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Revisions to USP 31–NF 26, Second Supplement

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Revisions to USP 31–NF 26, Second Supplement 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 Dissolution <711> CAPSULES PF 33(4) Pg. 645 DEHYDROACETIC ACID PF 33(4) Title Pg. 703 DEHYDROACETIC ACID PF 33(4) Chemical Info Pg. 703 DEHYDROACETIC ACID PF 33(4) Definition Pg. 703 DEHYDROACETIC ACID PF 33(4) Packaging and storage Pg. 703 DEHYDROACETIC ACID PF 33(4) USP Reference standards <11> Pg. 703 DEHYDROACETIC ACID PF 33(4) Identification Pg. 703 DEHYDROACETIC ACID PF 33(4) Heavy Metals, Method II <231> Pg. 703 DEHYDROACETIC ACID PF 33(4) Loss on drying <731> Pg. 703 DEHYDROACETIC ACID PF 33(4) Melting range, Class I <741> Pg. 703 DEHYDROACETIC ACID PF 33(4) Residue on ignition <281> Pg. 703 DEHYDROACETIC ACID PF 33(4) Assay Pg. 703 DIDANOSINE TABLETS FOR ORAL SUSPENSION PF 32(3) Pg. Title 784 DIDANOSINE TABLETS FOR ORAL SUSPENSION PF 32(3) Pg. Definition 784 file:///C|/Documents%20and%20Settings/rwt/Desktop/revisions/usp31nf26secondSupplement03.html[4/26/2011 1:18:07 PM] 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 file:///C|/Documents%20and%20Settings/rwt/Desktop/revisions/usp31nf26secondSupplement03.html[4/26/2011 1:18:07 PM] 903 DILTIAZEM HYDROCHLORIDE Definition PF 33(5) Pg. 907 DIMENHYDRINATE INJECTION USP Reference standards <11> PF 33(5) Pg. 907 DIMENHYDRINATE INJECTION Identification PF 33(5) Pg. 907 DIMENHYDRINATE PF 33(5) Pg. Identification 907 DINOPROST TROMETHAMINE Title INJECTION PF 33(5) Pg. 908 DINOPROST TROMETHAMINE Definition INJECTION PF 33(5) Pg. 908 DINOPROST TROMETHAMINE Packaging and storage INJECTION PF 33(5) Pg. 908 DINOPROST TROMETHAMINE Labeling INJECTION PF 33(5) Pg. 908 DINOPROST TROMETHAMINE USP Reference standards <11> INJECTION PF 33(5) Pg. 908 DINOPROST TROMETHAMINE Identification INJECTION PF 33(5) Pg. 908 DINOPROST TROMETHAMINE Bacterial endotoxins <85> INJECTION PF 33(5) Pg. 908 DINOPROST TROMETHAMINE Sterility <71> INJECTION PF 33(5) Pg. 908 DINOPROST TROMETHAMINE pH <791> INJECTION PF 33(5) Pg. 908 DINOPROST TROMETHAMINE Other requirements INJECTION PF 33(5) Pg. 908 DINOPROST TROMETHAMINE Assay INJECTION PF 33(5) Pg. 908 ENOXAPARIN SODIUM Title INJECTION PF 31(3) Pg. 761 ENOXAPARIN SODIUM Definition INJECTION PF 31(3) Pg. 761 ENOXAPARIN SODIUM Packaging and storage INJECTION PF 31(3) Pg. 761 ENOXAPARIN SODIUM Labeling INJECTION PF 31(3) Pg. 761 ENOXAPARIN SODIUM USP Reference standards file:///C|/Documents%20and%20Settings/rwt/Desktop/revisions/usp31nf26secondSupplement03.html[4/26/2011 1:18:07 PM] INJECTION PF 31(3) Pg. 761 ENOXAPARIN SODIUM Identification A, B, C INJECTION PF 31(3) Pg. 761 ENOXAPARIN SODIUM Clarity INJECTION PF 31(3) Pg. 761 ENOXAPARIN SODIUM Color INJECTION PF 31(3) Pg. 761 ENOXAPARIN SODIUM pH INJECTION PF 31(3) Pg. 761 ENOXAPARIN SODIUM Benzyl alcohol content INJECTION PF 31(3) Pg. 761 ENOXAPARIN SODIUM Free sulfate content INJECTION PF 31(3) Pg. 761 ENOXAPARIN SODIUM Anti-factor IIa activity INJECTION PF 31(3) Pg. 761 ENOXAPARIN SODIUM Anti-factor Xa to anti-factor IIa ratio INJECTION PF 31(3) Pg. 761 ENOXAPARIN SODIUM Other requirements - Sterility Tests INJECTION PF 31(3) Pg. 761 <71> ENOXAPARIN SODIUM Other requirements INJECTION PF 31(3) Pg. 761 ENOXAPARIN SODIUM Assay (anti-factor Xa activity) INJECTION PF 31(3) Pg. 761 ENOXAPARIN SODIUM Bacterial endotoxins INJECTION PF 31(3) Pg. 761 ENOXAPARIN SODIUM Definition INJECTION PF 33(1) Pg. 58 ENOXAPARIN SODIUM Appearance of solution (Clarity and INJECTION PF 33(1) Pg. 58 degree of color of liquids) ENOXAPARIN SODIUM Benzyl alcohol content (if present) INJECTION PF 33(1) Pg. 58 ENOXAPARIN SODIUM Bacterial endotoxins <85> INJECTION PF 33(1) Pg. 58 ENOXAPARIN SODIUM Free sulfate content INJECTION PF 33(1) Pg. 58 ENOXAPARIN SODIUM Assay (anti-factor Xa activity) INJECTION PF 33(1) Pg. 58 ENOXAPARIN SODIUM PF 29(6) Title Pg. 1876 ENOXAPARIN SODIUM PF 29(6) Chemical structure file:///C|/Documents%20and%20Settings/rwt/Desktop/revisions/usp31nf26secondSupplement03.html[4/26/2011 1:18:07 PM] Pg. 1876 ENOXAPARIN SODIUM PF 29(6) CAS number Pg. 1876 ENOXAPARIN SODIUM PF 29(6) Definition Pg. 1876 ENOXAPARIN SODIUM PF 29(6) Packaging and storage Pg. 1876 ENOXAPARIN SODIUM PF 29(6) USP Reference standards Pg. 1876 ENOXAPARIN SODIUM PF 29(6) Identification A, B, C, D, E Pg. 1876 ENOXAPARIN SODIUM PF 29(6) Appearance of solution Pg. 1876 ENOXAPARIN SODIUM PF 29(6) Specific absorbance Pg. 1876 ENOXAPARIN SODIUM PF 29(6) pH Pg. 1876 ENOXAPARIN SODIUM PF 29(6) Loss on drying Pg. 1876 ENOXAPARIN SODIUM PF 29(6) Nitrogen content Pg. 1876 ENOXAPARIN SODIUM PF 29(6) Heavy metals Pg. 1876 ENOXAPARIN SODIUM PF 29(6) Sodium content Pg. 1876 ENOXAPARIN SODIUM PF 29(6) Molar ratio of sulfate to carboxylate Pg. 1876 ENOXAPARIN SODIUM PF 29(6) Benzyl alcohol content Pg. 1876 ENOXAPARIN SODIUM PF 29(6) Anti-factor IIa activity Pg. 1876 ENOXAPARIN SODIUM PF 29(6) Assay (anti-factor Xa activity) Pg. 1876 ENOXAPARIN SODIUM PF 29(6) Bacterial endotoxins Pg. 1876 ENOXAPARIN SODIUM PF 33(1) Definition Pg. 52 ENOXAPARIN SODIUM PF 33(1) USP Reference standards <11> Pg. 52 ENOXAPARIN SODIUM PF 33(1) Identification file:///C|/Documents%20and%20Settings/rwt/Desktop/revisions/usp31nf26secondSupplement03.html[4/26/2011 1:18:07 PM] Pg. 52 ENOXAPARIN SODIUM PF 33(1) Appearance of solution (Clarity and Pg. 52 degree of color of liquids) ENOXAPARIN SODIUM PF 33(1) pH <791> Pg. 52 ENOXAPARIN SODIUM PF 33(1) Molar ratio of sulfate to carboxylate Pg. 52 (see Chromatography <621>) ENOXAPARIN SODIUM PF 33(1) Benzyl alcohol content Pg. 52 ENOXAPARIN SODIUM PF 33(1) Anti-factor IIa activity Pg. 52 ENOXAPARIN SODIUM PF 33(1) Assay (anti-factor Xa activity) Pg. 52 ESTRADIOL AND NORETHINDRONE ACETATE Dissolution TABLETS PF 31(5) Pg. 1364 ESTRADIOL AND NORETHINDRONE ACETATE Dissolution TABLETS PF 33(2) Pg. 220 ETHINYL ESTRADIOL TABLETS Disintegration PF 31(4) Pg. 1067 ETHIONAMIDE PF 33(4) Pg. 648 Assay FAMOTIDINE TABLETS PF 33(4) Dissolution <711> Pg. 649 FORMALDEHYDE SOLUTION PF Definition 33(4) Pg. 650 FORMALDEHYDE SOLUTION PF Labeling 33(4) Pg. 650 FORMALDEHYDE SOLUTION PF Content of methanol 33(4) Pg. 650 FORMALDEHYDE SOLUTION PF Assay 33(4) Pg. 650 FULVESTRANT PF 33(5) Pg. 909 Title FULVESTRANT PF 33(5) Pg. 909 Chemical Info FULVESTRANT PF 33(5) Pg. 909 Definition FULVESTRANT PF 33(5) Pg. 909 Packaging and storage FULVESTRANT PF 33(5) Pg. 909 USP Reference standards <11> FULVESTRANT PF 33(5) Pg. 909 Identification FULVESTRANT PF 33(5) Pg. 909 Specific rotation <781S> file:///C|/Documents%20and%20Settings/rwt/Desktop/revisions/usp31nf26secondSupplement03.html[4/26/2011 1:18:07 PM] FULVESTRANT PF 33(5) Pg. 909 Water, Method Ic <921> FULVESTRANT PF 33(5) Pg. 909 Residue on ignition <281> FULVESTRANT PF 33(5) Pg. 909 Related compounds FULVESTRANT PF 33(5) Pg. 909 Diastereoisomer ratio FULVESTRANT PF 33(5) Pg. 909 Assay GAMMA CYCLODEXTRIN PF Microbial limits 31(3) Pg. 812 GAMMA CYCLODEXTRIN PF Title 31(3) Pg. 812 GAMMA CYCLODEXTRIN PF Molecular weight 31(3) Pg. 812 GAMMA CYCLODEXTRIN PF Packaging and storage 31(3) Pg. 812 GAMMA CYCLODEXTRIN PF Identification A, B, C 31(3) Pg. 812 GAMMA CYCLODEXTRIN PF Specific rotation 31(3) Pg. 812 GAMMA CYCLODEXTRIN PF Loss on drying 31(3) Pg. 812 GAMMA CYCLODEXTRIN PF Residue on ignition 31(3) Pg. 812 GAMMA CYCLODEXTRIN PF Heavy metals 31(3) Pg. 812 GAMMA CYCLODEXTRIN PF Chemical Info 33(4) Pg. 707 GAMMA CYCLODEXTRIN PF Definition 33(4) Pg. 707 GAMMA CYCLODEXTRIN PF USP Reference standards <11> 33(4) Pg. 707 GAMMA CYCLODEXTRIN PF Color and clarity of solution 33(4) Pg. 707 GAMMA CYCLODEXTRIN PF Related compounds 33(4) Pg. 707 GAMMA CYCLODEXTRIN PF Reducing substances 33(4) Pg. 707 GAMMA CYCLODEXTRIN PF Assay 33(4) Pg. 707 GLUCOSAMINE HYDROCHLORIDE PF 33(4) Pg. Specific rotation <781S> file:///C|/Documents%20and%20Settings/rwt/Desktop/revisions/usp31nf26secondSupplement03.html[4/26/2011 1:18:07 PM] 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 Labeling METHYLBROMIDE TABLETS PF 33(4) Pg. 654 HYDROCODONE BITARTRATE AND HOMATROPINE Dissolution <711> METHYLBROMIDE TABLETS PF 33(4) Pg. 654 HYDROPHOBIC COLLOIDAL Title SILICA PF 33(5) Pg.
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