11 :-jh nh~n den van chatidqc-hcm.gov.vn/images/docs/hieuchuan.pdf · may cbu§n dq di~n th~ va may...

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BO KHOA HQC v A CONG N GH:J;: C<)NG HOA xA HOI CmJ NG:S:iA VltT N.-<\M V AN PRONG DQc Tv do- phuc S6: 154.2015/ QD-VPCNCL Ha N9i, ngay 10 thcing 4 nam 201 5. uo Y TE VIIi::-< NG Hi t M T H U6C TP. IIO C Hi 1\ 11 :-J H cong pbong thi , So': ... .. 5 g0 .... . .. . .. .. .. . DEN GrAM DOC . Chuven- VAN PHONG CONG 1\1J4N CHAT ........ - Can cu Tieu va Qui k.")i ngay 30 tbang 6 nam 2006; - Can cu djnh s6 26/2007/QD-BKHCN ngay 31 thang 1 0 narn 2007 cila Bo tru6ng Bo Khoa h9c va Cong vb qui djnh t6 cbuc va dong cua T6 chuc cong - Can cu djnh s6 1101/QD-TTg ngay 23/7/2009 cua Thu tu6ng Chinh phu vb cac t6 chuc Sl,I thuoc bo Khoa hQC va Cong ngM; - Can cu djnh s6 1150/QD-BKHCN ngay 20 tbang 5 narn 2014 ban himh Di6u T6 chuc va dong Van phong Cong 1ugng; - Theo db nghi cua Doan chuyen gia dfmh gia va Ban thfun xet. 1: Cong nh?n Phong thi KIEM THU6C THANH PH6 HO cHi MINH Thu9c: BOYTE phu hqp theo ISOIIEC 17025:2005 v&i danh ID\lC cac phep thu kern theo QuySt d.inh nay 2: Phong thi duqc mang s6 VILAS 108. 3: Phong thi duqc cong a 1 phai tuan thu du cac yeu c6ng nh?n theo quy dinh hanh. 4: QuySt dinh nay c6 h,rc d:Sn ngay 13 thang 12 nam 20 17 va Phong thi se chiu sv giam sat dinh kY m6i nam m9t lk. No7 nhan: Ccr scr dugc danh gill; HS danh gill; . LliU VT .. ""(. AF 16.01 ban ha.nh: 6. 11 GIAM DOC - A "} vU XUANTHUY Trang 1 /1

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Page 1: 11 :-JH nh~n DEN VAN CHATidqc-hcm.gov.vn/images/docs/hieuchuan.pdf · May cbu§n dQ di~n th~ va may cbu§n dQ Karl-Fischer (I-20) mL EQ/QTHC-06 Potentiometric titrator and Karl-Fischer

BO KHOA HQC v A CONG N GH:J;: C<)NG HOA xA HOI CmJ NG:S:iA VltT N.-<\M

V AN PRONG DQc l~p- Tv do- H~nb phuc CONGN~CHATLUQNG

S6: 154.2015/ QD-VPCNCL Ha N9i, ngay 10 thcing 4 nam 2015.

uo Y TE

VIIi::-< K J~:I\ 1 NG Hi t M T H U6C TP. II O C Hi 1\11 :-J H

V~ vi~c cong nh~n pbong thi nghi~m , So': ... .. 5g0 .... ... ... .. .. . DEN NgaycJO{..Cf~/J.o..tr.

GrAM DOC . Chuven-

VAN PHONG CONG 1\1J4N CHAT LU<;~&iho~~·~;;··:::::·.·. ·.·.·.·.·.·.·.·.·.· .· :.·.· ........ - Can cu Lu~t Tieu chu~ va Qui chu~ k.")i thu~t ngay 30 tbang 6 nam 2006; - Can cu Quy~t djnh s6 26/2007 /QD-BKHCN ngay 31 thang 1 0 narn 2007 cila Bo tru6ng

Bo Khoa h9c va Cong ngh~ vb vi~c qui djnh t6 cbuc va ho~t dong cua T6 chuc cong nh~n; - Can cu Quy~t djnh s6 1101/QD-TTg ngay 23/7/2009 cua Thu tu6ng Chinh phu vb cac t6 chuc

Sl,I nghi~p thuoc bo Khoa hQC va Cong ngM; - Can cu Quy~t djnh s6 1150/QD-BKHCN ngay 20 tbang 5 narn 2014 v~ vi~c ban himh Di6u 1 ~

T6 chuc va Ho~t dong Van phong Cong nh~ Ch~t 1ugng; - Theo db nghi cua Doan chuyen gia dfmh gia va Ban thfun xet.

Di~u 1: Cong nh?n Phong thi nghi~m:

~N KIEM NGHI~M THU6C THANH PH6 HO cHi MINH

Thu9c: BOYTE

phu hqp theo ISOIIEC 17025:2005 v&i danh ID\lC cac phep thu kern theo QuySt d.inh nay

Di~u 2: Phong thi nghi~m duqc mang s6 hi~u: VILAS 108.

Di~u 3: Phong thi nghi~m duqc cong nh~ a Di~u 1 phai tuan thu d:~y du cac yeu c~u v~ c6ng nh?n theo quy dinh hi~n hanh.

Di~u 4: QuySt dinh nay c6 hi~u h,rc d:Sn ngay 13 thang 12 nam 20 17 va Phong thi nghi~m se chiu sv giam sat dinh kY m6i nam m9t lk.

No7 nhan: Ccr scr dugc danh gill; HS danh gill;

. LliU VT .. ""(.

AF 16.01 L~ ban ha.nh: 6. 11

~~-

GIAM DOC - A " }

vU XUANTHUY

Trang 1/1

Page 2: 11 :-JH nh~n DEN VAN CHATidqc-hcm.gov.vn/images/docs/hieuchuan.pdf · May cbu§n dQ di~n th~ va may cbu§n dQ Karl-Fischer (I-20) mL EQ/QTHC-06 Potentiometric titrator and Karl-Fischer

PHl} Ll}C ATTACHMEN T

(Kem theo quyit tfinh s6:J i:JJf,JOI() /QE>- VPCNCL ngay ) v thang 04 niim 2015 cua giam aac Viin phong Cong nh~n Chfit lu(J'ng)

Ten phong thf nghi~m: Vi~n Ki~m nghi~m tbu6c thimh pb6 Hfi Chi Minh

Laboratory: Institute of drug quality control Ho Chi Minh City (IDQC-HCMC)

Ca quan chu quan: BQ Y t~

Organization: Ministry of Health

Linh vvc thu nghi~m: Do lll'img - Hi~u chu§n

Field of testing: Measurement- Calibration

Nguo·i ph1,1 tnichl Representative: Th.s Tnrong Thj Thu Lao

Nguai c6 th§m quySn lcy/ Approved signatory:

SIT HQ va ten/ Name Ph~ vi duqc lcy/ Scope

1. Nguyin Ng(Jc Vinh Cac phep thfr dtrQ'C cong nh~n/ All accredited Calibrations

2. Truung Thi Thu Lan Cac phep thfr dtrQ'C cong nh~n/ All accredited Calibrations

S6 hi~u/ Code: VILAS 108

Dia chi/ Address: S6 200, Co B~c, Qu~n 1, Tp. Hfi Chi Minh

Dia di~m/Location: S6 200, Co B~c, Qu~n 1, Tp. Hfi Chi Minh

Di~n tho~i/ Tel: 08 38368518 Fax: 08 38367900

Email: [email protected] Web: www.idqc-hcm.gov.vn

DANH Ml}C PREP ~U CHUAN DU<}C CONG ~ LIST OF ACCREDITED CALIBRATION

Linh vvc hi~u chu§n: Kh6i ltrQ'Dg

Field of calibration: Mass Calibration

Ten d:;t,i hrgng do ho~c phtrO'Jig Kha nang do va

ti ~n d o dtrQ'C hi~u chuin Ph:;t.m vi do Quy trlnh hi~u chuAn hi~u chu§n (CMC)1

/

IT Measured quantities/ calibrated Range of measurement Calibration Calibration and

Procedure Measurement equipment

Capability (CMC/

Can pha n tich Tail to 5,1 g d= 0,002 mg 0,01 mg

(dp chinh xac I) Ten/ to100 g d= 0,01 mg EQ/QTHC-04 0, 13 mg 1.

A nalytical balances Tail to 300 g · d= 0,1 mg 0,11 mg (class I) Tail to 500 g d= 0,01 g 6,67 mg

Lfrn ban hfmh: 5.10 Trang: 113

Page 3: 11 :-JH nh~n DEN VAN CHATidqc-hcm.gov.vn/images/docs/hieuchuan.pdf · May cbu§n dQ di~n th~ va may cbu§n dQ Karl-Fischer (I-20) mL EQ/QTHC-06 Potentiometric titrator and Karl-Fischer

DANH Ml)C PHEP HIJ):U CHUAN f>lf <}C CONG NH~N

LIST OF ACCREDITED CALIBRATION

VILAS 108

Linh vtrc hieu chu~n: Nhiet . . . Field of calibration: Temperature

Ten d:_ti hrqng do ho~c phyrong Ph:_tm vi do Quy trinh hi~u cbu§n

IT ti~n do dtrQ'C hi~u chuan Measured quantities/ calibrated Range of measurement Calibration Procedure

equipment ..

2. Til s~y (50- 150) oc

EQ/QTHC-12 Drying Oven

3. Tu~m (30-50)°C

Incubator

B~ di~u nhi~t (0- 95) oc EQ/QTHC-15 4.

Water-baJh

5. Lo nung ( 400 - 800) oc EQ/QTHC-11

Oven

Linh vtrc hieu chu~n: H6a Jy Field of calibration: Physico - Chemical

Ten d:_ti ltrQ'Dg do ho~c pb.trong Ph:_tm vi do Quy trinh hi~u cbu§n

IT ti~n do dtrQ'C bi~u chuan

Measured quantities/ calibrated Range of measurement Calibration Procedure equipment

Quang phB tir ngo~i kba ki~n Bu6e s6ng/ Wavelength:

190 run - 800 run EQ/QTHC-01 6. Ultraviolet and visible

D(> h.ip thl,ll Absorbance: absorption spectrophotometry

0-2 Abs

Bu6e s6ng/ Wavelength: Quang phB bbng ngo~i 4000 cm·1

- 400 em·1 EQ/QTHC-03 7.

Infrared spectrophotometry D(> truy~n quang

T6e d(> dong: S~c kY long hi~u nang cao 1,0 mL/phUt - 2,0 (d~u do UV-Vis va Diod mL/phut

8. array) F/(N.I rate: EQ/QTHC-05

High performance Liquid 1, 0 mVmin. - 2, 0 mL/m in chromatography (UV- Vis

Bu6c s6ng/ Absorbance: and Diad array detectors)

190 run - 800 nm

Khii nang do va hi~u cbuh (CMC)1

/

Calibration and Measurement

Capability (CMC/

1,4 oc

0,4 oc

0,7 oc

2,8 oc

Khii nang do va hi~v cbu§n (CMC)1

/

Calibration and Measurement

Capability (CMC/

0,1 run

0,0011 Abs

0,1 em·1

0,026% T

o,ooos mLI phut

0,0005 mL/ min

0,2run

f /

L~n ban hfmh: 5 .l 0 Trang: 2/3

Page 4: 11 :-JH nh~n DEN VAN CHATidqc-hcm.gov.vn/images/docs/hieuchuan.pdf · May cbu§n dQ di~n th~ va may cbu§n dQ Karl-Fischer (I-20) mL EQ/QTHC-06 Potentiometric titrator and Karl-Fischer

IT

·.

9.

10.

11.

I2.

13.

14.

15.

16.

17.

DANH M l)C PHEP HI~U CHUAN DUQC CONG NH~N

LIST OF ACCREDITED CALIBRATION

VILAS 108

Ten d~i hrQllg do ho~c phu·ong ti~n do dtrqc hi~u cbuAn Ph~m vi do Quy t rinb bi~u chuAn

Measured quantities/ calibrated Range of measurement Calibration Procedure equipment

T be d9 quay:

M ay do d{l boa tan thu6c vien 50 - ISO vong I phut

Revolution rate: nen va vien nang (thi~t bj

50 -150 revolutions I canh kbu~y va gio quay)

min EQ/QTHC-02

Dissolution tester for tablets Nhi~t d91Temperature:

and capsules {basket and 30-40 oc

paddle apparatus) Thai gian: I o - I20 phllt

Time: 10 - 120 min

Nhi~t §m k~ (10- 85) oc Thermo-hygrometer (10- 90) %RH

EQ/QTHC-14

May cbu§n dQ di~n th~ va may cbu§n d Q Karl-Fischer

(I- 20) mL EQ/QTHC-06 Potentiometric titrator and

Karl-Fischer titrator

May do pH (0-14)pH EQ/QTHC-09

pH meter Nhi~t df)/Temperature

(35- 39) oc May th ir dQ ra

T~ s6 dao d9ng/ EQ/QTHC-07 Disintegration tester

Vibration frequency

(28 - 30) 1~ phut

Nhi~t d91Temperature

May thir dQ ra thu6c d~n (36- 38) oc Supp ository Disintegration s6 1~ quay cua gi6/

EQ/QTHC-08

tester Oscillational frequency

10 l~IO phllt

Kha nang do va hieu cbu§n

(CMq1/ Calibration

and Measurement Capability (CMC)'

0,35 vong/ phllt 0,35 revolutions/

min

0,4 oc

0,36 giay 0,36 seconds

I,6 oc 3,4%

""" q

"" 0,164% )N

;4 CfN

0,01 pH /

:;;---

1,2%

0,23%

Chu thich/ Note: EQ/QTHC: Qui trinb hi~u chu~n do PTN xay dlplg I Laboratory - developed methods

(1) Kha nang do va hi~u chu~ (CMC) duqc th€ hi~n b6i d(> kh6ng dam bao do mcr r(>ng, di~n d~t cr muc tin c?y 95%, thubng dung h~ s6 phu k=2 va c6ng b6 t6i da t6i 2 chfr s6 c6 nghia. Calibration and Measurement Capability (CMC) expressed as an expanded uncertainty, expressed at approximately 95% level of confidence, usually using a coverage factor k=2 and expressed with maximum 2 significance digits . .

r l... AFL 01.10 LAn ban hanh: 5.10 Trang: 3/3

Page 5: 11 :-JH nh~n DEN VAN CHATidqc-hcm.gov.vn/images/docs/hieuchuan.pdf · May cbu§n dQ di~n th~ va may cbu§n dQ Karl-Fischer (I-20) mL EQ/QTHC-06 Potentiometric titrator and Karl-Fischer

IT

1.

2.

3.

PHl) Ll)C ATTACHMENT

(Kem tit eo quyit tljnh s6: J6!1-.2o!f? !QD- VPCNCL ngiiy .)CJtluing 04 niim 2 cua Gitim tt6c Viin phong Cong nh~n Chat lll'{J71g)

Ten phong thi nghi~m: Vi~n Ki~m nghi~m thu&c thimh ph& HB Chi Minh

Laboratory: Institute of drug quality control Ho Chi Minh City

Ca quan chu quim: B{) Y t~

Organization: Ministry of Health

Linh VlJC thu nghi~m: DtrQ'c

Field of testing: Pharmaceutical

Ngum ph1,1 tnl.ch/ Representative: Ths. Trtrong Thi Thu Lao

Ngum c6 thfun quy~n k)'/ Approved signatory:

SIT HQ va ten/ Name Ph?ID vi duqc k)'/ Scope

1. Nguyin Ngpc Vinh Oic phep thfr dU'Q'C cong nh~nl All accredited tests

2. Trll'O'ng Thj Thu Lan Oic phep thfr dU'Q'C cong nh~nl All accredited tests

3. Trim Thj Qujmh Chi Oic phep thfr dU'Q'C cong nh~nl All accredited tests

S6 hi~u/ Code: VILAS 108

D!a chi/ Address: SB 200, Co Bic, Qu~n 1, Tp. HB Chi Minh

D!a di~m/Location: SB 200, Co Bic, Qu~n 1, Tp. HB Chi Minh

Di~n tho~ Tel: 08 38368518 Fax: 08 38367900

Email: [email protected] Web: www.idqc-hcm.gov.vn

DANH Ml)C PHEP THU DU<}C CONG ~ LIST OF ACCREDITED TESTS

Linh VlJC thu nghi~m: DtrQ'c Field ofTesting: Phamarceutical

Ten san ph§m, v~t li~u Ten pbep thfr cl} tb~ Gi6i b~n phat hi~n Phu-ong phap tbfr du-gc tbfr The Name of specific tests (n~u c6)/ Pb~m vi do Test method

Materials or Detection limit (if product tested any)/range of

measurement

Xac dinh d(> trong cua dung Duqc di6n Vi~t Nat

ThoBe: Cac nguyen, dich Duqc di6n cac nu6·c

pht;~ li~u lam thu6c Clarity of solution Tieu chufuJ CCY sa do

va cac d~ng thu6c f)o thS tich Y t~ dp s6 dang k

thanh phAm Vietnamese Determination of volume Pharmacopoeia,

Drug: Materials and Xac dinh d9 Iiing c~ Foreign

Finished products Determination of d1y residue

Pharmacopoeias a1 In- House Specijicat1

J" t;.;":FL 01.09 Lfut ban hilnh : 5 .I 0 Trang: 1121 -

Page 6: 11 :-JH nh~n DEN VAN CHATidqc-hcm.gov.vn/images/docs/hieuchuan.pdf · May cbu§n dQ di~n th~ va may cbu§n dQ Karl-Fischer (I-20) mL EQ/QTHC-06 Potentiometric titrator and Karl-Fischer

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4.

5.

6.

7.

8.

9.

10.

11.

12.

13.

14.

15.

16.

17.

18.

DANH MlJC PREP TWNG~M DUQC CONG ~

LIST OF ACCREDITED TESTS

VILAS 108

Ten sfm ph§m, v~t li~u Ten phep thfr q th~ Gi&i h:.m phat hi~n dtrgc thfr The Name of specific tests (n~u c6)/ Ph~m vi <lo

Materials or Detection limit (if product tested any)/range of

measurement

Pbep thir do d6ng d~u kh6i ltrQng

·• Test for uniformity of weight

Pbep thir do d6ng d~u ham . ltrQTig

Test for uniformity dosage units

Pbep thir do ra

Test for disintergration

Phep thir do hOa tan

Test for dissolution

Xac djnh do cirng

Determination of hardness

Xac djnh do mai mon

Determination of friability

Tbu&c: Cac nguyen, Xac dinh do d6ng nhit

phl} li~u lam thuAc Determination of homogeneity

va cac d~ng tbu&c xac dinh do kin thanh ph~m Determination of leakage

Drug: Materials and Xac djnh gi6i h?n tiSu phan

Finished products

Phrrong phap thfr

Test method

f <;

Duqc diSn Vi~t Nam, c =

Duqc diSn cac nu&c va ':<

\ Tieu chuAn ccr sa do Bo Y t~ cip s6 dang kY

Vietnamese Pharmacopoeia,

Foreign Pharmacopoeias and Limit test for particulate

matter In- House Specifications

Xac djnh chi s6 Acid appoved by MOH

Determination of Acid value

Xac djnh chi s6 Ester

Determination of Ester value

Xac djnh chi s6 Iod

Determination of Iodine value

Xac djnh chi s6 Acetyl

Determination of Acetyl value

Xac djnh chi s6 Peroxyd

Determination of Peroxide value

Xac djnh chi s6 xa phong h6a Determination of saponijicable value

~ ~----------------------~----------------------------------------------------L---

-- AFL01.09 Lfulbanhimh:5.10 Trang:2/21 ~

Page 7: 11 :-JH nh~n DEN VAN CHATidqc-hcm.gov.vn/images/docs/hieuchuan.pdf · May cbu§n dQ di~n th~ va may cbu§n dQ Karl-Fischer (I-20) mL EQ/QTHC-06 Potentiometric titrator and Karl-Fischer

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>

19.

20.

21.

22.

23.

24.

25.

DANH Ml)C PREP TmJ NGHltM DU(/C CONG NI!4N LIST OF ACCREDITED TESTS

VILAS 108

Ten san ph§m, v~t li~u Ten phep thfr C\J th~ Gi6'i h~n phat hi~n c:1trQ'C thfr The Name of specific tests (n~u c6)/ Ph~m vi c:1o

Materials or Detection limit (if product tested any)/range of

measurement

Xac dinh chi s6 khuc x~ Determination of refractive index

Xac dinh cac chit khong xa .

phong hoa

Determination of unsaponi.ficable matter

Xac dinh nhi~t d9 n6ng chay Determination of melting point

Xac dinh mau s~c cua dung djch

Determination colour of solution

Xac dinh kb6i luqng rieng va tY tr9ng

Determination of density

Xac dinh tY l~ Vl,lll nat cua

ThuAc: Cac nguyen, dUQ'C li~U

ph~ li~u l:im thuAc Determination of scraps in va cac d~og thuAc crude herbal drugs

thanh ph~m Xac dinh g6c quay qrc va g6c Drug: Materials and quay C\fC rieng

Finished products Determination of optical

PhtrO'ng phap thfr

Test method

Dugc diSn Vi~t Nam, DUQ'C diSn cac nu6c va Tieu chuin ccr so do B9

Y t~ dp s6 dang kY

Vietnamese Pharmacopoeia,

Foreign Pharmacopoeias and

rotation and specific optical In- House Specifications rotation appoved by MOH

26. Xac dinh d9 nh6t cua chit long Determination of viscosity

27. Xac dinh chi s6 pH

Determination of pH value

Xac dinh ham luqng ethanol 28. Determination of Ethanol

content

Xac dinh ham luqng nu6'c (thu6c thti Karl Fischer, phuong phap d t v6i dung moi), mat kh6i lugn~ do lam

29. kh6 (phuong phap say)

Determination ofwater (with Karl Fischer reagent, distillation with solvent) and loss on drying (drying)

lj;=FL 01.09 L§n ban hanb : 5.10 Trang: 3/21

Page 8: 11 :-JH nh~n DEN VAN CHATidqc-hcm.gov.vn/images/docs/hieuchuan.pdf · May cbu§n dQ di~n th~ va may cbu§n dQ Karl-Fischer (I-20) mL EQ/QTHC-06 Potentiometric titrator and Karl-Fischer

IT

·.

30.

31.

32.

DANH MT)C PREP TmJ NG~M IHJ'QC CONG ~

LIST OF ACCREDITED TESTS

VILAS 108

Ten san phftm, v~t li~u Ten phep thfr cl} th~ Gi6'i h~n phat hi~n <1trQ'C thfr The Name of specific tests (n~u c6)/ Ph~m vi do

Materials or Detection limit (if product tested any)/range of

measurement

Xac djnh ham hn;mg tro (tro toan phk, tro sulfat, tro khong tan trong acid, tro tan trong nu&c)

..

Determination of ash (ash,

sulphated ash, acid-insoluble

ash, water-soluble ash)

Xac dinh t~p ch~t lien quan

(phuong phap sic kY 16-p mong, sic kY long, s~c kY khi)

Determination of related

substances (I'LC, HP LC, GC)

Thir dinh tinh (phuang pbap h6a hQc, ph6 tir ngo~i, ph6 h6ng ngo~i, s~c kY 16-p mong, sic kY long, sic kY khi, soi b9t

Thubc: Cac nguyen, duqc li~u, vi phiu nhu9m soi

phl} li~u lam thubc kinh hi6n vi)

va cac d~ng thubc Tests for identification thanh ph~m (chemical, UV- VIS, JR., TLC,

Drug: Materials and HP LC, GC, microscopical Finished products identification for crude herbal

Phu·o·ng phap thfr

Test method

Duqc diSn Vi~t Nam, Duqc di6n cac nu&c va Tieu chuin co so do B9

Y t~ dp s6 dang kY

Vietnamese Pharmacopoeia,

Foreign Pharmacopoeias and

drugs) In- House Specificatiom

Xac djnh gi&i h~ cac ~p ch~t appoved by MOH

33. (phuang phap h6a h9c)

Limit tests for impurities

(chemical method)

Dinh luQng cac ch~t chinh: Phuong phap quang hQc (UV-

Vis, huynh quang), phuong phap chuk d<) (do thS tich, do

di~n th~, do ampe ), s~c kY 34. long, s~c kY khi, pha.n ClJC k~.

Test for assay :

spetrophotometry (UV-Vis,

fluorescence), volumetry,

potentiometly, amperometry,

HPLC, GC, polarimetry)

~ -~FL 01 .09 L~n ban hanh : 5.10 Trang: 4/21

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35.

36.

37.

38.

39.

DANH MVC PHEP THU NGHltM fH1QC CONG ~

LIST OF ACCREDITED TESTS

VILAS 108

Ten san pb§m, v~t li~u Ten phep thir ct..t th~ Gim h~n phat hi~n OU'Q'C thir The Name of specific tests (n~u c6)/ Ph~m vi do

Materials or Detection limit (if product tested any)/range of

measurement

Dinh Iuong kim lo~i (phuong phcip quang ph6 h~p th1,1 nguyen ru) .. Atomic absorption spectrophotometry

Djnh Iuong nitrogen trong hop ch~t hfru ca.

Dertermination of Nitrogen in organic compounds.

Dinh Iuong tinh d~u trong dugc li~u .

Determination of volatile oil in

ThuBc: Cac nguyen, herbal drugs.

phi! li~u lam thuBc Phep thli n9i doc t6 vi khufut va cac d~ng thu6c Test for bacterial endotoxins

thanh ph~m

Drug: Materials and Thli d9c tinh

Finished products Test for toxicity

Phll'O'ng phap thir

Test method

Dugc di~n Vi~t Nam, Dugc di~n cac nucrc va Tieu chufut ccr so do B9

Y t~ dp s6 dang kY

Vietnamese Pharmacopoeia,

Foreign Pharmacopoeias and

Phep thli ch~t gay s6t In- House Specification: 40.

Test for pyrogens appoved by MOH

Xac dinh bo~t h,rc thu6c khang sinh bfulg phuong phap thir vi

41. sinh v~t

Microbiological assay of

antibiotics

Thli gi&i h~ nhi~m khufut

42. Test f or microbial contamination

43 . Thir vo kbufut

Test f or sterility

44. Xac djnh chi s6 pH

Determination of pH value Tieu chufut ca sa B9 .

Ntr6'c gQi diu Xac djnh gi6-i h~ arsen ~ ~ ~ d- kY 45 .

te cap so ang

Shampoo Limit test for arsenic In House Speci.ficatio

Xac djnh gi&i h~n chi appoved by MOH

46. Limit test for lead

, .. "AFL 01.09 L~n ban hanh : 5.10 Trang: 5/21 v

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IT

47.

48.

49.

50.

51.

52.

DANH MlJC PREP TmJ NG~M IH1QC CONG ~

LIST OF ACCREDITED TESTS

VILAS 108

Ten san ph§m, v~t li~u Ten phep thir CIJ th~ Gi6i h~n phat hi~n OU'Q'C thir The Name of specific tests (n~u c6)/ Ph~m vi oo

Materials or Detection limit (if product tested any)lrange of

measurement

Xac dinh chi s6 pH

Determination of pH value

Xac d!nh gi&i h~ arsen

Test for arsenic limit I

Xac d!nh gi&i h~ chi

Test for lead limit

Tht'r gi&i h~ nhi~m khu~

Test for microbial contamination.

My phllm Xac djnh gim hem Thuy ngan LOD = 0, I J.ig/mL

Cosmetics Test for mercury limit LOQ = 0,5 J.ig/mL

LOD = 0,7161 J.ig/mL

LOQ = 2, 1 7 J.ig/mL

Ethyl paraben

D!nh tinh va d!nh lugng d~ LOD = 0,6435 J.ig/mL xuftt paraben LOQ = 1 ,95 J.ig/mL

Identification and assay of Propyl paraben derivative parabene LOD = 0,3102 J.!g/mL

LOQ = 0,94 J.!g/mL

Butyl paraben LOD = 2,3331 J.!g/mL

LOQ = 7,07 J.!g/mL

PhtrO'ng phap thir

Test method

Tieu chu~ co sa B9 Y t~ dp s6 dang kY

In House Specifications appoved by MOH

ACMTHA05

ACMINO 04

Xac d!nh ham luQng thu6c III Tai li~u cua FDA. USA-2001 , 2004; Dugc di~n

trong djch sinh hQc bfulg cac nu&c va cac phuong

I. phuong phap HPLC ap d1,mg phap noi b9

Thuoc trong trong tht'r nghi~m danh gia Bioanalytical Method

53 . djch sinh h«;>c tuong duong sinh hQc Validation- FDA. USA-

Drugs in biological HPLC method for quantitative

2001, Handling and

matrices Retention of BA and BE determination of drugs in Testing Samples- FDA. biological matrices used in USA-2004; Foreign bioequivalence studies Pharmacopoeias and In

House methods

<:, 'LAFL 01 .09 Lful ban banh : 5.10 Trang: 6/21

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IT

>

54.

55.

56.

57.

•.

DANH MlJC PREP TmJ NGIIltM Dl1QC CONG !\~

LIST OF ACCREDITED TESTS

VILAS 108

Ten san ph~m, v~t li~u Ten phep thfr c~;~ th~ Gi&i h1.1n phat hi~n c:'JtrQ'C tbfr The Name of specific tests (n~u c6)/ Ph1.1m vi do

Materials or Detection limit (if product tested any)lrange of

measurement

Dinh tinh, djnh luQng glucose, fructose, manito! va sorbitol LOD LOQ (LC) Glucose 0,23 0,69 A liquid chromatography . Fructose 0,22 0,66

Thl}'c phim method for identification and Manito! 0,24 0,74 determination of glucose, Sorbitol 0,12 0,35

chuc nang fructose, manito/ and sorbitol (J.Lg/mL) (J.Lg/mL) Dietary (LC)

supplements TLC: LOD J.Lg/mL

Dinh tinh Ginsenosid Rgl va Rgl 0,8 Rbl Rb1 0,8 Identification of gensenoside HPLC: LOD Rgl and Rbl Jlg/mL

Rg1 0,015

Rbl 0,014

Dinh tinh: LOD(J..Lg) Quercetin 0,8

Kaempferon 0,8 Dinh tinh, djnh lugng Flavonol Dinh lugng: (J.lg/mL)

Thl}'c phim glycosid Quercetin:

chuc nang Identification and LOD: 0,043

Dietary quantification of Flavonol LOQ 0,129 glycosid

supplements Kaempferon :

LOD: 0,031

LOQ: 0,093

Dinh luQ11g acid ascorbic (HPLC) LOD:0,0339 mg/mL

Determination of ascorbic acid LOQ:0,1028 mg/mL (HPLC)

Ghi chU/ Note:- MT/WI: PhtrO'Dg phap n9i bQ I Laboratory 's developm ent m ethods

d ~ /\FL 01.09 Lin ban hanh : 5.10

PhtrO'ng phap thfr Test method

MTIWI-TP-01

MTIWI-TP-02

I

MTIWI-TP-03

MT!Wl-TP-09

Trang: 7/21

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DANH Ml}C PREP THU NGm:.e;M DU Q'C CONG ~

LIST OF ACCREDITED TESTS

VILAS 108

[1]: Phl} ll}C Danh IDl}C cac lo~i thuAc va phrrong phap thfr xac djnh t rong Djch sinh hqc

TI T en thuBc/ Phll'ong phap thir Drug name Test method

1. ~inh hrqng Paracetamol va Ibuprofen trong dich sinh bQC bang phuang phap HPLC

MTIWI-T:DSH-0 1 • ·.

Determine Paracetamol and Ibuprofen in biological matrices by HP LC method

2. Dinh luqng Cefuroxim trong huy€t tuang nguoi b~g phuong phap HPLC MTIWI-T:DSH-02 Determine Cefuroxime in human plasma by HP LC method

3. Dinh luQng Indinavir trong huy€t tuang nguai b~g phuang phap HPLC MTIWI-T:DSH-03 Determine Indinavir in human plasma by HP LC method

4. :Dinh luQllg Clarithromycin trong huy€t tuang ngucYi b~g phuong phap HPLC

MT/WI-T:DSH-04 Determine Clarithromycin in human plasma by HP LC method

5. :Dinh luqng ~Iodipin, tron~ huySt tuong nguai bkg phuong phap HPLC dau do khoi ph6

MTIWI-T:DSH-05 Determine Amlodipine in human plasma by LC MS/MS method

6. :Dinh luqng Cetirizin trong huy€t tuang nguoi b~g phuang phap HPLC diu do kh6i ph6 MTIWI-T:DSH-06 Determine Cetirizine in human plasma by LC MSIMS method

7. Dinh Iuqng Ioratadin va chi t chuysn boa desloratadin trong huy€t tuong nguai b~g phuang phap HPLC diu do kh6i pb6

MTIWI-T:DSH-07 Determine Loratadine and Desloratadine metabolite in human plasma by LC MSIMS method

8. Dinh luQng Cefadroxil trong huySt tuong nguoi b~g phuong phapHPLC MTIWI-T:DSH-08 Determine Cef adroxil in human plasma by HP LC method

9. :Dinh luQng Paracetamol trong huySt tuong nguOi b~g phuang phap HPLC MTIWI-T:DSH-09 Determine Paracetamol in human plasma by HPLC method

10. :Dinh hrqng Atorvastatin va chclt cbuySn h6a trong huySt tuong nguai b~g phuong phap HPLC diu do kh6i ph6

MT/WI-T:DSH-12 Determine Atorvastatin and metabolite in human plasma by LC MSIMS method

AFL 01.09 L~n ban h1mh : 5.10 Trang: 8/21

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TT

11.

12.

13 .

14.

15.

16.

17.

18.

19.

20.

21.

J - 'AFL 01.09

DANH Ml}C p.HJtp THlJ NG~M DUQ'C C6NG ~

LIST OF ACCREDITED TESTS

VILAS 108

Ten thu6d Phtrong phap thir Drug name Test method

Dinh luQng Cephalex.in trong huy~t tuong ngucYi bing phuong phap HPLC MTIWI-TDSH- 13 Determine Cephalexin in human plasma by HP LC method

Dinh luQng Ciprofloxacin trong huy~t tuong ngucri bing phuong phap HPLC

I MTIWI-TDSH-14 Determine Ciprojloxacin in human plasma by HP LC method

Dinh luQng Levofloxacin trong huy~t tuong nguOi bing phuong phap HPLC MTIWI-TDSH-15 Determine Levojloxacin in human plasma by HP LC method

Dinh luQng Fexofenadin trong huy~t tuong nguai b~ng phuong phap HPLC d~u do kh6i ph6

MTIWI-TDSH-16 Determine Fexofenadine in human plasma by LC MSIMS method

Dinh luQng Cefaclor trong huy~t tuong nguo·i bing phuong phap HPLC MTIWI-TDSH-17 Determine Cefaclor in human plasma by HP LC method

Dinh luQng Trimetazi~in trong _buy~~ tuong nguOi bing phuong phap HPLC dau do khoi pho

MTIWI-TDSH-18 Determine Trimetazidine in human plasma by LC MS/MS method

Dinh luQng Bisoprolol trong huy~t tuong nguai bing phuong phap HPLC d~u do kh6i ph6

MTIWI-TDSH-19 Determine Bisoprolol in human plasma by LC MSIMS method

Dinh luQng Amox.icillin va Acid clavuclanic trong huy~t tuong nguai bing phuong phap HPLC d~u do kh6i ph6

MT/WI-TDSH-20 Determine Amoxicillin and Clavuclanic Acide in human plasma by LC MSIMS method

Dinh luQng Losartan trong huy~t tuong ngucri bing phuong phap HPLC d~u do kh6i ph6 MTIWI-TDSH-21 Determine Losartan in human plasma by LC MSIMS method

Dinh luQng Quercetin trong huy~t tuong ngucri bing phuong ph<ip HPLC d~u do kh6i ph6

MT/WI-TDSH-22 Determine Quercetin in human plasma by LC MSIMS method

Dinh luQng Gliclazid trong huy~t tuong nguo·i bing phuong phapHPLC MTIWI-TDSH-23 Determine Gliclazide in human plasma by HPLC method

L~n ban hanh : 5.10 Trang: 9/21

~

~~ ":t.

\

Page 14: 11 :-JH nh~n DEN VAN CHATidqc-hcm.gov.vn/images/docs/hieuchuan.pdf · May cbu§n dQ di~n th~ va may cbu§n dQ Karl-Fischer (I-20) mL EQ/QTHC-06 Potentiometric titrator and Karl-Fischer

TT

22.

23.

24.

25.

26.

27.

28.

29.

30.

31.

32.

33.

J· ·AFL 01.09

DANH Ml)C PREP TIIlr NGH!¥M Dtr<}C CONG ~

LIST OF ACCREDITED TESTS

VILAS 108

Ten tbu6c/ Phuong phap thfr Drug name Test method

Djnh luQTig Rosuvastatin trong huy~t tuong nguai bAng phuong phap HPLC aAu do kh6i ph6

MTIWI-TDSH-24 Determine Rosuvastatin in human plasma by LC MSIMS method

Djnh luQng Methylpre_dnisolon,tron~ huy~t tuong nguo·i bAng phuong phap HPLC dau do khoi pho .. MTIWI-TDSH-25 Determine Methylprednisolone in human plasma by LC MSIMS method

Djnh luQTig Metformin trong huy~t tuong ngu(yi bing phuong phap HPLC MT/WI-TDSH-26 Determine Metformin in human plasma by HP LC method

Djnh luQTig Atenolol trong huySt tuong nguo·i bAng phuong phap HPLC aAu do kh6i ph6 MTIWI-TDSH-27 Determine Atenolol in human plasma by LC MSIMS method

Djnh luQTig Cefixim trong huy~t tuong nguai bAng phuong phap HPLC MT/WI-TDSH-28 Determine Cefixime in human plasma by HP LC method

Djnh luQTig Aceclofenac trong huy~t tuong nguo·i bAng phuong phap HPLC MTIWI-TDSH-29 Determine Aceclofenac in human plasma by HPLC method

Djnh lu911g G!imepirid_ tron~ huy~t tuong nguoi bing phuong phap HPLC aau do khoi ph6

MTIWI-TDSH-30 Determine Glimepiride in human plasma by LC MSIMS method

Dinh luQTig Azithromycin trong huySt tuong nguai bAng phuong pbap HPLC aAu do di~n h6a MT/WI-TDSH-31 Determine Azithromycin in human plasma by LC-EC method

Dinh luQTig Azithrom~cin tron~ huy~t tuong nguai bAng phuong phap HPLC dau do khoi pho

MT/WI-TDSH-32 Determine Azithromycin in human plasma by LC MSIMS method

Djnh luQTig Levodropropizin trong huy~t tuong nguo·i bAng phuong phap HPLC aAu do khbi ph6

MTIWI-TDSH-33 Determine Levodropropizine in human plasma by LC MS/MS method

Dinh luQng Adefovir trong huy~t tuong nguo·i bAng phuong phap HPLC aAu do kh6i ph6 MT/WI-TDSH-34 Determine Adefovir in human plasma by LC MSIMS method

Djnh luQTig Glibenclamid trong huySt tuong nguai bing phuong phap HPLC dAu do kh6i ph6

MT/WI-TDSH-35 Determine Glibenclamide in human plasma by LC MS/MS method

L§n ban hanh : 5 .10 Trang: 10/21

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IT

34.

35.

36.

37.

38.

39.

40.

41.

42.

43.

J ~L 01.09

DANH MVC PBEP TmJ NGH:JtM Dl1Q'C COKG NJ4N LIST OF ACCREDITED TESTS

VILAS 108

Ten thu6c/ Phuong ph:ip thfr Drug name Test method

Dinh luong Felodipin trong huySt tuang ngucri bkg phuang phap HPLC diu do kh6i ph6 MT!WI-TDSH-36 Determine Felodipine in human plasma by LC MS/MS method

D~ lu<;mg T~nofovir ~ong. huySt tuong ngucri bkg phuang phap HPLC dau do khoi ph6 MT/WI-TDSH-3 7 Determine Tenofovir in human plasma by LC MSIMS method

Dinh lu?Tig Nifedipin, ch~t chuy~l! h6a troi?-g huy~t tuang ngucn bang phuang phap HPLC dau do khoi pho

MTIWI-TDSH-38

Determine Nifedipine and its metabolite in human plasma by LC MSIMS method

Dinh luqng Ofloxacin trong huy~t tuang nguCri bkg MT/WI-TBSH-39

phuang phap HPLC

Determine Ojloxacin in human plasma by HP LC method

Dinb luqng Carbamazepin trong huy~t tuang ngucn bkg phuang phap HPLC MTIWI-TBSH-40

Determine Carbamazepine in human plasma by HP LC method

Dinb luQTig Losartan, ch~t chuy~n h6a va Hydroclorothiazid trong huy~t tuang nguCri bkg phuang phap HPLC d:ftu do kh6i ph6

MTIWI-TBSH-41

Determine Losartan, its metabolite and Hydrochlorothiazide in human plasma by LC MSIMS method

Dinh luQTig Tamsulosin trong huy~t tuang ngucn bkg phuang phap HPLC d~u do kb6i ph6 MT !WI-TBSH -4 2 Determine Tamsulosine in human plasma by LC MSIMS method

Dinh luqng V ~rapamil va ch~t chuy~n h~a trong ~uy~t. tuang ngucn bang phuang phap HPLC dau do khoi pho MT/WI-TDSH-43 Determine Verapamil and its metabolite in human plasma by LC MSIMS method

Dinb luQTig V alsartan trong huy~t tuang ngucn bkg phuang phap HPLC d~u do kb6i ph6 MT !WI-TBSH -44 Determine Valsartan in human plasma by LC MS/MS method

Dinh luQTig Rhein trong huy~t tuang ngucn bkg phuang phap HPLC MTIWI-TDSH-45 Determine Rheine in human plasma by HPLC method

Un ban himh : 5. 10 Trang: 11/21

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TT

44.

·.

45.

46.

47.

48.

49.

50.

51.

52.

( " AFL 01.09

DANH MVC PREP TmJ NGH1¥M f>U'<;1C CONG ~

LIST OF ACCREDITED TESTS

VILAS 108

Ten tbu6c/ PhtrO'Dg phap thir Drug name Test method

Dinh luqng Arnoxicillin va Acid clavuclanic trong huy~t tuong ngum bAng phuong phap HPLC d~u do kh6i ph6 MT/WI-TDSH-20a (LC-MS/MS-API 5500)

Determine Amoxicillin and Clavulanic acid in human plasma by LC MSIMS method (LC-MSIMS-AP15500)

Dinh luqng Clarithromycin trong huy~t tuong ngum ' ' , ., '

bang phuong phap HPLC dau do khoi pho MT/WI-TDSH-04a Determine Clarithromycine in human plasma by LC MSIMS method

Dinh luqng Azithromycin trong huy~t tuong ngum bAng phuong phap HPLC d~u do kh6i ph6 (LC-MS IT-TOF) MT/WI-IDSH-32a

Determine Azithromycine in human plasma by LC MSIMS method (LC-MS IT-TOF)

Dinh luqng Nitroglycerin va 2 chit chuy~n h6a trong huy~t tuong ngum bAng phuong phap HPLC d~u do kh6i ph6

MT/WI-TDSH-46

Determine Nitroglycerine and 2 metabolites in human plasma by LC MSIMS method

Dinh lugng Telmisartan trong huy~t tuong ngum bAng phuong phap HPLC d~u do kh6i ph6 MT/WI-TDSH-47 Determine Telmisartan in human plasma by LC MSIMS method

Dinh lugng Irbesartan trong huy~t tuong ngum bkg phuong phap HPLC d~u do kh6i ph6 MT/WI-TDSH-48 Determine lrbesartan in human plasma by LC MSIMS method

Dinh lugng Paracetamol va Codein trong huy~t tuong ngum bkg phuong phap HPLC d~u do kh6i ph6 MT/WI-TDSH-49 Determine Paracetamol and Codeine in human plasma by LC MSIMS method

Dinh lugng Paracetamol va Cafein trong huy~t tuong ngum bkg phuong phap HPLC d~u do kh6i ph6 MT/WI-TDSH-50 Determine Paracetamol and Caffeine in human plasma by LC MSIMS method

Dinh luqng Pregabalin trong huy~t tuong nguai bkg phuong phap HPLC d~u do kh6i ph6 MT/WI-TDSH-51 Determine Pregabalin in human plasma by LC MSIMS method

L~n ban Mnh : 5.10 Trang: 12/21

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stt 1. 2. 3. 4. 5·. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. 21. 22. 23. 24. 25. 26. 27. 28. 29. 30. 31. 32. 33. 34. 35. 36. 37. 38. 39. 40. 41. 42. 43.

G"' AFL 01.09

DANH Ml}C PHEP TmJ NG~M IHJ'<}C CONG ~

LIST OF ACCREDITED TESTS

VILAS 108

[2] : Phl;lll;lC Danh IDl;lC cac ten nguyen li~u va ho~t chi t chinh

Ten boat chit chinh stt T en boat chi t chinh Acetaminophen (Paracetamol) 44. Amylase Acid folic 45. Anastrozole Cafe in 46. Anthocyanidin

8-Decalacton 47. Aripiprazol Abacavir sulfat 48. Artemether Acetazolamid 49. . Artemisinin Ace ton 50. Artesunat Acety lcystein 51. As Acetyl-dl-Leucin 52. Atenolol Acid acetyl salicylic (Aspirin) 53. A torvastatin Acid acridon acetic 54. Atovaquin Acid Boric 55. Atropin sulfat Acid clavulanic 56. Azithromycin Acid Linoleic 57. B.subtilis Acid mefenamic 58. Berberin hydroclorid Acid Nalidixic 59. Beta-caroten Acid quinic 60. Betahistin Acid Salicylic 61. Betamethason Acyclovir 62. Bifendat Adefovir 63 . Biolactyl Adenosine 64. Biotin Adrenal in 65. B!_phenyl dimethyl dicarboxilat Albendazol 66. Bisacodyl Alcol 67. Bisoprolol Alendronic acid 68. Bivarulidin Alfuzosin HCl 69. Bromelain Alimemazin Tartrat 70. Bromhexin Aljuzosin HCl 71. Brucin Allopurinol 72. Ca Allylestrenol 73. Calamine Alpha chymotrypsin 74. Calcitriol Aluminium Hydroxyd 75. Canderartan Alverin Citrat 76. Candesartan Alverin dipropilyl 77. Canxi carbonat Ambroxol 78. Canxi clorid Amikacin 79. Canxi glucoheptonat Amiodaron hydroclorid 80. Canxi gluconat Amitriptylin 81. Canxi lactate Amlodipin 82. Canxi rosuvastatin Amodiaquin HCl 83. Captopril Amoxicilin 84. Carbamazepin Ampicilin 85. Carbimazol Am_Qicilin Natri 86. Carbocistein

L~n ban himh : 5. 10 Trang: 13/21

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stt 87. 88. 89. 90. 91. 92. 93 . 94. 95. 96. 97. 98. 99. 100. 101. 102. 103. 104. 105. 106. 107. 108. 109. 110. 111. 112. 113. 114. 115. 116. 117. 118. 119. 120. 121. 122. 123. 124. 125. 126. 127. 128. 129.

130.

DANH Ml}C PREP TmJNG~M DUQC CONG NH4N LIST OF ACCREDITED TESTS

VILAS 108

Ten ho~t chit chinh stt Ten boat ch!t chinh Carbondioxyd 132. Clopropamid Carragenan 133. Cloramin B Carvediol 134. Clorarnphenicol Cd 135. Cloroquin phosphat Cefaclor 136. Clorphenirarnin maleat Cefadroxil 137. Clotrimazol Cefamandol nafat 138. Cloxacilin Cefdinir 139. Cloxinin lysinat Cefebure 140. Codein camphosulfonat Cefepim 141. Codeinphos_phat Cefixim 142. Colchicin Cefmetazol natri 143. Con 70 Cefoperazon 144. Cur cumin Cefotaxim N atri 145. Cyclocerin Cefotaxone 146. Cyproheptadin HCl Cefotiam 147. Deflazacort Cefpodoxim 148. Descloratadin Cefradin 149. Desogestrel Ceftazidim 150. Dexamethason Ceftezol 151. Dexarnethason acetat Ceftizoxim 152. Dexamethasone natri phosphat Ceftriazol 153. Dexclopheniramin maleat Cefuroxim axetil 154. Dextromethophan Bromid Cefuroxim Natri 155. Dextromethophan hydrobromid Celecoxib 156. Dextropropoxyphen HCl Cephalexin 157. Dextrose Cetirizin 158. Diacefyllin Cetrimine 159. Diacerein Chlorpromazin (Aminazin) 160. Diazepam Cholin Alfoscerat 161. Dibencozid Cholin hydrotartrat 162. Diclofenac natri Chondoitin Na 163. Didanosin Cilastatin 164. Diethylphtalat (DEP) Cimetidine 165. Dihydroarternisinin Cinnarizin 166. Dimenhydrinate Ciprofloxacin 167. Dimethicon Cisplastin 168. Dimethyl sulfoxid Citaloprarn 169. Diocta smectit Citicolin 170. Diosmin Clarithromycin 171. Diphenhydramin (Dimedrol) Clavophynarnox 172. Disoproxil fumarat Clindarnycin HCl 173. Distarch phosphat hydroxypropyl Clobetason butyrat 174. Docetaxel Clomiphen 175. Domperidol

131. Clopidogrel 176. D6ng sulphat

~~------~~-----------------~~-~-J~ AFLOI.09 L§.nbanhanh : 5.10 Trang: 14/21

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stt 177.

178.

179.

180.

181.

182.

183.

184.

185.

186.

187.

188.

189.

190.

191.

192.

193.

194.

195.

196.

197.

198.

199. 200.

201.

202.

203.

204.

205.

206.

207.

208.

209. 210.

211.

212.

213 .

214.

215.

216.

DANH Ml)C PHEP TmJ NGHI¥M DU'QC CONG ~

LIST OF ACCREDITED TESTS

VILAS 108

Ten ho~t ch~t chinh stt Ten boat ch~t chinh Dopamin 217. Guafenesin

Doxorubicin HCl 218. Guaiacol

Doxycyclin 219. H202 Drotaverin HCl 220. Haloperidol Dyphylin 221. Hecxamin Efavirenz 222. Hederacoside C

EGCG 2'23. Hg

Enalapril maleat 224. Hydroclothiazid

Eperisone 225. Hydrocortison sodium Succinat

Eprazinon 226. Hydroxylin HCl

Erlotinib 227. Hyoscin-N-butylbrornid

Erythromycin 228. Ibuprofen

Esomeprazol 229. Imezidim

Ethambutol 230. Imipenem

Ethanol 231. Imperatorin

Ethinylestradiol 232. Indinavir

Ethionamid 233. Indomethacin

Ethyl vanilin 234. Iod

Etodolac 235. Irbesartan

Etoricoxib 236. Isoniazid

Famotidin 237. Isosorbide mononitrate

Febuxostat 238. Itraconazol

Fenofibrate 239. Kali sorbat

Fentanyl citrat 240. Kali clorid

Fexofenadin 241. Kanamycin

Fluconazol 242. Kern Gluconat

Flunarizin 243. Kern oxid

Fructose-I ,6-diphosphat 244. Kern sulfat

Furosernid 245. Ketoconazol

Gabapentin 246. Ketoprofen

Gelatin 247. Lactobaclillus acidophilus

Gentamycin 248. Lactose

Glibenclamide 249. Lactulose

Gliclazid 250. Lamivudin

Glirnepirid 251. Lansoprazole

Glucosamin sulfat Natri clorid 252. L-Cystin

Glucosamin sulfat 253. Levodopa

Glucose 254. Levofloxacin

Glycerin 255. Levomepromazin

Griseofulvin 256. Levonoestradiol

~--------------------~------------------------------------------------<.1-. AFL 01.09 L§n ban hanh : 5.10 Trang: 15/21

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stt 257.

258.

259.

260. 261.

. 262.

263.

264.

265.

266.

267.

268.

269.

270.

271.

272.

273.

274.

275.

276.

277.

278.

279.

280.

281.

282.

283.

284.

285.

286.

287.

288.

289.

290.

291.

292.

293.

294.

295.

296.

297.

AFL 01.09

DANH Ml)C PREP TmJ NGHltM IHJ'Q'C CONG NII4N LIST OF ACCREDITED TESTS

VILAS 108

Ten boat cb~t cbinb stt Ten boat cb~t cbinh Levonogestrel 298. Methyl salisylat

Levosulpiride 299. Methyldopa

Levothiroxin 300. Methylprednison

L-Glutathion 301. Metoclopramide

Lidocain HCl 302. Metoprolol tartrat

Lincomycin 303 . Metronidazol

Liothyronin 304. Miconazol

Lipase 305. Mifepriston

Lisinopril 306. Misoprostol

Loperamid 307. Montelukast

Loratadin 308. Morphin sulfat

L-ornithin-Laspartat 309. Mosapride citrat

Losartan 310. Moxifloxacin

Lumefantrin 311. Mucopolysachride

Lupeol 312. Nabumetone

Lycopen 313. Naphazolin

Lysozym HCl 314. Natri citrat

Magnesihydroxyd 315. Natri clorid

Magnesi lactat 316. Natri comphosulfonat

Magnesi oxid 317. Natri Hydrocarbonat

Magnesi stearat 318. Natri thiosulfat

Magnesi sulfat 319. Nebivolol

Magnesi trisilicat 320. NefopamHCl

Manito I 321. Nelfmavir

Mebendazol 322. Neomycin

Mebeverine 323. Nevirapin

Meclofenoxat HCI 324. Nhom hydroxyd

Mecobalamin 325. Nifedipin

Medofenoxat HCl 326. Nifuroxazid

Mefloquin HCl 327. Niketamid

Meloxicam 328. Nirnesulid

Mephenesin 329. Nitrofurantoin

Meropenem 330. Norfloxacin

Metformin hydroclorid 331. Novocain HCl

Methadone hydrochlorid 332. Novomycin

Methimazol 333 . Nystatin

Methionin 334. Ofloxacin

Methotrexat 335. Olanprazol

Methyl cobalamin 336. Olanzapin

Methylprednisolon 337. Omeprazol

Methyl rosanilin 338. Orlisat

Lfut ban himh : 5.10 Trang: 16/21

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stt 339.

340.

341. 342.

343. 344.

345.

346.

347.

348.

349.

350.

351. 352.

353.

354.

355 .

356.

357.

358.

359.

360.

361.

362.

363.

364.

365.

366.

367.

368.

369.

370.

371.

372.

373.

374.

375.

376.

377.

378.

379.

J, AFL 0 1.09

DANH MVC PREP TmJ NG~M IHJ'QC CONG ~

LIST OF ACCREDITED TESTS

VILAS 108

Ten ho~t ch~t chinh stt Ten ho~t ch~t chinh Osthole 380. Propylthiouracil

Ouabain 381. Protease

Oxacillin 382. Prothionamid Oxornemazin 383. Pseudoephedrin HCl

Oxytocin 384. Pyrantel Parnoat

Kern 385. Pyrazinamid

Pancreatin 386. Pyriroetharnin

Pantoprazole 387. Pyrirnetharnin

Papaverin HCl 388. Quinin sulfat

Parafm 389. Rabeprazol natri

Pb 390. Ranitidin

Pearlitol 391. Ribavirin

Pefloxacin 392. Rifampicin

Peginteferon alfa-2a 393. Risedronat natri

Peni V-K 394. Risperidon

Penicilin G (Benzyl penicilin) 395. Ritonavir

Peppermint oil 396. Rotundin

Perindopril 397. Roxithromycin

Phenobarbital 398. Rutin

Phenylephrin HCl 399. Salbutarnol

Phenyltoin 400. Saquinavir

Pidotirnod 401. S~t (II) sulfat

Pioglitazole 402. S~t fumarat

Piperaquin phosphat 403. Secnidazol

Piracetarn 404. Selen

Piroxicarn 405. Serratiopeptidase

Poioglitazone 406. Sildenafil

Polysacharide 407. Silyrnarin

Polyvinyl 408. Sirnethicon

Povidol Iod 409. Sirnvastatin

Praziquantel 410. Sodium lauryl sulfat

Prednisolon 411. Sodium Starch Glycolat

Prednisolon acetat 412. Sorbitol

Prednison 413. Spinololacton

Pregabalin 414. Spiramycin

Prirnaquin phosphat 415. Stavudin

Procain HCl 416. Streptomycin

Procarbazin hydroclorid 417. Stricnin sulphat

Proguanil HCl 418. Succrafat

Promethazin HCl 419. Sulbactarn Propanolol HCl 420. Sulfadoxin

Lfut ban hanh : 5.10 Trang: 17/21

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stt 421.

422.

423.

424.

425.

426.

427. 428.

429.

430. 431.

432.

433.

434.

435. 436.

437.

438. 439.

440.

441. 442.

443.

444.

445.

446.

447. 448.

J··· AFL 01 .09

DANH Ml}C PHEP TmJ NGHI¥M DUQC CONG NJ4N

LIST OF ACCREDITED TESTS

VILAS 108

Ten ho~t chit chinh stt Ten ho~t chit chinh S ulfaguanidin 449. Trimethoprim

Sulfamethoxazol 450. Trimethoprim

Sulfamethoxazol 451. Triprolidin HCL

Sulfogaiacol 452. Tromethamin

Sulpirid 453. Trypsin

Tadalafil 454. Tyrothricin

Tamsulosin 45). Umexirn

Taurin 456. Ursodiol

Telmisaran 457. Utrixon Tenofovir 458. Val proate N atri

Tenoxicam 459. Vancomycin HCl

Terbutalin sulfat 460. Vaselin

Terpin hydrat 461. Vinpocetin

Tetracain 462. Vitamin A

T etracyclin 463. Vitamin B 1 HCl

Tetrahydrozolon HCl 464. Vitamin B 1 Nitrat

Tbeophylin 465. Vitamin B12

Tbymomodulin 466. Vitamin B2

Tinidazol 467. Vitamin B5

Titanium dioxid 468. Vitamin B6

Tobramycin 469. Vitamin C

Tolperisone 470. Vitamin D3

Tramadol 471. Vitamin E

Tranexamic 472. Vitamin K

Tretinoin 473. Vitamin PP

Triamcinolon 474. Xanh methylen

Trimebutin 475. Xyclomethazolin

Trimetazidin 2HCl 476. Zidovudin

L§n ban hanh : 5.10 Trang: 18/21

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Stt 1. 2. 3.

·. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. 21. 22. 23. 24. 25. 26. 27. 28. 29. 30. 31. 32. 33. 34. 35. 36.

37.

38.

39.

40.

41.

42.

DANH MT)C PREP TmJ NGHI:.E:M IHJ'Q'C CONG ~

LIST OF ACCREDITED TESTS

VILAS 108

[3]: Phi} ll}C Danh IDl,lC cac ten DU'(}'C li~u

Ten drr<rc li~u Stt Ten drr<rc li~u A giao 44. Cot khi cu An rue huang 45. Cot toai bo Artiso 46. Chi xac Ba kich 47. Chi thlJC Ba runhan 48. Chi tli B<;tcha 49. CM day B<;tch bien d~u 50. Cugai B<;tch c~p 51. D<;t cam B<;tch chi 52. Danb danb B<;tch boa xa 53. Dam duang hoac B<;tch linh 54. Day dau xuang B<;tch ph1,1c linh 55. Di~p h<;t chau B<;tch qua 56. D<;ti hoang B<;tch Thuqc 57. D<;ti hoi B~ch tru~t 58. D<;ti tao Bach b(> 59. D<;ti cot bi B<;tch mao can 60. Dan sam B<;tch d~u khau 61. Dang sam Bach hqp 62. Dang tam B<;tch T~t le 63. Dao nhan Banh<;t 64. Dia hoang Ban chi lien 65. Dinh lang Beo hoa dau 66. Dia du Bien sue 67. Dia lien Binh lang 68. Dia long Bimbim 69. Dinh huang Binh voi 70. 86 trQng Bo cong anh 71. D(>c ho<;tt Bo bo 72. Dan bi BQ mfun 73. Duang quy Borneol 74. Duemgkhu Caulcy ru 75. Eucalyptol Cau dang 76. Eugenol Cau tich 77. Ginkgo biloba Cat canb 78. Girng Cat can 79. Grindelia Cankhuang 80. Hathuo

Cam thao 81. H<;tt sen Camphor 82. H~uphac

Co nhQ n6i 83. H<;t thao kho Cue hoa 84. H~nhan Co ngQt 85. H~c ph1,1

43. 1

Coi xay I 86.

1 Hoa hoe I

~~------~----------------~~-AFL0 1.09 Lili1 banhanh : 5.10 Trang:l9/21

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Stt 87.

88.

89.

90.

91. 92.

93. 94.

95.

96.

97.

98.

99.

100.

101.

102.

103. 104.

105.

106.

107.

108.

109.

110. 111.

112.

113.

114.

115.

116.

117.

118.

119.

120. 121.

122.

123.

124.

125.

126.

DANH MVC PHEP THU NGIII¥M DU<}C CONG NH4N LIST OF ACCREDITED TESTS

VILAS 108

Ten dtrQ'c li~u Stt Ten dtrQ'c li~u

Hoai son 128. Longnhan

Hoang ba 129. LongdOm.

Hoang dckg 130. Lien ki~u Hoang kY 131. Ma hoang

Hoang lien 132. M;;1ch nha

Hoang cfun 133. M<;1chmon

Ho;;1t th;;1ch 134.• Mad~ H6ng hoa 135. Ma ti~n H6ng sam 136. Mai illl,IC

Huy~n sam 137. M~u don bi

Huy~n h6 138. M?n kinh tfr Huy~t giac 139. Min triu

Huang ph\1 140. M9c qua

Hy thiem 141. Mi~t giap

ich m~u 142. M9t duqc

ich tri nhan 143. Me den

Ke diu ngl,Ia 144. Menthol

Khi~m thl,Ic 145. M9choa trkg

Kh6 sam 146. M9chuong

Kim ti~n thao 147. M9cthong

Kimnganhoa 148. M9c qua

Kimanh 149. Muu

Kim ngan cu9ng 150. Mu6ng trau

Kinh Gi&i 151. Nfun linh chi

Ke huy~t dfuig 152. Ngai Ctiu

Ke n9i kim 153. Nga tru~t

Kh6 qua 154. Ng~y huang

Khuong hoang 155. Ngh~

Khuong ho;;1t 156. Ngo thu du

Ky tfr 157. NgQc trUe

La b;;1c 158. Nguu t~t La khoi 159. Ngii b9i tfr

La I6t 160. N gii gia bi chan chim

La sen 161. Ngii vi tfr

La vong 162. Nguubang

L;;1c tien 163. Nguu hoang

Lien nh\lc 164. Nhan trill Lien tam 165. Nhan sam

L9c nhung 166. Nhi h6ng sam

Long c6t 167. Nhl,lc thung dung

I 127. 1 Long nao I 168.

1 Nhii huang

~~e ----~------------~b/-J-. AFL 01.09 L§n ban harm : 5.10 Trang: 20/21

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Stt 169.

170.

171.

172.

173.

174.

175.

176.

177.

178.

179.

180.

181.

182.

183.

184.

185.

186.

187. 188.

189.

190.

191.

192.

193.

194.

195.

196.

197.

198.

199.

200. 201.

202.

DANH Mt)C PREP TmJ NGHltM IHJ'QC CONG 1\~

LIST OF ACCREDITED TESTS

VILAS 108

Ten dtrgc li~u Stt Ten dugc li~u Nh1,1c d~u khau 203. San tra ·

0 d~u 204. Sua ong chua

Oro 205. T~c ke

6 ~c c6t 206. Tao 6 duqc 207. Tao nhan

Phl,lC thk 208. Tan di boa Phen chua 209. 'J;ang b~cb bi Palmatin 210. Tang di~p Pha c6 chi 211. Tang ky sinh

Phong ky 212. Tang chi

Phong phong 213. Trinh nfr boang cung

Pbl,lC linh 214. T1,1c do~ Phl,lC thk 215. Tuuy~n Ph1,1 ru 216. Tyba

Qua lau 217. Ty gia

qu~ chi 218. Uy linh tien

Qu~ nhl,l.c 219. U~tkim Quy d~u (r~ Duang quy) 220. Yru Quy vi (r~ con Duang quy) 22 1. Xa xang

Quy ban 222. Xa ti~n tU Rauma 223. X~ can Rauom 224. Xich d6ng nam Raumeo 225. Xich thuqc

Rau ngo 226. Xuyen b6i m~u Ruscogenines 227. Xuyen khung

Sa nhan 228. Xuyen quy

Sa sam 229. Xuyen san giap

Sa xang ru 230. Xuyen tam lien

Sai h6 231. Xuyen tieu

Sai d~t 232. Vangd~g Sam ng9C linh 233. Vi~n chi

sam d~hanb 234. Vo mang C\}t

Sinh dja 235. Tang phien tieu

San thu

L~ ban himh: 5.10

)

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