| Upcoming Revisions to USP 30–NF 25, First Supplement |
Scientific Liaison |
ALFADEX
USP 29–NF 24 p. 3268
PF 32(2) p. 395
Definition
Packaging and storage (add)
Loss on drying <731> (delete)
Water, Method I <921> (add)
Reducing sugars
Light-absorbing impurities
Organic volatile impurities, Method IV <467> (delete)
Residual solvents <467> (delete)
Assay
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ALLOPURINOL
USP 29–NF 24 p. 75
PF 32(2) p. 302
Definition
Packaging and storage
USP Reference standards <11>
Chromatographic purity (Delete)
Related compounds (add)
Assay
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Alumina, Magnesia, and Calcium Carbonate Tablets
USP 27, p. 75
PF29(6) p. 1835
Current Title (not to change until February 1, 2007)
PF29(6) p. 1836
New Title: Alumina, Magnesia, and Calcium Carbonate Chewable Tablets (to become official February 1, 2007)
Definition
Labeling
Identification
Disintegration
Uniformity of dosage units
Acid-neutralizing capacity
Assay for aluminum hydroxide
Assay for magnesium hydroxide
Assay for calcium carbonate
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Alumina, Magnesia, and Simethicone Tablets
USP 27, p. 78
PF29(6) p. 1841
Current Title (not to change until February 1, 2007)
PF29(6) p. 1842
New Title: Alumina, Magnesia, and Simethicone Chewable Tablets (to become official February 1, 2007)
Definition
Packaging and storage
Labeling
USP Reference standards
Identification A, B, C
Uniformity of dosage units
Acid-neutralizing capacity
Defoaming activity
Sodium content
Assay for aluminum hydroxide
Assay for magnesium hydroxide
Assay for polydimethylsiloxane
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Alumina, Magnesia, Calcium Carbonate, and Simethicone Tablets
USP 27, p. 75
PF29(6) p. 1837
Current Title (not to change until February 1, 2007)
PF29(6) p. 1837
New Title: Alumina, Magnesia, Calcium Carbonate, and Simethicone Chewable Tablets (to become official February 1, 2007)
Definition
Packaging and storage
Labeling
USP Reference standards
Identification A, B
Microbial limits
Uniformity of dosage units
Acid-neutralizing capacity
Defoaming activity
Sodium content
Assay for aluminum hydroxide
Assay for magnesium hydroxide
Assay for calcium carbonate
Assay for polydimethylsiloxane
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ALUMINUM SULFATE AND CALCIUM ACETATE FOR TOPICAL SOLUTION
PF 32(3) p. 755
Title
Definition
Packaging and storage
Identification A & B
pH <791>
Assay for aluminum sulfate
Assay for calcium acetate
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Amino Methacrylate Copolymer (new)
PF 31(4) p. 1137
Title
Definition
Packaging and storage
USP Reference standards
Color of solution
Identification A, B; Viscosity
Loss on drying
Residue on ignition
Limit of monomers
Assay
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AMLODIPINE BESYLATE (new)
PF 32(3) p. 757
Title
Chemical Info
Definition
Packaging and storage
USP Reference standards <11>
Identification A & B
Optical rotation <781A>
Water, Method I <921>
Residue on ignition <281>
Heavy metals, Method II <231>
Related compounds
Assay
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ATRACURIUM BESYLATE
USP 29–NF 24 p. 216
PF 32(2) p. 305
Chromatographic purity
Assay
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AZITHROMYCIN
USP 29–NF 24 p. 227
PF 32(2) p. 306
Labeling
USP Reference standards <11>
Limit of related substances
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Bismuth Subsalicylate Oral Suspension (new)
PF 31(4) p. 1035
Microbial limits
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Bismuth Subsalicylate Oral Suspension (new)
PF 31(4) p. 1035
Title
Definition
Identification A, B
pH
Assay
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Bismuth Subsalicylate Tablets (new)
PF 31(3), p. 741
Disintegration
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Bismuth Subsalicylate Tablets (new)
PF 31(3), p. 741
Title
Definition
Labeling
Identification A, B
Assay
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BISOCTRIZOLE (new)
PF 32(2) p. 309
Title
Chemical Info
Definition
Packaging and storage
USP Reference standards <11>
Identification A, B
Heavy metals
Limit of bisoctrizole related compound A and the bisoctrizole isomer
Related compounds
Limit of residual solvents
Assay
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Budesonide (new)
PF 30(6), p. 1978
Microbial limits
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Budesonide (new)
PF 30(6), p. 1978
Title
Chemical formula
Molecular weight
Chemical names
CAS number
Definition
Packaging and storage
USP Reference standards
Identification A, B
Loss on drying
Organic volatile impurities
Limit of methanol
Limit of 21-acetate of budesonide
Limit of 11-ketobudesonide
Related compounds
Assay
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BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS
USP 29–NF 24 p. 322
PF 32(2) p. 312
Drug release <724>
Dissolution <711>
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Calcium Carbonate, Magnesia, and Simethicone Tablets
USP 27, p. 302
PF29(6) p. 1853
Current Title (not to change until February 1, 2007)
PF29(6) p. 1854
New Title: Calcium Carbonate, Magnesia, and Simethicone Chewable Tablets (to become official February 1, 2007)
Definition
Packaging and storage
Labeling
USP Reference standards
Identification A, B, C
Uniformity of dosage units
Acid-neutralizing capacity
Defoaming activity
Sodium content
Assay for polydimethylsiloxane
Assay for calcium carbonate and magnesium hydroxide
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Calcium Silicate
NF23 p. 2970
PF 31(5) p. 1417
Definition
pH
Limit of fluoride
Assay for silicon dioxide
Assay for calcium oxide
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CEFADROXIL FOR ORAL SUSPENSION
USP 29–NF 24 2S p. 3715
PF 32(2) p. 315
Dissolution <711> (add)
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CEFEPIME HYDROCHLORIDE
USP 29–NF 24 p. 409
PF 32(2) p. 316
Limit of N-methylpyrrolidine
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CEFEPIME HYDROCHLORIDE
USP 29–NF 24 p. 409
PF 32(2) p. 316
Related compounds
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CHLORHEXIDINE GLUCONATE ORAL RINSE
USP 29–NF 24 p. 476
PF 32(3) p. 768
Assay
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CHLORHEXIDINE GLUCONATE SOLUTION
USP 29–NF 24 p. 477
PF 32(3) p. 768
Assay
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CHLOROPHYLLIN COPPER COMPLEX SODIUM
USP 29–NF 24 p. 478
PF 32(3) p. 769
Content of total copper
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CHOLESTYRAMINE RESIN
USP 29–NF 24 p. 503
PF 32(2) p. 320
Dialyzable quaternary amines
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CIMETIDINE
USP 29–NF 24 p. 512
PF 32(3) p. 769
Identification A
Chromatographic purity
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CIPROFLOXACIN AND DEXAMETHASONE OTIC SUSPENSION (new)
PF 32(2) p. 321
Sterility <71>
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CIPROFLOXACIN AND DEXAMETHASONE OTIC SUSPENSION (new)
PF 32(2) p. 321
Title
Definition
Packaging and storage
USP Reference standards <11>
Identification A, B
pH <791>
Particle size
Osmolality <785>
Limit of ciprofloxacin formamide
Ciprofloxacin related compounds
Dexamethasone related compounds
Assay for ciprofloxacin
Assay for dexamethasone
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CIPROFLOXACIN HYDROCHLORIDE
USP 29–NF 24 p. 517
PF 32(2) p. 325
Chromatographic purity
Assay
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CIPROFLOXACIN INJECTION
USP 29–NF 24 p. 518
PF 32(2) p. 326
Limit of ciprofloxacin ethylenediamine analog
Assay
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CIPROFLOXACIN
USP 29–NF 24 p. 516
PF 32(2) p. 320
Chromatographic purity
Assay
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COCONUT OIL (new)
PF 32(2) p. 397
Title
Chemical Info
Definition
Packaging and storage
Identification
Melting range <741>
Acid value <401>
Peroxide value <401>
Unsaponifiable matter <401>
Fatty acid composition
Water, Method I <921>
Arsenic, Method II <211>
Alkaline impurities
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