POTASSIUM CITRATE EXTENDED-RELEASE TABLETS |
PERFORMANCE TESTS/Dissolution <711> |
USPNF Online
|
Online |
18-Nov-2022 |
1-Dec-2022 |
NA
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NA
|
In Test 6: Change Times: 0.5, 1, and 4 h—for strengths 540 and 1080 mg as potassium citrate monohydrate; 0.5, 1, and 6 h—for strength 1620 mg as potassium citrate monohydrate. to: Times: 0.5, 1, and 4 h—for strength 540 mg as potassium… Read More
In Test 6: Change Times: 0.5, 1, and 4 h—for strengths 540 and 1080 mg as potassium citrate monohydrate; 0.5, 1, and 6 h—for strength 1620 mg as potassium citrate monohydrate. to: Times: 0.5, 1, and 4 h—for strength 540 mg as potassium citrate monohydrate; 0.5, 1, and 6 h—for strengths 1080 and 1620 mg as potassium citrate monohydrate.
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METAPROTERENOL SULFATE TABLETS |
Identification/A. |
USPNF Online
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Online |
24-Feb-2023 |
1-Mar-2023 |
NA
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NA
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Change Proceed as directed in Identification test A under Metaproterenol Sulfate Inhalation Solution, beginning with “Allow the spots to dry”: to: Allow the spots to dry, and develop the chromatogram in a solvent system consisting… Read More
Change Proceed as directed in Identification test A under Metaproterenol Sulfate Inhalation Solution, beginning with “Allow the spots to dry”: to: Allow the spots to dry, and develop the chromatogram in a solvent system consisting of the upper layer of a freshly prepared mixture of butyl alcohol, water, and formic acid (50:25:7) until the solvent front has moved about three-fourths of the length of the plate. Remove the plate from the developing chamber, mark the solvent front, and allow the solvent to evaporate. Locate the spots on the plate by examination under short-wavelength UV light:
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DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE CAPSULES |
IDENTIFICATION |
USPNF Online
|
Online |
28-Apr-2023 |
1-May-2023 |
NA
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NA
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Change A. The UV-Vis spectrum of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay. to: A. The UV spectrum of the major peak of the Sample solution… Read More
Change A. The UV-Vis spectrum of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay. to: A. The UV spectrum of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.
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CLOMIPHENE CITRATE TABLETS |
IMPURITIES/Organic Impurities |
USPNF Online
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Online |
28-Jul-2023 |
1-Aug-2023 |
NA
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NA
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In Table 2: Change Clomiphene related compound A 0.87 – 2.0 to: Clomiphene related compound A 0.87 1.0 2.0 |
UREA |
SPECIFIC TESTS |
USPNF Online
|
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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LINEZOLID TABLETS |
PERFORMANCE TESTS |
USPNF Online
|
Online |
26-Jan-2024 |
1-Feb-2024 |
NA
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NA
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In Dissolution 〈711〉/Test 1/Analysis: Change Result = (rU/rS) × CS × V × (1/L) × 100 rU = peak response of linezolid from the Sample… Read More
In Dissolution 〈711〉/Test 1/Analysis: Change Result = (rU/rS) × CS × V × (1/L) × 100 rU = peak response of linezolid from the Sample solution rS = peak response of linezolid from the Standard solution CS = concentration of USP Linezolid RS in the Standard solution (mg/mL) V = volume of Medium, 900 mL L = label claim (mg/Tablet) to: Result = (rU/rS) × CS × V × (1/L) × D × 100 rU = peak response of linezolid from the Sample solution rS = peak response of linezolid from the Standard solution CS = concentration of USP Linezolid RS in the Standard solution (mg/mL) V = volume of Medium, 900 mL L = label claim (mg/Tablet) D = dilution factor of the Sample solution, as needed
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MILK THISTLE CAPSULES |
PERFORMANCE TESTS/Disintegration and Dissolution <2040>, Dissolution |
USPNF Online
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Online |
24-Jun-2022 |
1-Aug-2022 |
NA
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NA
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In Medium: Change Buffer containing 2% lauryl sulfate; 900 mL to: Buffer containing 2% sodium lauryl sulfate; 900 mL |
PENICILLIN G BENZATHINE INJECTABLE SUSPENSION |
IDENTIFICATION |
USPNF Online
|
Online |
18-Nov-2022 |
1-Dec-2022 |
NA
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NA
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Change It responds to the Identification test under Penicillin G Benzathine Oral Suspension. to: Mix a portion of it with methanol to obtain a solution containing about 3000 Penicillin G Units per mL. Apply 20 µL of this test solution and… Read More
Change It responds to the Identification test under Penicillin G Benzathine Oral Suspension. to: Mix a portion of it with methanol to obtain a solution containing about 3000 Penicillin G Units per mL. Apply 20 µL of this test solution and 20 µL of a Standard solution of USP Penicillin G Benzathine RS in methanol containing 2.5 mg per mL to a suitable thin-layer chromatographic plate (see Chromatography 〈621〉) coated with a 0.25-mm layer of chromatographic silica gel, and allow the spots to dry. Using an unlined developing chamber, develop the chromatogram in a solvent system consisting of a mixture of methanol, acetonitrile, and ammonium hydroxide (70:30:3) until the solvent front has moved about three-fourths of the length of the plate. Remove the plate from the developing chamber, and allow to air-dry. Spray the plate uniformly with a spray reagent prepared as follows. Dissolve 20 g of tartaric acid and 1.7 g of bismuth subnitrate in 80 mL of water. Add 2.5 mL of this solution, 2.5 mL of potassium iodide solution (4 in 10), and 10 g of tartaric acid to 50 mL of water, and mix. Examine the chromatograms: the principal spot obtained from the test solution corresponds in RF value to that obtained from the Standard solution.
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METAPROTERENOL SULFATE ORAL SOLUTION |
Identification/A. |
USPNF Online
|
Online |
24-Feb-2023 |
1-Mar-2023 |
NA
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NA
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Change Proceed as directed in Identification test A under Metaproterenol Sulfate Inhalation Solution, beginning with “Allow the spots to dry”: to: Allow the spots to dry, and develop the chromatogram in a solvent system consisting… Read More
Change Proceed as directed in Identification test A under Metaproterenol Sulfate Inhalation Solution, beginning with “Allow the spots to dry”: to: Allow the spots to dry, and develop the chromatogram in a solvent system consisting of the upper layer of a freshly prepared mixture of butyl alcohol, water, and formic acid (50:25:7) until the solvent front has moved about three-fourths of the length of the plate. Remove the plate from the developing chamber, mark the solvent front, and allow the solvent to evaporate. Locate the spots on the plate by examination under short-wavelength UV light:
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FLUTICASONE PROPIONATE NASAL SPRAY |
OTHER COMPONENTS/Content of Phenylethyl Alcohol |
USPNF Online
|
Online |
28-Apr-2023 |
1-May-2023 |
NA
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NA
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In Sample solution: Change Transfer 1.0 g of the Nasal Spray to a 50-mL volumetric flask. Add about 40 mL of Diluent, and sonicate for 10 min until the supernatant is clear. Use the clear supernatant for analysis. to: Transfer 1.0 g of the… Read More
In Sample solution: Change Transfer 1.0 g of the Nasal Spray to a 50-mL volumetric flask. Add about 40 mL of Diluent, and sonicate for 10 min until the supernatant is clear. Use the clear supernatant for analysis. to: Transfer 1.0 g of the Nasal Spray to a 50-mL volumetric flask. Add about 40 mL of Diluent, and sonicate for 10 min. Dilute with Diluent to volume, and shake. Allow to stand for 10 min until the supernatant is clear. Use the clear supernatant for analysis.
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POLYVINYL ALCOHOL |
IMPURITIES |
USPNF Online
|
Online |
28-Jul-2023 |
1-Aug-2023 |
NA
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NA
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In Limit of Methanol (Methyl Alcohol) and Methyl Acetate/Analysis: Change CU = concentration of methanol (methyl alcohol) or methyl acetate in the Sample solution (mg/mL) to: CU =… Read More
In Limit of Methanol (Methyl Alcohol) and Methyl Acetate/Analysis: Change CU = concentration of methanol (methyl alcohol) or methyl acetate in the Sample solution (mg/mL) to: CU = concentration of Polyvinyl Alcohol in the Sample solution (mg/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 |
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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ESCITALOPRAM TABLETS |
ASSAY/Procedure |
USPNF Online
|
Online |
28-Apr-2023 |
1-May-2023 |
NA
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NA
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In Buffer: Change Adjust with 1 N sodium hydroxide VS to a pH of 5.2. to: Adjust with 1 N sodium hydroxide to a pH of 5.2. |
TRIMETHOBENZAMIDE HYDROCHLORIDE |
CHEMICAL INFORMATION |
USPNF Online
|
Online |
28-Jul-2023 |
1-Aug-2023 |
NA
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NA
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Change N-[p-[2-(Dimethylamino)ethoxy]benzyl]-3,4,5-trimethoxy benzamide monohydrochloride to: N-[4-[2-(Dimethylamino)ethoxy]benzyl]-3,4,5-trimethoxybenzamide monohydrochloride |
OIL- AND WATER-SOLUBLE VITAMINS WITH MINERALS 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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COCOYL CAPRYLOCAPRATE |
SPECIFIC TESTS |
USPNF Online
|
Online |
23-Feb-2024 |
1-May-2024 |
NA
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NA
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In Fats and Fixed Oils 〈401〉, Procedures, Hydroxyl Value/Analysis: Change Calculate the acid value as directed in the chapter. to: Calculate the hydroxyl value as directed in the chapter. |
MILK THISTLE TABLETS |
PERFORMANCE TESTS/Disintegration and Dissolution <2040>, Dissolution |
USPNF Online
|
Online |
24-Jun-2022 |
1-Aug-2022 |
NA
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NA
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In Medium: Change Buffer containing 2% lauryl sulfate; 900 mL to: Buffer containing 2% sodium lauryl sulfate; 900 mL |
ECONAZOLE NITRATE |
ADDITIONAL REQUIREMENTS/USP Reference Standards <11> |
USPNF Online
|
Online |
26-Aug-2022 |
1-Sep-2022 |
NA
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USPNF 2023 Issue 2
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In USP Econazole Related Compound C RS: Change 1-(4-Chlorobenzyl)-3-{2-[(4-chlorobenzyl)oxy]-2-(2,4-dichlorophenyl)ethyl}-1H-imidazol-3-ium nitrate (salt). C25H21Cl14N3O4 569.… Read More
In USP Econazole Related Compound C RS: Change 1-(4-Chlorobenzyl)-3-{2-[(4-chlorobenzyl)oxy]-2-(2,4-dichlorophenyl)ethyl}-1H-imidazol-3-ium nitrate (salt). C25H21Cl14N3O4 569.26 to: 1-(4-Chlorobenzyl)-3-{2-[(4-chlorobenzyl)oxy]-2-(2,4-dichlorophenyl)ethyl}-1H-imidazol-3-ium chloride. C25H21Cl5N2O 542.71
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PENICILLIN G BENZATHINE AND PENICILLIN G PROCAINE INJECTABLE SUSPENSION |
IDENTIFICATION |
USPNF Online
|
Online |
18-Nov-2022 |
1-Dec-2022 |
NA
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NA
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In Test A: Change It responds to the Identification test under Penicillin G Benzathine Oral Suspension: the spot obtained from the test solution, corresponding in RF value to that obtained from the Standard solution, is… Read More
In Test A: Change It responds to the Identification test under Penicillin G Benzathine Oral Suspension: the spot obtained from the test solution, corresponding in RF value to that obtained from the Standard solution, is completely resolved from a second spot, produced by penicillin G procaine. to: Mix a portion of it with methanol to obtain a solution containing about 3000 Penicillin G Units per mL. Apply 20 µL of this test solution and 20 µL of a Standard solution of USP Penicillin G Benzathine RS in methanol containing 2.5 mg per mL to a suitable thin-layer chromatographic plate (see Chromatography 〈621〉) coated with a 0.25-mm layer of chromatographic silica gel, and allow the spots to dry. Using an unlined developing chamber, develop the chromatogram in a solvent system consisting of a mixture of methanol, acetonitrile, and ammonium hydroxide (70:30:3) until the solvent front has moved about three-fourths of the length of the plate. Remove the plate from the developing chamber, and allow to air-dry. Spray the plate uniformly with a spray reagent prepared as follows. Dissolve 20 g of tartaric acid and 1.7 g of bismuth subnitrate in 80 mL of water. Add 2.5 mL of this solution, 2.5 mL of potassium iodide solution (4 in 10), and 10 g of tartaric acid to 50 mL of water, and mix. Examine the chromatograms: the principal spot obtained from the test solution corresponds in RF value to that obtained from the Standard solution. The spot obtained from the test solution, corresponding in RF value to that obtained from the Standard solution, is completely resolved from a second spot, produced by penicillin G procaine.
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TRIETHYL CITRATE |
ASSAY/Procedure |
USPNF Online
|
Online |
24-Feb-2023 |
1-May-2023 |
NA
|
NA
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In System suitability/Suitability requirements/Tailing factor: Change NMT 1.5 for the triethyl citrate to trimethyl citrate peaks to: NMT 1.5 for the triethyl citrate and trimethyl citrate peaks |