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