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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
cma@usp.org
ACETAMINOPHEN AND CAFFEINE
TABLETS
ACETAMINOPHEN 24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Clydewyn Anthony
cma@usp.org
ACETAMINOPHEN AND
PSEUDOEPHEDRINE HYDROCHLORIDE
TABLETS
ACETAMINOPHEN 24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Clydewyn Anthony
cma@usp.org
ACETAMINOPHEN DIPHENHYDRAMINE CITRATE TABLETS
ACETAMINOPHEN 24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Clydewyn Anthony
cma@usp.org
ACYCLOVIR ACYCLOVIR 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Ordinary Impurities
TLC Replace Modern Procedure
Behnam Davani
bd@usp.orgALFENTANIL
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 cma@usp.orgAMINOPHYLLINE AMINOPHYLLINE 24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceImpurities Missing Add Quantitative
stability indicating procedure
Domenick Vicchio
dwv@usp.org
AMINOPHYLLINE DELAYED-RELEASE
TABLETS
AMINOPHYLLINE 24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Domenick Vicchio
dwv@usp.org
AMINOPHYLLINE INJECTION
AMINOPHYLLINE 24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Domenick Vicchio
dwv@usp.org
AMINOPHYLLINE ORAL SOLUTION
AMINOPHYLLINE 24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Domenick Vicchio
dwv@usp.org
AMINOPHYLLINE RECTAL SOLUTION
AMINOPHYLLINE 24-May 2010 (Initial posting)
Submission Needed
Drug Product Assay UV Replace Modern Procedure
Domenick Vicchio
dwv@usp.org
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
dwv@usp.org
AMINOPHYLLINE SUPPOSITORIES
AMINOPHYLLINE 24-May 2010 (Initial posting)
Submission Needed
Drug Product Assay Titration Replace Stability Indicating
Assay
Domenick Vicchio
dwv@usp.orgAMINOPHYLLINE SUPPOSITORIES
AMINOPHYLLINE 24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Domenick Vicchio
dwv@usp.org
AMINOPHYLLINE TABLETS
AMINOPHYLLINE 24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Domenick Vicchio
dwv@usp.org
AMOXAPINE TABLETS
AMOXAPINE 24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Ravi Ravichandran
rr@usp.org
ANILERIDINE ANILERIDINE 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Titration Replace Stability Indicating
Assay
Clydewyn Anthony
cma@usp.orgANILERIDINE ANILERIDINE 24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceImpurities Missing Add Quantitative
stability indicating procedure
Clydewyn Anthony
cma@usp.org
ANILERIDINE HYDROCHLORIDE
ANILERIDINE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Titration Replace Stability Indicating
Assay
Clydewyn Anthony
cma@usp.orgANILERIDINE
HYDROCHLORIDEANILERIDINE
HYDROCHLORIDE24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceImpurities Missing Add Quantitative
stability indicating procedure
Clydewyn Anthony
cma@usp.org
ANTAZOLINE PHOSPHATE
ANTAZOLINE PHOSPHATE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Titration Replace Stability Indicating
Assay
Elena Gonikberg
eg@usp.orgANTAZOLINE PHOSPHATE
ANTAZOLINE PHOSPHATE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Related Compounds
TLC Replace Modern Procedure
Elena Gonikberg
eg@usp.orgANTIPYRINE ANTIPYRINE 24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceAssay Titration Replace Stability
Indicating Assay
Clydewyn Anthony
cma@usp.orgANTIPYRINE ANTIPYRINE 24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceOrdinary Impurities
TLC Replace Modern Procedure
Clydewyn Anthony
cma@usp.org
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
cma@usp.orgASPIRIN ASPIRIN 24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceLimit of free salicylic acid
Colorimetric Replace Modern Procedure
Clydewyn Anthony
cma@usp.orgASPIRIN CAPSULES ASPIRIN 24-May 2010
(Initial posting)Submission
NeededDrug Product Assay Open
Column LCReplace Modern
ProcedureClydewyn Anthony
cma@usp.orgASPIRIN CAPSULES ASPIRIN 24-May 2010
(Initial posting)Submission
NeededDrug Product Limit of free
salicylic acidOpen
Column LCReplace Modern
ProcedureClydewyn Anthony
cma@usp.orgASPIRIN
SUPPOSITORIESASPIRIN 24-May 2010
(Initial posting)Submission
NeededDrug Product Assay Open
Column LCReplace Modern
ProcedureClydewyn Anthony
cma@usp.orgASPIRIN
SUPPOSITORIESASPIRIN 24-May 2010
(Initial posting)Submission
NeededDrug Product Limit of free
salicylic acidOpen
Column LCReplace Modern
ProcedureClydewyn Anthony
cma@usp.orgAUROTHIOGLUCOSE AUROTHIOGLUCOSE 24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceAssay Titration Replace Stability
Indicating Assay
Clydewyn Anthony
cma@usp.orgAUROTHIOGLUCOSE AUROTHIOGLUCOSE 24-May 2010 Submission Drug Impurities Missing Add Quantitative Clydewyn
(Initial posting) Needed Substance stability indicating procedure
Anthony cma@usp.org
AZATADINE MALEATE AZATADINE MALEATE 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Titration Replace Stability Indicating
Assay
Domenick Vicchio
dwv@usp.orgAZATADINE MALEATE AZATADINE MALEATE 24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceChromatogra
phic PurityTLC/UV Replace Modern
ProceduresDomenick
Vicchio dwv@usp.org
AZATADINE MALEATE TABLETS
AZATADINE MALEATE 24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Domenick Vicchio
dwv@usp.org
AZATADINE MALEATE TABLETS
AZATADINE MALEATE 24-May 2010 (Initial posting)
Submission Needed
Drug Product Assay UV Replace Modern Procedure
Domenick Vicchio
dwv@usp.orgBENDROFLUMETHIAZ
IDEBENDROFLUMETHIAZ
IDE24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceAssay Titration Replace Stability
Indicating Assay
Sujatha Ramakrishna sxr@usp.org
BENOXINATE HYDROCHLORIDE
BENOXINATE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Titration Replace Stability Indicating
Assay
Domenick Vicchio
dwv@usp.org
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
dwv@usp.orgBENZOCAINE BENZOCAINE 24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceOrdinary Impurities
TLC Replace Modern Procedure
Domenick Vicchio
dwv@usp.orgBENZOCAINE CREAM BENZOCAINE 24-May 2010
(Initial posting)Submission
NeededDrug Product Assay Titration Replace Stability
Indicating Assay
Domenick Vicchio
dwv@usp.orgBENZOCAINE CREAM BENZOCAINE 24-May 2010
(Initial posting)Submission
NeededDrug Product Impurities Missing Add Quantitative
stability indicating procedure
Domenick Vicchio
dwv@usp.org
BENZOCAINE OINTMENT
BENZOCAINE 24-May 2010 (Initial posting)
Submission Needed
Drug Product Assay Titration Replace Stability Indicating
Assay
Domenick Vicchio
dwv@usp.orgBENZOCAINE
OINTMENTBENZOCAINE 24-May 2010
(Initial posting)Submission
NeededDrug Product Impurities Missing Add Quantitative
stability indicating procedure
Domenick Vicchio
dwv@usp.org
BENZOCAINE OTIC SOLUTION
BENZOCAINE 24-May 2010 (Initial posting)
Submission Needed
Drug Product Assay Titration Replace Stability Indicating
Domenick Vicchio
Assay dwv@usp.orgBENZOCAINE OTIC
SOLUTIONBENZOCAINE 24-May 2010
(Initial posting)Submission
NeededDrug Product Impurities Missing Add Quantitative
stability indicating procedure
Domenick Vicchio
dwv@usp.org
BENZOCAINE TOPICAL SOLUTION
BENZOCAINE 24-May 2010 (Initial posting)
Submission Needed
Drug Product Assay Titration Replace Stability Indicating
Assay
Domenick Vicchio
dwv@usp.orgBENZOCAINE
TOPICAL SOLUTIONBENZOCAINE 24-May 2010
(Initial posting)Submission
NeededDrug Product Impurities Missing Add Quantitative
stability indicating procedure
Domenick Vicchio
dwv@usp.org
BETAXOLOL HYDROCHLORIDE
BETAXOLOL HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Titration Replace Stability Indicating
Assay
Feiwen Mao fm@usp.org
BROMODIPHENHYDRAMINE
HYDROCHLORIDE
BROMODIPHENHYDRAMINE
HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Titration Replace Stability Indicating
Assay
Domenick Vicchio
dwv@usp.orgBROMODIPHENHYDR
AMINE HYDROCHLORIDE
BROMODIPHENHYDRAMINE
HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Impurities Missing Add Quantitative stability
indicating procedure
Domenick Vicchio
dwv@usp.org
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
dwv@usp.org
BROMODIPHENHYDRAMINE
HYDROCHLORIDE ORAL SOLUTION
BROMODIPHENHYDRAMINE
HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Domenick Vicchio
dwv@usp.org
BROMPHENIRAMINE MALEATE
BROMPHENIRAMINE MALEATE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Chromatographic Purity
GC - Packed Column
Replace Modern Procedure
Domenick Vicchio
dwv@usp.orgBROMPHENIRAMINE
MALEATEBROMPHENIRAMINE
MALEATE24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceAssay Titration Replace Stability
Indicating Assay
Domenick Vicchio
dwv@usp.orgBROMPHENIRAMINE
MALEATE ORAL SOLUTION
BROMPHENIRAMINE MALEATE
24-May 2010 (Initial posting)
Submission Needed
Drug Product Assay Titration Replace Stability Indicating
Assay
Domenick Vicchio
dwv@usp.orgBROMPHENIRAMINE
MALEATE ORAL SOLUTION
BROMPHENIRAMINE MALEATE
24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Domenick Vicchio
dwv@usp.org
BUPIVACAINE BUPIVACAINE 24-May 2010 Submission Drug Assay Titration Replace Stability Domenick HYDROCHLORIDE HYDROCHLORIDE (Initial posting) Needed Substance Indicating
AssayVicchio
dwv@usp.orgBUPIVACAINE
HYDROCHLORIDEBUPIVACAINE
HYDROCHLORIDE24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceChromatogra
phic PurityTLC Replace Modern
Procedure Domenick
Vicchio dwv@usp.org
BUTABARBITAL SODIUM TABLETS
BUTABARBITAL SODIUM
24-May 2010 (Initial posting)
Submission Needed
Drug Product Assay GC - Packed Column
Replace Modern Procedure
Ravi Ravichandran
rr@usp.orgBUTAMBEN BUTAMBEN 24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceAssay Titration Replace Stability
Indicating Assay
Domenick Vicchio
dwv@usp.orgBUTAMBEN BUTAMBEN 24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceImpurities Missing Add Quantitative
stability indicating procedure
Domenick Vicchio
dwv@usp.org
BUTORPHANOL TARTRATE
BUTORPHANOL TARTRATE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Titration Replace Stability Indicating
Assay
Clydewyn Anthony
cma@usp.orgBUTORPHANOL
TARTRATEBUTORPHANOL
TARTRATE24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceChromatogra
phic PurityTLC Replace Modern
ProcedureClydewyn Anthony
cma@usp.org
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
cma@usp.orgBUTORPHANOL
TARTRATE INJECTION
BUTORPHANOL TARTRATE
24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Clydewyn Anthony
cma@usp.org
BUTORPHANOL TARTRATE NASAL
SOLUTION
BUTORPHANOL TARTRATE
24-May 2010 (Initial posting)
Submission Needed
Drug Product Identification TLC Replace Procedure without
Benzene
Clydewyn Anthony
cma@usp.org
Current procedure uses
Benzene CARBINOXAMINE
MALEATECARBINOXAMINE
MALEATE24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceAssay Titration Replace Stability
Indicating Assay
Domenick Vicchio
dwv@usp.orgCARBINOXAMINE
MALEATECARBINOXAMINE
MALEATE24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceOrdinary Impurities
TLC Replace Modern Procedure
Domenick Vicchio
dwv@usp.orgCARBINOXAMINE
MALEATE TABLETSCARBINOXAMINE
MALEATE24-May 2010
(Initial posting)Submission
NeededDrug Product Assay Titration Replace Stability
Indicating Assay
Domenick Vicchio
dwv@usp.orgCARBINOXAMINE
MALEATE TABLETSCARBINOXAMINE
MALEATE24-May 2010
(Initial posting)Submission
NeededDrug Product Impurities Missing Add Quantitative
stability indicating
Domenick Vicchio
dwv@usp.orgprocedure
CEFADROXIL CEFADROXIL 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Chromatographic Purity
TLC Replace Modern Procedure
Ahalya Wise aww@usp.org
CEFADROXIL CAPSULES
CEFADROXIL 24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Ahalya Wise aww@usp.org
CEFADROXIL FOR ORAL SUSPENSION
CEFADROXIL 24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Ahalya Wise aww@usp.org
CEFADROXIL TABLETS
CEFADROXIL 24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Ahalya Wise aww@usp.org
CEFAZOLIN CEFAZOLIN 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Impurities Missing Add Quantitative stability
indicating procedure
Ahalya Wise aww@usp.org
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 aww@usp.org
CEFAZOLIN INJECTION
CEFAZOLIN 24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Ahalya Wise aww@usp.org
CEFPROZIL CEFPROZIL 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Impurities Missing Add Quantitative stability
indicating procedure
Ahalya Wise aww@usp.org
CEFPROZIL FOR ORAL SUSPENSION
CEFPROZIL 24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Ahalya Wise aww@usp.org
CEFPROZIL TABLETS CEFPROZIL 24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Ahalya Wise aww@usp.org
CEFTRIAXONE SODIUM
CEFTRIAXONE SODIUM
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Impurities Missing Add Quantitative stability
Ahalya Wise aww@usp.org
indicating procedure
CEFUROXIME AXETIL CEFUROXIME AXETIL 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Impurities Missing Add Quantitative stability
indicating procedure
Ahalya Wise aww@usp.org
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 aww@usp.org
CEFUROXIME AXETIL TABLETS
CEFUROXIME AXETIL 24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Ahalya Wise aww@usp.org
CHLORPHENIRAMINE MALEATE
CHLORPHENIRAMINE MALEATE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Related Compounds
GC - Packed Column
Replace Modern Procedure
Domenick Vicchio
dwv@usp.orgCLEMASTINE FUMARATE
CLEMASTINE FUMARATE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Titration Replace Stability Indicating
Assay
Domenick Vicchio
dwv@usp.org
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
dwv@usp.org
CYCLIZINE HYDROCHLORIDE
CYCLIZINE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Titration Replace Stability Indicating
Assay
Elena Gonikberg
eg@usp.orgCYCLIZINE
HYDROCHLORIDECYCLIZINE
HYDROCHLORIDE24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceOrdinary Impurities
TLC Replace Modern Procedure
Elena Gonikberg
eg@usp.orgCYPROHEPTADINE HYDROCHLORIDE
CYPROHEPTADINE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Titration Replace Stability Indicating
Assay
Domenick Vicchio
dwv@usp.orgCYPROHEPTADINE HYDROCHLORIDE
CYPROHEPTADINE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Impurities Missing Add Quantitative stability
indicating procedure
Domenick Vicchio
dwv@usp.org
CYPROHEPTADINE HYDROCHLORIDE ORAL SOLUTION
CYPROHEPTADINE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Domenick Vicchio
dwv@usp.org
CYPROHEPTADINE CYPROHEPTADINE 24-May 2010 Submission Drug Product Impurities Missing Add Quantitative Domenick HYDROCHLORIDE
TABLETSHYDROCHLORIDE (Initial posting) Needed stability
indicating procedure
Vicchio dwv@usp.org
DEXBROMPHENIRAMINE MALEATE
DEXBROMPHENIRAMINE MALEATE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Related Compounds
GC - Packed Column
Replace Modern Procedure
Domenick Vicchio
dwv@usp.orgDEXBROMPHENIRAMI
NE MALEATEDEXBROMPHENIRAMI
NE MALEATE24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceAssay Titration Replace Stability
Indicating Assay
Domenick Vicchio
dwv@usp.orgDEXCHLORPHENIRA
MINE MALEATEDEXCHLORPHENIRA
MINE MALEATE24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceRelated
CompoundsGC - Packed
ColumnReplace Modern
ProcedureDomenick
Vicchio dwv@usp.org
DEXCHLORPHENIRAMINE MALEATE
DEXCHLORPHENIRAMINE MALEATE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Titration Replace Stability Indicating
Assay
Domenick Vicchio
dwv@usp.orgDIFLUNISAL DIFLUNISAL 24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceChromatogra
phic PurityTLC Replace Modern
Procedure Clydewyn Anthony
cma@usp.orgDIHYDROCODEINE
BITARTRATEDIHYDROCODEINE
BITARTRATE24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceOrdinary Impurities
TLC Replace Modern Procedure
Clydewyn Anthony
cma@usp.org
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
dwv@usp.orgDIPHENHYDRAMINE
CITRATEDIPHENHYDRAMINE
CITRATE24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceImpurities Missing Add Quantitative
stability indicating procedure
Domenick Vicchio
dwv@usp.org
DIPHENHYDRAMINE HYDROCHLORIDE
DIPHENHYDRAMINE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Impurities Missing Add Quantitative stability
indicating procedure
Domenick Vicchio
dwv@usp.org
DIPHENHYDRAMINE HYDROCHLORIDE
CAPSULES
DIPHENHYDRAMINE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Domenick Vicchio
dwv@usp.org
DIPHENHYDRAMINE HYDROCHLORIDE
INJECTION
DIPHENHYDRAMINE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Domenick Vicchio
dwv@usp.org
DIPHENHYDRAMINE HYDROCHLORIDE ORAL SOLUTION
DIPHENHYDRAMINE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating
Domenick Vicchio
dwv@usp.orgprocedure
DISOPYRAMIDE PHOSPHATE
DISOPYRAMIDE PHOSPHATE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Titration Replace Stability Indicating
Assay
Sujatha Ramakrishna sxr@usp.org
DISOPYRAMIDE PHOSPHATE
DISOPYRAMIDE PHOSPHATE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Chromatographic Purity
TLC Replace Modern Procedure
Sujatha Ramakrishna sxr@usp.org
DISOPYRAMIDE PHOSPHATE CAPSULES
DISOPYRAMIDE PHOSPHATE
24-May 2010 (Initial posting)
Submission Needed
Drug Product Assay UV Replace Modern Procedure
Sujatha Ramakrishna sxr@usp.org
DISOPYRAMIDE PHOSPHATE CAPSULES
DISOPYRAMIDE PHOSPHATE
24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Sujatha Ramakrishna sxr@usp.org
DISOPYRAMIDE PHOSPHATE
EXTENDED-RELEASE CAPSULES
DISOPYRAMIDE PHOSPHATE
24-May 2010 (Initial posting)
Submission Needed
Drug Product Assay UV Replace Modern Procedure
Sujatha Ramakrishna sxr@usp.org
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 sxr@usp.org
DOXYLAMINE SUCCINATE
DOXYLAMINE SUCCINATE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Titration Replace Stability Indicating
Assay
Domenick Vicchio
dwv@usp.orgDOXYLAMINE SUCCINATE
DOXYLAMINE SUCCINATE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Related Compounds
GC - Packed Column
Replace Modern Procedure
Domenick Vicchio
dwv@usp.orgDYDROGESTERONE DYDROGESTERONE 24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceSpecific Rotation
Specific Rotation
Replace Procedure without 1,1,1-Trichloroethan
e
Domenick Vicchio
dwv@usp.org
EPHEDRINE EPHEDRINE 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Titration Replace Stability Indicating
Assay
Domenick Vicchio
dwv@usp.orgEPHEDRINE
HYDROCHLORIDEEPHEDRINE
HYDROCHLORIDE24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceAssay Titration Replace Stability
Indicating Assay
Domenick Vicchio
dwv@usp.orgEPHEDRINE SULFATE EPHEDRINE SULFATE 24-May 2010 Submission Drug Assay Titration Replace Stability Domenick
(Initial posting) Needed Substance Indicating Assay
Vicchio dwv@usp.org
ESTRADIOL VALERATE
ESTRADIOL VALERATE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Ordinary Impurities
TLC Replace Modern Procedure
Domenick Vicchio
dwv@usp.orgESTRONE ESTRONE 24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceOrdinary Impurities
TLC Replace Modern Procedure
Domenick Vicchio
dwv@usp.orgETHCHLORVYNOL ETHCHLORVYNOL 24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceAssay GC - Packed
ColumnReplace Modern
ProcedureRavi
Ravichandran rr@usp.org
ETHCHLORVYNOL CAPSULES
ETHCHLORVYNOL 24-May 2010 (Initial posting)
Submission Needed
Drug Product Assay GC - Packed Column
Replace Modern Procedure
Ravi Ravichandran
rr@usp.orgFRUCTOSE FRUCTOSE 24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceAssay Angular
RotationReplace Stability
Indicating Assay
Domenick Vicchio
dwv@usp.orgFRUCTOSE AND
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
dwv@usp.org
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 aww@usp.org
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 aww@usp.org
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 fm@usp.org
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
cma@usp.org
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
cma@usp.orgp
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
cma@usp.org
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
cma@usp.org
GUANABENZ ACETATE
GUANABENZ ACETATE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Titration Replace Stability Indicating
Assay
Sujatha Ramakrishna sxr@usp.org
GUANABENZ ACETATE
GUANABENZ ACETATE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Chromatographic Purity
TLC Replace Modern Procedure
Sujatha Ramakrishna sxr@usp.org
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 sxr@usp.org
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
dwv@usp.orgHYDRALAZINE
HYDROCHLORIDE INJECTION
HYDRALAZINE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Product Assay Titration Replace Stability Indicating
Assay
Sujatha Ramakrishna sxr@usp.org
HYDROCODONE BITARTRATE
TABLETS
HYDROCODONE BITARTRATE
24-May 2010 (Initial posting)
Submission Needed
Drug Product Assay Titration Replace Stability Indicating
Assay
Clydewyn Anthony
cma@usp.orgHYDROCODONE
BITARTRATE TABLETS
HYDROCODONE BITARTRATE
24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Clydewyn Anthony
cma@usp.org
HYDROMORPHONE HYDROCHLORIDE
INJECTION
HYDROMORPHONE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Product Assay UV Replace Modern Procedure
Clydewyn Anthony
cma@usp.orgHYDROMORPHONE HYDROCHLORIDE
INJECTION
HYDROMORPHONE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Clydewyn Anthony
cma@usp.org
HYDROMORPHONE HYDROCHLORIDE
HYDROMORPHONE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
Clydewyn Anthony
TABLETS indicating procedure
cma@usp.org
HYDROXYAMPHETAMINE HYDROBROMIDE
HYDROXYAMPHETAMINE HYDROBROMIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Titration Replace Stability Indicating
Assay
Feiwen Mao fm@usp.org
HYDROXYAMPHETAMINE HYDROBROMIDE
HYDROXYAMPHETAMINE HYDROBROMIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Ordinary Impurities
TLC Replace Modern Procedure
Feiwen Mao fm@usp.org
HYDROXYPROGESTERONE CAPROATE
HYDROXYPROGESTERONE CAPROATE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay UV Replace Modern Procedure
Mary Waddell msw@usp.org
HYDROXYPROGESTERONE CAPROATE
HYDROXYPROGESTERONE CAPROATE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Ordinary Impurities
TLC Replace Modern Procedure
Mary Waddell msw@usp.org
IBUPROFEN AND PSEUDOEPHEDRINE
HYDROCHLORIDE TABLETS
IBUPROFEN 24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Clydewyn Anthony
cma@usp.org
IMIPENEM IMIPENEM 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Solvents GC - Packed Column
Replace Modern Procedure
Ahalya Wise aww@usp.org
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 aww@usp.org
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 aww@usp.org
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 aww@usp.org
INDOMETHACIN INDOMETHACIN 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Impurities Missing Add Quantitative stability
indicating procedure
Clydewyn Anthony
cma@usp.org
LEVONORDEFRIN LEVONORDEFRIN 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Titration Replace Stability Indicating
Assay
Sujatha Ramakrishna sxr@usp.org
LEVORPHANOL TARTRATE
LEVORPHANOL TARTRATE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Titration Replace Stability Indicating
Assay
Clydewyn Anthony
cma@usp.orgLEVORPHANOL
TARTRATELEVORPHANOL
TARTRATE24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceOrdinary Impurities
TLC Replace Modern Procedure
Clydewyn Anthony
cma@usp.orgLEVORPHANOL
TARTRATE INJECTION
LEVORPHANOL TARTRATE
24-May 2010 (Initial posting)
Submission Needed
Drug Product Assay Titration Replace Stability Indicating
Assay
Clydewyn Anthony
cma@usp.orgLEVORPHANOL
TARTRATE INJECTION
LEVORPHANOL TARTRATE
24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Clydewyn Anthony
cma@usp.org
LEVORPHANOL TARTRATE TABLETS
LEVORPHANOL TARTRATE
24-May 2010 (Initial posting)
Submission Needed
Drug Product Assay Titration Replace Stability Indicating
Assay
Clydewyn Anthony
cma@usp.orgLEVORPHANOL
TARTRATE TABLETSLEVORPHANOL
TARTRATE24-May 2010
(Initial posting)Submission
NeededDrug Product Impurities Missing Add Quantitative
stability indicating procedure
Clydewyn Anthony
cma@usp.org
LIDOCAINE ORAL TOPICAL SOLUTION
LIDOCAINE 24-May 2010 (Initial posting)
Submission Needed
Drug Product Assay Titration Replace Stability Indicating
Assay
Mary Waddell msw@usp.org
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 msw@usp.org
LITHIUM HYDROXIDE LITHIUM HYDROXIDE 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Titration Replace Stability Indicating
Assay
Ravi Ravichandran
rr@usp.orgMAPROTILINE
HYDROCHLORIDEMAPROTILINE
HYDROCHLORIDE24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceAssay Titration Replace Stability
Indicating Assay
Ravi Ravichandran
rr@usp.orgMAPROTILINE
HYDROCHLORIDEMAPROTILINE
HYDROCHLORIDE24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceChromatogra
phic PurityTLC Replace Modern
Procedure Ravi
Ravichandran rr@usp.org
MAPROTILINE HYDROCHLORIDE
TABLETS
MAPROTILINE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Ravi Ravichandran
rr@usp.org
MAZINDOL MAZINDOL 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Titration Replace Stability Indicating
Assay
Clydewyn Anthony
cma@usp.orgMAZINDOL MAZINDOL 24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceChromatogra
phic PurityTLC Replace Modern
Procedure Clydewyn Anthony
cma@usp.orgMEPHOBARBITAL MEPHOBARBITAL 24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceAssay Titration Replace Stability
Indicating Assay
Ravi Ravichandran
rr@usp.orgMEPHOBARBITAL MEPHOBARBITAL 24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceImpurities Missing Add Quantitative
stability indicating procedure
Ravi Ravichandran
rr@usp.org
METARAMINOL BITARTRATE
METARAMINOL BITARTRATE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Titration Replace Stability Indicating
Assay
Sujatha Ramakrishna sxr@usp.org
METARAMINOL BITARTRATE
METARAMINOL BITARTRATE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Impurities Missing Add Quantitative stability
indicating procedure
Sujatha Ramakrishna sxr@usp.org
METHDILAZINE HYDROCHLORIDE
METHDILAZINE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay UV Replace Modern Procedure
Feiwen Mao fm@usp.org
METHDILAZINE HYDROCHLORIDE
METHDILAZINE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Ordinary Impurities
TLC Replace Modern Procedure
Feiwen Mao fm@usp.org
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 msw@usp.org
METHOHEXITAL METHOHEXITAL 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Ordinary Impurities
TLC Replace Modern Procedure
Mary Waddell msw@usp.org
METHOXYFLURANE METHOXYFLURANE 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay GC - Packed Column
Replace Modern Procedure
Mary Waddell msw@usp.org
METHYCLOTHIAZIDE METHYCLOTHIAZIDE 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Titration Replace Stability Indicating
Assay
Sujatha Ramakrishna sxr@usp.org
METHYCLOTHIAZIDE METHYCLOTHIAZIDE 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Impurities UV Replace Modern Procedure
Sujatha Ramakrishna sxr@usp.org
METHYCLOTHIAZIDE TABLETS
METHYCLOTHIAZIDE 24-May 2010 (Initial posting)
Submission Needed
Drug Product Assay UV Replace Modern Procedure
Sujatha Ramakrishna sxr@usp.org
METHYCLOTHIAZIDE TABLETS
METHYCLOTHIAZIDE 24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Sujatha Ramakrishna sxr@usp.org
METHYLDOPA METHYLDOPA 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Titration Replace Stability Indicating
Assay
Sujatha Ramakrishna sxr@usp.org
METHYLDOPA METHYLDOPA 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Related compounds
TLC Replace Modern Procedure
Sujatha Ramakrishna sxr@usp.org
METHYSERGIDE MALEATE
METHYSERGIDE MALEATE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Titration Replace Stability Indicating
Assay
Ravi Ravichandran
rr@usp.orgMETHYSERGIDE
MALEATEMETHYSERGIDE
MALEATE24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceOrdinary Impurities
TLC Replace Modern Procedure
Ravi Ravichandran
rr@usp.orgMETOCLOPRAMIDE HYDROCHLORIDE
METOCLOPRAMIDE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Titration Replace Stability Indicating
Assay
Elena Gonikberg
eg@usp.orgMETOCLOPRAMIDE HYDROCHLORIDE
METOCLOPRAMIDE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Chromatographic Purity
TLC Replace Modern Procedure
Elena Gonikberg
eg@usp.orgMETOPROLOL
TARTRATEMETOPROLOL
TARTRATE24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceAssay Titration Replace Stability
Indicating Assay
Sujatha Ramakrishna sxr@usp.org
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 sxr@usp.org
METYROSINE METYROSINE 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Titration Replace Stability Indicating
Assay
Sujatha Ramakrishna sxr@usp.org
METYROSINE METYROSINE 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Chromatographic Purity
TLC Replace Modern Procedure
Sujatha Ramakrishna sxr@usp.org
METYROSINE CAPSULES
METYROSINE 24-May 2010 (Initial posting)
Submission Needed
Drug Product Assay UV Replace Modern Procedure
Sujatha Ramakrishna sxr@usp.org
METYROSINE CAPSULES
METYROSINE 24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Sujatha Ramakrishna sxr@usp.org
NADOLOL NADOLOL 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Titration Replace Stability Indicating
Assay
Sujatha Ramakrishna sxr@usp.org
NADOLOL NADOLOL 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Chromatographic Purity
TLC Replace Modern Procedure
Sujatha Ramakrishna sxr@usp.org
NALOXONE HYDROCHLORIDE
NALOXONE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Titration Replace Stability Indicating
Assay
Clydewyn Anthony
cma@usp.orgNALOXONE
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
cma@usp.org
NAPROXEN NAPROXEN 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Ordinary Impurities
TLC Replace Modern Procedure
Clydewyn Anthony
cma@usp.orgNAPROXEN NAPROXEN 24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceAssay Titration Replace Stability
Indicating Assay
Clydewyn Anthony
cma@usp.org
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
cma@usp.org
NAPROXEN ORAL SUSPENSION
NAPROXEN 24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Clydewyn Anthony
cma@usp.org
NAPROXEN SODIUM NAPROXEN SODIUM 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Chromatographic Purity
TLC Replace Modern Procedure
Clydewyn Anthony
cma@usp.orgNAPROXEN SODIUM NAPROXEN SODIUM 24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceAssay Titration Replace Stability
Indicating Assay
Clydewyn Anthony
cma@usp.orgNAPROXEN SODIUM
TABLETSNAPROXEN SODIUM 24-May 2010
(Initial posting)Submission
NeededDrug Product Impurities Missing Add Quantitative
stability indicating procedure
Clydewyn Anthony
cma@usp.org
NAPROXEN TABLETS NAPROXEN 24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Clydewyn Anthony
cma@usp.org
NORTRIPTYLINE HYDROCHLORIDE
CAPSULES
NORTRIPTYLINE HYDROCHLORIDE
CAPSULES
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Impurities Missing Add Quantitative stability
indicating procedure
Ravi Ravichandran
rr@usp.org
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
rr@usp.org
NOSCAPINE NOSCAPINE 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Titration Replace Stability Indicating
Assay
Clydewyn Anthony
cma@usp.orgNOSCAPINE NOSCAPINE 24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceOrdinary Impurities
TLC Replace Modern Procedure
Clydewyn Anthony
cma@usp.orgOXAZEPAM OXAZEPAM 24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceAssay Titration Replace Stability
Indicating Assay
Ravi Ravichandran
rr@usp.orgOXAZEPAM OXAZEPAM 24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceImpurities Missing Add Quantitative
stability indicating procedure
Ravi Ravichandran
rr@usp.org
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
rr@usp.orgOXAZEPAM TABLETS OXAZEPAM 24-May 2010
(Initial posting)Submission
NeededDrug Product Impurities Missing Add Quantitative
stability indicating procedure
Ravi Ravichandran
rr@usp.org
OXTRIPHYLLINE OXTRIPHYLLINE 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Titration Replace Stability Indicating
Assay
Mary Waddell msw@usp.org
OXTRIPHYLLINE OXTRIPHYLLINE 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Ordinary Impurities
TLC Replace Modern Procedure
Mary Waddell msw@usp.org
OXYMORPHONE HYDROCHLORIDE
OXYMORPHONE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Ordinary Impurities
TLC Replace Modern Procedure
Clydewyn Anthony
cma@usp.orgOXYMORPHONE
HYDROCHLORIDEOXYMORPHONE
HYDROCHLORIDE24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceAssay Titration Replace Stability
Indicating Assay
Clydewyn Anthony
cma@usp.orgPARALDEHYDE PARALDEHYDE 24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceAssay Titration Replace Stability
Indicating Assay
Ravi Ravichandran
rr@usp.orgPENTAZOCINE PENTAZOCINE 24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceOrdinary Impurities
TLC Replace Modern Procedure
Clydewyn Anthony
cma@usp.orgPENTAZOCINE PENTAZOCINE 24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceAssay Titration Replace Stability
Indicating Assay
Clydewyn Anthony
cma@usp.orgPENTAZOCINE
HYDROCHLORIDEPENTAZOCINE
HYDROCHLORIDE24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceOrdinary Impurities
TLC Replace Modern Procedure
Clydewyn Anthony
cma@usp.orgPENTAZOCINE
HYDROCHLORIDEPENTAZOCINE
HYDROCHLORIDE24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceAssay Titration Replace Stability
Indicating Assay
Clydewyn Anthony
cma@usp.orgPENTAZOCINE
INJECTIONPENTAZOCINE 24-May 2010
(Initial posting)Submission
NeededDrug Product Assay Open
Column LCReplace Modern
ProcedureClydewyn Anthony
cma@usp.orgPHENAZOPYRIDINE HYDROCHLORIDE
PHENAZOPYRIDINE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Ordinary Impurities
TLC Replace Modern Procedure
Clydewyn Anthony
cma@usp.orgPHENAZOPYRIDINE HYDROCHLORIDE
PHENAZOPYRIDINE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay UV Replace Modern Procedure
Clydewyn Anthony
cma@usp.org
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
rr@usp.orgPHENELZINE
SULFATE TABLETSPHENELZINE
SULFATE24-May 2010
(Initial posting)Submission
NeededDrug Product Disintegration Disintegration Add Dissolution Ravi
Ravichandran rr@usp.org
PHENMETRAZINE HYDROCHLORIDE
PHENMETRAZINE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Ordinary Impurities
TLC Replace Modern Procedure
Clydewyn Anthony
cma@usp.orgPHENOXYBENZAMINE HYDROCHLORIDE
PHENOXYBENZAMINE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Titration Replace Stability Indicating
Assay
Sujatha Ramakrishna sxr@usp.org
PHENOXYBENZAMINE HYDROCHLORIDE
PHENOXYBENZAMINE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Ordinary Impurities
TLC Replace Modern Procedure
Sujatha Ramakrishna sxr@usp.org
PHENSUXIMIDE PHENSUXIMIDE 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Ordinary Impurities
TLC Replace Modern Procedure
Ravi Ravichandran
rr@usp.orgPHENYLEPHRINE HYDROCHLORIDE
PHENYLEPHRINE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Chromatographic Purity
TLC Replace Modern Procedure
Clydewyn Anthony
cma@usp.orgPHENYLEPHRINE PHENYLEPHRINE 24-May 2010 Submission Drug Product Impurities Missing Add Quantitative Clydewyn HYDROCHLORIDE
INJECTIONHYDROCHLORIDE (Initial posting) Needed stability
indicating procedure
Anthony cma@usp.org
PHENYLEPHRINE HYDROCHLORIDE
NASAL JELLY
PHENYLEPHRINE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Clydewyn Anthony
cma@usp.org
PHENYLEPHRINE HYDROCHLORIDE NASAL SOLUTION
PHENYLEPHRINE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Clydewyn Anthony
cma@usp.org
PHENYLEPHRINE HYDROCHLORIDE NASAL SOLUTION
PHENYLEPHRINE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Product pH Missing Add Need procedure for
pH
Clydewyn Anthony
cma@usp.orgPHENYLEPHRINE HYDROCHLORIDE
OPHTHALMIC SOLUTION
PHENYLEPHRINE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Clydewyn Anthony
cma@usp.org
PHENYLPROPANOLAMINE BITARTRATE
PHENYLPROPANOLAMINE BITARTRATE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Titration Replace Stability Indicating
Assay
Clydewyn Anthony
cma@usp.org
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
rr@usp.org
POLYMYXIN B SULFATE
POLYMYXIN B SULFATE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Microbiological Assay
Replace Modern Procedure
Ahalya Wise aww@usp.org
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 aww@usp.org
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 aww@usp.org
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 sxr@usp.org
PRILOCAINE HYDROCHLORIDE
PRILOCAINE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Titration Replace Stability Indicating
Assay
Mary Waddell msw@usp.org
PRILOCAINE HYDROCHLORIDE
PRILOCAINE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Impurities Missing Add Quantitative stability
indicating procedure
Mary Waddell msw@usp.org
PRIMIDONE ORAL SUSPENSION
PRIMIDONE 24-May 2010 (Initial posting)
Submission Needed
Drug Product Assay GC - Packed Column
Replace Modern Procedure
Ravi Ravichandran
rr@usp.orgPROCAINAMIDE
HYDROCHLORIDEPROCAINAMIDE
HYDROCHLORIDE24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceOrdinary Impurities
TLC Replace Modern Procedure
Sujatha Ramakrishna sxr@usp.org
PROCAINE HYDROCHLORIDE
PROCAINE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Titration Replace Stability Indicating
Assay
Mary Waddell msw@usp.org
PROCAINE HYDROCHLORIDE
PROCAINE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Chromatographic Purity
TLC Replace Modern Procedure
Mary Waddell msw@usp.org
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 fm@usp.org
PROCARBAZINE HYDROCHLORIDE
PROCARBAZINE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Impurities Missing Add Quantitative stability
indicating procedure
Feiwen Mao fm@usp.org
PROCARBAZINE HYDROCHLORIDE
CAPSULES
PROCARBAZINE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Product Assay Polarographic
Replace Modern Procedure
Feiwen Mao fm@usp.org
PROCARBAZINE HYDROCHLORIDE
CAPSULES
PROCARBAZINE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Feiwen Mao fm@usp.org
PROMETHAZINE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Titration Replace Stability Indicating
Assay
Sujatha Ramakrishna sxr@usp.org
PROMETHAZINE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Related Substances
TLC Replace Modern Procedure
Sujatha Ramakrishna sxr@usp.org
PROPARACAINE HYDROCHLORIDE
PROPARACAINE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Ordinary Impurities
TLC Replace Modern Procedure
Mary Waddell msw@usp.org
PROPARACAINE HYDROCHLORIDE
PROPARACAINE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Titration Replace Stability Indicating
Assay
Mary Waddell msw@usp.org
PROPOXYCAINE HYDROCHLORIDE
PROPOXYCAINE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Titration Replace Stability Indicating
Assay
Mary Waddell msw@usp.org
PROPOXYCAINE HYDROCHLORIDE
PROPOXYCAINE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Chromatographic Purity
TLC Replace Modern Procedure
Mary Waddell msw@usp.org
PROTRIPTYLINE HYDROCHLORIDE
TABLETS
PROTRIPTYLINE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Ravi Ravichandran
rr@usp.org
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
cma@usp.org
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
cma@usp.org
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
cma@usp.org
PSEUDOEPHEDRINE HYDROCHLORIDE
TABLETS
PSEUDOEPHEDRINE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Clydewyn Anthony
cma@usp.org
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
cma@usp.org
PSEUDOEPHEDRINE SULFATE
PSEUDOEPHEDRINE SULFATE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Ordinary Impurities
TLC Replace Modern Procedure
Clydewyn Anthony
cma@usp.orgPSEUDOEPHEDRINE
SULFATEPSEUDOEPHEDRINE
SULFATE24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceAssay Titration Replace Stability
Indicating Assay
Clydewyn Anthony
cma@usp.orgQUINIDINE
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 sxr@usp.org
QUINIDINE GLUCONATE
QUINIDINE GLUCONATE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Chromatographic Purity
TLC Replace Modern Procedure
Sujatha Ramakrishna sxr@usp.org
SALICYLAMIDE SALICYLAMIDE 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Chromatographic Purity
TLC Replace Modern Procedure
Clydewyn Anthony
cma@usp.orgSALICYLAMIDE SALICYLAMIDE 24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceAssay Titration Replace Stability
Indicating Assay
Clydewyn Anthony
cma@usp.orgSALSALATE CAPSULES
SALSALATE 24-May 2010 (Initial posting)
Submission Needed
Drug Product Dissolution Missing Add Add Dissolution Procedure
Clydewyn Anthony
cma@usp.orgSCOPOLAMINE
HYDROBROMIDESCOPOLAMINE
HYDROBROMIDE24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceAssay Titration Replace Stability
Indicating Assay
Feiwen Mao fm@usp.org
SCOPOLAMINE HYDROBROMIDE
SCOPOLAMINE HYDROBROMIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Impurities Missing Add Quantitative stability
indicating procedure
Feiwen Mao fm@usp.org
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 fm@usp.org
SCOPOLAMINE HYDROBROMIDE
INJECTION
SCOPOLAMINE HYDROBROMIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Feiwen Mao fm@usp.org
SCOPOLAMINE HYDROBROMIDE
OPHTHALMIC OINTMENT
SCOPOLAMINE HYDROBROMIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Product Assay GC - Packed Column
Replace Modern Procedure
Feiwen Mao fm@usp.org
SCOPOLAMINE HYDROBROMIDE
OPHTHALMIC OINTMENT
SCOPOLAMINE HYDROBROMIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Feiwen Mao fm@usp.org
SCOPOLAMINE HYDROBROMIDE
OPHTHALMIC SOLUTION
SCOPOLAMINE HYDROBROMIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Product Assay GC - Packed Column
Replace Modern Procedure
Feiwen Mao fm@usp.org
SCOPOLAMINE HYDROBROMIDE
OPHTHALMIC
SCOPOLAMINE HYDROBROMIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating
Feiwen Mao fm@usp.org
SOLUTION procedureSCOPOLAMINE
HYDROBROMIDE TABLETS
SCOPOLAMINE HYDROBROMIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Product Assay GC - Packed Column
Replace Modern Procedure
Feiwen Mao fm@usp.org
SCOPOLAMINE HYDROBROMIDE
TABLETS
SCOPOLAMINE HYDROBROMIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Feiwen Mao fm@usp.org
SODIUM MONOFLUOROPHOS
PHATE
SODIUM MONOFLUOROPHOS
PHATE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Titration Replace Stability Indicating
Assay
Elena Gonikberg
eg@usp.org
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
cma@usp.orgSODIUM SALICYLATE SODIUM SALICYLATE 24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceImpurities Missing Add Quantitative
stability indicating procedure
Clydewyn Anthony
cma@usp.org
SODIUM SALICYLATE TABLETS
SODIUM SALICYLATE 24-May 2010 (Initial posting)
Submission Needed
Drug Product Assay Titration Replace Stability Indicating
Assay
Clydewyn Anthony
cma@usp.org
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
cma@usp.org
SPIRONOLACTONE SPIRONOLACTONE 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Ordinary Impurities
TLC Replace Modern Procedure
Sujatha Ramakrishna sxr@usp.org
SPIRONOLACTONE SPIRONOLACTONE 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Limit of mercapto
compounds
Titration Replace Stability Indicating
Assay
Sujatha Ramakrishna sxr@usp.org
SULFABENZAMIDE SULFABENZAMIDE 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Ordinary Impurities
TLC Replace Modern Procedure
Behnam Davani
bd@usp.orgSULFACETAMIDE
SODIUMSULFACETAMIDE
SODIUM24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceOrdinary Impurities
TLC Replace Modern Procedure
Behnam Davani
bd@usp.orgSULFACETAMIDE
SODIUMSULFACETAMIDE
SODIUM24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceAssay Titration Replace Stability
Indicating Assay
Behnam Davani
bd@usp.orgSULFAMETHAZINE SULFAMETHAZINE 24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceOrdinary Impurities
TLC Replace Modern Procedure
Elena Gonikberg
eg@usp.orgSULFAMETHAZINE SULFAMETHAZINE 24-May 2010
(Initial posting)Submission
NeededDrug
Substanceassay Titration Replace Stability
Indicating Assay
Elena Gonikberg
eg@usp.orgSULFAPYRIDINE SULFAPYRIDINE 24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceAssay Titration Replace Stability
Indicating Assay
Behnam Davani
bd@usp.orgSULFAPYRIDINE SULFAPYRIDINE 24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceImpurities Missing Add Quantitative
stability indicating procedure
Behnam Davani
bd@usp.org
SULFAPYRIDINE TABLETS
SULFAPYRIDINE 24-May 2010 (Initial posting)
Submission Needed
Drug Product Assay Titration Replace Stability Indicating
Assay
Behnam Davani
bd@usp.orgSULFAPYRIDINE
TABLETSSULFAPYRIDINE 24-May 2010
(Initial posting)Submission
NeededDrug Product Impurities Missing Add Quantitative
stability indicating procedure
Behnam Davani
bd@usp.org
SULISOBENZONE SULISOBENZONE 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Titration Replace Stability Indicating
Assay
Feiwen Mao fm@usp.org
TESTOSTERONE TESTOSTERONE 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay TLC/UV Replace Modern Procedures
Mary Waddell msw@usp.org
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 msw@usp.org
TESTOSTERONE ENANTHATE
TESTOSTERONE ENANTHATE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay UV Replace Modern Procedure
Mary Waddell msw@usp.org
TESTOSTERONE ENANTHATE
TESTOSTERONE ENANTHATE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Ordinary Impurities
TLC Replace Modern Procedure
Mary Waddell msw@usp.org
TETRACAINE TETRACAINE 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Titration Replace Stability Indicating
Assay
Mary Waddell msw@usp.org
TETRACAINE TETRACAINE 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Chromatographic Purity
TLC Replace Modern Procedure
Mary Waddell msw@usp.org
THIOPENTAL SODIUM THIOPENTAL SODIUM 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay UV Replace Modern Procedure
Mary Waddell msw@usp.org
THIOPENTAL SODIUM THIOPENTAL SODIUM 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Ordinary Impurities
TLC Replace Modern Procedure
Mary Waddell msw@usp.org
TIMOLOL MALEATE TIMOLOL MALEATE 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Titration Replace Stability Indicating
Assay
Sujatha Ramakrishna sxr@usp.org
TRETINOIN TOPICAL SOLUTION
TRETINOIN 24-May 2010 (Initial posting)
Submission Needed
Drug Product Assay UV Replace Modern Procedure
Feiwen Mao fm@usp.org
TRETINOIN TOPICAL SOLUTION
TRETINOIN 24-May 2010 (Initial posting)
Submission Needed
Drug Product Impurities Missing Add Quantitative stability
indicating procedure
Feiwen Mao fm@usp.org
TRIFLUPROMAZINE TRIFLUPROMAZINE 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Ordinary Impurities
TLC Replace Modern Procedure
Ravi Ravichandran
rr@usp.orgTRIFLUPROMAZINE TRIFLUPROMAZINE 24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceAssay Titration Replace Stability
Indicating Assay
Ravi Ravichandran
rr@usp.orgTRIFLUPROMAZINE HYDROCHLORIDE
TRIFLUPROMAZINE HYDROCHLORIDE
24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Titration Replace Stability Indicating
Assay
Ravi Ravichandran
rr@usp.orgTRIPROLIDINE
HYDROCHLORIDETRIPROLIDINE
HYDROCHLORIDE24-May 2010
(Initial posting)Submission
NeededDrug
SubstanceAssay Titration Replace Stability
Indicating Assay
Mary Waddell msw@usp.org
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 msw@usp.org
VANCOMYCIN VANCOMYCIN 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Assay Microbiological Assay
Replace Modern Procedure
Ahalya Wise aww@usp.org
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 aww@usp.org
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 aww@usp.org
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 aww@usp.org
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 aww@usp.org
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 sxr@usp.org
WARFARIN SODIUM WARFARIN SODIUM 24-May 2010 (Initial posting)
Submission Needed
Drug Substance
Isopropyl alcohol Content
GC - Packed Column
Replace Modern Procedure
Feiwen Mao fm@usp.org
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