monographs in need of modernization (last updated 24-may ......monograph name monograph family date...
TRANSCRIPT
Monograph Name Monograph Family Date Added to List
Last Update for Item
Status Publication Monograph Type
Monograph Test
Procedure Replace or Add Test
Replacement Procedures
Liaison Comments
ACETAMINOPHEN AND CAFFEINE
CAPSULES
ACETAMINOPHEN 24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Clydewyn Anthony
ACETAMINOPHEN AND CAFFEINE
TABLETS
ACETAMINOPHEN 24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Clydewyn Anthony
ACETAMINOPHEN AND
PSEUDOEPHEDRINE HYDROCHLORIDE
TABLETS
ACETAMINOPHEN 24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Clydewyn Anthony
ACETAMINOPHEN DIPHENHYDRAMINE CITRATE TABLETS
ACETAMINOPHEN 24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Clydewyn Anthony
ACYCLOVIR ACYCLOVIR 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Ordinary Impurities
TLC Replace Modern Procedure
Behnam Davani
HYDROCHLORIDEALFENTANIL
HYDROCHLORIDE24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceAssay Titration Replace Stability
Indicating A
Clydewyn Anthony
@
Monographs in Need of Modernization (Last Updated 24-May-2010)
Assay [email protected] AMINOPHYLLINE 24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceImpurities Missing Add Quantitative
stability indicating procedure
Domenick Vicchio
AMINOPHYLLINE DELAYED-RELEASE
TABLETS
AMINOPHYLLINE 24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Domenick Vicchio
AMINOPHYLLINE INJECTION
AMINOPHYLLINE 24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Domenick Vicchio
AMINOPHYLLINE ORAL SOLUTION
AMINOPHYLLINE 24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Domenick Vicchio
AMINOPHYLLINE RECTAL SOLUTION
AMINOPHYLLINE 24-May 2010 (Initial posting)
Submission Needed
Drug Product Assay UV Replace Modern Procedure
Domenick Vicchio
Monograph Name Monograph Family Date Added to List
Last Update for Item
Status Publication Monograph Type
Monograph Test
Procedure Replace or Add Test
Replacement Procedures
Liaison Comments
Monographs in Need of Modernization (Last Updated 24-May-2010)
AMINOPHYLLINE RECTAL SOLUTION
AMINOPHYLLINE 24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Domenick Vicchio
AMINOPHYLLINE SUPPOSITORIES
AMINOPHYLLINE 24-May 2010 (Initial posting)
Submission Needed
Drug Product Assay Titration Replace Stability Indicating
Assay
Domenick Vicchio
[email protected] SUPPOSITORIES
AMINOPHYLLINE 24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Domenick Vicchio
AMINOPHYLLINE TABLETS
AMINOPHYLLINE 24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Domenick Vicchio
AMOXAPINE TABLETS
AMOXAPINE 24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Ravi Ravichandran
ANILERIDINE ANILERIDINE 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Titration Replace Stability Indicating
Assay
Clydewyn Anthony
[email protected] ANILERIDINE 24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceImpurities Missing Add Quantitative
stability indicating procedure
Clydewyn Anthony
ANILERIDINE HYDROCHLORIDE
ANILERIDINE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Titration Replace Stability Indicating
Assay
Clydewyn Anthony
HYDROCHLORIDEANILERIDINE
HYDROCHLORIDE24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceImpurities Missing Add Quantitative
stability indicating procedure
Clydewyn Anthony
ANTAZOLINE PHOSPHATE
ANTAZOLINE PHOSPHATE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Titration Replace Stability Indicating
Assay
Elena Gonikberg
[email protected] PHOSPHATE
ANTAZOLINE PHOSPHATE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Related Compounds
TLC Replace Modern Procedure
Elena Gonikberg
[email protected] ANTIPYRINE 24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceAssay Titration Replace Stability
Indicating Assay
Clydewyn Anthony
[email protected] ANTIPYRINE 24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceOrdinary Impurities
TLC Replace Modern Procedure
Clydewyn Anthony
Monograph Name Monograph Family Date Added to List
Last Update for Item
Status Publication Monograph Type
Monograph Test
Procedure Replace or Add Test
Replacement Procedures
Liaison Comments
Monographs in Need of Modernization (Last Updated 24-May-2010)
ASPIRIN ASPIRIN 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Titration Replace Stability Indicating
Assay
Clydewyn Anthony
[email protected] ASPIRIN 24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceLimit of free salicylic acid
Colorimetric Replace Modern Procedure
Clydewyn Anthony
[email protected] CAPSULES ASPIRIN 24-May 2010
(Initial posting)Submission
NeededDrug Product Assay Open
Column LCReplace Modern
ProcedureClydewyn Anthony
[email protected] CAPSULES ASPIRIN 24-May 2010
(Initial posting)Submission
NeededDrug Product Limit of free
salicylic acidOpen
Column LCReplace Modern
ProcedureClydewyn Anthony
SUPPOSITORIESASPIRIN 24-May 2010
(Initial posting)Submission
NeededDrug Product Assay Open
Column LCReplace Modern
ProcedureClydewyn Anthony
SUPPOSITORIESASPIRIN 24-May 2010
(Initial posting)Submission
NeededDrug Product Limit of free
salicylic acidOpen
Column LCReplace Modern
ProcedureClydewyn Anthony
[email protected] AUROTHIOGLUCOSE 24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceAssay Titration Replace Stability
Indicating Assay
Clydewyn Anthony
[email protected] AUROTHIOGLUCOSE 24-May 2010 Submission Drug Impurities Missing Add Quantitative Clydewyn
(Initial posting) Needed Substance stability indicating procedure
Anthony [email protected]
AZATADINE MALEATE AZATADINE MALEATE 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Titration Replace Stability Indicating
Assay
Domenick Vicchio
[email protected] MALEATE AZATADINE MALEATE 24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceChromatogra
phic PurityTLC/UV Replace Modern
ProceduresDomenick
Vicchio [email protected]
AZATADINE MALEATE TABLETS
AZATADINE MALEATE 24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Domenick Vicchio
AZATADINE MALEATE TABLETS
AZATADINE MALEATE 24-May 2010 (Initial posting)
Submission Needed
Drug Product Assay UV Replace Modern Procedure
Domenick Vicchio
IDEBENDROFLUMETHIAZ
IDE24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceAssay Titration Replace Stability
Indicating Assay
Sujatha Ramakrishna [email protected]
BENOXINATE HYDROCHLORIDE
BENOXINATE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Titration Replace Stability Indicating
Assay
Domenick Vicchio
Monograph Name Monograph Family Date Added to List
Last Update for Item
Status Publication Monograph Type
Monograph Test
Procedure Replace or Add Test
Replacement Procedures
Liaison Comments
Monographs in Need of Modernization (Last Updated 24-May-2010)
BENOXINATE HYDROCHLORIDE
BENOXINATE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Ordinary Impurities
TLC Replace Modern Procedure
Domenick Vicchio
[email protected] BENZOCAINE 24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceOrdinary Impurities
TLC Replace Modern Procedure
Domenick Vicchio
[email protected] CREAM BENZOCAINE 24-May 2010
(Initial posting)Submission
NeededDrug Product Assay Titration Replace Stability
Indicating Assay
Domenick Vicchio
[email protected] CREAM BENZOCAINE 24-May 2010
(Initial posting)Submission
NeededDrug Product Impurities Missing Add Quantitative
stability indicating procedure
Domenick Vicchio
BENZOCAINE OINTMENT
BENZOCAINE 24-May 2010 (Initial posting)
Submission Needed
Drug Product Assay Titration Replace Stability Indicating
Assay
Domenick Vicchio
OINTMENTBENZOCAINE 24-May 2010
(Initial posting)Submission
NeededDrug Product Impurities Missing Add Quantitative
stability indicating procedure
Domenick Vicchio
BENZOCAINE OTIC SOLUTION
BENZOCAINE 24-May 2010 (Initial posting)
Submission Needed
Drug Product Assay Titration Replace Stability Indicating
Domenick Vicchio
Assay [email protected] OTIC
SOLUTIONBENZOCAINE 24-May 2010
(Initial posting)Submission
NeededDrug Product Impurities Missing Add Quantitative
stability indicating procedure
Domenick Vicchio
BENZOCAINE TOPICAL SOLUTION
BENZOCAINE 24-May 2010 (Initial posting)
Submission Needed
Drug Product Assay Titration Replace Stability Indicating
Assay
Domenick Vicchio
TOPICAL SOLUTIONBENZOCAINE 24-May 2010
(Initial posting)Submission
NeededDrug Product Impurities Missing Add Quantitative
stability indicating procedure
Domenick Vicchio
BETAXOLOL HYDROCHLORIDE
BETAXOLOL HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Titration Replace Stability Indicating
Assay
Feiwen Mao [email protected]
BROMODIPHENHYDRAMINE
HYDROCHLORIDE
BROMODIPHENHYDRAMINE
HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Titration Replace Stability Indicating
Assay
Domenick Vicchio
AMINE HYDROCHLORIDE
BROMODIPHENHYDRAMINE
HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Impurities Missing Add Quantitative stability
indicating procedure
Domenick Vicchio
Monograph Name Monograph Family Date Added to List
Last Update for Item
Status Publication Monograph Type
Monograph Test
Procedure Replace or Add Test
Replacement Procedures
Liaison Comments
Monographs in Need of Modernization (Last Updated 24-May-2010)
BROMODIPHENHYDRAMINE
HYDROCHLORIDE ORAL SOLUTION
BROMODIPHENHYDRAMINE
HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Product Assay Titration Replace Stability Indicating
Assay
Domenick Vicchio
BROMODIPHENHYDRAMINE
HYDROCHLORIDE ORAL SOLUTION
BROMODIPHENHYDRAMINE
HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Domenick Vicchio
BROMPHENIRAMINE MALEATE
BROMPHENIRAMINE MALEATE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Chromatographic Purity
GC - Packed Column
Replace Modern Procedure
Domenick Vicchio
MALEATEBROMPHENIRAMINE
MALEATE24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceAssay Titration Replace Stability
Indicating Assay
Domenick Vicchio
MALEATE ORAL SOLUTION
BROMPHENIRAMINE MALEATE
24-May 2010 (Initial posting)
Submission Needed
Drug Product Assay Titration Replace Stability Indicating
Assay
Domenick Vicchio
MALEATE ORAL SOLUTION
BROMPHENIRAMINE MALEATE
24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Domenick Vicchio
BUPIVACAINE BUPIVACAINE 24-May 2010 Submission Drug Assay Titration Replace Stability Domenick HYDROCHLORIDE HYDROCHLORIDE (Initial posting) Needed Substance Indicating
AssayVicchio
HYDROCHLORIDEBUPIVACAINE
HYDROCHLORIDE24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceChromatogra
phic PurityTLC Replace Modern
Procedure Domenick
Vicchio [email protected]
BUTABARBITAL SODIUM TABLETS
BUTABARBITAL SODIUM
24-May 2010 (Initial posting)
Submission Needed
Drug Product Assay GC - Packed Column
Replace Modern Procedure
Ravi Ravichandran
[email protected] BUTAMBEN 24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceAssay Titration Replace Stability
Indicating Assay
Domenick Vicchio
[email protected] BUTAMBEN 24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceImpurities Missing Add Quantitative
stability indicating procedure
Domenick Vicchio
BUTORPHANOL TARTRATE
BUTORPHANOL TARTRATE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Titration Replace Stability Indicating
Assay
Clydewyn Anthony
TARTRATEBUTORPHANOL
TARTRATE24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceChromatogra
phic PurityTLC Replace Modern
ProcedureClydewyn Anthony
Current procedure uses
Benzene
Monograph Name Monograph Family Date Added to List
Last Update for Item
Status Publication Monograph Type
Monograph Test
Procedure Replace or Add Test
Replacement Procedures
Liaison Comments
Monographs in Need of Modernization (Last Updated 24-May-2010)
BUTORPHANOL TARTRATE
BUTORPHANOL TARTRATE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Chromatographic Purity
GC - Packed Column
Replace Modern Procedure
Clydewyn Anthony
TARTRATE INJECTION
BUTORPHANOL TARTRATE
24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Clydewyn Anthony
BUTORPHANOL TARTRATE NASAL
SOLUTION
BUTORPHANOL TARTRATE
24-May 2010 (Initial posting)
Submission Needed
Drug Product Identification TLC Replace Procedure without
Benzene
Clydewyn Anthony
Current procedure uses
Benzene CARBINOXAMINE
MALEATECARBINOXAMINE
MALEATE24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceAssay Titration Replace Stability
Indicating Assay
Domenick Vicchio
MALEATECARBINOXAMINE
MALEATE24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceOrdinary Impurities
TLC Replace Modern Procedure
Domenick Vicchio
MALEATE TABLETSCARBINOXAMINE
MALEATE24-May 2010
(Initial posting)Submission
NeededDrug Product Assay Titration Replace Stability
Indicating Assay
Domenick Vicchio
MALEATE TABLETSCARBINOXAMINE
MALEATE24-May 2010
(Initial posting)Submission
NeededDrug Product Impurities Missing Add Quantitative
stability indicating
Domenick Vicchio
CEFADROXIL CEFADROXIL 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Chromatographic Purity
TLC Replace Modern Procedure
Ahalya Wise [email protected]
CEFADROXIL CAPSULES
CEFADROXIL 24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Ahalya Wise [email protected]
CEFADROXIL FOR ORAL SUSPENSION
CEFADROXIL 24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Ahalya Wise [email protected]
CEFADROXIL TABLETS
CEFADROXIL 24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Ahalya Wise [email protected]
CEFAZOLIN CEFAZOLIN 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Impurities Missing Add Quantitative stability
indicating procedure
Ahalya Wise [email protected]
Monograph Name Monograph Family Date Added to List
Last Update for Item
Status Publication Monograph Type
Monograph Test
Procedure Replace or Add Test
Replacement Procedures
Liaison Comments
Monographs in Need of Modernization (Last Updated 24-May-2010)
CEFAZOLIN FOR INJECTION
CEFAZOLIN 24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Ahalya Wise [email protected]
CEFAZOLIN INJECTION
CEFAZOLIN 24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Ahalya Wise [email protected]
CEFPROZIL CEFPROZIL 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Impurities Missing Add Quantitative stability
indicating procedure
Ahalya Wise [email protected]
CEFPROZIL FOR ORAL SUSPENSION
CEFPROZIL 24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Ahalya Wise [email protected]
CEFPROZIL TABLETS CEFPROZIL 24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Ahalya Wise [email protected]
CEFTRIAXONE SODIUM
CEFTRIAXONE SODIUM
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Impurities Missing Add Quantitative stability
Ahalya Wise [email protected]
indicating procedure
CEFUROXIME AXETIL CEFUROXIME AXETIL 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Impurities Missing Add Quantitative stability
indicating procedure
Ahalya Wise [email protected]
CEFUROXIME AXETIL FOR ORAL
SUSPENSION
CEFUROXIME AXETIL 24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Ahalya Wise [email protected]
CEFUROXIME AXETIL TABLETS
CEFUROXIME AXETIL 24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Ahalya Wise [email protected]
CHLORPHENIRAMINE MALEATE
CHLORPHENIRAMINE MALEATE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Related Compounds
GC - Packed Column
Replace Modern Procedure
Domenick Vicchio
[email protected] FUMARATE
CLEMASTINE FUMARATE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Titration Replace Stability Indicating
Assay
Domenick Vicchio
Monograph Name Monograph Family Date Added to List
Last Update for Item
Status Publication Monograph Type
Monograph Test
Procedure Replace or Add Test
Replacement Procedures
Liaison Comments
Monographs in Need of Modernization (Last Updated 24-May-2010)
CLEMASTINE FUMARATE TABLETS
CLEMASTINE FUMARATE
24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Domenick Vicchio
CYCLIZINE HYDROCHLORIDE
CYCLIZINE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Titration Replace Stability Indicating
Assay
Elena Gonikberg
HYDROCHLORIDECYCLIZINE
HYDROCHLORIDE24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceOrdinary Impurities
TLC Replace Modern Procedure
Elena Gonikberg
[email protected] HYDROCHLORIDE
CYPROHEPTADINE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Titration Replace Stability Indicating
Assay
Domenick Vicchio
[email protected] HYDROCHLORIDE
CYPROHEPTADINE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Impurities Missing Add Quantitative stability
indicating procedure
Domenick Vicchio
CYPROHEPTADINE HYDROCHLORIDE ORAL SOLUTION
CYPROHEPTADINE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Domenick Vicchio
CYPROHEPTADINE CYPROHEPTADINE 24-May 2010 Submission Drug Product Impurities Missing Add Quantitative Domenick HYDROCHLORIDE
TABLETSHYDROCHLORIDE (Initial posting) Needed stability
indicating procedure
Vicchio [email protected]
DEXBROMPHENIRAMINE MALEATE
DEXBROMPHENIRAMINE MALEATE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Related Compounds
GC - Packed Column
Replace Modern Procedure
Domenick Vicchio
NE MALEATEDEXBROMPHENIRAMI
NE MALEATE24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceAssay Titration Replace Stability
Indicating Assay
Domenick Vicchio
MINE MALEATEDEXCHLORPHENIRA
MINE MALEATE24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceRelated
CompoundsGC - Packed
ColumnReplace Modern
ProcedureDomenick
Vicchio [email protected]
DEXCHLORPHENIRAMINE MALEATE
DEXCHLORPHENIRAMINE MALEATE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Titration Replace Stability Indicating
Assay
Domenick Vicchio
[email protected] DIFLUNISAL 24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceChromatogra
phic PurityTLC Replace Modern
Procedure Clydewyn Anthony
BITARTRATEDIHYDROCODEINE
BITARTRATE24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceOrdinary Impurities
TLC Replace Modern Procedure
Clydewyn Anthony
Monograph Name Monograph Family Date Added to List
Last Update for Item
Status Publication Monograph Type
Monograph Test
Procedure Replace or Add Test
Replacement Procedures
Liaison Comments
Monographs in Need of Modernization (Last Updated 24-May-2010)
DIPHENHYDRAMINE CITRATE
DIPHENHYDRAMINE CITRATE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Titration Replace Stability Indicating
Assay
Domenick Vicchio
CITRATEDIPHENHYDRAMINE
CITRATE24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceImpurities Missing Add Quantitative
stability indicating procedure
Domenick Vicchio
DIPHENHYDRAMINE HYDROCHLORIDE
DIPHENHYDRAMINE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Impurities Missing Add Quantitative stability
indicating procedure
Domenick Vicchio
DIPHENHYDRAMINE HYDROCHLORIDE
CAPSULES
DIPHENHYDRAMINE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Domenick Vicchio
DIPHENHYDRAMINE HYDROCHLORIDE
INJECTION
DIPHENHYDRAMINE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Domenick Vicchio
DIPHENHYDRAMINE HYDROCHLORIDE ORAL SOLUTION
DIPHENHYDRAMINE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating
Domenick Vicchio
DISOPYRAMIDE PHOSPHATE
DISOPYRAMIDE PHOSPHATE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Titration Replace Stability Indicating
Assay
Sujatha Ramakrishna [email protected]
DISOPYRAMIDE PHOSPHATE
DISOPYRAMIDE PHOSPHATE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Chromatographic Purity
TLC Replace Modern Procedure
Sujatha Ramakrishna [email protected]
DISOPYRAMIDE PHOSPHATE CAPSULES
DISOPYRAMIDE PHOSPHATE
24-May 2010 (Initial posting)
Submission Needed
Drug Product Assay UV Replace Modern Procedure
Sujatha Ramakrishna [email protected]
DISOPYRAMIDE PHOSPHATE CAPSULES
DISOPYRAMIDE PHOSPHATE
24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Sujatha Ramakrishna [email protected]
DISOPYRAMIDE PHOSPHATE
EXTENDED-RELEASE CAPSULES
DISOPYRAMIDE PHOSPHATE
24-May 2010 (Initial posting)
Submission Needed
Drug Product Assay UV Replace Modern Procedure
Sujatha Ramakrishna [email protected]
Monograph Name Monograph Family Date Added to List
Last Update for Item
Status Publication Monograph Type
Monograph Test
Procedure Replace or Add Test
Replacement Procedures
Liaison Comments
Monographs in Need of Modernization (Last Updated 24-May-2010)
DISOPYRAMIDE PHOSPHATE
EXTENDED-RELEASE CAPSULES
DISOPYRAMIDE PHOSPHATE
24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Sujatha Ramakrishna [email protected]
DOXYLAMINE SUCCINATE
DOXYLAMINE SUCCINATE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Titration Replace Stability Indicating
Assay
Domenick Vicchio
[email protected] SUCCINATE
DOXYLAMINE SUCCINATE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Related Compounds
GC - Packed Column
Replace Modern Procedure
Domenick Vicchio
[email protected] DYDROGESTERONE 24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceSpecific Rotation
Specific Rotation
Replace Procedure without 1,1,1-Trichloroethan
e
Domenick Vicchio
EPHEDRINE EPHEDRINE 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Titration Replace Stability Indicating
Assay
Domenick Vicchio
HYDROCHLORIDEEPHEDRINE
HYDROCHLORIDE24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceAssay Titration Replace Stability
Indicating Assay
Domenick Vicchio
[email protected] SULFATE EPHEDRINE SULFATE 24-May 2010 Submission Drug Assay Titration Replace Stability Domenick
(Initial posting) Needed Substance Indicating Assay
Vicchio [email protected]
ESTRADIOL VALERATE
ESTRADIOL VALERATE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Ordinary Impurities
TLC Replace Modern Procedure
Domenick Vicchio
[email protected] ESTRONE 24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceOrdinary Impurities
TLC Replace Modern Procedure
Domenick Vicchio
[email protected] ETHCHLORVYNOL 24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceAssay GC - Packed
ColumnReplace Modern
ProcedureRavi
Ravichandran [email protected]
ETHCHLORVYNOL CAPSULES
ETHCHLORVYNOL 24-May 2010 (Initial posting)
Submission Needed
Drug Product Assay GC - Packed Column
Replace Modern Procedure
Ravi Ravichandran
[email protected] FRUCTOSE 24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceAssay Angular
RotationReplace Stability
Indicating Assay
Domenick Vicchio
SODIUM CHLORIDE INJECTION
FRUCTOSE AND SODIUM CHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Product Assay Angular Rotation
Replace Stability Indicating
Assay
Domenick Vicchio
Monograph Name Monograph Family Date Added to List
Last Update for Item
Status Publication Monograph Type
Monograph Test
Procedure Replace or Add Test
Replacement Procedures
Liaison Comments
Monographs in Need of Modernization (Last Updated 24-May-2010)
GENTAMICIN SULFATE
GENTAMICIN SULFATE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Microbiological Assay
Replace Modern Procedure
Ahalya Wise [email protected]
Need Data for Comparison to Microbiological Assay
GENTAMICIN SULFATE OINTMENT
GENTAMICIN SULFATE
24-May 2010 (Initial posting)
Submission Needed
Drug Product Assay Microbiological Assay
Replace Modern Procedure
Ahalya Wise [email protected]
Need Data for Comparison to Microbiological Assay
GLYCERIN OPHTHALMIC
SOLUTION
GLYCERIN OPHTHALMIC
24-May 2010 (Initial posting)
Submission Needed
Drug Product Assay Titration Replace Stability Indicating
Assay
Feiwen Mao [email protected]
GUAIFENESIN AND PSEUDOEPHEDRINE
HYDROCHLORIDE CAPSULES
GUAIFENESIN AND PSEUDOEPHEDRINE
HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Product Dissolution Missing Add Add Dissolution Procedure
Clydewyn Anthony
GUAIFENESIN AND PSEUDOEPHEDRINE
HYDROCHLORIDE CAPSULES
GUAIFENESIN AND PSEUDOEPHEDRINE
HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Clydewyn Anthony
GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE,
AND DEXTROMETHORPHA
N HYDROBROMIDE CAPSULES
GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE,
AND DEXTROMETHORPHA
N HYDROBROMIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Product Dissolution Missing Add Add Dissolution Procedure
Clydewyn Anthony
GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE,
AND DEXTROMETHORPHA
N HYDROBROMIDE CAPSULES
GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE,
AND DEXTROMETHORPHA
N HYDROBROMIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Clydewyn Anthony
GUANABENZ ACETATE
GUANABENZ ACETATE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Titration Replace Stability Indicating
Assay
Sujatha Ramakrishna [email protected]
GUANABENZ ACETATE
GUANABENZ ACETATE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Chromatographic Purity
TLC Replace Modern Procedure
Sujatha Ramakrishna [email protected]
GUANABENZ ACETATE
GUANABENZ ACETATE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Limit of 2,6-dichlorobenz
aldehyde
GC - Packed Column
Replace Modern Procedure
Sujatha Ramakrishna [email protected]
Monograph Name Monograph Family Date Added to List
Last Update for Item
Status Publication Monograph Type
Monograph Test
Procedure Replace or Add Test
Replacement Procedures
Liaison Comments
Monographs in Need of Modernization (Last Updated 24-May-2010)
HALOTHANE HALOTHANE 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Chromatographic Purity
GC - Packed Column
Replace Modern Procedure
Domenick Vicchio
HYDROCHLORIDE INJECTION
HYDRALAZINE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Product Assay Titration Replace Stability Indicating
Assay
Sujatha Ramakrishna [email protected]
HYDROCODONE BITARTRATE
TABLETS
HYDROCODONE BITARTRATE
24-May 2010 (Initial posting)
Submission Needed
Drug Product Assay Titration Replace Stability Indicating
Assay
Clydewyn Anthony
BITARTRATE TABLETS
HYDROCODONE BITARTRATE
24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Clydewyn Anthony
HYDROMORPHONE HYDROCHLORIDE
INJECTION
HYDROMORPHONE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Product Assay UV Replace Modern Procedure
Clydewyn Anthony
[email protected] HYDROCHLORIDE
INJECTION
HYDROMORPHONE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Clydewyn Anthony
HYDROMORPHONE HYDROCHLORIDE
HYDROMORPHONE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
Clydewyn Anthony
TABLETS indicating procedure
HYDROXYAMPHETAMINE HYDROBROMIDE
HYDROXYAMPHETAMINE HYDROBROMIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Titration Replace Stability Indicating
Assay
Feiwen Mao [email protected]
HYDROXYAMPHETAMINE HYDROBROMIDE
HYDROXYAMPHETAMINE HYDROBROMIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Ordinary Impurities
TLC Replace Modern Procedure
Feiwen Mao [email protected]
HYDROXYPROGESTERONE CAPROATE
HYDROXYPROGESTERONE CAPROATE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay UV Replace Modern Procedure
Mary Waddell [email protected]
HYDROXYPROGESTERONE CAPROATE
HYDROXYPROGESTERONE CAPROATE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Ordinary Impurities
TLC Replace Modern Procedure
Mary Waddell [email protected]
IBUPROFEN AND PSEUDOEPHEDRINE
HYDROCHLORIDE TABLETS
IBUPROFEN 24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Clydewyn Anthony
IMIPENEM IMIPENEM 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Solvents GC - Packed Column
Replace Modern Procedure
Ahalya Wise [email protected]
Monograph Name Monograph Family Date Added to List
Last Update for Item
Status Publication Monograph Type
Monograph Test
Procedure Replace or Add Test
Replacement Procedures
Liaison Comments
Monographs in Need of Modernization (Last Updated 24-May-2010)
IMIPENEM IMIPENEM 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Impurities Missing Add Quantitative stability
indicating procedure
Ahalya Wise [email protected]
IMIPENEM AND CILASTATIN FOR
INJECTABLE SUSPENSION
IMIPENEM AND CILASTATIN
24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Ahalya Wise [email protected]
IMIPENEM AND CILASTATIN FOR
INJECTION
IMIPENEM AND CILASTATIN
24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Ahalya Wise [email protected]
INDOMETHACIN INDOMETHACIN 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Impurities Missing Add Quantitative stability
indicating procedure
Clydewyn Anthony
LEVONORDEFRIN LEVONORDEFRIN 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Titration Replace Stability Indicating
Assay
Sujatha Ramakrishna [email protected]
LEVORPHANOL TARTRATE
LEVORPHANOL TARTRATE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Titration Replace Stability Indicating
Assay
Clydewyn Anthony
TARTRATELEVORPHANOL
TARTRATE24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceOrdinary Impurities
TLC Replace Modern Procedure
Clydewyn Anthony
TARTRATE INJECTION
LEVORPHANOL TARTRATE
24-May 2010 (Initial posting)
Submission Needed
Drug Product Assay Titration Replace Stability Indicating
Assay
Clydewyn Anthony
TARTRATE INJECTION
LEVORPHANOL TARTRATE
24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Clydewyn Anthony
LEVORPHANOL TARTRATE TABLETS
LEVORPHANOL TARTRATE
24-May 2010 (Initial posting)
Submission Needed
Drug Product Assay Titration Replace Stability Indicating
Assay
Clydewyn Anthony
TARTRATE TABLETSLEVORPHANOL
TARTRATE24-May 2010
(Initial posting)Submission
NeededDrug Product Impurities Missing Add Quantitative
stability indicating procedure
Clydewyn Anthony
LIDOCAINE ORAL TOPICAL SOLUTION
LIDOCAINE 24-May 2010 (Initial posting)
Submission Needed
Drug Product Assay Titration Replace Stability Indicating
Assay
Mary Waddell [email protected]
Monograph Name Monograph Family Date Added to List
Last Update for Item
Status Publication Monograph Type
Monograph Test
Procedure Replace or Add Test
Replacement Procedures
Liaison Comments
Monographs in Need of Modernization (Last Updated 24-May-2010)
LIDOCAINE ORAL TOPICAL SOLUTION
LIDOCAINE 24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Mary Waddell [email protected]
LITHIUM HYDROXIDE LITHIUM HYDROXIDE 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Titration Replace Stability Indicating
Assay
Ravi Ravichandran
HYDROCHLORIDEMAPROTILINE
HYDROCHLORIDE24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceAssay Titration Replace Stability
Indicating Assay
Ravi Ravichandran
HYDROCHLORIDEMAPROTILINE
HYDROCHLORIDE24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceChromatogra
phic PurityTLC Replace Modern
Procedure Ravi
Ravichandran [email protected]
MAPROTILINE HYDROCHLORIDE
TABLETS
MAPROTILINE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Ravi Ravichandran
MAZINDOL MAZINDOL 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Titration Replace Stability Indicating
Assay
Clydewyn Anthony
[email protected] MAZINDOL 24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceChromatogra
phic PurityTLC Replace Modern
Procedure Clydewyn Anthony
[email protected] MEPHOBARBITAL 24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceAssay Titration Replace Stability
Indicating Assay
Ravi Ravichandran
[email protected] MEPHOBARBITAL 24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceImpurities Missing Add Quantitative
stability indicating procedure
Ravi Ravichandran
METARAMINOL BITARTRATE
METARAMINOL BITARTRATE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Titration Replace Stability Indicating
Assay
Sujatha Ramakrishna [email protected]
METARAMINOL BITARTRATE
METARAMINOL BITARTRATE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Impurities Missing Add Quantitative stability
indicating procedure
Sujatha Ramakrishna [email protected]
METHDILAZINE HYDROCHLORIDE
METHDILAZINE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay UV Replace Modern Procedure
Feiwen Mao [email protected]
METHDILAZINE HYDROCHLORIDE
METHDILAZINE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Ordinary Impurities
TLC Replace Modern Procedure
Feiwen Mao [email protected]
Monograph Name Monograph Family Date Added to List
Last Update for Item
Status Publication Monograph Type
Monograph Test
Procedure Replace or Add Test
Replacement Procedures
Liaison Comments
Monographs in Need of Modernization (Last Updated 24-May-2010)
METHOHEXITAL METHOHEXITAL 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay UV Replace Modern Procedure
Mary Waddell [email protected]
METHOHEXITAL METHOHEXITAL 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Ordinary Impurities
TLC Replace Modern Procedure
Mary Waddell [email protected]
METHOXYFLURANE METHOXYFLURANE 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay GC - Packed Column
Replace Modern Procedure
Mary Waddell [email protected]
METHYCLOTHIAZIDE METHYCLOTHIAZIDE 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Titration Replace Stability Indicating
Assay
Sujatha Ramakrishna [email protected]
METHYCLOTHIAZIDE METHYCLOTHIAZIDE 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Impurities UV Replace Modern Procedure
Sujatha Ramakrishna [email protected]
METHYCLOTHIAZIDE TABLETS
METHYCLOTHIAZIDE 24-May 2010 (Initial posting)
Submission Needed
Drug Product Assay UV Replace Modern Procedure
Sujatha Ramakrishna [email protected]
METHYCLOTHIAZIDE TABLETS
METHYCLOTHIAZIDE 24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Sujatha Ramakrishna [email protected]
METHYLDOPA METHYLDOPA 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Titration Replace Stability Indicating
Assay
Sujatha Ramakrishna [email protected]
METHYLDOPA METHYLDOPA 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Related compounds
TLC Replace Modern Procedure
Sujatha Ramakrishna [email protected]
METHYSERGIDE MALEATE
METHYSERGIDE MALEATE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Titration Replace Stability Indicating
Assay
Ravi Ravichandran
MALEATEMETHYSERGIDE
MALEATE24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceOrdinary Impurities
TLC Replace Modern Procedure
Ravi Ravichandran
[email protected] HYDROCHLORIDE
METOCLOPRAMIDE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Titration Replace Stability Indicating
Assay
Elena Gonikberg
[email protected] HYDROCHLORIDE
METOCLOPRAMIDE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Chromatographic Purity
TLC Replace Modern Procedure
Elena Gonikberg
TARTRATEMETOPROLOL
TARTRATE24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceAssay Titration Replace Stability
Indicating Assay
Sujatha Ramakrishna [email protected]
Monograph Name Monograph Family Date Added to List
Last Update for Item
Status Publication Monograph Type
Monograph Test
Procedure Replace or Add Test
Replacement Procedures
Liaison Comments
Monographs in Need of Modernization (Last Updated 24-May-2010)
METOPROLOL TARTRATE
METOPROLOL TARTRATE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Chromatographic Purity
TLC Replace Modern Procedure
Sujatha Ramakrishna [email protected]
METYROSINE METYROSINE 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Titration Replace Stability Indicating
Assay
Sujatha Ramakrishna [email protected]
METYROSINE METYROSINE 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Chromatographic Purity
TLC Replace Modern Procedure
Sujatha Ramakrishna [email protected]
METYROSINE CAPSULES
METYROSINE 24-May 2010 (Initial posting)
Submission Needed
Drug Product Assay UV Replace Modern Procedure
Sujatha Ramakrishna [email protected]
METYROSINE CAPSULES
METYROSINE 24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Sujatha Ramakrishna [email protected]
NADOLOL NADOLOL 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Titration Replace Stability Indicating
Assay
Sujatha Ramakrishna [email protected]
NADOLOL NADOLOL 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Chromatographic Purity
TLC Replace Modern Procedure
Sujatha Ramakrishna [email protected]
NALOXONE HYDROCHLORIDE
NALOXONE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Titration Replace Stability Indicating
Assay
Clydewyn Anthony
HYDROCHLORIDENALOXONE
HYDROCHLORIDE24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceNoroxymorph
one hydrochloride
[(–)-4,5-epoxy-3,14-
dihydroxymorphinan-6-one hydrochloride
] and other impurities
TLC Replace Modern Procedure
Clydewyn Anthony
NAPROXEN NAPROXEN 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Ordinary Impurities
TLC Replace Modern Procedure
Clydewyn Anthony
[email protected] NAPROXEN 24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceAssay Titration Replace Stability
Indicating Assay
Clydewyn Anthony
Monograph Name Monograph Family Date Added to List
Last Update for Item
Status Publication Monograph Type
Monograph Test
Procedure Replace or Add Test
Replacement Procedures
Liaison Comments
Monographs in Need of Modernization (Last Updated 24-May-2010)
NAPROXEN DELAYED-RELEASE TABLETS
NAPROXEN 24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Clydewyn Anthony
NAPROXEN ORAL SUSPENSION
NAPROXEN 24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Clydewyn Anthony
NAPROXEN SODIUM NAPROXEN SODIUM 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Chromatographic Purity
TLC Replace Modern Procedure
Clydewyn Anthony
[email protected] SODIUM NAPROXEN SODIUM 24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceAssay Titration Replace Stability
Indicating Assay
Clydewyn Anthony
[email protected] SODIUM
TABLETSNAPROXEN SODIUM 24-May 2010
(Initial posting)Submission
NeededDrug Product Impurities Missing Add Quantitative
stability indicating procedure
Clydewyn Anthony
NAPROXEN TABLETS NAPROXEN 24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Clydewyn Anthony
NORTRIPTYLINE HYDROCHLORIDE
CAPSULES
NORTRIPTYLINE HYDROCHLORIDE
CAPSULES
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Impurities Missing Add Quantitative stability
indicating procedure
Ravi Ravichandran
NORTRIPTYLINE HYDROCHLORIDE ORAL SOLUTION
NORTRIPTYLINE HYDROCHLORIDE ORAL SOLUTION
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Impurities Missing Add Quantitative stability
indicating procedure
Ravi Ravichandran
NOSCAPINE NOSCAPINE 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Titration Replace Stability Indicating
Assay
Clydewyn Anthony
[email protected] NOSCAPINE 24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceOrdinary Impurities
TLC Replace Modern Procedure
Clydewyn Anthony
[email protected] OXAZEPAM 24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceAssay Titration Replace Stability
Indicating Assay
Ravi Ravichandran
[email protected] OXAZEPAM 24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceImpurities Missing Add Quantitative
stability indicating procedure
Ravi Ravichandran
Monograph Name Monograph Family Date Added to List
Last Update for Item
Status Publication Monograph Type
Monograph Test
Procedure Replace or Add Test
Replacement Procedures
Liaison Comments
Monographs in Need of Modernization (Last Updated 24-May-2010)
OXAZEPAM TABLETS OXAZEPAM 24-May 2010 (Initial posting)
Submission Needed
Drug Product Assay UV Replace Modern Procedure
Ravi Ravichandran
[email protected] TABLETS OXAZEPAM 24-May 2010
(Initial posting)Submission
NeededDrug Product Impurities Missing Add Quantitative
stability indicating procedure
Ravi Ravichandran
OXTRIPHYLLINE OXTRIPHYLLINE 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Titration Replace Stability Indicating
Assay
Mary Waddell [email protected]
OXTRIPHYLLINE OXTRIPHYLLINE 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Ordinary Impurities
TLC Replace Modern Procedure
Mary Waddell [email protected]
OXYMORPHONE HYDROCHLORIDE
OXYMORPHONE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Ordinary Impurities
TLC Replace Modern Procedure
Clydewyn Anthony
HYDROCHLORIDEOXYMORPHONE
HYDROCHLORIDE24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceAssay Titration Replace Stability
Indicating Assay
Clydewyn Anthony
[email protected] PARALDEHYDE 24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceAssay Titration Replace Stability
Indicating Assay
Ravi Ravichandran
[email protected] PENTAZOCINE 24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceOrdinary Impurities
TLC Replace Modern Procedure
Clydewyn Anthony
[email protected] PENTAZOCINE 24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceAssay Titration Replace Stability
Indicating Assay
Clydewyn Anthony
HYDROCHLORIDEPENTAZOCINE
HYDROCHLORIDE24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceOrdinary Impurities
TLC Replace Modern Procedure
Clydewyn Anthony
HYDROCHLORIDEPENTAZOCINE
HYDROCHLORIDE24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceAssay Titration Replace Stability
Indicating Assay
Clydewyn Anthony
INJECTIONPENTAZOCINE 24-May 2010
(Initial posting)Submission
NeededDrug Product Assay Open
Column LCReplace Modern
ProcedureClydewyn Anthony
[email protected] HYDROCHLORIDE
PHENAZOPYRIDINE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Ordinary Impurities
TLC Replace Modern Procedure
Clydewyn Anthony
[email protected] HYDROCHLORIDE
PHENAZOPYRIDINE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay UV Replace Modern Procedure
Clydewyn Anthony
Monograph Name Monograph Family Date Added to List
Last Update for Item
Status Publication Monograph Type
Monograph Test
Procedure Replace or Add Test
Replacement Procedures
Liaison Comments
Monographs in Need of Modernization (Last Updated 24-May-2010)
PHENELZINE SULFATE
PHENELZINE SULFATE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Ordinary Impurities
TLC Replace Modern Procedure
Ravi Ravichandran
SULFATE TABLETSPHENELZINE
SULFATE24-May 2010
(Initial posting)Submission
NeededDrug Product Disintegration Disintegration Add Dissolution Ravi
Ravichandran [email protected]
PHENMETRAZINE HYDROCHLORIDE
PHENMETRAZINE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Ordinary Impurities
TLC Replace Modern Procedure
Clydewyn Anthony
[email protected] HYDROCHLORIDE
PHENOXYBENZAMINE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Titration Replace Stability Indicating
Assay
Sujatha Ramakrishna [email protected]
PHENOXYBENZAMINE HYDROCHLORIDE
PHENOXYBENZAMINE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Ordinary Impurities
TLC Replace Modern Procedure
Sujatha Ramakrishna [email protected]
PHENSUXIMIDE PHENSUXIMIDE 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Ordinary Impurities
TLC Replace Modern Procedure
Ravi Ravichandran
[email protected] HYDROCHLORIDE
PHENYLEPHRINE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Chromatographic Purity
TLC Replace Modern Procedure
Clydewyn Anthony
[email protected] PHENYLEPHRINE 24-May 2010 Submission Drug Product Impurities Missing Add Quantitative Clydewyn HYDROCHLORIDE
INJECTIONHYDROCHLORIDE (Initial posting) Needed stability
indicating procedure
Anthony [email protected]
PHENYLEPHRINE HYDROCHLORIDE
NASAL JELLY
PHENYLEPHRINE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Clydewyn Anthony
PHENYLEPHRINE HYDROCHLORIDE NASAL SOLUTION
PHENYLEPHRINE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Clydewyn Anthony
PHENYLEPHRINE HYDROCHLORIDE NASAL SOLUTION
PHENYLEPHRINE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Product pH Missing Add Need procedure for
pH
Clydewyn Anthony
[email protected] HYDROCHLORIDE
OPHTHALMIC SOLUTION
PHENYLEPHRINE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Clydewyn Anthony
PHENYLPROPANOLAMINE BITARTRATE
PHENYLPROPANOLAMINE BITARTRATE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Titration Replace Stability Indicating
Assay
Clydewyn Anthony
Monograph Name Monograph Family Date Added to List
Last Update for Item
Status Publication Monograph Type
Monograph Test
Procedure Replace or Add Test
Replacement Procedures
Liaison Comments
Monographs in Need of Modernization (Last Updated 24-May-2010)
PHENYTOIN SODIUM INJECTION
PHENYTOIN SODIUM 24-May 2010 (Initial posting)
Submission Needed
Drug Product Alcohol and propylene
glycol content
GC - Packed Column
Replace Modern Procedure
Ravi Ravichandran
POLYMYXIN B SULFATE
POLYMYXIN B SULFATE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Microbiological Assay
Replace Modern Procedure
Ahalya Wise [email protected]
Need Data for Comparison to Microbiological Assay
POLYMYXIN B SULFATE AND
TRIMETHOPRIM OPHTHALMIC
SOLUTION
POLYMYXIN B SULFATE AND
TRIMETHOPRIM
24-May 2010 (Initial posting)
Submission Needed
Drug Product Assay Microbiological Assay
Replace Modern Procedure
Ahalya Wise [email protected]
Need Data for Comparison to Microbiological Assay
POLYMYXIN B SULFATE AND
TRIMETHOPRIM OPHTHALMIC
SOLUTION
POLYMYXIN B SULFATE AND
TRIMETHOPRIM
24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Ahalya Wise [email protected]
Need Data for Comparison to Microbiological Assay
PRAZOSIN HYDROCHLORIDE
PRAZOSIN HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Ordinary Impurities
TLC Replace Modern Procedure
Sujatha RamakrishnaHYDROCHLORIDE HYDROCHLORIDE (Initial posting) Needed Substance Impurities Procedure Ramakrishna [email protected]
PRILOCAINE HYDROCHLORIDE
PRILOCAINE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Titration Replace Stability Indicating
Assay
Mary Waddell [email protected]
PRILOCAINE HYDROCHLORIDE
PRILOCAINE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Impurities Missing Add Quantitative stability
indicating procedure
Mary Waddell [email protected]
PRIMIDONE ORAL SUSPENSION
PRIMIDONE 24-May 2010 (Initial posting)
Submission Needed
Drug Product Assay GC - Packed Column
Replace Modern Procedure
Ravi Ravichandran
HYDROCHLORIDEPROCAINAMIDE
HYDROCHLORIDE24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceOrdinary Impurities
TLC Replace Modern Procedure
Sujatha Ramakrishna [email protected]
PROCAINE HYDROCHLORIDE
PROCAINE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Titration Replace Stability Indicating
Assay
Mary Waddell [email protected]
PROCAINE HYDROCHLORIDE
PROCAINE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Chromatographic Purity
TLC Replace Modern Procedure
Mary Waddell [email protected]
Monograph Name Monograph Family Date Added to List
Last Update for Item
Status Publication Monograph Type
Monograph Test
Procedure Replace or Add Test
Replacement Procedures
Liaison Comments
Monographs in Need of Modernization (Last Updated 24-May-2010)
PROCARBAZINE HYDROCHLORIDE
PROCARBAZINE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Titration Replace Stability Indicating
Assay
Feiwen Mao [email protected]
PROCARBAZINE HYDROCHLORIDE
PROCARBAZINE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Impurities Missing Add Quantitative stability
indicating procedure
Feiwen Mao [email protected]
PROCARBAZINE HYDROCHLORIDE
CAPSULES
PROCARBAZINE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Product Assay Polarographic
Replace Modern Procedure
Feiwen Mao [email protected]
PROCARBAZINE HYDROCHLORIDE
CAPSULES
PROCARBAZINE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Feiwen Mao [email protected]
PROMETHAZINE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Titration Replace Stability Indicating
Assay
Sujatha Ramakrishna [email protected]
PROMETHAZINE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Related Substances
TLC Replace Modern Procedure
Sujatha Ramakrishna [email protected]
PROPARACAINE HYDROCHLORIDE
PROPARACAINE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Ordinary Impurities
TLC Replace Modern Procedure
Mary Waddell [email protected]
PROPARACAINE HYDROCHLORIDE
PROPARACAINE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Titration Replace Stability Indicating
Assay
Mary Waddell [email protected]
PROPOXYCAINE HYDROCHLORIDE
PROPOXYCAINE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Titration Replace Stability Indicating
Assay
Mary Waddell [email protected]
PROPOXYCAINE HYDROCHLORIDE
PROPOXYCAINE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Chromatographic Purity
TLC Replace Modern Procedure
Mary Waddell [email protected]
PROTRIPTYLINE HYDROCHLORIDE
TABLETS
PROTRIPTYLINE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Ravi Ravichandran
PSEUDOEPHEDRINE HYDROCHLORIDE
EXTENDED-RELEASE CAPSULES
PSEUDOEPHEDRINE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Clydewyn Anthony
PSEUDOEPHEDRINE HYDROCHLORIDE
EXTENDED-RELEASE TABLETS
PSEUDOEPHEDRINE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Clydewyn Anthony
Monograph Name Monograph Family Date Added to List
Last Update for Item
Status Publication Monograph Type
Monograph Test
Procedure Replace or Add Test
Replacement Procedures
Liaison Comments
Monographs in Need of Modernization (Last Updated 24-May-2010)
PSEUDOEPHEDRINE HYDROCHLORIDE ORAL SOLUTION
PSEUDOEPHEDRINE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Clydewyn Anthony
PSEUDOEPHEDRINE HYDROCHLORIDE
TABLETS
PSEUDOEPHEDRINE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Clydewyn Anthony
PSEUDOEPHEDRINE HYDROCHLORIDE, CARBINOXAMINE MALEATE, AND
DEXTROMETHORPHAN HYDROBROMIDE
ORAL SOLUTION
PSEUDOEPHEDRINE HYDROCHLORIDE, CARBINOXAMINE MALEATE, AND
DEXTROMETHORPHAN HYDROBROMIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Clydewyn Anthony
PSEUDOEPHEDRINE SULFATE
PSEUDOEPHEDRINE SULFATE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Ordinary Impurities
TLC Replace Modern Procedure
Clydewyn Anthony
SULFATEPSEUDOEPHEDRINE
SULFATE24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceAssay Titration Replace Stability
Indicating Assay
Clydewyn Anthony
GLUCONATEQUINIDINE
GLUCONATE24-May 2010
(I iti l ti )Submission
N d dDrug
S b tAssay Titration Replace Stability
I di tiSujatha
R k i hGLUCONATE GLUCONATE (Initial posting) Needed Substance Indicating Assay
Ramakrishna [email protected]
QUINIDINE GLUCONATE
QUINIDINE GLUCONATE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Chromatographic Purity
TLC Replace Modern Procedure
Sujatha Ramakrishna [email protected]
SALICYLAMIDE SALICYLAMIDE 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Chromatographic Purity
TLC Replace Modern Procedure
Clydewyn Anthony
[email protected] SALICYLAMIDE 24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceAssay Titration Replace Stability
Indicating Assay
Clydewyn Anthony
[email protected] CAPSULES
SALSALATE 24-May 2010 (Initial posting)
Submission Needed
Drug Product Dissolution Missing Add Add Dissolution Procedure
Clydewyn Anthony
HYDROBROMIDESCOPOLAMINE
HYDROBROMIDE24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceAssay Titration Replace Stability
Indicating Assay
Feiwen Mao [email protected]
SCOPOLAMINE HYDROBROMIDE
SCOPOLAMINE HYDROBROMIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Impurities Missing Add Quantitative stability
indicating procedure
Feiwen Mao [email protected]
Monograph Name Monograph Family Date Added to List
Last Update for Item
Status Publication Monograph Type
Monograph Test
Procedure Replace or Add Test
Replacement Procedures
Liaison Comments
Monographs in Need of Modernization (Last Updated 24-May-2010)
SCOPOLAMINE HYDROBROMIDE
INJECTION
SCOPOLAMINE HYDROBROMIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Product Assay GC - Packed Column
Replace Modern Procedure
Feiwen Mao [email protected]
SCOPOLAMINE HYDROBROMIDE
INJECTION
SCOPOLAMINE HYDROBROMIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Feiwen Mao [email protected]
SCOPOLAMINE HYDROBROMIDE
OPHTHALMIC OINTMENT
SCOPOLAMINE HYDROBROMIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Product Assay GC - Packed Column
Replace Modern Procedure
Feiwen Mao [email protected]
SCOPOLAMINE HYDROBROMIDE
OPHTHALMIC OINTMENT
SCOPOLAMINE HYDROBROMIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Feiwen Mao [email protected]
SCOPOLAMINE HYDROBROMIDE
OPHTHALMIC SOLUTION
SCOPOLAMINE HYDROBROMIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Product Assay GC - Packed Column
Replace Modern Procedure
Feiwen Mao [email protected]
SCOPOLAMINE HYDROBROMIDE
OPHTHALMIC
SCOPOLAMINE HYDROBROMIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating
Feiwen Mao [email protected]
SOLUTION procedureSCOPOLAMINE
HYDROBROMIDE TABLETS
SCOPOLAMINE HYDROBROMIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Product Assay GC - Packed Column
Replace Modern Procedure
Feiwen Mao [email protected]
SCOPOLAMINE HYDROBROMIDE
TABLETS
SCOPOLAMINE HYDROBROMIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Feiwen Mao [email protected]
SODIUM MONOFLUOROPHOS
PHATE
SODIUM MONOFLUOROPHOS
PHATE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Titration Replace Stability Indicating
Assay
Elena Gonikberg
Procedure without
radioactive thorium nitrate
SODIUM SALICYLATE SODIUM SALICYLATE 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Titration Replace Stability Indicating
Assay
Clydewyn Anthony
[email protected] SALICYLATE SODIUM SALICYLATE 24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceImpurities Missing Add Quantitative
stability indicating procedure
Clydewyn Anthony
SODIUM SALICYLATE TABLETS
SODIUM SALICYLATE 24-May 2010 (Initial posting)
Submission Needed
Drug Product Assay Titration Replace Stability Indicating
Assay
Clydewyn Anthony
Monograph Name Monograph Family Date Added to List
Last Update for Item
Status Publication Monograph Type
Monograph Test
Procedure Replace or Add Test
Replacement Procedures
Liaison Comments
Monographs in Need of Modernization (Last Updated 24-May-2010)
SODIUM SALICYLATE TABLETS
SODIUM SALICYLATE 24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Clydewyn Anthony
SPIRONOLACTONE SPIRONOLACTONE 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Ordinary Impurities
TLC Replace Modern Procedure
Sujatha Ramakrishna [email protected]
SPIRONOLACTONE SPIRONOLACTONE 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Limit of mercapto
compounds
Titration Replace Stability Indicating
Assay
Sujatha Ramakrishna [email protected]
SULFABENZAMIDE SULFABENZAMIDE 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Ordinary Impurities
TLC Replace Modern Procedure
Behnam Davani
SODIUMSULFACETAMIDE
SODIUM24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceOrdinary Impurities
TLC Replace Modern Procedure
Behnam Davani
SODIUMSULFACETAMIDE
SODIUM24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceAssay Titration Replace Stability
Indicating Assay
Behnam Davani
[email protected] SULFAMETHAZINE 24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceOrdinary Impurities
TLC Replace Modern Procedure
Elena Gonikberg
[email protected] SULFAMETHAZINE 24-May 2010
(Initial posting)Submission
NeededDrug
Substanceassay Titration Replace Stability
Indicating Assay
Elena Gonikberg
[email protected] SULFAPYRIDINE 24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceAssay Titration Replace Stability
Indicating Assay
Behnam Davani
[email protected] SULFAPYRIDINE 24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceImpurities Missing Add Quantitative
stability indicating procedure
Behnam Davani
SULFAPYRIDINE TABLETS
SULFAPYRIDINE 24-May 2010 (Initial posting)
Submission Needed
Drug Product Assay Titration Replace Stability Indicating
Assay
Behnam Davani
TABLETSSULFAPYRIDINE 24-May 2010
(Initial posting)Submission
NeededDrug Product Impurities Missing Add Quantitative
stability indicating procedure
Behnam Davani
SULISOBENZONE SULISOBENZONE 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Titration Replace Stability Indicating
Assay
Feiwen Mao [email protected]
TESTOSTERONE TESTOSTERONE 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay TLC/UV Replace Modern Procedures
Mary Waddell [email protected]
Monograph Name Monograph Family Date Added to List
Last Update for Item
Status Publication Monograph Type
Monograph Test
Procedure Replace or Add Test
Replacement Procedures
Liaison Comments
Monographs in Need of Modernization (Last Updated 24-May-2010)
TESTOSTERONE TESTOSTERONE 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Impurities Missing Add Quantitative stability
indicating procedure
Mary Waddell [email protected]
TESTOSTERONE ENANTHATE
TESTOSTERONE ENANTHATE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay UV Replace Modern Procedure
Mary Waddell [email protected]
TESTOSTERONE ENANTHATE
TESTOSTERONE ENANTHATE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Ordinary Impurities
TLC Replace Modern Procedure
Mary Waddell [email protected]
TETRACAINE TETRACAINE 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Titration Replace Stability Indicating
Assay
Mary Waddell [email protected]
TETRACAINE TETRACAINE 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Chromatographic Purity
TLC Replace Modern Procedure
Mary Waddell [email protected]
THIOPENTAL SODIUM THIOPENTAL SODIUM 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay UV Replace Modern Procedure
Mary Waddell [email protected]
THIOPENTAL SODIUM THIOPENTAL SODIUM 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Ordinary Impurities
TLC Replace Modern Procedure
Mary Waddell [email protected]
TIMOLOL MALEATE TIMOLOL MALEATE 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Titration Replace Stability Indicating
Assay
Sujatha Ramakrishna [email protected]
TRETINOIN TOPICAL SOLUTION
TRETINOIN 24-May 2010 (Initial posting)
Submission Needed
Drug Product Assay UV Replace Modern Procedure
Feiwen Mao [email protected]
TRETINOIN TOPICAL SOLUTION
TRETINOIN 24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Feiwen Mao [email protected]
TRIFLUPROMAZINE TRIFLUPROMAZINE 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Ordinary Impurities
TLC Replace Modern Procedure
Ravi Ravichandran
[email protected] TRIFLUPROMAZINE 24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceAssay Titration Replace Stability
Indicating Assay
Ravi Ravichandran
[email protected] HYDROCHLORIDE
TRIFLUPROMAZINE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Titration Replace Stability Indicating
Assay
Ravi Ravichandran
HYDROCHLORIDETRIPROLIDINE
HYDROCHLORIDE24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceAssay Titration Replace Stability
Indicating Assay
Mary Waddell [email protected]
Monograph Name Monograph Family Date Added to List
Last Update for Item
Status Publication Monograph Type
Monograph Test
Procedure Replace or Add Test
Replacement Procedures
Liaison Comments
Monographs in Need of Modernization (Last Updated 24-May-2010)
TRIPROLIDINE HYDROCHLORIDE
TRIPROLIDINE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Related compounds
TLC Replace Modern Procedure
Mary Waddell [email protected]
VANCOMYCIN VANCOMYCIN 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Microbiological Assay
Replace Modern Procedure
Ahalya Wise [email protected]
Need Data for Comparison to Microbiological Assay
VANCOMYCIN HYDROCHLORIDE
VANCOMYCIN HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Microbiological Assay
Replace Modern Procedure
Ahalya Wise [email protected]
Need Data for Comparison to Microbiological Assay
VANCOMYCIN HYDROCHLORIDE
CAPSULES
VANCOMYCIN HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Product Assay Microbiological Assay
Replace Modern Procedure
Ahalya Wise [email protected]
Need Data for Comparison to Microbiological Assay
VANCOMYCIN HYDROCHLORIDE FOR INJECTION
VANCOMYCIN HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Product Assay Microbiological Assay
Replace Modern Procedure
Ahalya Wise [email protected]
Need Data for Comparison to Mi bi l i lFOR INJECTION Microbiological Assay
VANCOMYCIN INJECTION
VANCOMYCIN 24-May 2010 (Initial posting)
Submission Needed
Drug Product Assay Microbiological Assay
Replace Modern Procedure
Ahalya Wise [email protected]
Need Data for Comparison to Microbiological Assay
VERAPAMIL HYDROCHLORIDE
VERAPAMIL HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Titration Replace Stability Indicating
Assay
Sujatha Ramakrishna [email protected]
WARFARIN SODIUM WARFARIN SODIUM 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Isopropyl alcohol Content
GC - Packed Column
Replace Modern Procedure
Feiwen Mao [email protected]