THEOPHYLLINE CAPSULES |
IDENTIFICATION |
USPNF Online
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Online |
26-Jan-2024 |
1-Feb-2024 |
NA
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NA
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Change A: The contents of the Capsules respond to Identification tests A and B under Theophylline Tablets. B: The retention time of the major peak in the chromatogram of the Assay preparation corresponds… Read More
Change A: The contents of the Capsules respond to Identification tests A and B under Theophylline Tablets. B: The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay. to: A: Triturate a quantity of the contents of Capsules, equivalent to about 500 mg of theophylline, with 10-mL and 5-mL portions of solvent hexane, and discard the solvent hexane. Triturate the residue with two 10-mL portions of a mixture of equal volumes of 6 N ammonium hydroxide and water, and filter each time. Evaporate the combined filtrates to about 5 mL, neutralize, if necessary, with 6 N acetic acid, using litmus, and then cool to about 15°, with stirring. Collect the precipitate on a filter, wash it with cold water, and dry at 105° for 2 hours: the theophylline so obtained melts between 270° and 274° (see Melting Range or Temperature 〈741〉, Procedures, Procedure for Class I). Retain the remaining portion of the theophylline for use in Identification test B. B: The IR absorption spectrum of a potassium bromide dispersion of the residue obtained in Identification test A exhibits maxima only at the same wavenumbers as that of a potassium bromide dispersion of USP Theophylline RS. C: The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay.
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DICYCLOMINE HYDROCHLORIDE |
IDENTIFICATION |
USPNF Online
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Online |
26-Jan-2024 |
1-Feb-2024 |
NA
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NA
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In B. Identification Tests—General 〈191〉, Chemical Identification Tests, Chloride: Change Meets the requirements when tested as specified in test B. to: Meets the requirements of the test for amine… Read More
In B. Identification Tests—General 〈191〉, Chemical Identification Tests, Chloride: Change Meets the requirements when tested as specified in test B. to: Meets the requirements of the test for amine hydrochlorides
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AMOXICILLIN ORAL SUSPENSION |
IDENTIFICATION |
USPNF Online
|
Online |
26-Jan-2024 |
1-Feb-2024 |
NA
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NA
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Change Shake a portion of Oral Suspension with a mixture of acetone and 0.1 N hydrochloric acid (4:1) to obtain a solution containing about 1 mg of amoxicillin per mL. The solution responds to the Identification test under Amoxicillin Capsules.… Read More
Change Shake a portion of Oral Suspension with a mixture of acetone and 0.1 N hydrochloric acid (4:1) to obtain a solution containing about 1 mg of amoxicillin per mL. The solution responds to the Identification test under Amoxicillin Capsules. to: Prepare a test solution by shaking a portion of Oral Suspension with a mixture of acetone and 0.1 N hydrochloric acid (4:1) to obtain a solution containing about 1 mg of amoxicillin per mL. Prepare a Standard solution of USP Amoxicillin RS in 0.1 N hydrochloric acid containing 1 mg per mL. Use within 10 minutes after preparation. Apply separately 5 µL of each solution on a thin-layer chromatographic plate coated with a 0.25-mm layer of chromatographic silica gel mixture (see Chromatography 〈621〉). Place the plate in a suitable chromatographic chamber, and develop the chromatogram in a solvent system consisting of a mixture of methanol, chloroform, water, and pyridine (90:80:30:10). When the solvent front has moved about three-fourths of the length of the plate, remove the plate from the chamber, and dry with warm air for 10 minutes. Locate the spots on the plate by spraying lightly with a solution of ninhydrin in alcohol containing 3 mg per mL, and dry at 110° for 15 minutes: the RF value of the principal spot obtained from the test solution corresponds to that obtained from the Standard solution.
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GLUCAGON |
PROCESS-RELATED IMPURITIES AND OTHER COMPONENTS |
USPNF Online
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Online |
29-Dec-2023 |
1-Jan-2024 |
NA
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NA
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In Acetic Acid in Peptides/Analysis: Change CSPA = concentration of potassium acetate in each of the Standard solutions (mg/mL) to: CSPA = concentration of potassium acetate in each of the … Read More
In Acetic Acid in Peptides/Analysis: Change CSPA = concentration of potassium acetate in each of the Standard solutions (mg/mL) to: CSPA = concentration of potassium acetate in each of the Standard solutions (µg/mL) AND In Ammonium/Analysis: Change CSAC = concentration of ammonium chloride in each of the Standard solutions (mg/mL) to: CSAC = concentration of ammonium chloride in each of the Standard solutions (µg/mL)
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<81> ANTIBIOTICS—MICROBIAL ASSAYS |
APPENDICES |
USPNF Online
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Online |
29-Dec-2023 |
1-Jan-2024 |
NA
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NA
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In two instances in Appendix 1 equations: Change 14.020 to: 14.022 |
SECOBARBITAL SODIUM |
OTHER REQUIREMENTS |
USPNF Online
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Online |
29-Dec-2023 |
1-Jan-2024 |
NA
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NA
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Change Where the label states that Seco barbital Sodium is sterile, it meets the requirements for Sterility Tests 〈71〉 and for Bacterial endotoxins under Secobarbital Sodium for Injection. Where the label states that Secobarbital Sodium… Read More
Change Where the label states that Seco barbital Sodium is sterile, it meets the requirements for Sterility Tests 〈71〉 and for Bacterial endotoxins under Secobarbital Sodium for Injection. Where the label states that Secobarbital Sodium must be subjected to further processing during the preparation of injectable dosage forms, it meets the requirements for Bacterial endotoxins under Secobarbital Sodium for Injection. to: Where the label states that Secobarbital Sodium is sterile, it meets the requirements for Sterility Tests 〈71〉 and the level of bacterial endotoxins is not more than 0.9 USP Endotoxin Units per mg of secobarbital sodium tested per Bacterial Endotoxins Test <85>. Where the label states that Secobarbital Sodium must be subjected to further processing during the preparation of injectable dosage forms, the level of bacterial endotoxins is not more than 0.9 USP Endotoxin Units per mg of secobarbital sodium tested per Bacterial Endotoxins Test <85>.
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ACARBOSE |
IMPURITIES |
USPNF Online
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Online |
29-Dec-2023 |
1-Jan-2024 |
NA
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NA
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In Chromatographic Purity/Analysis: Change Result = (rU/rA) × (1/F) × 100 to: Result = (rU/rA) × (1/F) |
AZITHROMYCIN |
IMPURITIES |
USPNF Online
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Online |
17-Nov-2023 |
1-Dec-2023 |
NA
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NA
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In Organic Impurities/Table 2: Change 3'-N-Demethyl-3'-N-[(4-methylphenyl)sulfonyl]azithromycinm to: 3′-N-{[4-(Acetylamino)phenyl]sulfonyl}-3′-demethylazithromycinm AND In Table 2/footnote m… Read More
In Organic Impurities/Table 2: Change 3'-N-Demethyl-3'-N-[(4-methylphenyl)sulfonyl]azithromycinm to: 3′-N-{[4-(Acetylamino)phenyl]sulfonyl}-3′-demethylazithromycinm AND In Table 2/footnote m: Change (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-Dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3-[N-(4-methylphenylsulfonyl)-N-methylamino]-3,4,6-trideoxy-ß-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. to: (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-Dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3-[N-(4-acetamidophenylsulfonyl)-N-methylamino]-3,4,6-trideoxy-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one.
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OLMESARTAN MEDOXOMIL TABLETS |
PERFORMANCE TESTS |
USPNF Online
|
Online |
17-Nov-2023 |
1-Dec-2023 |
NA
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NA
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In Dissolution 〈711〉/Test 5/Apparatus 2: Change 50 rpm. Use peak vessels. to: 50 rpm. Use apex vessels. |
CEFDINIR |
ADDITIONAL REQUIREMENTS |
USPNF Online
|
Online |
17-Nov-2023 |
1-Dec-2023 |
NA
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NA
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In USP Reference Standards 〈11〉/USP Cefdinir Related Compound A RS: Change 413.43 to: 413.42 |
AMOXICILLIN BOLUSES |
IDENTIFICATION |
USPNF Online
|
Online |
17-Nov-2023 |
1-Dec-2023 |
NA
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NA
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Change Application volume, Developing solvent system, Procedure—Proceed as directed for the Identification test under Amoxicillin Tablets. to: Application volume—5 µL. Developing solvent system… Read More
Change Application volume, Developing solvent system, Procedure—Proceed as directed for the Identification test under Amoxicillin Tablets. to: Application volume—5 µL. Developing solvent system—a mixture of methanol, chloroform, water, and pyridine (90:80:30:10). Procedure—Proceed as directed in Thin-Layer Chromatographic Identification Test <201>. Dry the plate with the aid of a current of warm air for 10 minutes. Locate the spots on the plate by spraying lightly with a solution of ninhydrin in alcohol containing 3 mg per mL, and dry at 110° for 15 minutes.
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DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE CAPSULES |
ADDITIONAL REQUIREMENTS |
USPNF Online
|
Online |
17-Nov-2023 |
1-Dec-2023 |
NA
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NA
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In USP Reference Standards 〈11〉/USP Dihydrodutasteride RS: Change N-[2,5-Bis(trifluoromethyl)phenyl]-3-oxo-4-aza-5α-androst-1-ene-17β-carboxamide. to: N-[2,5-Bis(trifluoromethyl)phenyl]-3-oxo-4-aza-5α-androstane-17β-carboxamide. |
Strychnine Sulfate |
REAGENTS AND REFERENCE TABLES |
USPNF Online
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Online |
17-Nov-2023 |
1-Dec-2023 |
NA
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NA
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In Reagent Specifications: Change CAS RN®: 60-41-3. to: CAS RN®: 60491-10-3. |
<915> MEASUREMENT OF STRUCTURAL STRENGTH OF SEMISOLIDS BY PENETROMETRY |
APPARATUS |
USPNF Online
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Online |
17-Nov-2023 |
1-Dec-2023 |
NA
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NA
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In Figure 2: Change 66±0.25 Ø to: 65±0.25 Ø |
DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE TABLETS |
PERFORMANCE TESTS |
USPNF Online
|
Online |
17-Nov-2023 |
1-Dec-2023 |
NA
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NA
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In Dissolution 〈711〉: Move Test 2 after Test 1 |
PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS |
PERFORMANCE TESTS |
USPNF Online
|
Online |
17-Nov-2023 |
1-Dec-2023 |
NA
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NA
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In Dissolution 〈711〉/Test 2/Acid stage: Change Acid stage standard solution: (L/10) mg/mL of USP Pantoprazole Sodium RS from the Standard stock solution in Acid stage medium, where L is the label claim… Read More
In Dissolution 〈711〉/Test 2/Acid stage: Change Acid stage standard solution: (L/10) mg/mL of USP Pantoprazole Sodium RS from the Standard stock solution in Acid stage medium, where L is the label claim in mg/Tablet to: Acid stage standard solution: (L/10000) mg/mL of USP Pantoprazole Sodium RS from the Standard stock solution in Acid stage medium, where L is the label claim in mg/Tablet AND In Dissolution <711>/Test 2/Buffer stage: Change Buffer stage standard solution: (L/1000) of USP Pantoprazole Sodium RS where L is the label claim in mg/Tablet to: Buffer stage standard solution: (L/1000) mg/mL of USP Pantoprazole Sodium RS from the Standard stock solution in Buffer stage medium, where L is the label claim in mg/Tablet
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CEFDINIR CAPSULES |
ADDITIONAL REQUIREMENTS |
USPNF Online
|
Online |
17-Nov-2023 |
1-Dec-2023 |
NA
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NA
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In USP Reference Standards 〈11〉/USP Cefdinir Related Compound A RS: Change 413.43 to: 413.42 AND In USP Reference Standards 〈11〉/USP Cefdinir Related Compound B RS: Change C14H13N4O4S… Read More
In USP Reference Standards 〈11〉/USP Cefdinir Related Compound A RS: Change 413.43 to: 413.42 AND In USP Reference Standards 〈11〉/USP Cefdinir Related Compound B RS: Change C14H13N4O4S2 365.41 to: C14H14N4O4S2 366.41
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AMOXICILLIN INTRAMAMMARY INFUSION |
IDENTIFICATION |
USPNF Online
|
Online |
17-Nov-2023 |
1-Dec-2023 |
NA
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NA
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Change The solution obtained responds to the Identification test under Amoxicillin Capsules. to: Prepare a Standard solution of USP Amoxicillin RS in 0.1 N hydrochloric acid containing 4 mg per mL. Use within 10 minutes after preparation.… Read More
Change The solution obtained responds to the Identification test under Amoxicillin Capsules. to: Prepare a Standard solution of USP Amoxicillin RS in 0.1 N hydrochloric acid containing 4 mg per mL. Use within 10 minutes after preparation. Apply separately 5 µL of each solution on a thin-layer chromatographic plate coated with a 0.25-mm layer of chromatographic silica gel mixture (see Chromatography <621>). Place the plate in a suitable chromatographic chamber, and develop the chromatogram in a solvent system consisting of a mixture of methanol, chloroform, water, and pyridine (90:80:30:10). When the solvent front has moved about three-fourths of the length of the plate, remove the plate from the chamber, and dry with warm air for 10 minutes. Locate the spots on the plate by spraying lightly with a solution of ninhydrin in alcohol containing 3 mg per mL, and dry at 110° for 15 minutes: the RF value of the principal spot obtained from the test solution corresponds to that obtained from the Standard solution.
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NORFLURANE |
IMPURITIES |
USPNF Online
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Online |
17-Nov-2023 |
1-Dec-2023 |
NA
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NA
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In Organic Impurities/Table 2: Change Line No. to: Peak Elution Order AND In Halides/Figure 1: Add label Flow Meter |
CEFDINIR |
IMPURITIES |
USPNF Online
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Online |
17-Nov-2023 |
1-Dec-2023 |
NA
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NA
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In Organic Impurities/Table 2/footnote a: Change 1N-[(Z)-2-(2-Aminothiazol-4-yl)-2-(hydroxyimino)acetyl]glycine. to: N-[(Z)-2-(2-Aminothiazol-4-yl)-2-(hydroxyimino)acetyl]glycine. |
AMIKACIN SULFATE |
ASSAY |
USPNF Online
|
Online |
17-Nov-2023 |
1-Dec-2023 |
NA
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NA
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In Procedure/Analysis: Change CU = concentration of amikacin in the Sample solution (mg/mL) to: CU = concentration of Amikacin Sulfate in the Sample solution (mg/mL) |
DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE CAPSULES |
PERFORMANCE TESTS |
USPNF Online
|
Online |
17-Nov-2023 |
1-Dec-2023 |
NA
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NA
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In Dissolution 〈711〉/Test for dutasteride/Tier 2/Medium: Change 10 g/L of cetyltrimethylammonium bromide and 750,000 USP units of activity/mg of pepsin, purified in 0.1 N hydrochloric acid; 900 mL to: Dissolve 10 g of… Read More
In Dissolution 〈711〉/Test for dutasteride/Tier 2/Medium: Change 10 g/L of cetyltrimethylammonium bromide and 750,000 USP units of activity/mg of pepsin, purified in 0.1 N hydrochloric acid; 900 mL to: Dissolve 10 g of cetyltrimethylammonium bromide and 1.6 g of pepsin, purified in 1000 mL of 0.1 N hydrochloric acid; 900 mL
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SODIUM SALICYLATE |
ADDITIONAL REQUIREMENTS |
USPNF Online
|
Online |
17-Nov-2023 |
1-Dec-2023 |
NA
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NA
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In USP Reference Standards 〈11〉: Add USP Phenol RS |
CEFDINIR FOR ORAL SUSPENSION |
ADDITIONAL REQUIREMENTS |
USPNF Online
|
Online |
17-Nov-2023 |
1-Dec-2023 |
NA
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NA
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In USP Reference Standards 〈11〉/USP Cefdinir Related Compound A RS: Change 413.43 to: 413.42 AND In USP Reference Standards 〈11〉/USP Cefdinir Related Compound B RS: Change C14H13N4O4S… Read More
In USP Reference Standards 〈11〉/USP Cefdinir Related Compound A RS: Change 413.43 to: 413.42 AND In USP Reference Standards 〈11〉/USP Cefdinir Related Compound B RS: Change C14H13N4O4S2 365.41 to: C14H14N4O4S2 366.41
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<631> COLOR AND ACHROMICITY |
METHOD II: INSTRUMENTAL (QUANTITATIVE) ASSESSMENT OF COLOR AND COLOR MATCHES |
USPNF Online
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Online |
17-Nov-2023 |
1-Dec-2023 |
NA
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NA
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In Table 5: Change Sum 98.809 100.000 107.307 White point 98.811 100.000 107.304 to: Sum 94.809 100.000 107.307 White point 94.811 100.000 107.304 |
UREA |
SPECIFIC TESTS |
USPNF Online
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Online |
27-Oct-2023 |
1-Nov-2023 |
NA
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NA
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In Alcohol-Insoluble Matter/Sample solution: Change 100 mg/mL of Urea dissolved in warm alcohol to: Dissolve 5.0 g of Urea in 50 mL of warm alcohol. AND In Alcohol-Insoluble Matter/Analysis: Change If any insoluble… Read More
In Alcohol-Insoluble Matter/Sample solution: Change 100 mg/mL of Urea dissolved in warm alcohol to: Dissolve 5.0 g of Urea in 50 mL of warm alcohol. AND In Alcohol-Insoluble Matter/Analysis: Change If any insoluble residue remains, pass the Sample solution through a tared filter, wash the residue and the filter with 20 mL of warm alcohol per 50 mL of Sample solution, and dry at 105° for 1 h. to: If any insoluble residue remains, pass the Sample solution through a tared filter, wash the residue and the filter with 20 mL of warm alcohol, and dry at 105° for 1 h.
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TELMISARTAN TABLETS |
ASSAY |
USPNF Online
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Online |
27-Oct-2023 |
1-Nov-2023 |
NA
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NA
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In Procedure/System suitability/Suitability requirements: Change Resolution: NLT 3 between telmisartan and telmisartan related compound A Tailing factor: NMT 2.0 for the telmisartan peak Capacity factor: NLT… Read More
In Procedure/System suitability/Suitability requirements: Change Resolution: NLT 3 between telmisartan and telmisartan related compound A Tailing factor: NMT 2.0 for the telmisartan peak Capacity factor: NLT 1.5 Relative standard deviation: NMT 2.0% to: Resolution: NLT 3 between telmisartan and telmisartan related compound A Tailing factor: NMT 2.0 for telmisartan Relative standard deviation: NMT 2.0% for telmisartan
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<430> PARTICLE SIZE ANALYSIS BY DYNAMIC LIGHT SCATTERING |
GLOSSARY |
USPNF Online
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Online |
27-Oct-2023 |
1-May-2024 |
NA
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NA
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In Average particle diameter: Change expressed in nanometers. to: expressed in meters. AND In Viscosity: Change in millipascal-seconds (mPa・s). to: in pascal-seconds (Pa・s). |
OIL-SOLUBLE VITAMINS CAPSULES |
STRENGTH |
USPNF Online
|
Online |
27-Oct-2023 |
1-Nov-2023 |
NA
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NA
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In Vitamin A, Method 3/Analysis: Change CS = concentration of retinyl acetate (C23H32O2) from USP Vitamin A RS in the Standard solution (μg/mL) to: CS = concentration… Read More
In Vitamin A, Method 3/Analysis: Change CS = concentration of retinyl acetate (C23H32O2) from USP Vitamin A RS in the Standard solution (μg/mL) to: CS = concentration of retinyl acetate (C22H32O2) from USP Vitamin A RS in the Standard solution (μg/mL)
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PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS |
ASSAY |
USPNF Online
|
Online |
27-Oct-2023 |
1-Nov-2023 |
NA
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NA
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In Procedure/System suitability/Tailing factor: Change NMT 2.0, System suitability solution to: NMT 2.0 for pantoprazole, System suitability solution |
TELMISARTAN TABLETS |
PERFORMANCE TESTS |
USPNF Online
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Online |
27-Oct-2023 |
1-Nov-2023 |
NA
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NA
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In Dissolution 〈711〉/Test 1/Analysis: Change Determine the percentage of telmisartan (C33H30N4O2) dissolved: Result = (AU × CS × V × 100)/(A… Read More
In Dissolution 〈711〉/Test 1/Analysis: Change Determine the percentage of telmisartan (C33H30N4O2) dissolved: Result = (AU × CS × V × 100)/(AS × D × L) to: Calculate the percentage of the labeled amount of telmisartan (C33H30N4O2) dissolved: Result = (AU/AS) × CS × V × D × (1/L) × 100 AND Change CS = concentration of the Standard solution (mg/mL) to: CS = concentration of USP Telmisartan RS in the Standard solution (mg/mL) AND In Dissolution 〈711〉/Test 2/Analysis: Change rU = peak response from the Sample solution rS = peak response from the Standard solution to: rU = peak response of telmisartan from the Sample solution rS = peak response of telmisartan from the Standard solution AND In Dissolution 〈711〉/Test 3/Analysis: Change CS = concentration of the Standard solution (mg/mL) to: CS = concentration of USP Telmisartan RS in the Standard solution (mg/mL)
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METHYLBENZETHONIUM CHLORIDE |
ASSAY |
USPNF Online
|
Online |
27-Oct-2023 |
1-Nov-2023 |
NA
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NA
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In Procedure/Analysis: Change Calculate the percentage of methylbenzethonium chloride (C28H44ClNO2 · H2O) in the portion of Methylbenzethonium Chloride taken: to: Calculate the percentage of… Read More
In Procedure/Analysis: Change Calculate the percentage of methylbenzethonium chloride (C28H44ClNO2 · H2O) in the portion of Methylbenzethonium Chloride taken: to: Calculate the percentage of methylbenzethonium chloride (C28H44ClNO2) in the portion of Methylbenzethonium Chloride taken:
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AMOXICILLIN FOR INJECTABLE SUSPENSION |
Identification |
USPNF Online
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Online |
27-Oct-2023 |
1-Nov-2023 |
NA
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NA
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Change Prepare a test solution containing the equivalent of 4 mg of amoxicillin per mL by adding 0.1 N hydrochloric acid to Amoxicillin for Injectable Suspension. Allow the solution to stand for 5 minutes before use: the solution responds to the Identification… Read More
Change Prepare a test solution containing the equivalent of 4 mg of amoxicillin per mL by adding 0.1 N hydrochloric acid to Amoxicillin for Injectable Suspension. Allow the solution to stand for 5 minutes before use: the solution responds to the Identification test under Amoxicillin Capsules. to: Prepare a test solution containing the equivalent of 4 mg of amoxicillin per mL by adding 0.1 N hydrochloric acid to Amoxicillin for Injectable Suspension. Allow the solution to stand for 5 minutes before use. Prepare a Standard solution of USP Amoxicillin RS in 0.1 N hydrochloric acid containing 4 mg per mL. Use within 10 minutes after preparation. Apply separately 5 µL of each solution on a thin-layer chromatographic plate coated with a 0.25-mm layer of chromatographic silica gel mixture (see Chromatography <621>). Place the plate in a suitable chromatographic chamber, and develop the chromatogram in a solvent system consisting of a mixture of methanol, chloroform, water, and pyridine (90:80:30:10). When the solvent front has moved about three-fourths of the length of the plate, remove the plate from the chamber, and dry with warm air for 10 minutes. Locate the spots on the plate by spraying lightly with a solution of ninhydrin in alcohol containing 3 mg per mL, and dry at 110° for 15 minutes: the RF value of the principal spot obtained from the test solution corresponds to that obtained from the Standard solution.
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OIL- AND WATER-SOLUBLE VITAMINS WITH MINERALS CAPSULES |
STRENGTH |
USPNF Online
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Online |
27-Oct-2023 |
1-Nov-2023 |
NA
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NA
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In Vitamin A, Method 3/Analysis: Change CS = concentration of retinyl acetate (C23H32O2) from USP Vitamin A RS in the Standard solution (μg/mL) to: CS = concentration… Read More
In Vitamin A, Method 3/Analysis: Change CS = concentration of retinyl acetate (C23H32O2) from USP Vitamin A RS in the Standard solution (μg/mL) to: CS = concentration of retinyl acetate (C22H32O2) from USP Vitamin A RS in the Standard solution (μg/mL)
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DIGOXIN TABLETS |
ASSAY |
USPNF Online
|
Online |
29-Sep-2023 |
1-Oct-2023 |
NA
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NA
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In Procedure/Analysis: Change CU = nominal concentration of in the Sample solution (µg/mL) to: CU = nominal concentration of digoxin in the Sample solution (µg/mL) |
DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS |
PERFORMANCE TESTS |
USPNF Online
|
Online |
29-Sep-2023 |
1-Oct-2023 |
NA
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NA
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In Dissolution 〈711〉/Test 8/Tolerances: Change The percentage of the labeled amount of valproic acid (C8H16O2) dissolved at the times specified conform to Dissolution <711>, Acceptance… Read More
In Dissolution 〈711〉/Test 8/Tolerances: Change The percentage of the labeled amount of valproic acid (C8H16O2) dissolved at the times specified conform to Dissolution <711>, Acceptance Table 1. to: The percentage of the labeled amount of valproic acid (C8H16O2) dissolved at the times specified conform to Dissolution <711>, Acceptance Table 2.
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TAMSULOSIN HYDROCHLORIDE CAPSULES |
IMPURITIES |
USPNF Online
|
Online |
29-Sep-2023 |
1-Oct-2023 |
NA
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NA
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In Organic Impurities/System suitability: Change Sample: Standard solution [Note—The relative retention times for methoxy tamsulosin, tamsulosin, ethoxyphenoxy ethyl bromide, and desethoxy tamsulosin are 0.73, 1.00, 1.80… Read More
In Organic Impurities/System suitability: Change Sample: Standard solution [Note—The relative retention times for methoxy tamsulosin, tamsulosin, ethoxyphenoxy ethyl bromide, and desethoxy tamsulosin are 0.73, 1.00, 1.80, and 2.80, respectively.] Suitability requirements Tailing factor: NMT 2.0 Relative standard deviation: NMT 5.0% Signal-to-noise ratio: NLT 10 to: Samples: Standard solution and Sensitivity solution [Note—The relative retention times for methoxy tamsulosin, tamsulosin, ethoxyphenoxy ethyl bromide, and desethoxy tamsulosin are 0.73, 1.00, 1.80, and 2.80, respectively.] Suitability requirements Tailing factor: NMT 2.0, Standard solution Relative standard deviation: NMT 5.0%, Standard solution Signal-to-noise ratio: NLT 10, Sensitivity solution
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SODIUM ALGINATE |
ASSAY |
USPNF Online
|
Online |
25-Aug-2023 |
1-Sep-2023 |
NA
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NA
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In Procedure/Analysis: Change Result = (V2 × N × WE)/(W × D) to: Result = (V2 × N × WE × 10)/(W × D) |
FOSAMPRENAVIR CALCIUM TABLETS |
PERFORMANCE TESTS |
USPNF Online
|
Online |
25-Aug-2023 |
1-Sep-2023 |
NA
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NA
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In Dissolution 〈711〉/Medium: Change 26.7 g/L of sodium acetate trihydrate in water. Add 133 mL of glacial acetic acid to this solution, and then dilute with water to 10 L; 900 mL. to: 0.02 M sodium acetate buffer, pH 3.5, prepared as follows.… Read More
In Dissolution 〈711〉/Medium: Change 26.7 g/L of sodium acetate trihydrate in water. Add 133 mL of glacial acetic acid to this solution, and then dilute with water to 10 L; 900 mL. to: 0.02 M sodium acetate buffer, pH 3.5, prepared as follows. Dissolve 2.67 g of sodium acetate in 100 mL of water. Add 13.3 mL of glacial acetic acid and then dilute with water to 1000 mL; 900 mL.
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ZIPRASIDONE HYDROCHLORIDE |
IMPURITIES |
USPNF Online
|
Online |
25-Aug-2023 |
1-Sep-2023 |
NA
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NA
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In Organic Impurities/Solution B: Change Acetonitrile, methanol, and Buffer (55:5:40). Adjust with potassium hydroxide TS to a pH of 6.0. to: Acetonitrile, methanol, and Buffer (55:5:40). Adjust with potassium hydroxide solution… Read More
In Organic Impurities/Solution B: Change Acetonitrile, methanol, and Buffer (55:5:40). Adjust with potassium hydroxide TS to a pH of 6.0. to: Acetonitrile, methanol, and Buffer (55:5:40). Adjust with potassium hydroxide solution to a pH of 6.0. AND In both equations in Organic Impurities/Analysis: Change 449.40 to: 449.39
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REAGENTS AND REFERENCE TABLES |
Solutions/Test Solutions and Indicator Solutions/Starch TS |
USPNF Online
|
Online |
25-Aug-2023 |
1-Sep-2023 |
NA
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NA
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Change Prepare this solution by one of the following procedures: to: Prepare this solution by one of the following procedures. Apply the Test for sensitivity to confirm suitability for freshly or previously prepared solutions or commercially bought… Read More
Change Prepare this solution by one of the following procedures: to: Prepare this solution by one of the following procedures. Apply the Test for sensitivity to confirm suitability for freshly or previously prepared solutions or commercially bought solutions. AND In Storage: Delete Use the Test for sensitivity to confirm suitability for use. AND In Procedure with No Preservative: Delete Apply the Test for sensitivity to confirm suitability for freshly or previously prepared solutions. AND In Test for sensitivity: Delete Use the Test for sensitivity to confirm suitability for use. AND In Procedure with Salicylic Acid as Preservative: Change Mix 1 g of soluble starch with 50 mL of cold water to: Mix 1 g of soluble starch with 5 mL of cold water
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BLACK CUMIN SEED THYMOQUINONE OIL |
DEFINITION |
USPNF Online
|
Online |
25-Aug-2023 |
1-Sep-2023 |
NA
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NA
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Change carvacol to: carvacrol |
CRANBERRY FRUIT DRY JUICE |
COMPOSITION |
USPNF Online
|
Online |
25-Aug-2023 |
1-Sep-2023 |
NA
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NA
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In Content of Proanthocyanidins/Standard stock solution: Change USP Procyanidin A2 RS to: USP Procyanidin A2 RS AND In Content of Proanthocyanidins/Analysis: Change Use the absorbance recorded for Standard… Read More
In Content of Proanthocyanidins/Standard stock solution: Change USP Procyanidin A2 RS to: USP Procyanidin A2 RS AND In Content of Proanthocyanidins/Analysis: Change Use the absorbance recorded for Standard solutions 1–5 to obtain a calibration curve (absorbance vs. concentration, in µg/mL, of procyanidin A2) and perform a linear regression analysis. Determine the concentration (C), in µg/mL, of total proanthocyanidins as procyanidin A2 in the Sample solution. to: Use the absorbance recorded for Standard solutions 1–5 to obtain a calibration curve (absorbance vs. concentration, in µg/mL, of procyanidin A2) and perform a linear regression analysis. Determine the concentration (C), in µg/mL, of total proanthocyanidins as procyanidin A2 in the Sample solution. AND In Content of Proanthocyanidins/Analysis: Change C = concentration of the Sample solution as procyanidin A2 from the regression line (µg/mL) to: C = concentration of the Sample solution as procyanidin A2 from the regression line (µg/mL) AND In Content of Proanthocyanidins/Acceptance criteria: Change procyanidin A2 to: procyanidin A2
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ZIPRASIDONE CAPSULES |
PERFORMANCE TESTS |
USPNF Online
|
Online |
25-Aug-2023 |
1-Sep-2023 |
NA
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NA
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In Dissolution 〈711〉/Test 1/Tier 1/Phosphate buffer, pH 7.5: Change sodium hydroxide to: sodium hydroxide solution AND In Dissolution 〈711〉/Test 1/Tier 1/Analysis: Change 449.40 to… Read More
In Dissolution 〈711〉/Test 1/Tier 1/Phosphate buffer, pH 7.5: Change sodium hydroxide to: sodium hydroxide solution AND In Dissolution 〈711〉/Test 1/Tier 1/Analysis: Change 449.40 to: 449.39 AND In Dissolution 〈711〉/Test 1/Tier 2/Solution A and Solution B: Change sodium hydroxide to: sodium hydroxide solution AND In Dissolution 〈711〉/Test 2/Tier 2/Analysis: Change 449.40 to: 449.39 AND In Dissolution 〈711〉/Test 3/Tier 2/Analysis: Change 449.40 to: 449.39
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AZITHROMYCIN |
ADDITIONAL REQUIREMENTS |
USPNF Online
|
Online |
25-Aug-2023 |
1-Sep-2023 |
NA
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NA
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In USP Reference Standards 〈11〉/USP Azaerythromycin A RS: Change 734.96 to: 734.97 AND In USP Azithromycin Related Compound F RS: Change 762.97 to: 762.98 AND In USP Desosaminylazithromycin RS: Change 590.79 to: 590.80 |
AMANTADINE HYDROCHLORIDE |
IDENTIFICATION |
USPNF Online
|
Online |
25-Aug-2023 |
1-Sep-2023 |
NA
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NA
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In A.: Change Spectroscopic Identification Tests 〈197〉, Infrared Spectroscopy: 197A, 197K, and 197S to: Spectroscopic Identification Tests 〈197〉, Infrared Spectroscopy: 197A, 197K, or 197S Procedure for… Read More
In A.: Change Spectroscopic Identification Tests 〈197〉, Infrared Spectroscopy: 197A, 197K, and 197S to: Spectroscopic Identification Tests 〈197〉, Infrared Spectroscopy: 197A, 197K, or 197S Procedure for 197S
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CRANBERRY FRUIT DRY JUICE |
DEFINITION |
USPNF Online
|
Online |
25-Aug-2023 |
1-Sep-2023 |
NA
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NA
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Change procyanidin A2 to: procyanidin A2 |
OCTOCRYLENE |
IDENTIFICATION |
USPNF Online
|
Online |
25-Aug-2023 |
1-Sep-2023 |
NA
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NA
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In A./Acceptance criteria: Change NMT 3.0%, calculated on the as-is basis to: Absorptivities, calculated on the as-is basis, do not differ by more than 3.0%. |
AZITHROMYCIN |
CHEMICAL INFORMATION |
USPNF Online
|
Online |
25-Aug-2023 |
1-Sep-2023 |
NA
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NA
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Change 748.98 to: 749.00 AND Change 767.00 to: 767.01 AND Change 785.02 to: 785.03 |
UREA C 13 |
IMPURITIES |
USPNF Online
|
Online |
25-Aug-2023 |
1-Sep-2023 |
NA
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NA
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In Isotopic Purity/Chromatographic system: Change Flow rate: Flow rate to: Flow rate: 1 mL/min |