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 OCTOCRYLENE PF 33(5) Pg. 929 OCTOCRYLENE PF 33(5) Pg. 929 OXANDROLONE TABLETS PF 33(5) Pg. 929 OXANDROLONE TABLETS PF 33(5) Pg. 929 OXYMETAZOLINE HYDROCHLORIDE NASAL SOLUTION PF 33(5) Pg. 932, Ultraviolet Absorption <197U> Chemical Info Labeling PAROXETINE HYDROCHLORIDE PF 33(5) Pg. 932 PAROXETINE Reaction Acidity Alkalinity Readily carbonizable substances <271> Limit of polycyclic aromatic hydrocarbons Limit of sulfur compounds Limit of related compound C Limit of 1-methyl-4-(p-
2 HYDROCHLORIDE PF 33(5) Pg. 932 PAROXETINE HYDROCHLORIDE PF 33(5) Pg. 932 PAROXETINE HYDROCHLORIDE PF 33(5) Pg. 932 PAROXETINE TABLETS PF 33(4) Pg. 672 PAROXETINE TABLETS PF 33(4) Pg. 672 PAROXETINE TABLETS PF 33(4) Pg. 672 POLOXAMER PF 33(4) Pg. 714 fluorophenyl)-1,2,3,6- tetrahydropyridine Chromatographic purity Uniformity of dosage units <905> POLOXAMER PF 33(4) Pg. 714 POLOXAMER PF 33(4) Pg. 714 POLOXAMER PF 33(4) Pg. 714 POVIDONE-IODINE PF 33(5) Pg. 937 Limit of free ethylene oxide, propylene oxide, and 1,4-dioxane Nitrogen content,method II<461> Labeling Microbial enumeration <2021> Absence of specified microorganisms <2022> Water, Method Ia <921> Residue on ignition <281>
3 Pesticide residues <561> Heavy metals, Method II <231> 0.1 N Hydrochloric acid insoluble fraction Content of anthocyanosides and anthocyanidins Other requirements Labeling Microbial enumeration <2021> Absence of specified microorganisms <2022> Water, Method Ia <921> Residue on ignition <281> Heavy metals, Method II <231>
4 PRIMAQUINE PHOSPHATE PF 33(5) Pg. 937 PRIMAQUINE PHOSPHATE PF 33(5) Pg. 937 PRIMAQUINE PHOSPHATE TABLETS PF 33(5) Pg. 938 PRIMAQUINE PHOSPHATE TABLETS PF 33(5) Pg. 938 Pesticide residues <561> Limit of gallic acid Limit of caffeine Content of polyphenols Other requirements Uniformity of dosage units <905> Chemical Info
5 Acid value <401> Hydroxyl value <401> Iodine value <401> Peroxide value <401> Saponification value <401> Unsaponifiable matter <401> Fatty acid composition <401> Water, Method Ia <921> Total ash <561> Alkaline impurities PULLULAN PF 33(5) Pg. 975 PULLULAN PF 33(5) Pg. 975 Chemical Info PULLULAN PF 33(5) Pg. 975 PULLULAN PF 33(5) Pg. 975 PULLULAN PF 33(5) Pg. 975 Labeling PULLULAN PF 33(5) Pg. 975 PULLULAN PF 33(5) Pg. 975 Viscosity <911> PULLULAN PF 33(5) Pg. 975 Microbial limits <61> PULLULAN PF 33(5) Pg. 975 ph <791> PULLULAN PF 33(5) Pg. 975 Loss on drying <731> PULLULAN PF 33(5) Pg. 975 Residue on ignition <281>
6 PULLULAN PF 33(5) Pg. 975 Heavy metals, Method II <231> PULLULAN PF 33(5) Pg. 975 Content of monosaccharide, disaccharide, and oligosaccharides PULLULAN PF 33(5) Pg. 975 Nitrogen content <461> PYRIMETHAMINE PF 33(5) Pg. 939 PYRIMETHAMINE PF 33(5) Pg. 939 Chemical Info Loss on drying <731> Residue on ignition <281> Heavy metals, Method II <231>
7 RITONAVIR PF 33(4) Pg. 679 SAQUINAVIR MESYLATE PF 33(5) Pg. 940 Dissolution <711> Uniformity of dosage units <905> Heavy metals, Method II <231> Chemical structure Molecular formula and weight Chemical names and CAS number USP Reference standards Refractive index Acidity or alkalinity Water
8 SEVOFLURANE PF 33(5) Pg. 940 SEVOFLURANE PF 33(5) Pg. 940 SEVOFLURANE PF 33(5) Pg. 940 SEVOFLURANE PF 33(5) Pg. 940 SILVER SULFADIAZINE PF 33(5) Pg. 951 SIMETHICONE CAPSULES PF 33(5) Pg. 948 SIMETHICONE CAPSULES PF 33(5) Pg. 948 SIMETHICONE ORAL SUSPENSION PF 33(5) Pg. 948 SIMETHICONE TABLETS PF 33(5) Pg. 948 SIMVASTATIN PF 33(5) Pg. 948 SIMVASTATIN PF 33(5) Pg. 948 Limit of fluoride Limit of nonvolatile residue Limit of peroxide Limit of peroxide Silver content Disintegration <701> Defoaming activity Defoaming activity Defoaming activity Chromatographic purity Chemical Info Appearance of solution Substances not precipitated by thioacetamide Limit of sulfate
9 Limit of iron Limit of lead General Chapters Monographs:A C D N O S T Z
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