Revisions to USP 31–NF 26, Second Supplement
(published May 2008)
Published April 2008
General Chapters Monographs:A–C D–N O–S T–Z
- Monograph Title
- Section Head
- Scientific Liaison
DANTROLENE SODIUM CAPSULES PF 33(4) Pg. 645
Dissolution <711>
DEHYDROACETIC ACID PF 33(4) Pg. 703
Title
DEHYDROACETIC ACID PF 33(4) Pg. 703
Chemical Info
DEHYDROACETIC ACID PF 33(4) Pg. 703
Definition
DEHYDROACETIC ACID PF 33(4) Pg. 703
Packaging and storage USP Reference standards <11> Identification
DEHYDROACETIC ACID PF 33(4) Pg. 703
DEHYDROACETIC ACID PF 33(4) Pg. 703
DEHYDROACETIC ACID PF 33(4) Pg. 703
Heavy Metals, Method II <231> Loss on drying <731> Melting range, Class I <741> Residue on ignition <281> Assay
DEHYDROACETIC ACID PF 33(4) Pg. 703
DEHYDROACETIC ACID PF 33(4) Pg. 703
DEHYDROACETIC ACID PF 33(4) Pg. 703
DEHYDROACETIC ACID PF 33(4) Pg. 703
DIDANOSINE TABLETS FOR ORAL SUSPENSION PF 32(3) Pg. Title 784
DIDANOSINE TABLETS FOR ORAL SUSPENSION PF 32(3) Pg. Definition 784
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DIDANOSINE TABLETS FOR ORAL SUSPENSION PF 32(3) Pg. Packaging and storage 784
DIDANOSINE TABLETS FOR ORAL SUSPENSION PF 32(3) Pg. Labeling 784
DIDANOSINE TABLETS FOR ORAL SUSPENSION PF 32(3) Pg. USP Reference stadards 784
DIDANOSINE TABLETS FOR ORAL SUSPENSION PF 32(3) Pg. Identification 784
DIDANOSINE TABLETS FOR ORAL SUSPENSION PF 32(3) Pg. Uniformity of dosage units 784
DIDANOSINE TABLETS FOR ORAL SUSPENSION PF 32(3) Pg. Loss on drying 784
DIDANOSINE TABLETS FOR ORAL SUSPENSION PF 32(3) Pg. Related compounds 784
DIDANOSINE TABLETS FOR ORAL SUSPENSION PF 32(3) Pg. Assay 784
DIDANOSINE TABLETS FOR ORAL SUSPENSION PF 33(5) Pg. Title 903
DIDANOSINE TABLETS FOR ORAL SUSPENSION PF 33(5) Pg. Definition 903
DIDANOSINE TABLETS FOR ORAL SUSPENSION PF 33(5) Pg. Labeling 903
DIDANOSINE TABLETS FOR ORAL SUSPENSION PF 33(5) Pg. Loss on drying <731> 903
DIDANOSINE TABLETS FOR ORAL SUSPENSION PF 33(5) Pg. Acid-neutralizing capacity <301> 903
DIDANOSINE TABLETS FOR ORAL SUSPENSION PF 33(5) Pg. Related compounds 903
DIDANOSINE TABLETS FOR ORAL SUSPENSION PF 33(5) Pg. Assay
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903 DILTIAZEM HYDROCHLORIDE PF 33(5) Pg. 907
Definition
DIMENHYDRINATE INJECTION PF 33(5) Pg. 907
USP Reference standards <11> Identification
DIMENHYDRINATE INJECTION PF 33(5) Pg. 907
DIMENHYDRINATE PF 33(5) Pg. 907
Identification
DINOPROST TROMETHAMINE INJECTION PF 33(5) Pg. 908
Title
DINOPROST TROMETHAMINE INJECTION PF 33(5) Pg. 908
Definition
DINOPROST TROMETHAMINE INJECTION PF 33(5) Pg. 908
Packaging and storage Labeling
DINOPROST TROMETHAMINE INJECTION PF 33(5) Pg. 908
DINOPROST TROMETHAMINE INJECTION PF 33(5) Pg. 908
USP Reference standards <11> Identification
DINOPROST TROMETHAMINE INJECTION PF 33(5) Pg. 908
DINOPROST TROMETHAMINE INJECTION PF 33(5) Pg. 908
Bacterial endotoxins <85> Sterility <71> pH <791>
DINOPROST TROMETHAMINE INJECTION PF 33(5) Pg. 908
DINOPROST TROMETHAMINE INJECTION PF 33(5) Pg. 908
DINOPROST TROMETHAMINE INJECTION PF 33(5) Pg. 908
Other requirements Assay
DINOPROST TROMETHAMINE INJECTION PF 33(5) Pg. 908
ENOXAPARIN SODIUM INJECTION PF 31(3) Pg. 761
Title
ENOXAPARIN SODIUM INJECTION PF 31(3) Pg. 761
Definition
ENOXAPARIN SODIUM INJECTION PF 31(3) Pg. 761
Packaging and storage Labeling
ENOXAPARIN SODIUM INJECTION PF 31(3) Pg. 761
ENOXAPARIN SODIUM
USP Reference standards
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INJECTION PF 31(3) Pg. 761 ENOXAPARIN SODIUM INJECTION PF 31(3) Pg. 761
Identification A, B, C Clarity
ENOXAPARIN SODIUM INJECTION PF 31(3) Pg. 761
ENOXAPARIN SODIUM INJECTION PF 31(3) Pg. 761
Color
ENOXAPARIN SODIUM INJECTION PF 31(3) Pg. 761 pH
ENOXAPARIN SODIUM INJECTION PF 31(3) Pg. 761
Benzyl alcohol content Free sulfate content Anti-factor IIa activity Anti-factor Xa to anti-factor IIa ratio
ENOXAPARIN SODIUM INJECTION PF 31(3) Pg. 761
ENOXAPARIN SODIUM INJECTION PF 31(3) Pg. 761
ENOXAPARIN SODIUM INJECTION PF 31(3) Pg. 761
ENOXAPARIN SODIUM INJECTION PF 31(3) Pg. 761
Other requirements - Sterility Tests <71>
ENOXAPARIN SODIUM INJECTION PF 31(3) Pg. 761
Other requirements Assay (anti-factor Xa activity) Bacterial endotoxins Definition
ENOXAPARIN SODIUM INJECTION PF 31(3) Pg. 761
ENOXAPARIN SODIUM INJECTION PF 31(3) Pg. 761
ENOXAPARIN SODIUM INJECTION PF 33(1) Pg. 58
ENOXAPARIN SODIUM INJECTION PF 33(1) Pg. 58
Appearance of solution (Clarity and degree of color of liquids)
ENOXAPARIN SODIUM INJECTION PF 33(1) Pg. 58
Benzyl alcohol content (if present) Bacterial endotoxins <85> Free sulfate content
ENOXAPARIN SODIUM INJECTION PF 33(1) Pg. 58
ENOXAPARIN SODIUM INJECTION PF 33(1) Pg. 58
ENOXAPARIN SODIUM INJECTION PF 33(1) Pg. 58
Assay (anti-factor Xa activity) Title
ENOXAPARIN SODIUM PF 29(6) Pg. 1876
ENOXAPARIN SODIUM PF 29(6)
Chemical structure
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Pg. 1876 ENOXAPARIN SODIUM PF 29(6) Pg. 1876
CAS number
ENOXAPARIN SODIUM PF 29(6) Pg. 1876
Definition
ENOXAPARIN SODIUM PF 29(6) Pg. 1876
Packaging and storage USP Reference standards Identification A, B, C, D, E Appearance of solution Specific absorbance pH
ENOXAPARIN SODIUM PF 29(6) Pg. 1876
ENOXAPARIN SODIUM PF 29(6) Pg. 1876
ENOXAPARIN SODIUM PF 29(6) Pg. 1876
ENOXAPARIN SODIUM PF 29(6) Pg. 1876
ENOXAPARIN SODIUM PF 29(6) Pg. 1876
ENOXAPARIN SODIUM PF 29(6) Pg. 1876
Loss on drying
ENOXAPARIN SODIUM PF 29(6) Pg. 1876
Nitrogen content
ENOXAPARIN SODIUM PF 29(6) Pg. 1876
Heavy metals
ENOXAPARIN SODIUM PF 29(6) Pg. 1876
Sodium content
ENOXAPARIN SODIUM PF 29(6) Pg. 1876
Molar ratio of sulfate to carboxylate Benzyl alcohol content Anti-factor IIa activity Assay (anti-factor Xa activity) Bacterial endotoxins Definition
ENOXAPARIN SODIUM PF 29(6) Pg. 1876
ENOXAPARIN SODIUM PF 29(6) Pg. 1876
ENOXAPARIN SODIUM PF 29(6) Pg. 1876
ENOXAPARIN SODIUM PF 29(6) Pg. 1876
ENOXAPARIN SODIUM PF 33(1) Pg. 52
ENOXAPARIN SODIUM PF 33(1) Pg. 52
USP Reference standards <11> Identification
ENOXAPARIN SODIUM PF 33(1)
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Pg. 52 ENOXAPARIN SODIUM PF 33(1) Appearance of solution (Clarity and
- Pg. 52
- degree of color of liquids)
ENOXAPARIN SODIUM PF 33(1) Pg. 52 pH <791>
ENOXAPARIN SODIUM PF 33(1) Molar ratio of sulfate to carboxylate
- Pg. 52
- (see Chromatography <621>)
ENOXAPARIN SODIUM PF 33(1) Pg. 52
Benzyl alcohol content
ENOXAPARIN SODIUM PF 33(1) Pg. 52
Anti-factor IIa activity
ENOXAPARIN SODIUM PF 33(1) Pg. 52
Assay (anti-factor Xa activity)
ESTRADIOL AND NORETHINDRONE ACETATE TABLETS PF 31(5) Pg. 1364
Dissolution Dissolution
ESTRADIOL AND NORETHINDRONE ACETATE TABLETS PF 33(2) Pg. 220
ETHINYL ESTRADIOL TABLETS PF 31(4) Pg. 1067
Disintegration
- Assay
- ETHIONAMIDE PF 33(4) Pg. 648
FAMOTIDINE TABLETS PF 33(4) Pg. 649
Dissolution <711>
FORMALDEHYDE SOLUTION PF 33(4) Pg. 650
Definition
FORMALDEHYDE SOLUTION PF 33(4) Pg. 650
Labeling
FORMALDEHYDE SOLUTION PF 33(4) Pg. 650
Content of methanol Assay
FORMALDEHYDE SOLUTION PF 33(4) Pg. 650
FULVESTRANT PF 33(5) Pg. 909 FULVESTRANT PF 33(5) Pg. 909 FULVESTRANT PF 33(5) Pg. 909 FULVESTRANT PF 33(5) Pg. 909 FULVESTRANT PF 33(5) Pg. 909 FULVESTRANT PF 33(5) Pg. 909 FULVESTRANT PF 33(5) Pg. 909
Title Chemical Info Definition Packaging and storage USP Reference standards <11> Identification Specific rotation <781S>
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FULVESTRANT PF 33(5) Pg. 909 FULVESTRANT PF 33(5) Pg. 909 FULVESTRANT PF 33(5) Pg. 909 FULVESTRANT PF 33(5) Pg. 909 FULVESTRANT PF 33(5) Pg. 909
Water, Method Ic <921> Residue on ignition <281> Related compounds Diastereoisomer ratio Assay
GAMMA CYCLODEXTRIN PF 31(3) Pg. 812
Microbial limits Title
GAMMA CYCLODEXTRIN PF 31(3) Pg. 812
GAMMA CYCLODEXTRIN PF 31(3) Pg. 812
Molecular weight Packaging and storage Identification A, B, C Specific rotation Loss on drying
GAMMA CYCLODEXTRIN PF 31(3) Pg. 812
GAMMA CYCLODEXTRIN PF 31(3) Pg. 812
GAMMA CYCLODEXTRIN PF 31(3) Pg. 812
GAMMA CYCLODEXTRIN PF 31(3) Pg. 812
GAMMA CYCLODEXTRIN PF 31(3) Pg. 812
Residue on ignition Heavy metals
GAMMA CYCLODEXTRIN PF 31(3) Pg. 812
GAMMA CYCLODEXTRIN PF 33(4) Pg. 707
Chemical Info
GAMMA CYCLODEXTRIN PF 33(4) Pg. 707
Definition
GAMMA CYCLODEXTRIN PF 33(4) Pg. 707
USP Reference standards <11> Color and clarity of solution Related compounds Reducing substances Assay
GAMMA CYCLODEXTRIN PF 33(4) Pg. 707
GAMMA CYCLODEXTRIN PF 33(4) Pg. 707
GAMMA CYCLODEXTRIN PF 33(4) Pg. 707
GAMMA CYCLODEXTRIN PF 33(4) Pg. 707
GLUCOSAMINE
- HYDROCHLORIDE PF 33(4) Pg.
- Specific rotation <781S>
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691 GLUCOSAMINE SULFATE POTASSIUM CHLORIDE PF 33(4) Identification Pg. 692
GLUCOSAMINE SULFATE POTASSIUM CHLORIDE PF 33(4) Specific rotation <781S> Pg. 692
GLUCOSAMINE SULFATE POTASSIUM CHLORIDE PF 33(4) Residue on ignition <281> Pg. 692
GLUCOSAMINE SULFATE SODIUM CHLORIDE PF 33(4) Pg. Identification 692
GLUCOSAMINE SULFATE SODIUM CHLORIDE PF 33(4) Pg. Specific rotation <781S> 692
GLUCOSAMINE SULFATE SODIUM CHLORIDE PF 33(4) Pg. Residue on ignition <281> 692
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE TABLETS PF
Labeling
33(4) Pg. 654 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE TABLETS PF
Dissolution <711>
33(4) Pg. 654 HYDROPHOBIC COLLOIDAL
Title
SILICA PF 33(5) Pg. 976
HYDROPHOBIC COLLOIDAL
Chemical Info
SILICA PF 33(5) Pg. 976
HYDROPHOBIC COLLOIDAL
Definition
SILICA PF 33(5) Pg. 976
HYDROPHOBIC COLLOIDAL
Packaging and storage
SILICA PF 33(5) Pg. 976
HYDROPHOBIC COLLOIDAL
Identification
SILICA PF 33(5) Pg. 976
HYDROPHOBIC COLLOIDAL
Limit of chloride
SILICA PF 33(5) Pg. 976
HYDROPHOBIC COLLOIDAL
Limit of lead
SILICA PF 33(5) Pg. 976
HYDROPHOBIC COLLOIDAL
Water-dispersible substances
SILICA PF 33(5) Pg. 976
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HYDROPHOBIC COLLOIDAL SILICA PF 33(5) Pg. 976
Loss on ignition <733> Assay
HYDROPHOBIC COLLOIDAL SILICA PF 33(5) Pg. 976
HYOSCYAMINE SULFATE PF 33(4) Pg. 659
Specific rotation <781S>
INOSITOL PF 33(4) Pg. 711 INOSITOL PF 33(4) Pg. 711 INOSITOL PF 33(4) Pg. 711 INOSITOL PF 33(4) Pg. 711 INOSITOL PF 33(4) Pg. 711 INOSITOL PF 33(4) Pg. 711 INOSITOL PF 33(4) Pg. 711 INOSITOL PF 33(4) Pg. 711 INOSITOL PF 33(4) Pg. 711 INOSITOL PF 33(4) Pg. 711 INOSITOL PF 33(4) Pg. 711 INOSITOL PF 33(4) Pg. 711 INOSITOL PF 33(4) Pg. 711 INOSITOL PF 33(4) Pg. 711 ISOSORBIDE MONONITRATE
Title Chemical Info Definition Packaging and storage USP Reference standards <11> Clarity of solution Color of solution Identification Conductivity Water, Method I <921> Barium Limit of lead Related compounds Assay
EXTENDED-RELEASE TABLETS Dissolution <711> PF 33(4) Pg. 659
ISOTRETINOIN CAPSULES PF
Dissolution <711>
33(4) Pg. 666
IVERMECTIN AND CLORSULON
Title
INJECTION PF 33(5) Pg. 921
IVERMECTIN AND CLORSULON
Definition
INJECTION PF 33(5) Pg. 921
IVERMECTIN AND CLORSULON
Packaging and storage
INJECTION PF 33(5) Pg. 921
IVERMECTIN AND CLORSULON
Labeling
INJECTION PF 33(5) Pg. 921
IVERMECTIN AND CLORSULON INJECTION PF 33(5) Pg. 921
USP Reference standards <11> Identification
IVERMECTIN AND CLORSULON INJECTION PF 33(5) Pg. 921
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IVERMECTIN AND CLORSULON INJECTION PF 33(5) Pg. 921
Bacterial endotoxins <85> Sterility <71>
IVERMECTIN AND CLORSULON INJECTION PF 33(5) Pg. 921
IVERMECTIN AND CLORSULON INJECTION PF 33(5) Pg. 921
Other requirements Assay for ivermectin Assay for clorsulon Title
IVERMECTIN AND CLORSULON INJECTION PF 33(5) Pg. 921
IVERMECTIN AND CLORSULON INJECTION PF 33(5) Pg. 921
IVERMECTIN INJECTION PF 33(5) Pg. 913
IVERMECTIN INJECTION PF 33(5) Pg. 913
Definition
IVERMECTIN INJECTION PF 33(5) Pg. 913
Packaging and storage Labeling
IVERMECTIN INJECTION PF 33(5) Pg. 913
IVERMECTIN INJECTION PF 33(5) Pg. 913
USP Reference standards <11> Identification
IVERMECTIN INJECTION PF 33(5) Pg. 913
IVERMECTIN INJECTION PF 33(5) Pg. 913
Bacterial endotoxins <85> Sterility <71>
IVERMECTIN INJECTION PF 33(5) Pg. 913
IVERMECTIN INJECTION PF 33(5) Pg. 913
Chromatographic purity Other requirements Assay
IVERMECTIN INJECTION PF 33(5) Pg. 913
IVERMECTIN INJECTION PF 33(5) Pg. 913
IVERMECTIN PASTE PF 33(5) Pg. 914
Title
IVERMECTIN PASTE PF 33(5) Pg. 914
Definition
IVERMECTIN PASTE PF 33(5) Pg. 914
Packaging and storage Labeling
IVERMECTIN PASTE PF 33(5) Pg. 914
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IVERMECTIN PASTE PF 33(5) Pg. 914
USP Reference standards <11> Identification
IVERMECTIN PASTE PF 33(5) Pg. 914
IVERMECTIN PASTE PF 33(5) Pg. 914
Chromatographic purity
IVERMECTIN PASTE PF 33(5) Pg. 914
Assay
- IVERMECTIN PF 33(5) Pg. 912
- Definition
Title
IVERMECTIN TABLETS PF 33(5) Pg. 918
IVERMECTIN TABLETS PF 33(5) Pg. 918
Definition
IVERMECTIN TABLETS PF 33(5) Pg. 918
Packaging and storage USP Reference standards <11> Identification
IVERMECTIN TABLETS PF 33(5) Pg. 918
IVERMECTIN TABLETS PF 33(5) Pg. 918
IVERMECTIN TABLETS PF 33(5) Pg. 918
Uniformity of dosage units <905> Limit of 8a-oxo-H2B1a Assay
IVERMECTIN TABLETS PF 33(5) Pg. 918
IVERMECTIN TABLETS PF 33(5) Pg. 918
IVERMECTIN TOPICAL SOLUTION PF 33(5) Pg. 916
Title
IVERMECTIN TOPICAL SOLUTION PF 33(5) Pg. 916
Definition
IVERMECTIN TOPICAL SOLUTION PF 33(5) Pg. 916
Packaging and storage Labeling
IVERMECTIN TOPICAL SOLUTION PF 33(5) Pg. 916
IVERMECTIN TOPICAL SOLUTION PF 33(5) Pg. 916
USP Reference standards <11> Identification
IVERMECTIN TOPICAL SOLUTION PF 33(5) Pg. 916
IVERMECTIN TOPICAL SOLUTION PF 33(5) Pg. 916
Chromatographic purity Assay
IVERMECTIN TOPICAL
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SOLUTION PF 33(5) Pg. 916 LIGHT MINERAL OIL PF 33(5) Pg. 972
Definition
LIGHT MINERAL OIL PF 33(5) Pg. 972
Packaging and storage Labeling
LIGHT MINERAL OIL PF 33(5) Pg. 972
LIGHT MINERAL OIL PF 33(5) Pg. 972
USP Reference standards <11> Identification
LIGHT MINERAL OIL PF 33(5) Pg. 972
LIGHT MINERAL OIL PF 33(5) Pg. 972
Viscosity <911> Acidity,Readily carbonizable
LIGHT MINERAL OIL PF 33(5) Pg. substances, Limit of polycyclic
- 972
- aromatic hydrocarbons, Limit of
sulfur compounds, and Solid paraffin
MAGALDRATE AND SIMETHICONE ORAL SUSPENSION PF 33(5) Pg. 923
Defoaming activity Defoaming activity Defoaming activity Assay
MAGALDRATE AND SIMETHICONE TABLETS PF 33(5) Pg. 923
MAGALDRATE AND SIMETHICONE TABLETS PF 33(5) Pg. 923
MEFLOQUINE HYDROCHLORIDE PF 33(4) Pg. 667
MINERAL OIL PF 33(5) Pg. 962 MINERAL OIL PF 33(5) Pg. 962 MINERAL OIL PF 33(5) Pg. 962 MINERAL OIL PF 33(5) Pg. 962 MINERAL OIL PF 33(5) Pg. 962 MINERAL OIL PF 33(5) Pg. 962 MINERAL OIL PF 33(5) Pg. 962 MINERAL OIL PF 33(5) Pg. 962 MINERAL OIL PF 33(5) Pg. 962
Chemical Info Definition Packaging and storage Labeling USP Reference standards <11> Identification Neutrality Acidity Readily carbonizable substances Limit of polycyclic aromatic hydrocarbons
MINERAL OIL PF 33(5) Pg. 962
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MINERAL OIL PF 33(5) Pg. 962 MINERAL OIL PF 33(5) Pg. 962
Limit of sulfur compounds Viscosity
MINERAL OIL, RECTAL PF 33(5) Pg. 964
Packaging and storage USP Reference standards <11> Identification
MINERAL OIL, RECTAL PF 33(5) Pg. 964
MINERAL OIL, RECTAL PF 33(5) Pg. 964
MINERAL OIL, RECTAL PF 33(5) Pg. 964
Viscosity
MINERAL OIL, RECTAL PF 33(5) Pg. 964
Neutrality
MINERAL OIL, RECTAL PF 33(5) Pg. 964
Acidity
MYCOPHENOLATE MOFETIL PF 33(5) Pg. 924
Title
MYCOPHENOLATE MOFETIL PF 33(5) Pg. 924
Chemical Info
MYCOPHENOLATE MOFETIL PF 33(5) Pg. 924
Definition
MYCOPHENOLATE MOFETIL PF 33(5) Pg. 924
Packaging and storage USP Reference standards <11> Identification
MYCOPHENOLATE MOFETIL PF 33(5) Pg. 924
MYCOPHENOLATE MOFETIL PF 33(5) Pg. 924
MYCOPHENOLATE MOFETIL PF 33(5) Pg. 924
Melting range, Class Ia <741> Loss on drying <731> Residue on ignition <281> Heavy metals, Method II <231> Related compounds Assay
MYCOPHENOLATE MOFETIL PF 33(5) Pg. 924
MYCOPHENOLATE MOFETIL PF 33(5) Pg. 924
MYCOPHENOLATE MOFETIL PF 33(5) Pg. 924
MYCOPHENOLATE MOFETIL PF 33(5) Pg. 924
MYCOPHENOLATE MOFETIL PF 33(5) Pg. 924
NAPHAZOLINE HYDROCHLORIDE
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Assay
OPHTHALMIC SOLUTION PF
33(5) Pg. 926
NICOTINE TRANSDERMAL SYSTEM PF 33(5) Pg. 927
Drug release <724> Assay
NICOTINE TRANSDERMAL SYSTEM PF 33(5) Pg. 927
NORETHINDRONE TABLETS PF 32(6) Pg. 1736
Labeling
NORETHINDRONE TABLETS PF 32(6) Pg. 1736
Disintegration <701> Dissolution <711>
NORETHINDRONE TABLETS PF 33(3) Pg. 432
General Chapters Monographs:A–C D–N O–S T–Z
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