Assay: limit-93.0-107.0% of the stated amount of Dicyclomine Hydrochloride.

ADDITIONAL TESTS

Nil.

LIMITS


LABELLING

Nil.


200 Numbers.

SHELF LIFE

Minimum 18 months.




Drug Name : Digoxin Injection IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

180


1. Description. 2. Identification. 3. pH- limit 6.7 to 7.3. 4. Sterility- Refer-G-INJ-005 5. Particulate matter- Refer- G-INJ-001 6. Extractable volume-Refer-INJ-004 7. Assay: limit-90.0-110.0% of the stated amount of Digoxin.

ADDITIONAL TESTS

Nil.

LIMITS


LABELLING

Nil.


200 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Dimercaprol Injection IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

181


1. Description. 2. Identification. 3. Acidity 4. Refractive index-Limit-1.481 to 1.486 determined at 20°C 5. Weight per ml-Limit-about 0.95 grams 6. Particulate matter- 7. Sterility- Refer- G-INJ-005. 8. Extractable volume- Refer- G-INJ-004. 9. Assay: limit-90.0-110.0% of the stated amount of Dimercaprol.

ADDITIONAL TESTS

Nil.

LIMITS


LABELLING

The label states that (1) the nature of the solvent; (2) the injection is meant for IM use only.


200 Numbers.

SHELF LIFE

Minimum 18 months.




Drug Name : Dobutamine Hydrochloride Injection USP Page 1 of 1


Official Standards : US Pharmacopeia 2008, Volume 2, Page No. 2002-2003

Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

182


1. Description. 2. Identification. 3. BET- NMT 2.08 USP EU/MG of Dobutamine 4. pH- limit 2.5 to 5.5,Refer USP page no-314 5. Particulate matter- ReferUSP-2008,page no-311 6. Sterility 7. Volume in container-Refer USP, page no-36 & 619. 8. Assay: limit-90.0-115.0% of the labelled amount of Dobutamine HCl

equivalent to Dobutamine.

ADDITIONAL TESTS

Nil.

LIMITS

For test 1 to 8, limit as per USP-2008

LABELLING

Label it to indicate that the injection is to be diluted to appropriate strength with a suitable parenteral vehicle prior to administration.


100 Numbers.

SHELF LIFE

Minimum 18 months.




Drug Name : Dopamine Hydrochloride Injection USP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

183


1. Description. 2. Identification. 3. BET- NMT 16.67 USP EU/MG of Dopamine Hydrochloride. Refer page no-

98 4. pH- limit 2.5 to 5.0,Refer USP page no-314 5. Particulate matter- ReferUSP-2008,page no-311 6. Sterility 7. Volume in container-Refer USP, page no-36 & 619. 8. Assay: limit-90.0-115.0% of the labelled amount of Dopamine HCl.

ADDITIONAL TESTS

Nil.

LIMITS


LABELLING

1. Label list to indicate that the injection is to be diluted with suitable parenteral vehicle prior to Intravenous Infusion

2. It may contain antioxidant and as per USP specification for labelling. Refer page no-34 of USP


100 Numbers.

SHELF LIFE

Minimum 18 months.




Drug Name : Doxurubicin Hydrochloride Injection IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

184


1. Description. 2. Identification. 3. pH- Limit, 2.5 to 4.5 for the preformed solution; 4.5 to 6.5 determined in the

injection prepared in accordance with the direction in the label. 4. BET-NMT2.2 EU/MG of Doxorubicin Hydrochloride. 5. Particulate matter- 6. Clarity and Color of constituted solution. 7. Sterility- Refer- G-INJ-005. 8. Extractable volume- Refer- G-INJ-004. 9. Assay: limit-90.0-115.0% of the stated amount of Doxorubicin Hydrochloride.

ADDITIONAL TESTS

Nil.

LIMITS


LABELLING

Nil.


200 Numbers.

SHELF LIFE

Minimum 18 months.




Drug Name : Electrolyte M Injection (Maintenance) Page 1 of 1


Official Standards : KMSCL In-house Method and Indian Pharmacopoeia

Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

185


1. Description. 2. Identification. 3. pH-Limit 3.0 to 7.0 4. 5-Hydroxy methyl furfural and Related substances(Refer IP-2007) 5. Particulate Contamination-Refer-G-INF-002 6. Sterility- Refer- G-INF-002. 7. Assay: 95.0 to 120.0 % of the total chloride and 90.0 to 110.0% of Dextrose

(anhydrous), Acetate and total Sodium and Potassium.

ADDITIONAL TESTS

Nil.

LIMITS


LABELLING

Nil.


50 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Electrolyte P Injection (Paediatric) Page 1 of 1


Official Standards : KMSCL In-house Method and Indian Pharmacopoeia

Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

186


1. Description. 2. Identification. 3. pH-Limit 5.0 to 6.0 4. Particulate Contamination-Refer-G-INF-002 5. Sterility- Refer- G-INF-002. 6. Assay: 90.0 % to 110.0% of total Sodium, Potassium, Chloride, Magnesium

phosphate and dextrose (anhydrous).

ADDITIONAL TESTS

Nil.

LIMITS

For tests 1 to 6, Limits as per KMSCL In house method and IP.

LABELLING

Nil.


50 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Etoposide Injection IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

187


1. Description. 2. Identification. 3. pH- limit -2.7 to 3.5 determined in a solution containing the equivalent of 5.0

pH-Limit 3.0 to 4.0,determined in a solution prepared by diluting a volume of the concentrate containing 0.1 gram of Etoposide to 50.0 ml with carbondioxide free water.

4. Cis-Etoposide 5. Uniformity of weight 6. Clarity of the constituted solution 7. Particulate matter-Refer-G-INJ-001 8. Sterility- Refer- G-INJ-005. 9. Assay: limit-95.0-105.0% of the stated amount of Etoposide.



LABELLING

The label states; 1. the direction for dilution of the contents, 2. that the diluted injection is to be given by Intravenous injection, 3. that the concentrate should be protected from light.


200 Numbers.

SHELF LIFE




Drug Name : Fluorouracil Injection IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

188


1. Description. 2. Identification. 3. pH-Limit 8.5 to 9.5 4. Related substances 5. Urea 6. Particulate matter-Refer-G-INJ-001 7. Sterility- Refer- G-INJ-005. 8. Extractable volume- Refer- G-INJ-004. 9. Assay: limit-90.0-110.0% of the stated amount of Fluorouracil.

ADDITIONAL TESTS

Nil.

LIMITS


LABELLING

The label states; 1. the strength in terms of the equivalent amount of Fluoro uracil in a suitable

dose – volume. 2. that if separation has occurred, the injection should be heated to 60°C,

shaken vigorously and allowed to cool to body temperature prior to use.


200 Numbers.

SHELF LIFE

Minimum 18 months.




Drug Name : Fluphenazine Decanoate Injection IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

189


1. Description. 2. Identification. 3. Related substance 4. Extractable volume. G-INJ-004 5. Sterility- refer-G-INJ-005 6. Particulate matter- Refer- G-INJ-001 7. Assay: limit-90.0-110.0% of the stated amount of Fluphenazine Decanoate.

ADDITIONAL TESTS

Nil.

LIMITS


LABELLING

The label states that the injection is for IM injection only.


100 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Frusemide Injection IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

190


1. Description. 2. Identification. 3. pH - Limit 8.0 to 9.3 4. Free amines 5. BET – NMT 3.5EU/mg of Frusemide. 6. Particulate matter - Refer-G-INJ-001 7. Sterility- Refer- G-INJ-005. 8. Extractable volume - Refer- G-INJ-004. 9. Assay: limit - 95.0-105.0% of the stated amount of Frusemide.

ADDITIONAL TESTS

Nil.

LIMITS


LABELLING

Nil.


200 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Gamma Globulin (I.V) IP Page 45 of 1

Synonym : Human Normal Immunoglobulin, Normal Immunoglobulin, Immune Human Serum Globulin, Human Gamma Globulin.

Copy No. 1


Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

191


1. Description. 2. Identification. 3. pH-Limit 6.4 to 7.2 4. Protein composition 5. Molecular size 6. Stability 7. Particulate matter/Particulate contamination-Refer-G-INJ-001 & Refer-G-INJ-002 8. Sterility- Refer- G-INJ-005. 9. Extractable volume/Uniformity of weight- Refer- G-INJ-004. 10. Assay: limit-90.0-110.0% of the quantity of protein stated on the label and in any

case, NLT10.0%w/v and NMT18.0 w/v of protein. Freeze-dried Human Normal immunoglobulin complies with the following additional requirements; 11. Solubility rate. 12. Loss on drying - NMT 2.0% Human Normal Immunoglobulin intended for use in the prevention of infective hepatitis (hepatitis A) complies with the following additional requirement; 13. Anti-hepatitis A activity - Limit: - The stated potency is NLT 100 units/ml. The

estimated potency is NLT the stated potency. The fiducial limits of error are NLT 80.0% and NMT125.0%

LIMITS- For test 1 to 13, limit as per IP-2007. LABELLING

The label states; 1. the volume and the protein concentration expressed in G/L or for freeze-dried

preparations, the total amount of protein in the container. 2. the type of source material 3. the name and quantity of any added preservative or stabilizing agent 4. the recommended human dose 5. that it is meant for IM injection only 6. the storage conditions.

QUANTITY REQUIRED FOR ANALYSIS-200 Numbers. SHELF LIFE- Minimum 18 months.




Drug Name : Gentamycin Injection IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

192


1. Description. 2. Identification. 3. pH- Limit 3.0 to 5.0 4. Composition of Gentamycin sulphate - HPLC. 5. BET- Not more than 1.67 EU/MG of Gentamycin. 6. Sterility- Refer-G-INJ-005 7. Particulate matter- Refer- G-INJ-001 8. Extractable volume- Refer-INJ-004 9. Assay: Limit - 95.0-110.0% of the stated amount of Gentamycin.

ADDITIONAL TESTS

Nil

LIMITS


LABELLING

The label states the strength in terms of the equivalent amount of Gentamycin in a suitable dose.


100 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Glycopyrrolate USP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

193


1. Description. 2. Identification. 3. BET- Not more than 555.5 USP EU/MG of Glycopyrrolate. 4. pH- Limit 2.0 to 3.0. 5. Volume in container 6. Particulate matter-Refer page no-36 Vol-1 of USP 7. Sterility 8. Assay: limit- 93.0 to 107.0% of the labelled amount of Glycopyrrolate.

ADDITIONAL TESTS

Nil.

LIMITS


LABELLING

Refer page no-34 of USP, Volume-I.


200 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Haloperidol Injection IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

194


1. Description. 2. Identification. 3. pH-Limit 2.8 to 3.6 4. Related substances 5. Extractable volume. Refer- G-INJ-004 6. Sterility- Refer-G-INJ-005 7. Particulate matter- Refer- G-INJ-001 8. Assay: limit-90.0-110.0% of the stated amount of Haloperidol.

ADDITIONAL TESTS

Nil.

LIMITS


LABELLING

The label states that the injection is for IM injection only.


100 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Heparin Sodium Injection IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

195


1. Description. 2. Identification. 3. pH- limit 5.5 to 8.0 4. BET-NMT0.03 Endotoxin per unit of Heparin 5. Particulate matter- Refer- G-INJ-001 6. Extractable volume-Refer-G-INJ-004 7. Sterility- Refer-G-INJ-005 8. Assay: Limit-90.0-110.0% of the stated potency in terms of units/ml.


LIMITS


LABELLING

The label states; 1. the strength in terms of the number of units in a suitable dose volume except

that for multiple dose containers the strength is stated as the number of Units/ml.

2. the source of the material (lung or mucosal), 3. when no anti-microbial preservative is present that the injection contain no

anti microbial preservative, 4. that any portion of the contents not used at once should be discarded






Drug Name : Human Anti-D Immunoglobulin IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

196


1. Description. 2. B19 Virus DNA maximum 104 IU/ML (if required), 3. Potency

Limit: The estimated potency is NLT 90.0%of the stated potency. The confidence limit (P=0.95) are NLT 80.0% and NMT 120.0% of the estimated potency.

ADDITIONAL TESTS

Nil.

LIMITS


LABELLING

Ref as per IP, Vol-3 page no-2079


200 Numbers.

SHELF LIFE

Minimum 18 months.




Drug Name : Hydrocortisone Sodium Succinate Injection IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

197


1. Description. 2. Identification. 3. pH- limit -6.5 to 8.0 determined in a solution containing the equivalent of 5.0

% wt/v of hydrocortisone 4. Related substance-HPLC 5. Uniformity of weight-Refer-G-POW-002 6. Sterility- Refer-G-INJ-005 7. Extractable volume.Refer- G-INJ-004 8. Particulate matter- (of constituted solution)Refer- G-INJ-001 9. Clarity of solution-(of constituted solution)Refer-G-POW-003 10. Assay: limit-95.0-105.0% of the stated amount of Hydrocortisone

ADDITIONAL TESTS Nil. LIMITS


LABELLING

The label states; 1. the strength in terms of the equivalent amount of hydrocortisone, 2. that the prepared solution should be used only if it is clear, 3. that the solution should be used immediately after preparation.


100 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Hydroxy Ethyl Starch I.V Infusion Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

198


1. Description. 2. Identification. 3. pH- limit 5.0 to 6.0 4. Particulate Contamination 5. Sterility- Refer-G-INJ-005 6. Assay: Limit-90.0-110.0% of the Hydroxyethyl starch and sodium chloride.

ADDITIONAL TESTS

Nil.

LIMITS

For test 1 to 6, limit as per KMSCL In-house method.

LABELLING

Nil.


50 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Iohexol Injection USP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

199


1. Description. 2. Identification. 3. BET- NMT 0.2 USP EU/ 50MG of Iodine 4. pH- limit 6.8 to 7.7 5. Particulate matter 6. Free iodide 7. Sterility 8. Volume in container 9. Assay for Iodine: limit-95.0-105.0% of the labelled amount of Iohexol as

organically bound Iodine.

ADDITIONAL TESTS

Nil.

LIMITS


LABELLING

1. Label containers of injection to direct the user to discard any unused portion. 2. The labelling states also that it is not to be used if it is discoloured or

contains a precipitate. Label also states its route of administration.


100 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Ketamine Injection IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

200


1. Description. 2. Identification. 3. pH- limit 3.0 to 5.5,determined in10 minutes after dissolution in 10 %wt/v

solution. 4. BET- not more than 0.40 EU/MG of Ketamine HCl 5. Sterility- Refer-G-INJ-005 6. Particulate matter- Refer- G-INJ-001 7. Extractable volume- Refer- G-INJ-004 8. Assay: limit-95.0-105.0% of the stated amount of Ketamine.

ADDITIONAL TESTS

Nil

LIMITS


LABELLING

The label states the strength in terms of Ketamine in a suitable dose volume.


100 Numbers.

SHELF LIFE

Minimum 18 months.




Drug Name : Leucovorin Calcium Injection USP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

201


1. Description. 2. Identification. 3. BET- NMT 1.95 USP EU/MG of Leucovorin calcium. 4. pH- limit 6.5 to 8.5. 5. Sterility 6. Foreign & Particulate matter 7. Volume in container-Refer USP, page no-36 & 619. 8. Assay: limit - 90.0-120.0% of the labelled amount of Leucovorin.

ADDITIONAL TESTS

Nil.

LIMITS


LABELLING

Nil.


100 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Lignocaine 2% with Adrenaline Injection IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

202


1. Description. 2. Identification. 3. pH – limit 3.0 to 4.5 4. Sterility- Refer-G-INJ-005 5. Particulate matter- Refer- G-INJ-001 6. Extractable volume-Refer-G-INJ-004 7. Assay: limit - NLT 95.0% and NMT 105.0% of the stated amount of

Lignocaine Hydrochloride and NLT 87.5% and NMT 112.5 % of the stated amount of Adrenaline.

ADDITIONAL TESTS

Nil.

LIMITS


LABELLING

The label states the strength of Adrenaline Bitartrate in terms of the equivalent amount of Adrenaline.


100 Numbers.

SHELF LIFE

Minimum 18 months.




Drug Name : Lignocaine Hydrochloride Injection Heavy IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

203


1. Description. 2. Identification. 3. pH- limit 5.0 to 7.0, 4. 2,6,di methyl aniline 5. Sterility- Refer-G-INJ-005 6. Particulate matter- Refer- G-INJ-001 7. Clarity of solution-Refer-G-POW-003 8. Extractable volume- Refer- G-INJ-004 9. Assay: limit-95.0-105.0% of the stated amount of Lignocaine HCl.

ADDITIONAL TESTS

Nil

LIMITS


LABELLING

Nil


200 Numbers.

SHELF LIFE

Minimum 18 months.




Drug Name : Lignocaine Hydrochloride Injection IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

204


1. Description. 2. Identification. 3. pH- limit 5.0 to 7.0, 4. 2,6,di methyl aniline 5. Sterility- Refer-G-INJ-005 6. Particulate matter- Refer- G-INJ-001 7. Clarity of solution-Refer-G-POW-003 8. Extractable volume- Refer- G-INJ-004 9. Assay: limit-95.0-105.0% of the stated amount of Lignocaine HCl.

ADDITIONAL TESTS

Nil

LIMITS


LABELLING

Nil


200 Numbers.

SHELF LIFE

Minimum 18 months.




Drug Name : Lorazepam Injection USP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

205


1. Description. 2. Identification. 3. BET- NMT 100.0 USP EU/MG of Lorazepam. 4. Related compounds 5. Sterility 6. Particulate matter 7. Volume in container 8. Assay: limit-90.0-110.0% of the labelled amount of Lorazepam.

ADDITIONAL TESTS

Nil.

LIMITS


LABELLING

Nil.


100 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Magnesium Sulphate Injection BP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

206


1. Description. 2. Identification. 3. Acidity or Alkalinity-Ph-5.5 to 7.0,refer page no-A225 4. Particulate Contamination-sub visible particles 5. Sterility- refer page no-2245 6. Uniformity of dosage units, refer page no-2246 7. Assay: limit-95.0-105.0% of the stated amount of Magnesium sulphate hepta

hydrate.

ADDITIONAL TESTS

Nil.

LIMITS


LABELLING

1. Strength is stated as the percentage w/v of Magnesium sulphate Hepta-hydrate and as the approximate concentration of Magnesium ions (mg2+) in millimoles/ml.

2. name and concentration of any added anti-microbial preservative.


100 Numbers.

SHELF LIFE

Minimum 18 months.




Drug Name : Mannitol Injection IP Page 1 of 1

Synonym : Mannitol IV Infusion Copy No. 1


Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

207


1. Description. 2. Identification. 3. pH-Limit 4.5 to 7.0 4. Particulate Contamination-Refer-G-INF-002 5. BET-NMT 0.5EU/ML. 6. Sterility- Refer- G-INF-002. 7. Assay: limit-95.0-105.0% of the stated amount of Mannitol.

ADDITIONAL TESTS

Nil.

LIMITS


LABELLING

The label states; 1. The strength as a percentage w/v of Mannitol, 2. That the injection should not be used if it contains visible solid particles that

do not dissolve on warming.


50 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Methotrexate Injection IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

208


1. Description. 2. Identification. 3. pH- limit 7.5 to 9.0. 4. Particulate matter- Refer- G-INJ-001 5. Extractable volume- Refer- G-INJ-004 6. Sterility- Refer-G-INJ-005 7. Assay: limit-95.0-110.0% of the stated amount of Methotrexate.

ADDITIONAL TESTS

Nil.

LIMITS


LABELLING

The label states that the injections is not intended for intrathecal injection when an anti-microbial preservative is present.


200 Numbers.

SHELF LIFE

Minimum 18 months




Drug Name : Methyl Ergometrine Maleate Injection IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

209


1. Description. 2. Identification. 3. pH- limit -2.7 to 3.5 determined in a solution containing the equivalent of

5.0 % wt/v of hydrocortisone 4. Related substance 5. Extractable volume. G-INJ-004 6. Sterility- refer-G-INJ-005 7. Particulate matter- Refer- G-INJ-001 8. Assay: limit-90.0-110.0% of the stated amount of Methyl Ergometrine

Maleate.

ADDITIONAL TESTS

Nil.

LIMITS


LABELLING

Nil.


100 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Methyl Prednisolone Sodium Succinate Injection USP Page 1 of 1

Synonym : Methyl Prednisolone Sodium Succinate for Injection Copy No. 1


Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

210


1. Description. 2. Identification. 3. Constituted solution 4. BET- NMT 0.17 USP EU/MG of Methyl Prednisolone. 5. pH- limit 7.0 to 8.0. 6. Loss on drying-NMT 2.0% 7. Particulate matter 8. Free Methyl Prednisolone 9. Uniformity of dosage units. 10. Sterility 11. Assay: limit-90.0-115.0% of the labeled amount of Methyl Prednisolone.

ADDITIONAL TESTS

Nil.

LIMITS


LABELLING

Nil.


100 Numbers.

SHELF LIFE

Minimum 18 months.




Drug Name : Metoclopramide Injection IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

211


1. Description. 2. Identification. 3. Appearance of the solution 4. pH- limit 3.0 to 5.0 5. Related substance 6. Sterility- Refer-G-INJ-005 7. Particulate matter- Refer- G-INJ-001 8. Extractable volume- Refer- G-INJ-004 9. Assay: Limit-90.0-110.0% of the stated amount of Anhydrous

Metoclopramide.

ADDITIONAL TESTS

Nil.

LIMITS


LABELLING

The label states the strength in terms of the equivalent amount of anhydrous Metoclopramide HCl in a suitable dose-volume.


100 Numbers.

SHELF LIFE

Minimum 18 months




Drug Name : Metoprolol Injection BP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

212


1. Description. 2. Identification. 3. Acidity or Alkalinity, pH-Limit 5.5 to 7.5.Refer page-A225 4. Related substances-HPLC 5. Particulate Contamination-Sub visible particles. Refer page-2245 6. Uniformity of dosage units. Refer page-2246 7. Extractable volume 8. Sterility 9. Assay: Limit-95.0-105.0% of the stated amount.

ADDITIONAL TESTS

Nil.

LIMITS


LABELLING

Name and Concentration of any added antimicrobial preservatives.


200 Numbers.

SHELF LIFE

Minimum 18 months.




Drug Name : Metronidazole Injection IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

213


1. Description. 2. Identification. 3. pH- limit 4.5 to 7.0. 4. BET- Not more than 0.35 EU/MG of Metronidazole. 5. Clarity of solution - Refer-G-POW-001 6. Extractable volume - Refer-G-INJ-004 7. Particulate matter - Refer- G-INJ-001 8. Sterility - Refer-G-INJ-005 9. Assay: Limit - 90.0-110.0% of the stated amount of Metronidazole.

ADDITIONAL TESTS

Nil

LIMITS


LABELLING

The label states that the contents should not be used if they contain any visible solid particle.


100 Numbers.

SHELF LIFE

Minimum 18 months.




Drug Name : Acetylcysteine Injection BP Page 1 of 1

Synonym : N-Acetylcysteine Injection Copy No. 1


Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

214


1. Description. 2. Identification. 3. Acidity or Alkalinity.pH, Limit-6.5 to 7.5 4. Specific Optical rotation-Limit-+21 to +27 5. Related substances-HPLC 6. Hydrogen sulphide 7. Sterility 8. Particulate Contamination-sub visible particles 9. Uniformity of dosage units 10. Assay: Limit-95.0-105.0% of the stated amount of Acetylcysteine.

ADDITIONAL TESTS

Nil.

LIMITS


LABELLING

1. The strength is stated in terms of an equivalent % w/v of Acetylcysteine. 2. Name and concentration of any added anti-microbial preservatives


200 Numbers.

SHELF LIFE

Minimum 18 months.




Drug Name : Naloxone Injection BP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

215


1. Description. 2. Identification. 3. Acidity-pH,Limit-3 To 4.5 4. Related substances 5. BET 6. Uniformity of dosage units 7. Sterility 8. Particulate Contamination-sub visible particles 9. Assay: limit-95.0-105.0% of the stated amount of Naloxone

ADDITIONAL TESTS

Nil.

LIMITS


LABELLING

1. Name and concentration of any added antimicrobial preservatives. 2. Quantity of active ingredient is stated in terms of the equivalent amount of

anhydrous Naloxone Hydrochloride 3. When Naloxone is prescribed for neonatal use Neonatal Naloxone Injection

(Containing the equivalent of 20 micrograms /ml of anhydrous Naloxone hydrochloride) shall be dispensed.


100 Numbers.

SHELF LIFE

Minimum 18 months.




Drug Name : Neostigmine Methylsulphate Injection IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

216


1. Description. 2. Identification. 3. pH- limit 4.0 to 6.5 4. 3-Hydroxy Trimethyl Anilinium Methyl Sulphate-HPLC 5. Sterility- Refer-G-INJ-005 6. Particulate matter- Refer- G-INJ-001 7. Uniformity of content- Refer- G-INJ-003 8. Extractable volume- Refer- G-INJ-004 9. Assay: limit-90.0-110.0% of the stated amount of Neostigmine

Methylsulphate.

ADDITIONAL TESTS

Nil

LIMITS


LABELLING

Nil


200 Numbers.

SHELF LIFE

Minimum 18 months.




Drug Name : Nitroglycerin Injection USP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

217


1. Description. 2. Identification. 3. BET- NMT 0.1 USP EU/microgram of Nitroglycerin. 4. pH-Limit,3.0 to 6.5 5. Particulate matter 6. Alcohol content-Limit 90.0 to 110.0% of the labelled amount of isopropyl

alcohol being used as the internal standard. 7. Sterility 8. Volume in container 9. Assay: limit-90.0-110.0% of the labeled amount of Nitroglycerin.

ADDITIONAL TESTS

Nil.

LIMITS


LABELLING

Where necessary, label it to indicate that it is to be diluted before use.


100 Numbers.

SHELF LIFE

Minimum 18 months.




Drug Name : Ofloxacin Injection IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

218


1. Description. 2. Identification. 3. pH- limit 3.5 to 5.8, 4. Sterility- Refer-G-INJ-005 5. Particulate contamination- Refer- G-INJ-001 6. Assay: Limit - 90.0-120.0% of the stated amount of Ofloxacin. Note:- Ofloxacin Infusion Official As Per IP 2007

ADDITIONAL TESTS

Nil

LIMITS


LABELLING

Nil


100 Numbers.

SHELF LIFE

Minimum 18 months.




Drug Name : Ondansetron Injection USP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

219


1. Description. 2. Identification. 3. BET- NMT 9.9 USP EU/MG of Ondansetron Hydrochloride. 4. pH- limit 3.3 to 4.0,Refer USP page no-314 5. Particulate matter 6. Limit of Ondansetron related compound D 7. Chromatographic purity 8. Sterility 9. Volume in container 10. Assay: limit-95.0-105.0% of the labeled amount of Ondansetron.

ADDITIONAL TESTS

Nil.

LIMITS


LABELLING

Specify the route of administration.


100 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Oxytocin Injection IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

220


1. Description. 2. Identification. 3. pH- limit -3.5 to 4. 4. Particulate matter- Refer- G-INJ-001 5. Uniformity of content-Refer-G-INJ-003 6. Extractable volume. Refer- G-INJ-004 7. Sterility- Refer-G-INJ-005 8. Assay: limit-90.0-110.0% of the stated amount of units of Oxytocin activity.

ADDITIONAL TESTS

Nil.

LIMITS


LABELLING

The label states; 1. the number of units of Oxytocin activity/ml 2. either the animal species from which it is obtained or whether it is synthetic,

as appropriate.


100 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Paclitaxel Injection USP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

221


1. Description. 2. Identification. 3. BET- NMT 0.67 USP EU/MG of Paclitaxel. 4. pH- Limit 3.0 to 7.0 5. Limit of degradation products. 6. Sterility 7. Foreign and Particulate matter 8. Volume in container 9. Assay: limit-90.0-110.0% of the labeled amount of Paclitaxel.

ADDITIONAL TESTS

Nil.

LIMITS


LABELLING

Label it to indicate that it is to be diluted with a suitable parenteral vehicle prior to intravenous infusion.


100 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Pancuronium Bromide Injection BP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

222


1. Description. 2. Identification. 3. Acidity-pH- limit 3.8 to 4.2-Refer page A-225 BP-2009 4. Related substances 5. Sterility- refer-G-INJ-005 6. Particulate contamination-sub visible particles, Refer- PAGE 2245 7. Uniformity of dosage units. 8. Assay: limit - 95.0-105.0% of the stated amount.


LIMITS


LABELLING

Nominal volume of the contents – page 2247, name and concentration of any added antimicrobial preservatives.


200 Numbers.

SHELF LIFE

Minimum 18 months.




Drug Name : Paracetamol Injection IP Page 1 of 1

Synonym : Acetaminophen Copy No. 1

Official Standards : Indian Pharmacopoeia 2007, Volume 3.

Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

223


1. Description. 2. Identification. 3. Sterility- Refer-G-INJ-005 4. Particulate matter- Refer- G-INJ-001 5. Extractable volume- Refer-G-INJ-004 6. Clarity of solution- Refer-G-POW-003 7. Assay: limit- 90.0-110.0% of the stated amount of Paracetamol.

ADDITIONAL TESTS

Nil

LIMITS


LABELLING

Nil


100 Numbers.

SHELF LIFE

Minimum 18 months.




Drug Name : Pentazocine Lactate Injection IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

224


1. Description. 2. Identification. 3. pH – limit 4.0 to 5.0 4. Related substance 5. Sterility- refer-G-INJ-005 6. Particulate matter- refer- G-INJ-001 7. Extractable volume-refer-G-INJ-004 8. Clarity of solution-refer-G-POW-003 9. Assay: limit-95.0-105.0% of the stated amount of Pentazocine

ADDITIONAL TESTS

Nil

LIMITS


LABELLING

The label states the strength in terms of the equivalent amount of Pentazocine in a suitable volume.


100 Numbers.

SHELF LIFE

Minimum 18 months.




Drug Name : Phenobarbitone Sodium Injection IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

225


1. Description. 2. Identification. 3. pH– Limit 10.0% to 11% 4. Particulate matter - Refer G-INJ-001 5. Extractable volume - Refer-G-INJ-004 6. Sterility – Refer G-INJ-005 7. Assay – NLT 95.0% and not more than 105.0% of the stated amount of

Phenobarbitone Sodium.

ADDITIONAL TESTS

Nil.

LIMITS


LABELLING

The label states that the injection should not be used if the solution is discoloured or if it contains precipitate.


100 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Phenytoin Sodium Injection BP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

226


1. Description. 2. Identification. 3. Alkalinity pH-11.5 to 12.1 4. Weight /ml -1.025 to 1.035 gm 5. Benzil and Benzophenone 6. Ethanol – by Gas chromatography – 9.0 to 110% v/v 7. Proppyline glycol 37.0 to 43% v/v 8. Sterility – refer G-INJ-005 9. Particulate contamination : sub visible 10. Assay: limit-90.0-110.0% of the stated amount of Phenytoin Sodium.

ADDITIONAL TESTS

Nil.

LIMITS


LABELLING

Nil.


100 Numbers.

SHELF LIFE

Minimum 18 months.




Drug Name : Phytomenadione Injection BP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

227


1. Description. 2. Identification. 3. Acidity or Alkalinity-pH-5.0 to 7.5 4. Extractable volume 5. Particulate Contamination-sub visible particles 6. Sterility 7. Assay: limit-90.0-115.0% of the stated amount of Phytomenadione

ADDITIONAL TESTS

Nil.

LIMITS


LABELLING

The label states that the injection should not be used if separation has occurred or if oil droplets have appeared.


100 Numbers.

SHELF LIFE

Minimum 18 months.




Drug Name : Potassium Chloride for Injection Concentrate USP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

228


1. Description. 2. Identification. 3. BET- Not more than 1.8 USP EU/MG of Bupivacaine Hydrochloride 4. pH- Limit 4.0 to 8.0. 5. Volume in container 6. Particulate matter 7. Sterility 8. Assay: limit-95.0 to 105.0 % of the labelled amount of Potassium chloride.


LIMITS For test 1 to 8, limit as per USP-2008.

LABELLING

The label states Potassium chloride content in terms of weight and of m Eq in a given volume. Label the concentrate to indicate that it is to be diluted to approximate strength with water or other suitable fluid prior to administration. Immediately following the name, the label bears the boxed warning;

Concentrate Must Be Diluted Before Use Ampoules must be identified by a black band or a series of black bands above the constriction. The label states also the total osmolar concentration in m Osmol per Litre where the contents are less than 100 ml the label alternatively may state the total osmolar concentration in m Osmol per mL






Drug Name : Pralidoxime Chloride Injection IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

229


1. Description. 2. Identification. 3. pH- limit 3.5 to 4.5,determined in a 5.0% wt/v solution. 4. Heavy metals 5. BET- Not more than 0.1 EU/MG of Pralidoxime chloride. 6. Uniformity of weight-Refer- G-POW-002 7. Clarity of solution-Refer-G-POW-003(of the constituted solution) 8. Sterility- Refer-G-POW-004 9. Particulate matter- Refer-G-POW-005 (of the constituted solution) 10. Assay: Limit-90.0-110.0% of the stated amount of Pralidoxime chloride

ADDITIONAL TESTS

Nil.

LIMITS


LABELLING

The label states the period within which the constituted injection should be used.


100 Numbers.

SHELF LIFE

Minimum 18 months.




Drug Name : Promethazine Injection IP Page 1 of 1

Synonym : Promethazine Hydrochloride Copy No. 1


Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

230


1. Description. 2. Identification. 3. pH- limit 5.0 to 6.0, 4. Related substances 5. Sterility- Refer-G-INJ-005 6. Extractable volume-Refer- G-INJ-004 7. Particulate matter- Refer- G-INJ-001 8. Assay: limit-95.0-105.0% of the stated amount of Promethazine HCl.

ADDITIONAL TESTS

Nil.

LIMITS


LABELLING

Nil.


100 Numbers.

SHELF LIFE

Minimum 18 months.


DRUGS AND MEDICINES Drug Code : D04010


Drug Name : Propofol Injection BP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

231


1. Description. 2. Identification. 3. Acidity or alkalinity-pH- limit 6.0 to 8.5 4. Propofol quinone and propofol dimer-HPLC 5. Sterility- Refer-G-INJ-005 6. Globule size 7. Free fatty acids 8. Lyso lecithin-HPLC 9. BET-page-2246,BP volume-3 10. Particulate contamination-sub visible particle 11. Uniformity of dosage units 12. Assay: limit-95.0-105.0% of the stated amount of propofol.

ADDITIONAL TESTS

Nil.

LIMITS


LABELLING

Name and concentrations of any added antimicrobial preservative.


60 Numbers.

SHELF LIFE

Minimum 18 months.




Drug Name : Protamine Sulphate Injection IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

233


1. Description. 2. Identification. 3. pH – limit 2.5 to 3.5 4. Optical rotation-limit 0.52°c to 0.68°c 5. Light absorption-Limit NMT 0.1 6. BET-NMT7.0EU/MG of Protamine sulphate. 7. Abnormal toxicity 8. Particulate matter- Refer- G-INJ-001 9. Uniformity of content-Refer-G--INJ-003 10. Sterility- Refer-G-INJ-005 11. Extractable volume-Refer-G-INJ-004 12. Assay: NLT 80.0% of the stated amount of Protamine sulphate.

ADDITIONAL TESTS

Nil.

LIMITS


LABELLING

1. States that dose is calculated from the results of the determinations of the

amount required to produce an acceptable blood clotting time in the patient 2. The approximate number of units of Heparin I ml is capable of neutralizing.


100 Numbers.





Drug Name : Quinine Injection IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

234


1. Description. 2. Identification. 3. pH- limit 1.5 to 3.0. 4. Other Cinchona alkaloids-HPLC 5. Extractable volume- Refer-G-INJ-004 6. Particulate matter- Refer- G-INJ-001 7. Sterility- Refer-G-INJ-005 8. Assay: Limit-95.0-105.0% of the stated amount of Quinine Dihydrochloride.

ADDITIONAL TESTS

Nil.

LIMITS


LABELLING

The label states that the solution must be diluted to a strength not exceeding 30mg/ml before administration and that care should be taken to ensure slow intravenous injection.


100 Numbers.

SHELF LIFE

Minimum 18 months.




Drug Name : Ranitidine Injection IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

235


1. Description. 2. Identification. 3. pH-Limit 6.7 to 7.3 4. Related substances 5. Particulate matter-Refer-G-INJ-001 6. Sterility- Refer- G-INJ-005. 7. Extractable volume- Refer- G-INJ-004. 8. Assay: limit-90.0-110.0% of the stated amount of Ranitidine.

ADDITIONAL TESTS

Nil.

LIMITS


LABELLING

The label states; 1. The strength in terms of the equivalent amount of ranitidine. 2. Where appropriate, that the injection is buffered.


200 Numbers.

SHELF LIFE

Minimum 18 months.




Drug Name : Ringer Lactate Injection IP Page 1 of 1

Synonym : Compound Sodium Lactate IV infusion, Ringer Lactate solution for Injection, Hartmann’s solution for Injection.

Copy No. 1


Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

236


1. Description. 2. Identification. 3. pH-Limit 5.0 to 7.0 4. Particulate Contamination-Refer-G-INF-002 5. BET-NMT 0.5EU/ML. 6. Sterility- Refer- G-INF-002. 7. Assay: limit - Compound sodium Lactate injection contains 0.27%w/v to

0.32%w/v of sodium, 0.019%w/v to 0.022%w/v of potassium, 0.37 %w/v to 0.42%w/v of total chloride, 0.025%w/v to 0.029 %w/v of calcium chloride and 0.23%w/v to 0.28%w/v of lactate calculated as C3H6O3

ADDITIONAL TESTS Nil. LIMITS For test 1 to 7, limit as per IP-2007. LABELLING

The label states; 1. The injection contains in millimoles per litre the following approximate

amounts of the ions. Sodium 131, Potassium 5, Calcium 2, bicarbonate (as lactate) 29 and chloride111.

2. That the injection should not be used if the solution contains visible and solid particles.






Drug Name : Sodium Calcium Edetate Injection BP Page 1 of 1

Synonym : Sodium Calcium Edetate IV Infusion Copy No. 1


Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

237


1. Description. 2. Identification. 3. Acidity or Alkalinity, pH-Limit 6.5 to 8.0 4. Sterility 5. Particulate Contamination-Sub visible particles. 6. Uniformity of dosage units. 7. Assay: Limit-19.0-21.0%w/v of the anhydrous Sodium Calcium Edetate.

ADDITIONAL TESTS

Nil.

LIMITS


LABELLING

1. Strength is stated as the equivalent amount of anhydrous sodium calcium edetate in a suitable dose-volume.

2. Sterile sodium calcium edentate concentrate 3. Solution must be diluted with Sodium chloride I.V infusion or Glucose I.V

infusion before administration. 4. Name and Concentration of any added antimicrobial preservatives.


200 Numbers.

SHELF LIFE

Minimum 18 months.




Drug Name : Sodium Chloride 0.9% & Dextrose 5.0% w/v IP Page 1 of 1

Synonym : Sodium Chloride & Dextrose Infusion, Copy No. 1 Sodium Chloride and Glucose IV Infusion


Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

238


1. Description. 2. Identification. 3. pH-Limit 3.5 to 6.5 4. 5-Hydroxy methyl furfural and related substances 5. Particulate Contamination-Refer-G-INF-002 6. BET-NMT 10.0EU/Gram of Dextrose. 7. Particulate contamination. - Refer- G-INF-001. 8. Sterility- Refer- G-INF-002. 9. Assay: 95.0 to 105.0 % 0f the stated amount of Sodium chloride and

Dextrose.

ADDITIONAL TESTS

Nil.

LIMITS


LABELLING

The label states; 1. The strength as the percentages w/v of sodium chloride and Dextrose 2. That a solution containing visible particles must not be used. 3. When the preparation is intended for intravenous infusion, the label states the

approximate concentrations, in millimoles per litre, of the sodium and chloride ions and the number of grams per litre of Dextrose






Drug Name : Sodium Chloride Injection IP 0.9%w/v Page 1 of 1

Synonym : Sodium Chloride I.V Infusion Copy No. 1


Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

239


1. Description. 2. Identification. 3. pH-Limit 4.5 to 7.0 4. Heavy metals-Limit 0.3ppm 5. Particulate Contamination-Refer-G-INF-002 6. BET-NMT 0.5EU/ML. 7. Sterility- Refer- G-INF-002. 8. Assay: NLT 0.85%w/v and NMT 0.95 %w/v of Sodium chloride.

ADDITIONAL TESTS

Nil.

LIMITS


LABELLING

The label states; 1. The strength as a percentage w/v of Sodium chloride 2. That a solution containing visible solid particles must not be used. 3. Label states that the injection contains approximate 150 millimoles each of

Sodium and Chloride ions per litre.


50 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Sodium Nitroprusside Injection USP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

240


1. Description. 2. Identification. 3. BET- NMT 0.05 USP EU/microgram of sodium Nitroprusside. Refer USP Page no-98 4. Water-NMT15.0%, Refer USP page no-370 5. Sterility 6. Uniformity of dosage unit- Refer USP-2008,page no-363 7. Foreign & Particulate matter- ReferUSP-2008,page no-36 8. Constituted solution- (a) completeness and clarity of solution

(b) particulate matter 9. Assay: limit-90.0-110.0% of the stated amount of Sodium Nitroprusside

ADDITIONAL TESTS

Nil.

LIMITS


LABELLING

As per USP specification.


100 Numbers.

SHELF LIFE

Minimum 18 months.




Drug Name : Sodium Thiosulphate Injection BP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

241


1. Description. 2. Identification. 3. Acidity or Alkalinity, pH-Limit 7.0 to 9.0 4. Sterility 5. Particulate Contamination-Sub visible particles. 6. Uniformity of dosage units. 7. Assay: Limit-95.0-105.0% of the stated amount.

ADDITIONAL TESTS

Nil.

LIMITS


LABELLING

Name and Concentration of any added antimicrobial preservatives.


200 Numbers.

SHELF LIFE

Minimum 18 months.




Drug Name : Sterile Water for Injection IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

242


1. Description. 2. Appearance of the solution 3. Acidity or Alkalinity 4. Ammonium 5. Calcium and Magnesium 6. Heavy metals 7. Chlorides 8. Nitrates 9. Sulphates 10. Oxidisable substances 11. Residue on evaporation 12. Particulate contamination- Refer- G-INJ-002. 13. BET 14. Sterility- Refer- G-INJ-005.

ADDITIONAL TESTS Nil. LIMITS For test 1 to 14, limit as per IP-2007.

LABELLING Nil. QUANTITY REQUIRED FOR ANALYSIS

200 Numbers.





Drug Name : Streptokinase Injection IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

243


1. Description. 2. Identification. 3. pH- Limit 6.8 to 7.5, determined on a freshly constituted injection containing

5000 units /ml. 4. Streptodornase 5. Streptolysin 6. BET 7. Uniformity of weight-Refer- G-POW-002 8. Clarity of solution-Refer-G-POW-003(of the constituted solution) 9. Particulate matter- Refer- G-POW-005 (of the constituted solution) 10. Sterility- Refer-G- POW-004 11. Assay: limit-90.0-111.0% of the stated potency.



LABELLING The label states the total number of units of streptokinase activity contained in it.


100 Numbers.





Drug Name : Succinyl Choline Injection IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

244


1. Description. 2. Identification. 3. pH- limit 3.0 to 5.0 4. Hydrolysis product 5. Sterility- refer-G-INJ-005 6. Particulate matter-. refer-G-INJ-001 7. Extractable volume- refer-G-INJ-004 8. Assay: limit-90.0-107.5% of the stated amount of Succinyl Choline Chloride.

ADDITIONAL TESTS

Nil.

LIMITS


LABELLING

Nil.


50 Numbers.

SHELF LIFE

Minimum 18 months.




Drug Name : Terbutaline Injection IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

245


1. Description. 2. Identification. 3. Uniformity of content-refer G-INJ-003 4. pH- limit 3.0 to 5.0, 5. BET- not more than 0.15 EU/MG of Ampicillin. 6. Sterility- refer-G-INJ-005 7. Water-not more than 2.0 % determined on 0.3grams. 8. Particulate matter- refer- G-INJ-001 9. Extractable volume- refer- G-INJ-004 10. Assay: limit-90.0-110.0% of the stated amount of Terbutaline.

ADDITIONAL TESTS

Nil

LIMITS


LABELLING

The label states that the injection should not be used if the solution is discoloured.


100 Numbers.

SHELF LIFE

Minimum 18 months.




Drug Name : Tetanus Toxoid Injection IP Page 1 of 1

Synonym : Tetanus vaccine (Adsorbed) Copy No. 1


Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

246


1. Description. 2. Identification. 3. Aluminium - Maximum 1.25 mg per single human use if Aluminium Hydroxide

or hydrated Aluminium phosphate is used as the adsorbent. 4. Free Formaldehyde-Maximum 0.2g/1 5. Antimicrobial preservative - NLT 85.0% and NMT 115.0 % 0f the intended

amount (where applicable) 6. Sterility - Refer-G-INJ-005 7. Abnormal toxicity 8. Potency of Tetanus component. 9. Extractable volume- Refer-G-INJ-004 10. Assay: The lower confidence limit of estimated potency shall not be less than

40.0 IU/SHD. ADDITIONAL TESTS Nil. LIMITS For test 1 to 10, limit as per IP-2007. LABELLING

The label states; 1. Human dose (ml), 2. Minimum units per single human use or the minimum IU per single human dose

if potency test done by challenge method or both, 3. The name and the amount of the adsorbent and preservatives, 4. That the vaccine must be shaken before use, 5. That the vaccine is not to be frozen.

QUANTITY REQUIRED FOR ANALYSIS 100 Numbers. SHELF LIFE Minimum 2 years.




Drug Name : Theophylline and Etophylline Injection Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

247


1. Description. 2. Identification. 3. Sterility- Refer-G-INJ-005 4. Particulate matter - Refer- G-INJ-001 5. Clarity of solution - Refer-G-POW-003 6. Extractable volume - Refer-G-INJ-004 7. Assay: limit - 90.0-1110.0% of the stated amount of Theophylline and

Etophylline.

ADDITIONAL TESTS

Nil

LIMITS


LABELLING

Nil


100 Numbers.

SHELF LIFE

Minimum 18 months.




Drug Name : Thiopentone Sodium Injection IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

248


1. Description. 2. Identification. 3. Appearance of solution 4. Related substances 5. Loss on drying 6. Uniformity of weight-Refer-G-POW-002 7. Clarity of solution-Refer-G-POW-003 8. Sterility- Refer-G-INJ-004 9. Particulate matter-. Refer-G-POW-005 10. Assay: Thiopentone injection contains Thiopentone, that is not less than

77.0% and not more than 92.0% and sodium that is not less than 9.4% and not more than 11.8% of the stated amount of Thiopentone sodium.

ADDITIONAL TESTS Nil. LIMITS For test 1 to 8, limit as per IP-2007. LABELLING

The label states the amount of active ingredient in terms of Thiopentone Sodium

QUANTITY REQUIRED FOR ANALYSIS 100 Numbers. SHELF LIFE Minimum 18 months.




Drug Name : Tramadol Injection IP Page 1 of 1


Official Standards : Indian Pharmacopoeia 2007, Volume 3, Page No.

Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

249


1. Description. 2. Identification. 3. Sterility- Refer-G-INJ-005 4. Particulate matter- Refer- G-INJ-001 5. Extractable volume - Refer-G-INJ-004 6. Assay: limit- 90.0-110.0% of the stated amount of Tramadol Hydrochloride.

ADDITIONAL TESTS

Nil

LIMITS


LABELLING

Nil


100 Numbers.

SHELF LIFE

Minimum 18 months.




Drug Name : Vancomycin Hydrochloride Injection Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

250


1. Description. 2. Identification. 3. Uniformity of weight - Refer G-POW-002 4. pH- limit 8.0 to 10.0, determined in10 minutes after dissolution in 10%w/v

solution. 5. Heavy metals - not more than 0.003% 6. BET - not more than 0.33usp EU/MG of Vancomycin. 7. Sterility - Refer-G-INJ-005 8. Chromatographic purity - Refer USP page-3501 9. Particulate matter - Refer- G-INJ-001 (of the constituted solution) and

USP-2008, page no-37 10. Completeness and clarity of solution-refer-G-POW-003 (of the constituted

solution) and USP-2008, page no-37 11. Assay: limit - 90.0-115.0% of the stated amount of Vancomycin.

ADDITIONAL TESTS Nil LIMITS


LABELLING Volume of the diluents to be added should be specified.


100 Numbers.





Drug Name : Vecuronium Bromide Injection Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

251


6. Description. 7. Identification. 8. Sterility- Refer-G-INJ-005 9. Particulate matter- Refer- G-INJ-001 10. Extractable volume-Refer-G-INJ-004 11. Clarity of solution-Refer-G-POW-003 12. Uniformity of content-Refer-G-INJ-003 13. BET-NMT10EU/mg of Vecuronium Bromide. 14. Sterility-Refer-G-INJ-005 15. Assay: limit-90.0-110.0% of the stated amount of Vecuronium Bromide.

ADDITIONAL TESTS Nil. LIMITS For test 1 to 10, limit as per KMSCL In-house Method. LABELLING Nil. QUANTITY REQUIRED FOR ANALYSIS 100 Numbers. SHELF LIFE Minimum 18 months.




Drug Name : Vincristine Sulphate Injection IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

252


1. Description. 2. Identification. 3. Appearance of solution 4. pH-Limit 3.5 to 5.0,determined in a solution containing0.15%w/v solution of

the dried contents 5. Related substances 6. BET-NMT 62.5 EU/mg of dried Vincristine sulphate. 7. Particulate matter-Refer-G-INJ-001 8. Uniformity of weight/Uniformity of content- Refer-G-INJ-001 9. Sterility- Refer- G-INJ-005. 10. Assay: limit-90.0-110.0% of the stated amount of Vincristine Sulphate.

ADDITIONAL TESTS

Nil.

LIMITS


LABELLING

The label states; 1. the strength in terms of the weight of dried Vincristine sulphate, 2. the names of auxiliary substances if any, 3. that the contents are to be used by IV only, 4. the storage conditions.



253

KKEE

RRAA

LLAA

MM

EEDD

II CCAA

LL

SSEE

RRVV

II CCEE

SS

CCOO

RRPP

OORR

AATT

II OONN

LL

TTDD

MMEEDDIICCAALL DDEEVVIICCEESS




DRUGS AND SUPPLIES Drug Code : S27007


Drug Name : Absorbent Cotton Wool IP Page 1 of 1

Synonym : Absorbent Cotton Copy No. 1

Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 970&971

Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

254


1. Description 2. Identification 3. Acidity or Alkalinity 4. Surface active substances 5. Absorbency 6. Foreign fibres 7. Fluorescence 8. Colouring matter 9. Ether soluble substances 10. Water soluble substances 11. Neps 12. Sulphated ash 13. Loss on drying


For tests 1 to 13, limits as per IP


2 units

SHELF LIFE




Drug Name : Adhesive Tape U.S.P. 10 cm x 5 m JR – roll Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

255


1. Description. 2. Dimensions. 3. Tensile Strength. 4. Adhesive Strength. 5. Sterility: (If sterile)

ADDITIONAL TESTS

Nil.

LIMITS


LABELLING

The package label of tape that has been renderd sterile indicates that the contents may not be sterile if the package bears evidence of damage or previously ha been opened. The package label indicates the length and width of the tape and the name of the manufacturer, packer or distributor.


SHELF LIFE


DRUGS AND SUPPLIES Drug Code : S27104 to

S27107 Quality Control Department

Drug Name : Black Braided Silk 1-25 M (Reels) Null Box of 6 Reels Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

257


1. Description 2. Length: Limit - not less than 95.0% of the length stated on the label. 3. Diameter : Limit – Ref. Table 4 4. Tensile Strength : Ref. Table 4 5. Sterility (If claimed sterile) 6. Needle attachment : Ref. SUT Table 5 6 7. Soluble chromium compounds 8. Extractable colour : Ref. SUT Table 3

ADDITIONAL TESTS

Nil.

LIMITS

AS per the reference.

LABELLING

As per USP 2008 Vol. 3 p. 3316 given under non absorbable surgical suture.


60 Numbers.

SHELF LIFE




Drug Name : Black Silk 5-0 ½ C 17 mm Needle Taper cut 76 cm. NULL Box of 12 Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

258


1. Description 2. Length: Limit – Not less than 95.0 percent of the length stated in the label. 3. Diameter : Limit – Ref. SUT Table 4 4. Tensile strength : Ref. SUT Table 4 5. Needle attachment : Ref. SUT Table 5 & 6 6. Sterility : (If claimed sterile) 7. Extractable colour : Limit - Ref. SUT Table 3 8. Soluble chromium compound: Limit – Colour extracted should be less

intense than the colour of the standard solution.

ADDITIONAL TESTS

Nil.

LIMITS


LABELLING

As per USP 2008, Vol. 3, Page 3316 given under non absorbable surgical suture.


30 + 30 Numbers.

SHELF LIFE




Drug Name : BP Blade – 10 / 11 / 15 / 20 / 21 / 22 / 23 / 24 Page 1 of 1


Official Standards : KMSCL In-house Specifications

Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

259


1. Description 2. Identification : 3. Nominal Volume 4. Extractable Volume 5. PH (5.0 – 6.0) 6. Bacterial Endotoxins : Not more than 5.56 EU/ml 7. Chloride : Not more than 0.0035% 8. Sterility 9. Particulate matter 10. Assay : Limit – It contains in each 100 ml, not less than 2.11 g and not more

than 2.33 g of monobasic sodium phosphate, not less than 30.30 g and not more than 33.50 g of dextrose, not less than 19.16 g and not more than 21.18 g, of total citrate, expressed as citric acid anhydrous, not less than 6.21 g and not more than 6.86 g of sodium, and not less than 0.247 g and not more than 0.303 g of adenine

ADDITIONAL TESTS

Nil.

LIMITS


LABELLING

Label it to indicate the number of ml of solution required per 100ml of whole blood or the number of ml of solution required per volume of whole blood to be collected.


30 + 30 Numbers.

SHELF LIFE




Drug Name : BP Blade – 10 / 11 / 15 / 20 / 21 / 22 / 23 / 24 Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

260


Physico Chemical Testing:

1. Surface Finish

2. Corrosion Test

3. Limits for acidity and alkalinity as per ISO - 9626: 2001.

Biological Testing:

4. Sterility

5. Pyrogen Test / BET

ADDITIONAL TESTS

Nil.

LIMITS

For test 1 to 5, limit as per KMSCL In-house Specifications.

LABELLING

Nil


100 Numbers.

SHELF LIFE




Drug Name : Braided Poly Glycolic Acid Suture 1 150cm without Needle Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

261


1. Description. 2. Length: Limit not less than 95.0% of the length stated on the label. 3. Diameter : Ref. SUT Table II 4. Tensile Strength : Ref. SUT Table II 5. Needle attachment : Ref. SUT Table V & VI 6. Sterility : If sterile 7. Extractable colour (If dyed) : Ref. SUT Table III 8. Soluble Chromium Compounds: Limit colour extracted should be loss


ADDITIONAL TESTS

Nil.

LIMITS


LABELLING

As per USP 2008, Volume 3, Page 3316, given under non absorbable surgical suture.


30 + 30 Numbers.

SHELF LIFE




Drug Name : Braided Poly Glycolic Acid Suture 1-0 150cm without Needle Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

262




ADDITIONAL TESTS

Nil.

LIMITS


LABELLING



30 + 30 Numbers.

SHELF LIFE




Drug Name : Braided Poly Glycolic Acid Suture 1-0 90cm ½ Circle Taper Cut Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

263




ADDITIONAL TESTS

Nil.

LIMITS


LABELLING



30 + 30 Numbers.

SHELF LIFE




Drug Name : Braided Poly Glycolic Acid Suture 190 cm ½ Circle Taper Cut (Heavy) 40mm Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

264




ADDITIONAL TESTS

Nil.

LIMITS


LABELLING



30 + 30 Numbers.

SHELF LIFE




Drug Name : Braided Poly Glycolic Acid Suture 2-0 150cm without Needle Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

265




ADDITIONAL TESTS

Nil.

LIMITS


LABELLING



30 + 30 Numbers.

SHELF LIFE




Drug Name : Braided Poly Glycolic Acid Suture 2-0 90cm ½ Circle Reverse Cutting 40mm Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

266




ADDITIONAL TESTS

Nil.

LIMITS


LABELLING



30 + 30 Numbers.

SHELF LIFE




Drug Name : Braided Poly Glycolic Acid Suture 3-0 45cm 3/8 Circle Reverse Cutting 12mm Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

267




ADDITIONAL TESTS

Nil.

LIMITS


LABELLING



30 + 30 Numbers.

SHELF LIFE




Drug Name : Catgut Atraumatic No. IRB 63 mm Blunt Needle Null Box of 12. Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

268




ADDITIONAL TESTS

Nil.

LIMITS


LABELLING



30 + 30 Numbers.

SHELF LIFE


DRUGS AND SUPPLIES Drug Code : S27120& S27121 Quality Control Department

Drug Name : Catgut Atromatic RB. Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

269


1. Description. 2. Length: Limit – The length of each suture is not less than 90% of the length

stated on the label and does not exceed 350 cm 3. Diameter: Limit – Ref. SUT Table I 4. Minimum Breaking Load – Ref. SUT Table I 5. Soluble chromium compounds: The solution is not more intensely coloured

than the standard solution (IPPM of Cr) 6. Needle Attachment: Ref SUT Table 5 & 6 7. Extractable colour : Ref. SUT Table 3 8. Sterility.

ADDITIONAL TESTS

Nil.

LIMITS


LABELLING

1. Gauge Number 2. Length in cm or m 3. If appropriate, that the needle is detachable 4. Name of the product 5. Intended use


SHELF LIFE




Drug Name : Catgut Chromic 1 – 0, RB, 3/8 circle 76 cm, 45mm Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

270


1. Description. 2. Length: Limit – The length of each suture is not less than 90% of the length

stated on the label and does not exceed 350 cm 3. Diameter: Limit – Ref. SUT Table I 4. Minimum Breaking Load – Ref. SUT Table I 5. Soluble chromium compounds: The solution is not more intensely coloured

than the standard solution (IPPM of Cr) 6. Needle Attachment: Ref SUT Table 5 & 6 7. Extractable colour : Ref. SUT Table 3 8. Sterility.

ADDITIONAL TESTS

Nil.

LIMITS


LABELLING



SHELF LIFE


DRUGS AND SUPPLIES Drug Code : S27110 & S27111 Quality Control Department

Drug Name : Catgut Chromic 1-0 152 cm Null (Box of 12) Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

271




ADDITIONAL TESTS

Nil.

LIMITS


LABELLING



30 + 30 Numbers.

SHELF LIFE




Drug Name : Catgut Chromic 2-0 ½ CRB 30mm Needle 76 cm Null Box of 12 Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

272




ADDITIONAL TESTS

Nil.

LIMITS


LABELLING



30 + 30 Numbers.

SHELF LIFE




Drug Name : Catgut Chromic 2-0 ½ CRB 30mm Needle 76 cm Null Box of 12 Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

273




ADDITIONAL TESTS

Nil.

LIMITS


LABELLING



30 + 30 Numbers.

SHELF LIFE



Drug Name : Catgut with Needle Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

274




ADDITIONAL TESTS

Nil.

LIMITS


LABELLING



30 + 30 Numbers.

SHELF LIFE



Drug Name : Catgut Plain BP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

275


1. Description 2. Length: Limit – The length of each suture is not less than 90% of the length

stated on the label and does not exceed 350 cm 3. Diameter: Limit – Ref. SUT Table I 4. Minimum Breaking Load – Ref. SUT Table I 5. Soluble chromium compounds: The solution is not more intensely odoured

than the standard solution (IPPM of Cr) 6. Needle Attachment: Ref SUT Table 5 & 6 7. Extractable colour : Ref. SUT Table 3 8. Sterility

ADDITIONAL TESTS

Nil.

LIMITS


LABELLING



SHELF LIFE




Drug Name : Disposable Needle 18 G Page 1 of 1


Official Standards : IS 10654 : 2002, ISO 7864 : 1993

Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

276


1. Description 2. Appearance 3. Cleanliness 4. Limits for acidity or alkalinity 5. Limits for extractable metals 6. Size designation 7. Colour of hub 8. Sheath 9. Length of needle 10. Needle point 11. Bond between hub and needle tube 12. Potency of lumen 13. Packaging 14. Sterility

LIMITS- For tests 1 to 14, limit as per IS 10654 : 2002, ISO 7864 : 1993 LABELLING

i) Primary Container 1. A description of the contents, including the designated metric size 2. The word “STERILE” 3. The lot number, prefixed by the word “LOT” 4. The name or trade mark or trade name or logo of the manufacturer or supplier ii) Secondary Container 1. A description of the contents, including the designated metric size 2. The word “STERILE” 3. The lot number, prefixed by the word “LOT” 4. The number, the type or angle of bevels, if appropriate, the words “thin-walled” or “extra-thin-walled” or

equivalent or an abbreviation. 5. The words “For SINGLE 6. USE” or equivalent 7. A warning to check the integrity of each primary container before use. 8. The date of sterilization 9. The name and address of the manufacturer or supplier 10. Information for handling storage and transportation iii) Storage Container 1. Description of the contents 2. The lot number, prefixed by the word “LOT” 3. The word “STERILE” 4. The date of sterilization 5. The name and address of the manufacturer or supplier 6. Information for handling, storage and transportation of the contents.

QUANTITY REQUIRED FOR ANALYSIS-100 numbers SHELF LIFE




Drug Name : Disposable Surgeon Is Mask (Double Layer) Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

277


1. Description :

2. Length :

3. Length of Tie Bands :

4. Colour :

5. Strength of Joint :

6. Numbers of Bands :

7. Sterility :

ADDITIONAL TESTS

Nil.

LIMITS


LABELLING

Nil


100 Numbers.

SHELF LIFE


DRUGS AND SUPPLIES Drug Code : S27031to S27033 Quality Control Department

Drug Name : Disposable Syringe Without Needle 2cc Page 1 of 1


Official Standards : British Pharmacopoeia 2009, Volume 4, Page No. A485

Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

278


1. Description. 2. Capacity. 3. Appearance of solution. 4. Acidity or alkalinity. 5. Absorbance: Does not exceed 0.4 6. Ethylene Oxide: (G.C.) Limit not greater than 10 ppm 7. Reducing substances. 8. Transparency. 9. Sterility.


LIMITS For test 1 to 8, limit as per BP-2009.

LABELLING

Label on the package states : 1. Batch number 2. Description of the syringe’ 3. That the syringe is fro single – use only

Label on the outer package states : 1. The method of sterilisation 2. That the syringe is sterile or that if is sterile only internally 3. The identity of the manufacturer 4. That the syringe is not to be used if the packaging is damaged or the sterility

protector is loose.


SHELF LIFE




Drug Name : Endo Tracheal Tube Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

279


1. Description 2. Tip : 3. Length : ± 5mm 4. I.D. (Inner diameter) : ± .015mm 5. O.D. (Outer diameter) : ± 0.15mm 6. Component Fitting : 7. Marking : 8. Radio Opaque Line : Present / Absent 9. Strength of Joint : 10. Leakage Test : 11. Sterility : 12. Chemical Test :

ADDITIONAL TESTS

Nil.

LIMITS


LABELLING

Nil


100 Numbers.

SHELF LIFE




Drug Name : Endotracheal Tube 5.5 with Cuff Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

280


1. Description 2. Tip : 3. Length : ± 5mm 4. I.D. (Inner diameter) : ± .015mm 5. O.D. (Outer diameter) : ± 0.15mm 6. Component Fitting : 7. Marking : 8. Radio Opaque Line : Present / Absent 9. Colour: 10. Balloon: 11. Value 12. Strength of Joint : 13. Leakage Test : 14. Leakage of Secondary Tube: 15. Sterility : 16. Chemical Test :

ADDITIONAL TESTS

Nil.

LIMITS


LABELLING

Nil


100 Numbers.

SHELF LIFE



S27062 to S27067& S27193 Quality Control Department

Drug Name : Folley’s Catheter Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

281


1. Description 2. Total Appearance 3. Functional Testing 4. Physical Testing 5. Intracutaneous Reactivity 6. Undue Toxicity 7. Sterility

ADDITIONAL TESTS

Nil.

LIMITS


LABELLING

Nil


100 Numbers.

SHELF LIFE




Drug Name : Infant Feeding Tube 4F Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

282


1. Description 2. Tip 3. Eye 4. Length ± 10mm 5. O.D ± .15mm 6. Component Fitting 7. Marking 8. Radio Opaque Line 9. Colour 10. Chemical Test 11. Sterility

ADDITIONAL TESTS

Nil.

LIMITS


STORAGE

Nil

LABELLING

Nil


100 Numbers.

SHELF LIFE




Drug Name : Insulin Syringe with Fixed Needle 29G (1ml) Page 1 of 1


Official Standards : IS : 12227-1987

Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

284


1. Description 2. Capacity of syringes 3. Graduation scale 4. Numbering of scale 5. Barrel 6. Piston / plunger Assembly 7. Size of Needle 8. Performance of Assembled syringe 9. Nozzle 10. Freedom from Extraneous matter 11. Limits for extractable matter 12. Lubrication of syringes and needles 13. Sterility 14. Bacterial Endotoxin : Less than 20 Eu/device

ADDITIONAL TESTS

Nil.

LIMITS

For test 1 to 11, limit as per IS: 12227-1987.

LABELLING

Nil


100 Numbers.

SHELF LIFE




Drug Name : Monofilament poly amide 10/0 CS – ultima ½ Circle double Needle 6mm Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

285




ADDITIONAL TESTS

Nil.

LIMITS


LABELLING



30 + 30 Numbers.

SHELF LIFE




Drug Name : Monofilament Poly Amide 10/0 CS – ultima 3/8 Circle double Needle 6mm Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

286




ADDITIONAL TESTS

Nil.

LIMITS


LABELLING



30 + 30 Numbers.

SHELF LIFE




Drug Name : Monofilament Poly Propylene Blue 3-0 70cm 3/8 Circle Cutting 22mm Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

287




ADDITIONAL TESTS

Nil.

LIMITS


LABELLING



30 + 30 Numbers.

SHELF LIFE




Drug Name : Monofilament Poly Propylene Blue 170cm ½ CRB (Heavy) 40mm Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

288




ADDITIONAL TESTS

Nil.

LIMITS


LABELLING



30 + 30 Numbers.

SHELF LIFE




Drug Name : Monofilament Poly Propylene Blue 1-0 70cm ½ CRB 30mm Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

289




ADDITIONAL TESTS

Nil.

LIMITS


LABELLING



30 + 30 Numbers.

SHELF LIFE




Drug Name : Monofilament polyamide 8/0 ½ circle reverse cutting micro point 8mm Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

290




ADDITIONAL TESTS

Nil.

LIMITS


LABELLING



30 + 30 Numbers.

SHELF LIFE




Drug Name : Non- Adherent Sterile Rayon Dressing Impregnated with 10 Povidone Iodine size 10 x 10cm Page 1 of 1


Official Standards : KMSCL In-house Specification

Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

291


1. Description. 2. Fibre Identification : (Shall comply with test for viscore)

3. Thread / 10cm : Courses NLT 76 - NMT 145, Wales NLT 60 - NMT 85

4. Weight / Unit Area of Fabric : NLT 150g/m2 – NMT 210g/m2

5. Content of Ointment on Dressing in g: 3.00g ± 0.50g.

6. Assay - Povidone Iodine Content: 10.00% w/w ± 2.00% w/w % w/w.

ADDITIONAL TESTS

Nil.

LIMITS


LABELLING



30 + 30 Numbers.

SHELF LIFE



S27203, S27204 & S27205 Quality Control Department

Drug Name : Oxygen Catheter 8F / 10F/ 12F Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

292


1. Description. 2. Physical test 3. Tip 4. Eye 5. Total Length : ± 10mm 6. Effective length : ± 10mm 7. O.D : ± 1mm 8. Component Fitting 9. Marking 10. Radio Opaque Line 11. Colour 12. Chemical test 13. Sterility

ADDITIONAL TESTS

Nil.

LIMITS


LABELLING

Ref IP/USP/IHS


100 Numbers.

SHELF LIFE




Drug Name : Paediatric Bag Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

293


1. Description 2. Identification : 3. Nominal Volume 4. Extractable Volume 5. PH (5.0 – 6.0) 6. Bacterial Endotoxins : Not more than 5.56 EU/ml 7. Chloride : Not more than 0.0035% 8. Sterility 9. Particulate matter 10. Assay : Limit – It contains in each 100 ml, not less than 2.11 g and not more

than 2.33 g of monobasic sodium phosphate, not less than 30.30 g and not more than 33.50 g of dextrose, not less than 19.16 g and not more than 21.18 g, of total citrate, expressed as citric acid anhydrous, not less than 6.21 g and not more than 6.86 g of sodium, and not less than 0.247 g and not more than 0.303 g of adenine

ADDITIONAL TESTS

Nil.

LIMITS


LABELLING

Label it to indicate the number of ml of solution required per 100ml of whole blood or the number of ml of solution required per volume of whole blood to be collected.


30 + 30 Numbers.

SHELF LIFE




Drug Name : Plaster of Paris Bandages BP 15 cm x 2.7m Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

294


1. Description. 2. Fibre Identification 3. Threads per 10 cm – (Warp 143 to 157 weft – 71 to 79) 4. Weight per amt area – (Fabric not less than 24 gm per m2, bandage not less

than 340 gm per m2) 5. Calcium sulphate hemihydrate - Not less than 88% of the calcium sulphate

content calculated as Calcium sulphate Hemi hydrate 6. Setting Time – The plaster mass remains work role for not less than Iminate

after removal if bandage freom water and not should be set after 8 mts. When removed from the mandival cast should not evaluable and the pressure of the fingers.

ADDITIONAL TESTS

Nil.

LIMITS


LABELLING


5 + 5 Rolls

SHELF LIFE




Drug Name : Poliglecarpone 25 (Dyed) Size 1/0 with Round Body Needle For Anastamosis Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

295




ADDITIONAL TESTS

Nil.

LIMITS


LABELLING



30 + 30 Numbers.

SHELF LIFE




Drug Name : Poliglecarpone 25 (Dyed) Size 2/0 with Black JB Shaped Round Body Needle For Anastamosis Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

296




ADDITIONAL TESTS

Nil.

LIMITS


LABELLING



30 + 30 Numbers.

SHELF LIFE




Drug Name : Poliglecarpone 25 (Dyed) Size 2/0 with Round Body Needle For Anastamosis Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

297




ADDITIONAL TESTS

Nil.

LIMITS


LABELLING



30 + 30 Numbers.

SHELF LIFE




Drug Name : Poliglecarpone 25 (Dyed) Size 3/0 with Black JB Shaped For Anastamosis Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

298




ADDITIONAL TESTS

Nil.

LIMITS


LABELLING



30 + 30 Numbers.

SHELF LIFE




Drug Name : Poliglecarpone 25 (Dyed) Size 3/0 with Cutting Needle For Subcuticular Suturing Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

299




ADDITIONAL TESTS

Nil.

LIMITS


LABELLING



30 + 30 Numbers.

SHELF LIFE




Drug Name : Poliglecarpone 25 Size 1/0 with Round Body Needle For Anastamosis Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

300


1. Description. 2. Length : Limit not less than 95.0% of the length stated on the label 3. Diameter : Ref. SUT Table II 4. Tensile Strength : Ref. SUT Table II 5. Needle attachment : Ref. SUT Table V & VI 6. Sterility : If sterile 7. Extractable colour (If dyed) : Ref. SUT Table III 8. Soluble Chromium Compounds: Limit colour extracted should be loss


ADDITIONAL TESTS

Nil.

LIMITS


LABELLING



30 + 30 Numbers.

SHELF LIFE




Drug Name : Poliglecarpone 25 Size 2/0 with Round Body Needle For Anastamosis Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

301


1. Description. 2. Length : Limit not less than 95.0% of the length stated on the label. 3. Diameter : Ref. SUT Table II 4. Tensile Strength : Ref. SUT Table II 5. Needle attachment : Ref. SUT Table V & VI 6. Sterility : If sterile 7. Extractable colour (If dyed) : Ref. SUT Table III 8. Soluble Chromium Compounds: Limit colour extracted should be loss


ADDITIONAL TESTS

Nil.

LIMITS


LABELLING



30 + 30 Numbers.

SHELF LIFE




Drug Name : Polydioxanone of Size 1 with ½ Circle RB, heavy 50mm needle Suture Length 1.5m, For Sheath Closure Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

302




ADDITIONAL TESTS

Nil.

LIMITS


LABELLING



30 + 30 Numbers.

SHELF LIFE




Drug Name : Polyglactin 910 of Size 1, ½ Circle 40mm CT Needle made of Special Grade Steal for 420 with Ribbed Body for Secure Grip

Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

303




ADDITIONAL TESTS

Nil.

LIMITS


LABELLING



30 + 30 Numbers.

SHELF LIFE




Drug Name : Polyglactin 910 of Size 1, ½ Circle 36mm OB Needle made of special grade Steal 420 with ribbed body for secure grip

Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

304




ADDITIONAL TESTS

Nil.

LIMITS


LABELLING



30 + 30 Numbers.

SHELF LIFE




Drug Name : Polyglactin 910 of Size 1-0, ½ Circle 36mm OB needle made of special grade steel 420 with ribbed body for secure grip

Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

305




ADDITIONAL TESTS

Nil.

LIMITS


LABELLING



30 + 30 Numbers.

SHELF LIFE




Drug Name : Polyglactin 910 Rapid Size 2/0 with Taper Needle For Episiotomy Repair Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

306




ADDITIONAL TESTS

Nil.

LIMITS


LABELLING



30 + 30 Numbers.

SHELF LIFE




Drug Name : Monofilament Poly Propylene Blue 3-0 70cm 3/8 Circle Cutting 22mm Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

307




ADDITIONAL TESTS

Nil.

LIMITS


LABELLING



30 + 30 Numbers.

SHELF LIFE




Drug Name : Poly Glycolic Acid 1-0, Round Body, ½ Circle, 40mm, 150cm Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

308




ADDITIONAL TESTS

Nil.

LIMITS


LABELLING



30 + 30 Numbers.

SHELF LIFE




Drug Name : Poly Glycolic Acid 2-0, Taper Cut, ½ Circle, 30mm, 90cm Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

309




ADDITIONAL TESTS

Nil.

LIMITS


LABELLING



30 + 30 Numbers.

SHELF LIFE




Drug Name : Poly Glycolic Acid No. 1, ½ Circle, 40mm, 90cm Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

310




ADDITIONAL TESTS

Nil.

LIMITS


LABELLING



30 + 30 Numbers.

SHELF LIFE




Drug Name : Poly Glycolic Acid Size 2/0 with Double Armed Needle for Episiotomy Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

311


1. Description. 2. Length : Limit not less than 95.0% of the length stated on the label 3. Diameter : Ref. SUT Table II 4. Tensile Strength : Ref. SUT Table II 5. Needle attachment : Ref. SUT Table V & VI 6. Sterility : If sterile 7. Extractable colour (If dyed) : Ref. SUT Table III 8. Soluble Chromium Compounds: Limit colour extracted should be loss


ADDITIONAL TESTS

Nil.

LIMITS


LABELLING



30 + 30 Numbers.

SHELF LIFE




Drug Name : Poly Glycolic Acid with Calcium Stearate Size 01 with 36mm Reverse Cutting Ortho Special (O.S) Needle

Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

312




ADDITIONAL TESTS

Nil.

LIMITS


LABELLING



30 + 30 Numbers.

SHELF LIFE




Drug Name : Poly Glycolic Acid with Calcium Stearate Size 5/0 with ethiprime Cutting 12mm Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

313




ADDITIONAL TESTS

Nil.

LIMITS


LABELLING



30 + 30 Numbers.

SHELF LIFE




Drug Name : Poly Glycolic Acid with Calcium Stearate Size 6/0 with Micropoint Spatulate 8mm Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

314




ADDITIONAL TESTS

Nil.

LIMITS


LABELLING



30 + 30 Numbers.

SHELF LIFE


DRUGS AND SUPPLIES Drug Code : S27136 t0


Drug Name : Poly Propylene 1, ½ CRB 30 mm needle Hoary 75cm Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

315




ADDITIONAL TESTS

Nil.

LIMITS


LABELLING



30 + 30 Numbers.

SHELF LIFE




Drug Name : Quadraple Bag with SAGM Platelet storage Page 167 of 1


Official Standards : Indian Pharmacopoeia 2007 & KMSCL In-house Method.

Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

316


For CPD as per IP 2007, Volume II, Page 737 – 738: 1. Description 2. Identification : 3. Test 4. PH : 5.0 – 6.0 5. Bacterial Endotoxins : Not more than 5.56 EU/ml Ref G – INJ 006 6. Sterility: Ref. G-INJ 005 7. Particulate matter : G – INJ 001 8. Extractable volume : G – INJ 004 9. Assay: Contains not less than 95.0% and not more than 1050% of the stated amounts of

sodium citrate, citric acid, Sodium Dihydrogen. For SAGM - KMSCL In-house Method:. 1. Description 2. Identification 3. PH : 4.7 – 5.7 FOR SAGM – 1 ; 5 – 6 FOR SAGM – 2 4. Bacterial Endotoxins : Should be less than 5.56 EU/ML REF G-INJ 006 5. Sterility: Ref. G-INJ 005 6. Particulate matter : G – INJ 001 7. Extractable volume : G – INJ 004 8. Assay : 90.0 – 110.0 % of sodium chloride, Adenine, Dextrose (monohydrate) and Mannitol Copy Print HIS of label claim SAGM Page – 1, 2, 3.

LIMITS Indian Pharmacopoeia 2007 & KMSCL In-house Method. LABELLING

1. It contains no antimicrobial agent 2. The composition and volume of the solution 3. Volume of solution required for 100 ,l; of whole blood 4. Where applicable, the maximum amount of blood to be collected in the container.

QUANTITY REQUIRED FOR ANALYSIS-50 numbers




Drug Name : Ryle’s Tube Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

317


1. Description Physical Tests: 2. Number of lateral eyes – Four 3. Marking Ist 50 ± 0.50cm

IInd 60 ± 0.50cm IIIrd 70 ± 0.50cm from distal end

4. Component Physico – Chemical Tests: 5. Non volatile matters NMT 15 mg 6. Reside on ignition NMT 05 mg 7. Radio Opaque line 8. Heavy metals NMT 1.0 PPM 9. Buffering Capacity NMT 10ml of 0.01N HCl Biological Tests: 10. Sterility


LIMITS


LABELLING Nil


SHELF LIFE




Drug Name : SICS Blade (Sharp Edge) Crescent Blade 2.8mm Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

318



1. Surface Finish

2. Corrosion Test

3. Limits for acidity and alkalinity as per ISO - 9626: 2001.

Biological Testing:

4. Sterility


ADDITIONAL TESTS

Nil.

LIMITS


LABELLING

Nil


100 Numbers.

SHELF LIFE




Drug Name : SICS Blade (Sharp Edge) Keratomo Blade (2.8mm) Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

319



1. Surface Finish

2. Corrosion Test

3. Limits for acidity and alkalinity Limits as per ISO - 9626 : 2001

Biological Testing:

4. Sterility


ADDITIONAL TESTS

Nil.

LIMITS


LABELLING

Nil


100 Numbers.

SHELF LIFE




Drug Name : Sics Blade (Sharp Edge) side port Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

320



1. Surface Finish

2. Corrosion Test

3. Limits for acidity and alkalinity as per ISO - 9626 : 2001.

Biological Testing:

4. Sterility



LIMITS


STORAGE

Nil

LABELLING

Nil


100 Numbers.

SHELF LIFE




Drug Name : Suction Catheter Size – 10 / 12 / 14 / 6 / 8 Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

321


1. Description 2. Tip 3. Eye 4. Total Length ± 10mm 5. Effective Length 6. O.D ± 15mm 7. Component Fitting 8. Marking 9. Radio Opaque line 10. Colour 11. Leakage Test 12. Chemical Test 13. Sterility 14. Strength of Joint

ADDITIONAL TESTS

Nil.

LIMITS


LABELLING

Nil


100 Numbers.

SHELF LIFE




Drug Name : Surgical Silk 2-0 St. RB 50 mm Needle 76cm Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

322




ADDITIONAL TESTS

Nil.

LIMITS


LABELLING



30 + 30 Numbers.

SHELF LIFE




Drug Name : Suture Pack Silk No. 1 Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

323


1. Description 2. Length: Limit - not less than 95.0% of the length stated on the label. 3. Diameter : Limit – Ref. Table 4 4. Tensile Strength : Ref. Table 4 5. Sterility (If claimed sterile) 6. Needle attachment : Ref. SUT Table 5 6 7. Soluble chromium compounds 8. Extractable colour : Ref. SUT Table 3

ADDITIONAL TESTS

Nil.

LIMITS

LABELLING

Nil


SHELF LIFE




Drug Name : Virgin Silk 8/0 3/8 Circle micropoint spatulated 6mm needle Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

324




ADDITIONAL TESTS

Nil.

LIMITS


LABELLING



30 + 30 Numbers.

SHELF LIFE




Drug Name : Virgin Silk 8/0 3/8 Circle micropoint spatulated double needle 6mm Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

325




ADDITIONAL TESTS

Nil.

LIMITS


LABELLING



30 + 30 Numbers.

SHELF LIFE

326

KKEE

RRAA

LLAA

MM

EEDD

II CCAA

LL

SSEE

RRVV

II CCEE

SS

CCOO

RRPP

OORR

AATT

II OONN

LL

TTDD

MMIISSCCEELLLLAANNEEOOUUSS






Drug Name : Activated Charcoal Powder IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

327


1. Description. 2. Identification. 3. Acidity or Alkalinity. 4. Acid soluble substances. 5. Ethanol soluble substances. 6. Alkali soluble coloured matter. 7. Chlorides. 8. Sulphates. 9. Sulphide. 10. Uncarbonised constituents. 11. Copper. 12. Lead. 13. Zinc. 14. Sulphated ash- Not more than 5.0% 15. Loss on drying- NMT 15.0% determined on 1.0 gram in an oven at 105 °C. 16. Adsorbing power.


LIMITS


LABELLING






Drug Name : Black Disinfectant Fluid Grade-III Page 1 of 1


Official Standards : IS 1061:1997

Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

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Name:

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Authorized By:

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(Managing Director)

328


1. Description 2. Stability after dilution 3. Germicidal value- Minimum 5.0 4. Mercury compounds-Should be absent. 5. Rideal Walker Co-efficient using Salmonella typhi - Should pass the test for

normal type.

ADDITIONAL TESTS

LIMITS

For test 1 to 5, limit as per IS 1061:1997.

LABELLING


20 Numbers.

SHELF LIFE

Minimum 2 years.




Drug Name : Bleaching Powder 30 % IP Page 1 of 1

Synonym : Chlorinated Lime Copy No. 1

Official Standards : Indian Pharmacopoeia 1985, Appendix A-172

Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

329


1. Description 2. Identification 3. Solubility-Slightly soluble in water. 4. Stability-Loses NMT 3.0 % of its available chlorine by weight when heated

to 100°C for 1 hour. 5. Assay: - Limit NLT 30.0%w/w of available chlorine.

ADDITIONAL TESTS

Nil

LIMITS

For test 1 to 5, limit as per IP-1985, Appendix A-172.

LABELLING


40 Numbers.

SHELF LIFE




Drug Name : Gentian Violet Paint BPC Page 1 of 1

Synonym : Crystal Violet Paint Copy No. 1

Official Standards : British Pharmaceutical Codex 1973

Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

330


1. Description. 2. Light absorption (NLT 0.32 at 585 nm).

ADDITIONAL TESTS

Nil

LIMITS

For test 1 to 2, limit as per BPC-1973

LABELLING


2 x 500 ml.

SHELF LIFE

Minimum 2 years.




Drug Name : Liquid Paraffin IP Page 1 of 1

Synonym : White Mineral Oil, Liquid Petroleum Copy No. 1


Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

331


1. Description 2. Weight per ml-Limit-0.866 to 0.904 gram 3. Dynamic Viscosity-Limit, 110 m Pas to 230 m Pas determined

at 20°c± 1° C by method B 4. Acidity or Alkalinity 5. Light absorption 6. Readily carbonisable substances 7. Solid Paraffin’s 8. Sulphur compounds

ADDITIONAL TESTS

Nil

LIMITS


LABELLING


2 Numbers.

SHELF LIFE

Minimum 18 months.




Drug Name : Nitrous Oxide IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

332


1. Description. 2. Identification. 3. Acidity or alkalinity. 4. Arsine and phosphine. 5. Carbon dioxide. 6. Carbon monoxide. 7. Halogens and hydrogen sulphide. 8. Nitric oxide and nitrogen dioxide. 9. Oxidising substances. 10. Water. 11. Assay- not less than 98.0 % v/v of Nitrous oxide.


LIMITS


LABELLING

The cylinder is printed blue and carries a label stating “NITROUS OXIDE”. In addition “NITROUS OXIDE” or the symbol “N2O”, should be Stenciled in paint on the shoulder of the cylinder.


1 Number.

SHELF LIFE




Drug Name : Oxygen IP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

333


1. Description. 2. Identification. 3. Carbon dioxide. 4. Carbon monoxide. 5. Water vapour. 6. Assay- not less than 99.0 % v/v of Oxygen.

ADDITIONAL TESTS

Nil

LIMITS


LABELLING

The shoulder of the metal cylinder should be painted white and the remainder should be painted black. The cylinder should carry a label stating “oxygen”, in addition “OXYGEN” or the Symbol “O2” should be stenciled in paint on the shoulder of the cylinder.


1 Number.

SHELF LIFE




Drug Name : Purified Talc IP Page 1 of 1

Synonym : Talc, Talcum Copy No. 1


Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

334


1. Description 2. Identification 3. Acidity or Alkalinity 4. Iron 5. Acid soluble substances 6. Water soluble substances 7. Carbonates 8. Chlorides 9. Organic Compounds 10. Loss on Drying-NMT 1.0% (180°C for 1 hour)


LIMITS


LABELLING


2 Numbers.

SHELF LIFE

Minimum 18 months.




Drug Name : Surgical Spirit 70.0%v/v BP Page 1 of 1



Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

335


1. Description 2. Identification 3. Weight/ml-Limit 0.817 to 0.827 4. Assay: -

For methyl salicylate-limit- 0.45%v/v to 0.55% v/v For diethylphthalate-limit- 1.80% v/v to 2.20% v/v

ADDITIONAL TESTS

Nil

LIMITS


LABELLING

1. The label states that the preparation is flammable and should be kept away from naked eye.

2. The date after which the spirit is not intended to be used. 3. The condition under which the spirit should be stored. (Refer page 2254

BP)


4 Numbers.

SHELF LIFE

Minimum 18 months.




Drug Name : Washing Soda Page 1 of 1


Official Standards : IS 251:1998, IS 251:1972

Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

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(Head - QA)

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336


1. Description 2. Bulk density: 3. Dense grade 950 to 1256 g/l. 4. Light grade 500 to 750 g/l. 5. Volatile matter content: not exceeding 2%. 6. Total alkalinity (as Na2CO3): not less than 98.5% on dry basis. 7. Matter insoluble in water: not less than 0.15%w/w. 8. Sulphates (as na2so4): not more than 0.08%w/w. 9. Chlorides (as NaCl): not more than 1%w/w. 10. Iron (as Fe2O3): not more tan 0.007%w/w.


LIMITS

For test 1 to 10, limit as per IS 251:1998 and IS 251:1972.

LABELLING

Packages may be marked with ISI certification. Should mention as, for washing/ cleaning use only.


2 Numbers.





Drug Name : White Soft Paraffin IP Page 1 of 1

Synonym : White Petroleum Jelly Copy No.

1


Prepared By:

Date:

Name:


Checked By:

Date:

Name:

(Head - QC)

Approved By:

Date:

Name:

(Head - QA)

Authorized By:

Date:

Name:

(Managing Director)

337


1. Description 2. Melting range –Limit-38°c to 56°c. 3. Acidity or Alkalinity 4. Light absorption-NMT 0.5 5. Fixed oils ,fats and resins 6. Foreign organic matter 7. Constitency 8. Sulphated Ash-Limit NMT 0.1%

ADDITIONAL TESTS

Nil

LIMITS


LABELLING

Nil


2 Numbers.

SHELF LIFE

Minimum 2 years.

338

KKEE

RRAA

LLAA

MM

EEDD

II CCAA

LL

SSEE

RRVV

II CCEE

SS

CCOO

RRPP

OORR

AATT

II OONN

LL

TTDD

GGEENNEERRAALL TTEESSTTSS




DRUGS AND MEDICINES Quality Control Department

GENERAL TESTS - TABLETS

339

≥25mg &≥25% <25mg or <25%

Uncoated WV CUFilm WV CU

Others CU CUHard WV CU

Suspension, emulsion or

gelCU CU

Solutions WV WVSingle

componentWV WV

Solution freeze-dried

in final container

WV WV

Others CU CU

CU CU

WV WV

CU CU

CU CUCU CUCU CUOthers

TabletsCoated

CapsulesSoft

Solids in single unit containersMultiple

component

Suspension, emulsion, or gel for systemic use only, packaged in single-unit containers

Solutions for inhalation packaged in glass or plastic ampuls and intended for use in nebulizers, and oral solutions packaged in unit-dose containsers and into soft capsules

Inhalations (other than solutions for inhalation packaged in glass or plastic ampulos and intended for use in nebulizers) packaged in premetered dosage units.

Transdermal systemsSuppositories

Table 1. Application of Content Uniformity (CU) and Weight Variation (WV) Tests for Dosage Forms

Dose & ratio of Drug Type SubtypeDosage Form




340

G-TAB- 001 Uniformity of content :

This test is applicable to tablets that contain 10mg or less than 10mg or less than 10% w/w of active ingredient. For tablets containing more than 1 active ingredient carry out the test for each active ingredient that corresponds to the aforementioned conditions. The test is also applicable to coated tablets other than film coated tablets, irrespective of their content of active substances. Determine the content of active ingredient(s) in each 10 tablets taken at random using the method given in the monograph or by any other suitable analytical method. The preparation complies with the test, if each individual content is 85.0 to 115.0 % of the average content. The preparation fails to comply with the test if more than 1individual content is outside these limits or if 1individual content is outside the limits of 75.0 to 125.0% of the average content.

If 1individual content is outside the limits of 85.0 to 115 .0% of the average content, but with in the limits of 75.0 to 125.0%, repeat the determination using another 20 tablets. The preparation complies with the test if not more than 1 of the individual contents of the total sample of 30 tablets is outside the limits of 85.0 to 115.0 % of average content and none is outside the limits of 75.0 to 125.0% of the average content.

G-TAB -002 Uniformity of weight:

Not applicable to coated tables other than film coated tablets and to tablets that are required to comply with the test for uniformity of content for all active ingredients.

Weigh individually 20 units selected at random and calculate the average weight.

Not more than 2 of the individual weights deviates from the average weight by more than the per cent shown in the table and none deviates by more than twice that percentage.

Average Weight (uncoated & film coated tablets) Percentage deviation

80mg or less 10

More than 80 mg but less than 250mg 7.5

250mg or more 5

G-TAB- 003 Dissolution:

Where required the requirements for this test are given in the individual monograph.

Level Number tested Acceptance Criteria

S1 6 Each unit is not less than D* + 5 % **

S2 6 Average of 12 units (S1+S2) is equal to or greater than D, and no unit is less than D-15 % **

S3 12 Average of 24 units (S1+S2+S3) is equal to or greater than D, not, More than 2 units are less than D-15%** and no unit is less than D-25 %**

*D is the amount of dissolved active ingredient specified in the individual monograph, expressed as a percentage of the labelled content.

** Percentage of the labelled content.




341

G-TAB- 004 Disintegration:

(Not necessary if dissolution test is prescribed):

Formulation Limit

Uncoated tablets 15 minutes( with disc, in water at 37 ± 20 C

Coated tablets other than film coated 60 minutes( with disc, in water at 37 ± 20, if fails repeat with another 6 tablets in 0.1 M Hcl at 37 ± 20C

Film Coated tablets 30 minutes (with disc, in water at 37 ±20C)

Dispersible tablets 3 minutes (with disc, in water 240-260 C )

Effervescent Tablets 5 minutes (see page No. 664 of IP 2007 , Vol 2)

Soluble Tablets 3 minutes ( with disc, in water at 15 C – 25 C )

Enteric Coated tablets If the tablet has a soluble external coating, immerse the basket in water at room at temperature for 5 minutes. Suspend the assembly in the beaker containing 0.1 M hydrochloric acid and operate without the disc for 120 minutes, unless otherwise stated in the individual monograph. Remove the assembly from the liquid. No tablet shows signs of cracks that would allow the escape of the contents of disintegration, apart from fragments of coating. Replace the liquid in the beaker with mixed phosphate buffer PH 6.8, add a disc, to each tube and operate the apparatus for a further 60 minutes. Remove the assembly from the liquid. The tablets pass the test if all six have disintegrated.

G-TAB- 005 Uniformity of Dispersion :

(only for dispersible tablets ):

Place 2 tablets in 100ml of water and stir gently until completely dispersed. A smooth dispersion is obtained which passes through a sieve screen with a nominal mesh aperture of 710 mm (sieve number 22)

ADDITIONAL TESTS

G-TAB-006 Hardness:

Minimum 3 Kg / cm2

G-TAB-007 Friability: (only for uncoated tablets )

A maximum loss of weight not greater than 1% is acceptable for most tablets If obviously cracked , chipped or broken tablets are present in the sample after tumbling the sample fails the test. (Reference Page 183 of IP 2007 Vol. 1




342

G-CAP-001 Uniformity of weight:

(The test is not required if the test uniformity of content is prescribed )

If average weight of capsule contents;

a) less than300 mg, deviation allowed is 10% b) 300 mg or more, deviation allowed is 7.5%.

G-CAP-002 Uniformity of Content:

This test is applicable to capsules that contain less than 10mg or less than 10% w/w of active ingredient. For capsules containing more than 1 active ingredient carry out the test for each active ingredient that corresponds to the aforementioned conditions.

Determine the content of active ingredient in each of 10 capsules taken at random using the method given in the monograph or by any other suitable analytical method of equivalent accuracy and precession. The capsules comply with the test if not more than 1 of the individual values thus obtained is outside the limits 85 to 115 % of the average value and none is outside the limits 75 to 125% . If 2 or 3 individual values are outside the limits 85 to 115% of the average values repeat the determination using another 20 capsules. The capsules comply with the test if in the total sample of 30 capsules not more than 3 individual values are outside the limits 85 to 115% and none is outside the limits 75 to 125% of the average value.

The test is not applicable for capsules containing multivitamins and trace elements.

G-CAP- 003 Disintegration:

(This test is not required for the capsules for which dissolution test is included in the individual monograph)

a) Hard Gelatin capsules--30 minutes b) Soft Gelatin capsules--60 minutes c) Enteric coated capsules—2 Hours in 0.1 M Hcl. without discs. No capsule shows signs of disintegration or

of rapture permitting the escape of the contents . Replace the medium in the vessel with mixed phosphate buffer PH 6.8 Add a disc to each tube and operate the apparatus for a further 60 minutes . They pass the test if no residue remains on the screen or on the underside of the discs, or, if a residue remains , it consists of fragments of shell or of a soft mass with no palpable , unmoistened core.

G-CAP- 004 Dissolution:

LEVEL Number tested Acceptance criteria

S-1 6 Each unit is not less than D *+ 5 Per cent **

S-2 6 Average of 12 units (S1+S2)is equal to or greater than D, and no unit is less than D-15.0 % **

S-3 12 Average of 24 units(S1+S2+S3) is equal to or greater than D, not more than 2 units are less than D-15 % **and no unit is less than D-25.0 %**

*D is the amount of dissolved active ingredient specified in the individual monograph, expressed as a percentage of the labelled content.

**Percentages of the labelled content



GENERAL TESTS - ORAL LIQUIDS

343

(Elixirs, Linctuses, Mixtures, Oral drops, Syrups, Orals emulsions,

Oral Solutions, Oral Suspensions)

G-ORA-001 Uniformity of content:

Unless otherwise specified, single dose liquids in suspension form or powders or granules presented in single dose containers and that contain less than 10mg or less than 10% of active ingredient comply with the following test. For oral liquids containing more than 1 active ingredient, carry out the test for each active ingredient that corresponds to the above conditions. Determine the contents of active ingredient(s) of each 10 containers taken at random using the method given in the monograph or by any other suitable analytical method of equivalent accuracy and precision. The preparation complies with the test if the individual values thus obtained are all between 85 to 115 % of average value. The preparation fails to comply with the test if more than 1 individual value is outside the limits 85 to 115% of average value or if anyone individual value is outside the limits 75 to 125% of the average value. If one individual value is outside the limits 85 to 115 % but within the limits 75 to 125% of the average value, repeat the determination using another 20 containers taken at random. The preparation complies with the test if in the total sample of 30 containers not more than 3 individual values are outside the limits 85 to 115 % and not more than one is outside the limits 75 to 125% of the average value.

G-ORA-002 Uniformity of volume:

The average net volume of the contents of the 10 containers is not less than the labelled amount , and the net volume of the contents of any single containers is not less than 91 per cent and not more than 109 per cent of the labelled amount where the labelled amount is 50 ml or less, or not less than 95.5 per cent and not more than 104.5 per cent of the labelled amount where the labelled amount is more than 50 ml but not more than 200 ml, or not less than 97 per cent but not more than 103 per cent of the labelled amount where the labelled amount is more than 200ml but not more than 300 ml.

If this requirement is not met, determine the net volume of the contents of 10 additional containers. The average net volume of the contents of the 20 containers is not less than the labelled amount, and the net volume of the contents of not more than 1 of the 20 containers is less than 91 per cent or more than 109 per cent of the labelled amount where the labelled amount is 50 ml or less or less than 95.5 per cent or more than 104.5 per cent of the labelled amount where the labelled amount is more than 50 ml but not more than 200 ml, or less than 97 per cent or more than 103 per cent of the labelled amount where the labelled amount is more than 200ml but not more than 300 ml.



GENERAL TESTS - ORAL POWDERS

344

G-ORP-001 Uniformity of content:

Unless otherwise specified, Oral powders presented in single dose containers that contain less than 10 mg of active ingredient per dose or that contain less than 10 % w/w of active ingredient comply with the following test. For oral powders containing more than 1 active ingredient carry out the test for each active ingredient that corresponds to the above conditions. Determine the content of active ingredient(s) of each 10 containers taken at random using the method given in the monograph or by any other suitable analytical method of equivalent accuracy and precision. The preparation complies with the test if the individual values thus obtained are all between 85 to 115 % of average value. The preparation fails to comply with the test if more than 1 individual value is outside the limits 85 to 115% of average value or if anyone individual value is outside the limits 75 to 125% of average value. If one individual value is outside the limits 85 to 115 % but within the limits 75 to 125% of the average value, repeat the determination using another 20 containers taken at random. The preparation complies with the test if in the total sample of 30 containers not more than 3 individual values are outside the limits 85 to 115 % and not more than one is outside the limits 75 to 125% of the average value.

Note: Test for Uniformity of content is not applicable to preparations containing multivitamins and trace elements.

G-ORP-002 Uniformity of Weight:

The average net weight of the contents of the 10 containers is not less than the labelled amount and the net weight of the contents of any single containers is not less than 91 % and not more than 109 % of the labelled amount where the labelled amount is 50gm or less, or not less than 95.5% and not more than 104.5% of the labelled amount where the labelled is more than 50gm but not more than 100gm.

If this requirement is not met determine the net weight of the contents of 10 of additional containers. The average net weight of the contents of the 20 containers is not less than the labelled amount, and the net weight of the contents of not more than 1 of the 20 containers is less than 91% or more than 109% of the labelled amount where the labelled amount is 50gm, or less than 95.5% or more than 104.5% of the labelled amount is more than 50gm but not more than 100gm.



GENERAL TESTS - GELS

345

G-GEL-001 Uniformity of weight:

The average net weight of the contents of the 10 containers is not less than the labelled amount and the net weight of the contents of any single container is not less than 91 % and not more than 109 % of the labelled amount where the labelled amount is 50gm or less, or not less than 95.5% and not more than 104.5% of the labelled amount where the labelled is more 50gm but not more than 100gm.

If this requirement is not met determine the net weight of the contents of 10 of additional containers. The average net weight of the contents of the 20 containers is not less than the labelled amount, and the net weight of the contents of not more than 1 of the 20 containers is less than 91% or more than 109% of the labelled amount where the labelled amount is 50gm or less than 95.5% or more than 104.5% of the labelled amount is more than 50gm but not more than 100gm.

G-GEL -002 Sterility: (if labelled as sterile)

Should comply with the test for sterility as per IP 2007.



GENERAL TESTS - CREAMS

346

G-CRE-001 Uniformity of weight:

The average net weight of the contents of the 10 containers is not less than the labelled amount and the net weight of the contents of any single container is not less than 91 % and not more than 109 % of the labelled amount where the labelled amount is 50gm or less, or not less than 95.5% and not more than 104.5% of the labelled amount where the labelled amount is more than 50gm but not more than 100gm.

If this requirement is not met determine the net weight of the contents of 10 additional containers . The average net weight of the contents of the 20 containers is not less than the labelled amount, and the net weight of the contents of not more than 1 of the 20 containers is less than 91% or more than 109% of the labelled amount where the labelled amount is 50gm or less, 95.5% or more than 104.5% of the labelled amount where the labelled amount 50gm but not more than 100gm.

G-CRE -002 Sterility: (if labelled as sterile)

Should comply with the Test for Sterility as per IP 2007.



GENERAL TESTS - OINTMENTS

347

G-OIN-001 Uniformity of weight:

The average net weight of the contents of the 10 containers is not less than the labelled amount and the net weight of the contents of any single containers is not less than 91 % and not more than 109 % of the labelled amount where the labelled amount is 50gm or less, or not less than 95.5% and not more than 104.5% of the labelled amount where the labelled is more 50gm but not more than 100gm.

If this requirement is not met determine the net weight of the contents of 10 of additional containers. The average net weight of the contents of the 20 containers is not less than the labelled amount, and the net weight of the contents of not more than 1 of the 20 containers is less than 91% or more than 109% of the labelled amount where the labelled amount is 50gm or less than 95.5% or more than 104.5% of the labelled amount is more than 50gm but not more than 100gm.

G-OIN -002 Sterility: (if labelled as sterile)

Should comply with the Test for Sterility as per IP 2007.



GENERAL TESTS - PESSARIES

348

1. COMPRESSED PESSARIES – (VAGINAL TABLET) 2. SHELL PESSARIES - (VAGINAL SOFT CAPSULES) 3. MOULDED PESSARIES

G-PES-001 Uniformity of Content:

This test is applicable to Pessaries that contain less than 10mg or less than 10% of active ingredient. For pesssaries containing more than 1 active ingredient carry out the test for each active ingredient that corresponds to the above conditions. Determine the content of active ingredient in each of 10 pessaries taken at random using the method given in the monograph or by any other suitable analytical method of equivalent accuracy and precision. The preparation complies with the test, if not more than 1of the individual content thus obtained is outside the limits 85.0 to 115.0 % of the average content and none is outside the limits 75.0 to 125 % of the average content.

If 2 or 3 individual contents are outside the limits of 85.0 to 115 .0% of the average content, repeat the determination using another 20 dosage units. The preparation complies with the test if in the total sample of 30 pessaries not more than 3 individual contents are outside the limits 85.0 to 115.0 % and none is outside the limits 75.0 to 125.0% of the average content.

G-PES-002 Uniformity of Weight:

This test is not applicable to pessaries that are required to comply with the test for uniformity of content for all active ingredients .Weigh individually 20 Pessaries, taken at random, and determine the average weight. Not more than two of the individual weights deviate from the average weight by more than 5 per cent and none deviates by more than 10 per cent.

G-PES-003 Disintegration:

Not more than 30 minutes for compressed pessaries and shell pessaries. Not more than 60 minutes for moulded pessaries. The test is not necessarily applicable to pessaries intended for modified release or for prolonged local action.



GENERAL TESTS - SUPPOSITORIES

349

1. MOULDED SUPPOSITORIES 2. SHELL SUPPOSITORES (RECTAL CAPSULES )

G-SUP-001 Uniformity of Content:

This test is applicable to Suppositories that contain less than 10mg or less than 10% of active ingredient. For Suppositories containing more than 1 active ingredient carry out the test for each active ingredient that corresponds to the above conditions. Determine the content of active ingredient in each of 10 suppositories taken at random using the method given in the monograph or by any other suitable analytical method of equivalent accuracy and precision. The preparation complies with the test, if not more than 1of the individual content thus obtained is outside the limits 85.0 to 115.0 % of the average content and none is outside the limits 75.0 to 125 % of the average content.

If 2 or 3 individual contents are outside the limits of 85.0 to 115 .0% of the average content, repeat the determination using another 20 dosage units. The preparation complies with the test if in the total sample of 30 suppositories not more than 3 individual contents are outside the limits 85.0 to 115.0 % and none is outside the limits 75.0 to 125.0% of the average content

G-SUP-002 Uniformity of Weight:

This test is not applicable to Suppositories that are required to comply with the test for uniformity of content for on active ingredients .Weigh individually 20 Suppositories, taken at random, and determine the average weight. Not more than two of the individual weights deviate from the average weight by more than 5 per cent and none deviates by more than 10 percent.

G-SUP-003 Disintegration:

Not more than 30 minutes for shell suppositories. Not more than 60 minutes for moulded suppositories



GENERAL TESTS - EYE / EAR DROPS

350

G-EAR-001 Uniformity of Volume:

The average net volume of the contents of 10 containers is not less than the labelled amount and a net volume of contents of any single container is not less than 91% and not more than 109% of the labelled amount.

G-EAR-002 Particle Size:

(Test is applicable to ear drops and eye drops that are suspensions)

Not more than 20 particles have a maximum dimension greater than 25 µm and not more than 10 particles have a maximum dimension greater than 50 µm and none has maximum dimension greater than 100 µm .

G-EAR-003 Sterility:

(Where the label indicates the ear drops / eye drops are sterile)

Should comply with the test for sterility as per IP2007. Droppers supplied separately also should comply with sterility test



GENERAL TESTS - EYE OINTMENTS

351

G-EYO-001 Uniformity of Weight:

The average net weight of the contents of the 10 containers is not less than the labelled amount and the net weight of the contents of any single container is not less than 91 % and not more than 109 % of the labelled amount where the labelled amount is 50gm or less.

.

If this requirement is not met determine the net weight of the contents of 10 of additional containers. The average net weight of the contents of the 20 containers is not less than the labelled amount, and the net weight of the contents of not more than 1 of the 20 containers is less than 91% or more than 109% of the labelled amount where the labelled amount is 50gm or less.

G-EYO-002 Particle Size:

(Test is applicable to ear drops and eye drops that are suspensions)

Not more than 20 particles have a maximum dimension greater than 25 µm and not more than 10 particles have a maximum dimension greater than 50 µm and none has a maximum dimension greater than 100 µm .

G-EYO-003 Sterility:

(Where the label indicates the ear drops / eye drops are sterile)

Should comply with the test for sterility as per IP2007.



GENERAL TESTS - NASAL PREPARATIONS

352

G-NAS-001 Uniformity of Content:

Unless otherwise specified in individual monograph nasal preparation that are presented in single dose containers and that contain less than 10 mg or less than 10 % of active ingredient comply with the following test. For nasal preparations containing more than 1 active ingredient carry out the test for each active ingredient that corresponds to the above conditions. Determine the content of active ingredient(s) of each 10 containers taken at random using the method given in the monograph or by any other suitable analytical method of equivalent accuracy and precision. The preparation complies with the test if the individual values thus obtained are all between 85 and 115 % of average value. The preparation fails to comply with the test if more than 1 individual value is outside the limits 85 to 115% of average value or if any one individual value is outside the limits 75 to 125% of average value. If one individual value is outside the limits 85 to 115 % but within the limits 75 to 125% of the average value, repeat the determination using another 20 containers taken at random. The preparation complies with the test if in the total sample of 30 containers not more than one individual value is outside the limits 85 to 115 % and none is outside the limits 75 to 125% of the average value.

G-NAS-002 Uniformity of Weight / Volume:

Nasal preparation supplied in single application containers comply with this test. The average net weight / net volume of contents of 10 containers is not less than 91% and not more than 109% of the labelled amount where the labelled amount is 50gm / 50ml or less. If the requirement is not met determine the net weight / net volume of 10 additional containers. The average net weight / net volume of 20 containers are not less than the labelled amount and net weight / net volume of not more than 1 of 20 containers is less than 91 % or more than 109% of the labelled amount where the labelled amount is 50gm / 50ml or less).



GENERAL TESTS - PARENTERAL PREPARATIONS As Per Indian Pharmacopoeia

353

A. INJECTIONS

G-INJ-001 Particulate Matter:

Injections that are solutions, when examined under suitable conditions of visibility, are clear and practically free from particles that can be observed on visual inspection by the unaided eye. For multiple dose injections, single dose small volume parenteral preparations and parenteral solutions constituted from sterile solids the test for visible particles under (2.5.9) particulate contamination in IP 2007 volume 1 page 186 is adequate.

Parenteral Preparations in containers that are labelled as containing 100ml or more of a single dose large volume injection intended for administration by intravenous infusion should comply with the limits of sub visible particles under the test for particulate contamination in IP 2007 volume 1 page 186 -188

G-INJ-002 Particulate Contamination:

Injections that are supplied in containers with a nominal content of 100ml or more comply with the test for particulate contamination.

Method 1

Sample Particle size in µm

(equal to or greater than)

Maximum number of Particles

(Average in the units tested)

Preparation in containers with nominal content of more than 100 ml

10

25

12 per ml

2 per ml

Preparation in containers with nominal content of 100 ml

10

25

3000 per container

300 per container

Less than 100 ml 10

25

3000 per container

300 per container

Method 2

Sample Particle size in µm


Maximum number of particles



10

25

25 per ml

3 per ml


10

25

6000 per container

600 per container

Less than 100 ml 10

25

6000 per container

600 per container

G-INJ-003 Uniformity of Content:

Unless otherwise specified in individual monograph suspensions for injection that are presented in single dose containers and that contain less than 10 mg or less than 10 % of active ingredient comply with the following test.




354

For suspensions for injections containing more than 1 active ingredient carry out the test for each active ingredient that corresponds to the above conditions. Determine the content of active ingredient(s) of each of 10 containers taken at random using the method given in the monograph or by any other suitable analytical method of equivalent accuracy and precision. The preparation complies with the test if the individual values thus obtained are all between 85 and 115% of average value. The preparation fails to comply with the test if more than 1 individual value is outside the limits 85 to 115% of average value or if any one individual value is outside the limits 75 to 125% of average value. If one individual value is outside the limits 85 to 115% but within the limits 75 to 125% of the average value, repeat the determination using another 20 containers taken at random. The preparation complies with the test if in the total sample of 30 containers not more than one individual value is outside the limits 85 to 115 % and none is outside the limits 75 to 125% of the average value.

Note: The test for uniformity of content is not applicable to suspensions for injections containing multivitamins and trace elements.

G-INJ-004 Extractable Volume:

Sl. No. Nominal Volume Limits

1. Does not exceed 5 ml Average content of the 5 containers is not less than the nominal volume and not more than 115% of the nominal volume

2. Greater 5 ml The contents of each of the 3 containers are not less than the nominal volume and not more than 110% of the nominal volume

G-INJ-005 Sterility:


G-INJ-006 Bacterial Endotoxins / Pyrogen:

As per individual monograph.

B. INFUSIONS




355

G-INF-001 Particulate Contamination:

ntravenous infusions that are solutions, when examined under suitable conditions of visibility are clear and practically free from particles that can be observed on visual inspection by the unaided eye. Intravenous infusions that are solutions and are supplied in containers with a nominal content of 100ml or more comply with the test for particulate contamination.

Method 1

Sample

Particle size in µm


Maximum number of Particles



10

25

12 per ml

2 per ml


10

25

3000 per container

300 per container

Less than 100 ml 10

25

3000 per container

300 per container

Method 2

Sample

Particle size in µm





10

25

25 per ml

3 per ml


10

25

6000 per container

600 per container

Less than 100 ml 10

25

6000 per container

600 per container

G-INF-002 Sterility:


G-INF-003 Bacterial Endotoxins / Pyrogen:

As per individual monograph.




356

C. POWDERS FOR INJECTION

G-POW-001 Uniformity of Content:

Unless otherwise stated in the individual monograph, Powders for injection that contain 10mg or less than 10mg or less than 10 % of active ingredient or that have a unit weight equal to or less than 50mg comply with the test for Uniformity of content. For Powders for injection containing more than 1 active ingredient carry out the test for each active ingredient that corresponds to the above conditions. This test is not applicable to powders for injection containing multivitamins and trace elements. Determine the content of active ingredient(s) of each of 10 containers taken at random using the method given in the monograph or by any other suitable analytical method of equivalent accuracy and precision. The preparation complies with the test if the individual values thus obtained are all between 85 and 115 % of average value. The preparation fails to comply with the test if more than 1 individual value is outside the limits 85 to 115% of average value or if anyone individual value is outside the limits 75 to 125% of average value. If one individual value is outside the limits 85 to 115 % but within the limits 75 to 125% of the average value, repeat the determination using another 20 containers taken at random. The preparation complies with the test if in the total sample of 30 containers not more than one individual value is outside the limits 85 to 115 % and none is outside the limits 75 to 125% of the average value.

G-POW-002 Uniformity of Weight:

For powders for injection that are required to comply with the test for Uniformity of content of all active ingredients, the test for uniformity of weight is not required.

Out of 20 units tested not more than 2 of the individual weights deviate from the average weight by more than 10 % and none deviates by more than 20%.

G-POW-003 Clarity of Solution:

Constitute the injection as directed on the label.

a) The solid dissolves completely, leaving no visible residue as un dissolved matter

b) The constituted injection is not significantly less clear than an equal volume of the diluents or of water for injections contained in a similar container and examined in the same manner.

G-POW-004 Sterility:


G-POW-005 Particulate Matter:

Constitute the injection as directed on the label; the solution is essentially free from particles of foreign matter that can be seen on visual inspection.



GENERAL TESTS - PARENTERAL PREPARATIONS As Per British Pharmacopoeia

357

INJECTIONS BP

I. Particulate contamination; sub-visible particles

TABLE I (A) Light Obscuration particle count test method I

1. Large volume parenterals 1 Unit 2. Small volume parenterals less than

25 ml Contents of 10or more units are combined in a clean container to obtain a volume of not less than 25 ml

3. Small – volume parenterals having a volume of 25 ml or more

Tested Individually NMT than 10 units may be tested.

Remove 4 portions, each of not less than 5 ml, and count the number of particles of 10-25 µm and calculate the mean number of particles.

Table II

Evaluation Sample Particle size Maximum number of particles Preparation in containers with a nominal volume

Equal to greater than

Average number of particles present in the units

More than 100 ml 10 µm 25 per ml 25 µm 3 per ml

Less than 100l 10 µm 6000 per container 25 µm 600 per container

100ml 10 µm 6000 per container 25 µm 600 per container

If the average number of particles exceeds the limit, test the preparation by the microscopic particle count test.

B) Microscopic particle count test method

1. Large volume parenterals 1 Unit 2. Small volume parenterals

less than 25 ml Contents of 10or more units are combined in a clean container to obtain a volume of not less than 25 ml

3. Small – volume parenterals having a volume of 25 ml or more

Tested Individually xxxxxxxxx than 10 units may be tested.

Evaluation

Sample Particle size


Preparation in containers with a nominal volume

Equal to or greater than








358

METHOD II

Particle contamination : Visible particlesSelect 5 container and record the presence of any particles by visual

Note: For preparation for human use, solutions for infusions or solutions for injection comply with the test.

Preparations for subcutaneous or intramuscular injections higher limits may be appropriate.

VET: If the content is more than 100 ml comply with the test.

Particulate contamination BP

A. Particulate contamination : Sub-visible particles

Particulate contamination of injections and infusions consists of extraneous, mobile un dissolved particles, other than gas hobbles, unintentionally present in the solutions.

1. Method – I Light obscuration particle count test

2. Method – II Microscopic particle count test

When examining injections and infusions for sub-visible particles, method I is preferably applied. If any conclusion required use Method II.

Not all parenteral preparations can be examined for such visible particles by one or both of these methods.

When method I is not applicable e.g. In case of preparations having reduced clarity or increased viscosity. (Emulsions, colloids and liposomal preparations), Method II.

Products that produce air or gas bubbles when drawn into the sensor require microscopic particle count testing.

If the viscosity of the preparation to be tested is sufficiently high so as to preclude the examination by either test method, a quantitative dilution with an appropriate diluent may be made to viscosity.

B. Particulate contamination : Visible particles

Particulate contamination of injections and infusions consists of extraneous, mobile un dissolved particles, other than gas bubbles, unintentionally present in the solutions

The test is intended to provide a simple procedure for the visual assessment of the quality of parenteral solutions as regards visible particles

Injection BP

Uniformity of dosage units

Single-dose suspensions for injection or if specified in the monograph should comply with the test.

Dosage forms Type Sub Type Dose and Ratio of active substances ≥ 25 mg or ≥ 25% < 25mg or < 25%

Solids in single dose container

Single component

mv mv

Multiple component

Solutions freeze dried in final container

mv Mv

Others cu cu Solutions enclosed single dose container

mv mv




359

a. Uniformity of Content :

Limit 1. For suspensions of active substance

less than 2 mg or less than 2% of total mass

Powders for Injections or Infusions with content of active substance less than 2 mg or less than 2% of the total mass, or with a unit mass equal to or less than 40 mg comply with test. If the preparation contains more than one active substance, the requirement applies only to that substance that corresponds to the above conditions.

2. Unit mass equal to or less than 40 mg

Active substances less than 2 mg or less than 2% of the total mass or otherwise stated in the monograph comply with the test.

3. Mass Variation :

Weigh 10 individual containers and calculate the active substance for each container using the formula.

X1 = 1 x A/

X1 = Estimated individual content of active substances

1 = Individual mass of dosage unit

A = Assay value (content of active substance)

= Average weight

Ref: Page 10

Criteria

Sample meet the requirement if the acceptance value of 1st ten dosage units is less than or equal to L1%. If the acceptance value is greater than L1, test the next 20 dosage units and calculate the acceptance value. The requirement are met if the final acceptance value of 30 dosage units is less than or equal to L1% and no individual / content of the dosage unit is less than

[1-(L2) (.01)] m or more than 1 + (L2) (.01)] m

L1 is 15.0, L2 is 25.0 and m is mean of individual contents expressed as percentage of label claim.

Sterility

BET / Pyrogens

Any preparation where the label states that it is free from Bacterial Endotoxin or a pyrogenic complies with the test.

Note: BET: If the single dose is 15 ml or more comply with the test.




360

1. Extractable volume

Single dose, multiple doses, large volume parenterals.

No. of containers Limit a. Single dose 10 ml or more 1 Not less than the nominal

volume taken individually or collectively

More than 3 ml and less than 10 ml

3

3 ml or less 5 b. Multi dose 1 Each syringe (dose)

delivers not less than the stated dose.

Extractable volume

Limit: The volume is not les than the nominal volume in case of containers examined individually.

In case of containers with a nominal volume of 2 ml or less, is not less than the sum of the nominal volumes of the containers taken collectively.

Multi dose containers:

For injections in multi dose containers select one container and proceed as directed for single dose containers, using the same number of separate syringe assemblies as the number of doses specified.

Limit: The volume is such that each syringe delivers not less than the stated also.




361

POWDERS FOR INJECTION BP

I. Particulate contamination; sub-visible particles

Powders for parenteral use are reconstituted with particle free water or with an appropriate solvent without contamination of particles when particle free water is not suitable.

Ref: Injection Uniformity of dosage unit BET: STERILITY: Uniformity of Dosage Unit

Ref :

Limit 1. For suspensions of active

substance less than 2 mg or less than 2% of total mass

Powders for Injections or Infusions with content of active substance less than 2 mg or less than 2% of the total mass, or with a unit mass equal to or less than 40 mg comply with test. If the preparation contains more than one active substance, the requirement applies only to that substance that corresponds to the above conditions.

2. Unit mass equal to or less than 40 mg

Table: Injections

A. Uniformity of Contents :

Powders for Injections or Infusions with content of active substance less than 2 mg or less than 2% of the total mass, or with a unit mass equal to or less than 40 mg comply with test. If the preparation contains more than one active substance, the requirement applies only to those substances that correspond to the above conditions.

Limit: The preparation complies with the test if each individual content is between 85% and 115% of the average content.

The preparation fails to comply with the test if more than one individual content is outside these limits or if one individual content is outside the limits of this to 125% of the average content.

If one individual content is outside the limits of 85% - 115% but within the limits of 75% to 125%, determine the individual contents of another 20 dosage units taken at random.

The preparation complies with the test if not more than one of the individual contents of the 30 units is outside 85% to 115% of the average content and none is outside the limits of 75% - 125% of the average content.

Uniformity of Mass:

Powders for injections or infusions comply with the test for uniformity of mass of single dose preparations.

If the test for uniformity of content is prescribed for all the active substances, the test for uniformity of mass is not required.

When required for the Assay of a powder for injection, determine the weight of the contents of 10 containers as described in the test for uniformity of weight.




362

Limit:

Weigh individually 20 units taken at random or, for single dose preparations presented in individual containers, the contents of 20 units, and determine the average mass not more than 2 of the individual masses deviate from the average mass by more than the percentage deviation and none deviates by more than twice that percentage.

(Uniformity of weight (mass) Table GENERAL CHART

Pharmaceutical Form Average mass Percentage Deviation

Tablets (uncoated and film coated)

8 mg or less more than 80 mg and less than 250 mg or more

10 7.5 5

Capsules, granule (uncoated, single dose) and powders (single –dose)

Less than 300 mg 10 300 mg or more 7.5

Powders for parenteral use (single dose)

More than 40 mg 10

Suppositories and pessaries All masses 5 Powders for eye drops Les than 300 mg 10

Application of content uniformity and mv test for dosage forms B.P. (GENRAL CHART)

Dosage Forms Type Sub-type Dose and ratio of active substance

≥ 25 mg & ≥ 25%

< 25 mg or <25%

Tablets Uncoated mv cu Coated Film coated mv cu Others cu cu Capsules Hard mv cu Soft Suspensions,

emulsions, gels cu cu

Solutions mv cu Solids in single dose containers

Single component

mv mv

Multiple component


mv mv

Other cu cu Solutions enclosed in single dose containers

mv mv

Others cu cu




363

Capsules, powders other than for parenteral use, granules, suppositories, pessaries. BP

The preparation complies with the test if NMT one individual content is outside the limits of 85% - 15% of the average content and none is outside the limits of 75% - 125% of the average content.

The preparation fails to comply with the test if more than 3 individual contents are outside the limits of 85% - 115% of the average content or if one or more individual contents are outside the limits of 75% - 125% of the average content.

If two or three individual contents are outside the limits of 85 – 115% but within the limits of 75 – 125% determine the contents of another 20 dosage units.

The preparation complies with the test if NMT 3 individual contents of the thirty units are outside the limits of 85 – 115% of the average content.

III. BET

IV. STERILITY




364

INFUSION BP

a) Extractable volume

Select one container. Transfer the contents into dry measuring cylinder

Limit: The volume is not less than the nominal volume

Ref: Page 1

b) Particulate contamination; sub-visible particles

c) Sterility :

d) BET :



GENERAL TESTS - PARENTERAL PREPARATIONS As Per United States Pharmacopeia

365

INJECTION USP

1. Volume in container for single dose / multi dose / large volume intravenous infusion

2. Foreign and particulate matter

3. Sterility

4. Uniformity of content only for suspensions, emulsions and gels in single dose container

5. BET if specified

Powders for Injection

1. Completeness and clarity of solution – Constituted Solution

2. Particulate matter – Constituted Solution

3. Sterility

4. Uniformity of dosage units – At variation for freeze dried

CU for pure drug 5 excipients

5. BET if specified

Infusions

1. Volume in container

2. Foreign and particulate matter

3. Sterility

4. BET if specified




366

A. Volume in container

I. Single does containers :

Volume of Container No. of containers

10 ml or more 1

More than 3 ml and less than 10 ml 3

3 ml or loss 5

2 ml or less

Contents to be poled to obtain a volume required for measurement. Use separate syringe for each container.

10 ml or more Empty the container directly in to a graduated cylinder.

Result: Volume is not less than the nominal volume in case of containers xxxxx

In case of containers with nominal volumes of the containers taken collectively.

II. Multi-dose containers

Select 1 container and proceed as directed for single dose containers, using the same number of separate syringe assembles as the number of doses specified.

Result: Each syringe deliver not less than the stated dose

III. Large volume intravenous solutions :

Select 1 container and transfer the contents to a dry measuring cylinder

Result: The value is not less than the nominal volume.

B. Foreign and particulate matter, Same as BP page 1-4

Evaluation Chart

1.

Evaluation Sample Particle size Maximum number of particles










367

2. Evaluation Sample Particle size Maximum number of

particles Preparation in containers with a nominal volume






3.

100ml 10 µm 25/ml per 25 µm 3/ml

Microscopic particle count Evaluation chart 1 Sample Particle

size Maximum number of particles







2 Sample Particle

size Maximum number of particles







3.

Sample Particle size


100ml 10 µm 12/ml 25 µm 2/ml




368

C. Uniformity of dosage units

1. Weight variation

Dosage forms Type Sub Type Dose and Ratio of active substances ≥ 25 mg or ≥ 25% < 25mg or < 25%

Solids in single dose container

Single component

mv mv

Multiple component


mv Mv

Others cu cu Solutions enclosed single dose container

mv mv

>25mg <25mg Freeze dried solids and suspension, emulsion or gel for systemic use only, packaged in single unit container

cu cu

Solns. For inhalations packed in glass or plastic ampule inhalation use as nebulizer and oral solutions packed in unit dose container and in to soft capsule

Xxxx Xxxxx

2. CU :

1. For powders for which at variation is not applicable

2. coated tablets other than film coated 25 mg or more of drug or 25% w/w

3. Suspensions, emulsion or gels in single unit containers for systemic administration

4. Tbulatins other than nebulizers at variation

Solutions for inhalations used in nebulizers, oral solutions packed in unit dose containers, soft capsule, solids – freeze dried solids (including sterile solids) in single unit containers having added sustain.

Tables, capsule, film coated tabs contain more than 25 mg or 25% w/w of active substance

Criteria: Same as BP

D. BET

E. STERILITY


DRUGS AND SUPPLIES Quality Control Department

GENERAL TESTS - SUTURES

369

SUT-Table 1. Diameter and Tensile Strength of (Collagen Absorbable) Sutures

Limits on Average Diameter

(mm) knot-Pull Tensile

Strength (kgf) Knot-Pull Tensile strength

(in N)

USP Size

Metric Size

(Gauge no:). Min. Max.

Limit on average

Min.

Limit on individual

strand Min.

Limit on average

Min.

limit on individual

starnd Min. 9-0 0.4 0.04 0.049 _ _ _ _ 8-0 0.5 0.05 0.069 0.045 0.025 0.44 0.24 7-0 0.7 0.07 0.099 0.07 0.055 0.69 0.54 6-0 1 0.1 0.149 0.18 0.1 1.76 0.98 5-0 1.5 0.15 0.199 0.38 0.2 3.73 1.96 4-0 2 0.2 0.249 0.77 0.4 7.55 3.92 3-0 3 0.3 0.339 1.25 0.68 12.2 6.67 2-0 3.5 0.35 0.399 2 1.04 19.6 10.2 0 4 0.4 0.499 2.77 1.45 27.2 14.2 1 5 0.5 0.599 3.8 1.95 37.3 19.1 2 6 0.6 0.699 4.51 2.4 44.2 25.5 3 7 0.7 0.799 5.9 2.99 57.8 29.3 4 8 0.8 0.899 7 3.49 68.6 34.2




370

SUT-Table 2. Diameter and Tensile Strength of Synthetic Suture (Absorbable Synthetic)

Limits on average

diameter (mm)

Knot- Pull Tensile Strength (in kgf) (except where

otherwise specified)* Limit on average

Min.

Knot- Pull Tensile Strength (in N) (except where

otherwise specified)

USP size Min. Metric size (Gauge

no:) Max. Min. Max. 12-0 0.01 0.001 0.009 _ _ 11-0 0.1 0.01 0.019 _ _ 10-0 0.2 0.02 0.029 0.025* 0.24* 9-0 0.3 0.03 0.039 0.050* 0.49* 8-0 0.4 0.04 0.049 0.07 0.69 7-0 0.5 0.05 0.069 0.14 1.37 6-0 0.7 0.07 0.099 0.25 2.45 5-0 1 0.1 0.149 0.68 6.67 4-0 1.5 0.15 0.199 0.95 9.32 3-0 2 0.2 0.249 1.77 17.4 2-0 3 0.3 0.339 2.68 26.3 0 3.5 0.35 0.399 3.9 38.2 1 4 0.4 0.499 5.08 49.8 2 5 0.5 0.599 6.35 62.3

3 and 4 6 0.6 0.699 7.29 71.5 5 7 0.7 0.799 _ _

* The tensile strength of the specified USP size is measured by straight pull.

SUT-Table 3. Matching Solutions (Extractable Colour)

Parts of each CS per 10 parts of total volume.

Color of suture (Extractable color)

Cobaltous Chloride CS Ferric Chloride CS Cupric Sulphate CS

Yellow - Brown 0.2 1.2 _

Pink - Red 1 _ _

Green - Blue _ _ 2

Violet 1.6 _ 8.4




371

Limits on average diameter (mm)

Limits on average Knot-Pull (Except where otherwise specified)a Tensile Strength (in

kgf)b

Limits on average Knot-Pull (except where otherwise specified)a Tensile

Strength (in N)b

USP size Metric size (gauge no:) Min. Max. Class I Min. Class II Min.

Class III Min. Class I Min.

Class II Min.

Class III Min.

12-0 0.01 0.001 0.009 0.001a _ 0.002a 0.01a _ 0.02a

11-0 0.1 0.01 0.019 0.006a 0.005a 0.02a 0.06a 0.05a 0.20a

10-0 0.2 0.02 0.029 0.019a 0.014a 0.06a 0.194a 0.14a 0.59a

9-0 0.3 0.03 0.039 0.043a 0.029a 0.07a 0.424a 0.28a 0.68a

8-0 0.4 0.04 0.049 0.06 0.04 0.11 0.59 0.39 1.08

7-0 0.5 0.05 0.069 0.11 0.06 0.16 1.08 0.59 1.57

6-0 0.7 0.07 0.099 0.2 0.11 0.27 1.96 1.08 2.65

5-0 1 0.1 0.149 0.4 0.23 0.54 3.92 2.26 5.3

4-0 1.5 0.15 0.199 0.6 0.46 0.82 5.88 4.51 8.04

3-0 2 0.2 0.249 0.96 0.66 1.36 9.41 6.47 13.3

2-0 3 0.3 0.339 1.44 1.02 1.8 14.1 10 17.6

0 3.5 0.35 0.399 2.16 1.45 3.40a 21.2 14.2 33.3a

1 4 0.4 0.499 2.72 1.81 4.76a 26.7 17.8 46.7a

2 5 0.5 0.599 3.52 2.54 5.90a 34.5 24.9 57.8a

3 and 4 6 0.6 0.699 4.88 3.68 9.11a 47.8 36.1 89.3a

5 7 0.7 0.799 6.16 _ 11.4a 60.4 _ 112a

6 8 0.8 0.899 7.28 _ 13.6a 71.4 _ 133a

7 9 0.9 0.999 9.04 _ 15.9a 88.6 _ 156a

8 10 1 1.099 _ _ 18.2a _ _ 178a

9 11 1.1 1.199 _ _ 20.5a _ _ 201a

10 12 1.2 1.299 _ _ 22.8a _ _ 224a

a The tensile strength of sizes smaller than USP size 8-0 (Metric size 0.4) is measured by straight pull. The tensile strength of sizes larger than USP size 2-0 (metric size 3) of monofilament class III (metallic) Non absorbable surgical suture is measured by straight pull. Silver wire meets the tensile strength values of class I sutures but is tested in the same manner as class III sutures.

b The limits on Knot-Pull tensile strength applied to Non absorbable surgical suture that has been sterilized. For non sterile sutures of class I and class II , the limits are 25% higher.




372

SUT-Table 5.

Standard Needle Attachment for Absorbable and Nonabsorbable Sutures

Metric Size (Gauge number) Limits on Needle Attachment

Absorbable collagen Suture

Non absorbable

and synthetic absorbable

sutures USP size Average (in kgf) (Min.)

Individual (in kgf)(Min.)

Average (In N)(Min.) Individual (in N)(Min)

0.1 11-0 0.007 0.005 0.069 0.049

0.2 10-0 0.014 0.01 0.137 0.098

0.4 0.3 9-0 0.021 0.015 0.206 0.147

0.5 0.4 8-0 0.05 0.025 0.49 0.245

0.7 0.5 7-0 0.08 0.04 0.784 0.392

1 0.7 6-0 0.17 0.08 1.67 0.784

1.5 1 5-0 0.23 0.11 2.25 1.08

2 1.5 4-0 0.45 0.23 4.41 2.25

3 2 3-0 0.68 0.34 6.67 3.33

3.5 3 2-0 1.1 0.45 10.8 4.41

4 3.5 0 1.5 0.45 14.7 4.41

5 4 1 1.8 0.6 17.6 5.88

6 and larger 5 and larger 2 and larger 1.8 0.7 17.6 6.86

SUT- Table 6.

Removable Needle Attachment for Absorbable and Non absorbable Sutures

Metric Size (Gauge number) Limits on Needle Attachment

Absorbable collagen Suture

Non absorbable and synthetic absorbable

sutures USP size Minimum(in kgf) Maximum (in

kgf) Minimum (in N) Maximum (in

N)

1.5 1 5-0 0.028 1.59 0.274 15.6

2 1.5 4-0 0.028 1.59 0.274 15.6

3 2 3-0 0.028 1.59 0.274 15.6

3.5 3 2-0 0.028 1.59 0.274 15.6

4 3.5 0 0.028 1.59 0.274 15.6

5 4 1 0.028 1.59 0.274 15.6

6 5 2 0.028 1.59 0.274 15.6

373

REFERENCES

Indian Pharmacopoeia

British Pharmacopoeia

United States Pharmacopoeia

British Pharmaceutical Codex

National formulary

ISO

ISI

Drugs and Cosmetic Act

Remington

I.M. Finar

374

ABBREVATIONS

G –CAP General tests Capsules

G-CRE General tests Creams

G-EAR General tests Ear /Eye drops

G-EYO General tests Eye ointments

G-GEL General tests Gels

G-NAS General tests Nasal drops/solutions/sprays

G-OIN General tests Ointments

G-ORA General tests Oral liquids

G-ORP General tests Oral powders

G-PES General tests Pesseries

G-SUP General tests Suppositories

G-TAB General tests Tablets

IP Indian Pharmacopoeia

BP British Pharmacopoeia

USP United States Pharmacopoeia

BPC British Pharmaceutical Codex

NFI National formulary

NLT Not less than

NMT Not more than

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