POTASSIUM PHOSPHATES COMPOUNDED INJECTION |
ASSAY |
USPNF Online
|
Online |
30-Aug-2024 |
1-Sep-2024 |
NA
|
NA
|
In Procedure for Potassium/Chromatographic system/Column: Change 4.6-mm × 25-cm; packing L97 to: 4-mm × 25-cm; packing L97 AND In Procedure for Phosphate/Chromatographic system/Column: Change 4.6-mm ×… Read More
In Procedure for Potassium/Chromatographic system/Column: Change 4.6-mm × 25-cm; packing L97 to: 4-mm × 25-cm; packing L97 AND In Procedure for Phosphate/Chromatographic system/Column: Change 4.6-mm × 25-cm; packing L103 to: 4-mm × 25-cm; packing L103
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EXENATIDE INJECTION |
PRODUCT-RELATED SUBSTANCES AND IMPURITIES |
USPNF Online
|
Online |
26-Jul-2024 |
1-Aug-2024 |
NA
|
NA
|
In Procedure/Chromatographic system/Column: Change 4.6-mm × 10-cm; 3-µm packing L52 to: 4.6-mm × 10-cm; 3-µm packing L52; two columns in series |
CRANBERRY FRUIT JUICE DRY EXTRACT |
IDENTIFICATION |
USPNF Online
|
Online |
26-Jul-2024 |
1-Aug-2024 |
NA
|
NA
|
In A. HPTLC for Articles of Botanical Origin <203>/Sample solution: Change Mix 50 mg of Cranberry Fruit Juice Dry Extract with 7 mL of water. Sonicate for 10 min at room temperature, centrifuge, and save the supernatant. Precondition an… Read More
In A. HPTLC for Articles of Botanical Origin <203>/Sample solution: Change Mix 50 mg of Cranberry Fruit Juice Dry Extract with 7 mL of water. Sonicate for 10 min at room temperature, centrifuge, and save the supernatant. Precondition an SPE cartridge (L2; 500 mg/6 mL) with 3 mL of methanol, and drain it with suction. Load 3 mL of water onto the cartridge and apply suction until the solvent reaches 1–2 mm above the top of the cartridge's stationary phase. Then load the cartridge with 1.5 mL of the supernatant, apply suction, and discard the eluate. Add 1 mL of a mixture of water and methanol (80:20). Load 1 mL of methanol and collect the eluate as the Sample solution. to: Mix 50 mg of Cranberry Fruit Juice Dry Extract with 7 mL of water. Sonicate for 10 min at room temperature, centrifuge, and save the supernatant. Precondition an SPE cartridge (L2; 500 mg/6 mL) with 3 mL of methanol, and drain it with suction. Load 3 mL of water onto the cartridge and apply suction until the solvent reaches 1–2 mm above the top of the cartridge's stationary phase. Then load the cartridge with 1.5 mL of the supernatant, apply suction, and discard the eluate. Add 1 mL of a mixture of water and methanol (80:20), apply suction, and discard the eluate. Load 1 mL of methanol and collect the eluate as the Sample solution.
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NICARDIPINE HYDROCHLORIDE |
ADDITIONAL REQUIREMENTS |
USPNF Online
|
Online |
26-Jul-2024 |
1-Aug-2024 |
NA
|
NA
|
In USP Reference Standards <11>/USP Nicardipine Related Compound B RS: Change 3-{2-[Benzyl(methyl)amino]ethyl}5-methyl 2,6-dimethyl-4-(3-nitrophenyl)pyridine-3,5-dicarboxylate oxalate. to: 3-{2-[Benzyl(methyl)amino]ethyl} 5-methyl 2,… Read More
In USP Reference Standards <11>/USP Nicardipine Related Compound B RS: Change 3-{2-[Benzyl(methyl)amino]ethyl}5-methyl 2,6-dimethyl-4-(3-nitrophenyl)pyridine-3,5-dicarboxylate oxalate. to: 3-{2-[Benzyl(methyl)amino]ethyl} 5-methyl 2,6-dimethyl-4-(3-nitrophenyl)pyridine-3,5-dicarboxylate oxalate. AND In USP Reference Standards <11>/USP Nicardipine Related Compound D RS: Change Bis{2-[benzyl(methyl)amino]ethyl}2,6-dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate dihydrochloride. to: Bis{2-[benzyl(methyl)amino]ethyl} 2,6-dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate dihydrochloride.
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EDETATE DISODIUM COMPOUNDED OPHTHALMIC SOLUTION |
DEFINITION |
USPNF Online
|
Online |
28-Jun-2024 |
1-Jul-2024 |
NA
|
NA
|
In two instances: Change to a pH between 6.5 and 7.5. to: to a pH between 6.1 and 7.1. |
DESCRIPTION AND SOLUBILITY |
Hydrogenated Castor Oil |
USPNF Online
|
Online |
28-Jun-2024 |
1-Aug-2026 |
NA
|
NA
|
Change White, crystalline wax. Freely soluble in water, in saline TS, and in dextrose solutions; very slightly soluble in alcohol; practically insoluble in chloroform and in ether. Insoluble in water and in most common organic solvents. NF category:… Read More
Change White, crystalline wax. Freely soluble in water, in saline TS, and in dextrose solutions; very slightly soluble in alcohol; practically insoluble in chloroform and in ether. Insoluble in water and in most common organic solvents. NF category: Stiffening agent; lubricant; film-forming agent; release-modifying agent. to: White, crystalline wax. Insoluble in water and in most common organic solvents. NF category: Stiffening agent; lubricant; film-forming agent; release-modifying agent.
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NEOMYCIN AND POLYMYXIN B SULFATES AND LIDOCAINE CREAM |
ASSAY |
USPNF Online
|
Online |
28-Jun-2024 |
1-Jul-2024 |
NA
|
NA
|
Change Assay for neomycin—Proceed with Cream as directed in the Assay for neomycin under Neomycin and Polymyxin B Sulfates Cream. Assay for polymyxin B—Proceed with Cream as directed in the Assay for polymyxin B… Read More
Change Assay for neomycin—Proceed with Cream as directed in the Assay for neomycin under Neomycin and Polymyxin B Sulfates Cream. Assay for polymyxin B—Proceed with Cream as directed in the Assay for polymyxin B under Neomycin and Polymyxin B Sulfates Cream. to: Assay for neomycin—Proceed as directed under Antibiotics—Microbial Assays 〈81〉, using an accurately weighed portion of Cream, equivalent to about 1.75 mg of neomycin, shaken in a separator with about 50 mL of ether, and extracted with four 20-mL portions of Buffer B.3. Combine the aqueous extracts, and dilute with Buffer B.3 to an appropriate volume to obtain a stock solution of convenient concentration. Dilute this stock solution quantitatively and stepwise with Buffer B.3 to obtain a Test Dilution having a concentration assumed to be equal to the median dose level of the Standard. Assay for polymyxin B—Proceed as directed under Antibiotics—Microbial Assays 〈81〉, using an accurately weighed portion of Cream shaken with about 50 mL of ether in a separator, and extracted with four 25-mL portions of Buffer B.6. Combine the aqueous extracts, and dilute with Buffer B.6 to an appropriate volume to obtain a stock solution. Dilute this stock solution quantitatively and stepwise with Buffer B.6 to obtain a Test Dilution having a concentration assumed to be equal to the median dose level of the Standard (10 Polymyxin B Units per mL). Add to each test dilution of the Standard a quantity of USP Neomycin Sulfate RS, dissolved in Buffer B.6, to obtain the same concentration of neomycin present in the Test Dilution.
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NAPROXEN SODIUM |
SPECIFIC TESTS |
USPNF Online
|
Online |
28-Jun-2024 |
1-Aug-2024 |
NA
|
NA
|
In Loss on Drying <731>/Analysis: Change Dry at 105° for 3 h. to: Dry in vacuum at 105° for 3 h. |
METRONIDAZOLE CAPSULES |
IMPURITIES |
USPNF Online
|
Online |
31-May-2024 |
1-Jun-2024 |
NA
|
NA
|
In Organic Impurities: Change Mobile phase, Sample solution, and Chromatographic system: Proceed as directed in the Assay. to: Mobile phase and Chromatographic system: Proceed as directed in the … Read More
In Organic Impurities: Change Mobile phase, Sample solution, and Chromatographic system: Proceed as directed in the Assay. to: Mobile phase and Chromatographic system: Proceed as directed in the Assay. AND Change Standard solution: 1 µg/mL of metronidazole from USP Metronidazole RS and 2 µg/mL of tinidazole related compound A from USP Tinidazole Related Compound A RS in Mobile phase to: Standard solution: 1 µg/mL of metronidazole from USP Metronidazole RS and 2 µg/mL of tinidazole related compound A from USP Tinidazole Related Compound A RS in Mobile phase Sample solution: Nominally 1 mg/mL of metronidazole prepared as follows. Mix the contents of Capsules (NLT 20). Transfer an amount equivalent to 100 mg of metronidazole to a 100-mL volumetric flask, add 80 mL of Mobile phase, and sonicate with intermittent shaking for 10 min. Shake for 30 min, and dilute with Mobile phase to volume. Centrifuge a portion of the solution.
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PROCAINAMIDE HYDROCHLORIDE |
ASSAY |
USPNF Online
|
Online |
31-May-2024 |
1-Jun-2024 |
NA
|
NA
|
In Resolution solution: Change p-aminoben zoic acid to: p-aminobenzoic acid |
DOCETAXEL |
IMPURITIES |
USPNF Online
|
Online |
31-May-2024 |
1-Jun-2024 |
NA
|
NA
|
In Organic Impurities, Procedure 1: Change System suitability solution, Standard solution, Sample solution, and Chromatographic system: Proceed as directed in the Assay. to: Mobile phase, Diluent, System… Read More
In Organic Impurities, Procedure 1: Change System suitability solution, Standard solution, Sample solution, and Chromatographic system: Proceed as directed in the Assay. to: Mobile phase, Diluent, System suitability solution, Standard solution, Sample solution, and Chromatographic system: Proceed as directed in the Assay.
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TYLOSIN INJECTION |
SPECIFIC TESTS |
USPNF Online
|
Online |
31-May-2024 |
1-Jun-2024 |
NA
|
NA
|
Change pH 〈921〉 to: pH 〈791〉 |
CEFUROXIME AXETIL FOR ORAL SUSPENSION |
ASSAY |
USPNF Online
|
Online |
31-May-2024 |
1-Jun-2024 |
NA
|
NA
|
In Procedure/System suitability: Change [Note—The relative retention times for acetanilide, cefuroxime axetil diastereoisomer B, cefuroxime axetil diastereoisomer A, and cefuroxime axetil delta-3 isomers are 0.4, 0.8, 0.9, and 1.0, respectively.]… Read More
In Procedure/System suitability: Change [Note—The relative retention times for acetanilide, cefuroxime axetil diastereoisomer B, cefuroxime axetil diastereoisomer A, and cefuroxime axetil delta-3 isomers are 0.4, 0.8, 0.9, and 1.0, respectively.] to: [Note—The relative retention times for cefuroxime axetil diastereoisomer B, cefuroxime axetil diastereoisomer A, and cefuroxime axetil delta-3 isomers are 0.8, 0.9, and 1.0, respectively.]
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BROMPHENIRAMINE MALEATE |
SPECIFIC TESTS |
USPNF Online
|
Online |
26-Apr-2024 |
1-May-2024 |
NA
|
NA
|
Change Optical Rotation 〈781〉 to: Optical Rotation, Angular Rotation 〈781A〉 |
RIVASTIGMINE TARTRATE |
IMPURITIES |
USPNF Online
|
Online |
26-Apr-2024 |
1-May-2024 |
NA
|
NA
|
In Organic Impurities/Procedure 1/Impurity Table 1/footnote d: Change 3-Nitrophenyl ethyl(methyl)carbamate. to: 4-Nitrophenyl ethyl(methyl)carbamate. |
ISOSORBIDE MONONITRATE TABLETS |
IMPURITIES |
USPNF Online
|
Online |
26-Apr-2024 |
1-May-2024 |
NA
|
NA
|
In Organic Impurities/Standard solution: Change isosorbide related compound A to: isosorbide mononitrate related compound A AND In System suitability/Suitability requirements/Relative standard… Read More
In Organic Impurities/Standard solution: Change isosorbide related compound A to: isosorbide mononitrate related compound A AND In System suitability/Suitability requirements/Relative standard deviation: Change isosorbide related compound A, to: isosorbide mononitrate related compound A, AND In four instances in Analysis: Change isosorbide related compound A, to: isosorbide mononitrate related compound A, AND In Table 1: Change Isosorbide related compound A to: Isosorbide mononitrate related compound A
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DAPSONE TABLETS |
PERFORMANCE TESTS |
USPNF Online
|
Online |
26-Apr-2024 |
1-May-2024 |
NA
|
NA
|
In Dissolution 〈711〉/Standard solution: Change USP Dapsone RS of a known concentration in Medium to: (L/1000) mg/mL of USP Dapsone RS in Medium, where L is the label claim in mg/Tablet. Transfer a portion of this… Read More
In Dissolution 〈711〉/Standard solution: Change USP Dapsone RS of a known concentration in Medium to: (L/1000) mg/mL of USP Dapsone RS in Medium, where L is the label claim in mg/Tablet. Transfer a portion of this solution containing 0.2 mg of dapsone to a 25-mL volumetric flask, add 5 mL of 1 N sodium hydroxide, and dilute with water to volume.
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RIVASTIGMINE TARTRATE |
ADDITIONAL REQUIREMENTS |
USPNF Online
|
Online |
26-Apr-2024 |
1-May-2024 |
NA
|
NA
|
In USP Reference Standards 〈11〉: Change USP Rivastigmine Tartrate R-Isomer RS to: USP Rivastigmine Tartrate R-Isomer RS (R)-3-[1-(Dimethylamino)ethyl]phenyl ethylmethylcarbamate, hydrogen tartrate. C14H22N2… Read More
In USP Reference Standards 〈11〉: Change USP Rivastigmine Tartrate R-Isomer RS to: USP Rivastigmine Tartrate R-Isomer RS (R)-3-[1-(Dimethylamino)ethyl]phenyl ethylmethylcarbamate, hydrogen tartrate. C14H22N2O2 · C4H6O6 400.42
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DOXORUBICIN HYDROCHLORIDE |
ASSAY |
USPNF Online
|
Online |
26-Apr-2024 |
1-May-2024 |
NA
|
NA
|
In Procedure/System suitability solution: Add link to USP Store for USP Epirubicin Hydrochloride RS |
DILUTED ISOSORBIDE MONONITRATE |
IMPURITIES |
USPNF Online
|
Online |
26-Apr-2024 |
1-May-2024 |
NA
|
NA
|
In Organic Impurities/Standard solution: Change isosorbide related compound A to: isosorbide mononitrate related compound A AND In System suitability/Suitability requirements/Relative standard… Read More
In Organic Impurities/Standard solution: Change isosorbide related compound A to: isosorbide mononitrate related compound A AND In System suitability/Suitability requirements/Relative standard deviation: Change isosorbide related compound A, to: isosorbide mononitrate related compound A, AND In four instances in Analysis: Change isosorbide related compound A, to: isosorbide mononitrate related compound A, AND In Table 1: Change Isosorbide related compound A to: Isosorbide mononitrate related compound A
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SUCROSE |
IMPURITIES |
USPNF Online
|
Online |
29-Mar-2024 |
1-Apr-2024 |
NA
|
NA
|
In Sulfite/Analysis/footnote 1: Change Test kit for sulfite determination may be ordered from the following suppliers: Megazyme Ltd. (Product code: K-ETSULPH); R-Biopharm (Enzytec) (Article No.: E6275); BioSenTec/Nzytech (Catalogue No.: AK00071).… Read More
In Sulfite/Analysis/footnote 1: Change Test kit for sulfite determination may be ordered from the following suppliers: Megazyme Ltd. (Product code: K-ETSULPH); R-Biopharm (Enzytec) (Article No.: E6275); BioSenTec/Nzytech (Catalogue No.: AK00071). to: Test kit for sulfite determination may be ordered from the following suppliers: Megazyme Ltd. (Product code K-ETSULPH); R-Biopharm (Enzytec) (Article No. E6275); Nzytech (Catalogue No. AK00071) and BioSenTec (Product reference 040-E).
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LIDOCAINE |
ASSAY |
USPNF Online
|
Online |
29-Mar-2024 |
1-Apr-2024 |
NA
|
NA
|
In Procedure: Change Column: 3.9-mm × 30-cm; 4-µm packing L1 to: Column: 3.9-mm × 30-cm; 10-µm packing L1 |
LIDOCAINE, RACEPINEPHRINE AND TETRACAINE HYDROCHLORIDES COMPOUNDED TOPICAL GEL |
DEFINITION |
USPNF Online
|
Online |
29-Mar-2024 |
1-Apr-2024 |
NA
|
NA
|
Change Prepare Lidocaine, Racepinephrine, and Tetracaine Hydrochlorides Compounded Topical Gel containing 40 mg/mL of lidocaine hydrochloride, 1 mg/mL of racepinephrine hydrochloride, and 10 mg/mL of tetracaine hydrochloride as follows (see Pharmaceutical… Read More
Change Prepare Lidocaine, Racepinephrine, and Tetracaine Hydrochlorides Compounded Topical Gel containing 40 mg/mL of lidocaine hydrochloride, 1 mg/mL of racepinephrine hydrochloride, and 10 mg/mL of tetracaine hydrochloride as follows (see Pharmaceutical Compounding—Sterile Preparations <797>). to: Prepare Lidocaine, Racepinephrine, and Tetracaine Hydrochlorides Compounded Topical Gel containing 40 mg/mL of lidocaine hydrochloride, 1 mg/mL of racepinephrine hydrochloride, and 10 mg/mL of tetracaine hydrochloride as follows (see Pharmaceutical Compounding—Nonsterile Preparations <795>).
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IPRATROPIUM BROMIDE INHALATION SOLUTION |
IMPURITIES |
USPNF Online
|
Online |
29-Mar-2024 |
1-Apr-2024 |
NA
|
NA
|
In Organic Impurities: Change Column: 4.6-mm × 25-µm; 5-µm packing L1 to: Column: 4.6-mm × 25-cm; 5-µm packing L1 |
ENSULIZOLE |
IDENTIFICATION |
USPNF Online
|
Online |
29-Mar-2024 |
1-Apr-2024 |
NA
|
NA
|
In B.: Change The retention time of the major peak of the Sample solution exhibits maxima and minima at the same wavelengths as those of the Standard solution, as obtained in the Assay. to: The retention time of the major… Read More
In B.: Change The retention time of the major peak of the Sample solution exhibits maxima and minima at the same wavelengths as those of the Standard solution, as obtained in the Assay. to: The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.
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PROPOFOL |
ASSAY |
USPNF Online
|
Online |
23-Feb-2024 |
1-Mar-2024 |
NA
|
NA
|
In Procedure 2/Mobile phase: Change Hexane, acetonitrile, and alcohol (990: 7.5: 1) to: Hexane, acetonitrile, and alcohol, absolute (990: 7.5: 1) |
METHYLNALTREXONE BROMIDE |
CHEMICAL INFORMATION |
USPNF Online
|
Online |
23-Feb-2024 |
1-Mar-2024 |
NA
|
NA
|
Correct the chemical structure |
IODIXANOL INJECTION |
IMPURITIES |
USPNF Online
|
Online |
23-Feb-2024 |
1-Mar-2024 |
NA
|
NA
|
In Organic Impurities, Procedure 2/footnote 4: Change 5-[[3-[[3-[[[3-[[3-[[3,5-Bis-[[[2,3-dihydroxypropyl]amino]carbonyl]-2,4,6-triiodophenyl](acetylimino)]-2-hydroxypropyl](acetylimino)]-5-[[[2,3-dihydroxypropyl]amino]carbonyl]-2,4,6-triiodophenyl]carbonyl]amino]-2-hy… Read More
In Organic Impurities, Procedure 2/footnote 4: Change 5-[[3-[[3-[[[3-[[3-[[3,5-Bis-[[[2,3-dihydroxypropyl]amino]carbonyl]-2,4,6-triiodophenyl](acetylimino)]-2-hydroxypropyl](acetylimino)]-5-[[[2,3-dihydroxypropyl]amino]carbonyl]-2,4,6-triiodophenyl]carbonyl]amino]-2-hy droxypropyl]oxy]-2-hydroxypropyl](acetylimino)]-N,N'-bis(2,3-dihy droxypropyl)-2,4,6-triiodo-1,3-benzendicarboxamide. to: 5-[[3-[[3-[[[3-[[3-[[3,5-Bis-[[[2,3-dihydroxypropyl]amino]carbonyl]-2,4,6-triiodophenyl](acetylamino)]-2-hydroxypropyl](acetylamino)]-5-[[[2,3-dihydroxypropyl]amino]carbonyl]-2,4,6-triiodophenyl]carbonyl]amino]-2-hydroxypropyl]oxy]-2-hydroxypropyl](acetylamino)]-N,N'-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-1,3-benzendicarboxamide.
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THALIDOMIDE CAPSULES |
ASSAY |
USPNF Online
|
Online |
23-Feb-2024 |
1-Mar-2024 |
NA
|
NA
|
In Procedure: Change 1000C(RU/RS) to: 500C(RU/RS) |
<1228.1> DRY HEAT DEPYROGENATION |
INTRODUCTION |
USPNF Online
|
Online |
23-Feb-2024 |
1-Mar-2024 |
NA
|
NA
|
Change parental manufacturing to: parenteral manufacturing |
COCOYL CAPRYLOCAPRATE |
SPECIFIC TESTS |
USPNF Online
|
Online |
23-Feb-2024 |
1-May-2024 |
NA
|
NA
|
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. |
METOLAZONE |
IMPURITIES |
USPNF Online
|
Online |
23-Feb-2024 |
1-Mar-2024 |
NA
|
NA
|
In Organic Impurities/Chromatographic system/Column: Change 4.6-mm × 25-cm; 5-µm packing 1 to: 4.6-mm × 25-cm; 5-µm packing L1 |
IODIXANOL INJECTION |
ADDITIONAL REQUIREMENTS |
USPNF Online
|
Online |
23-Feb-2024 |
1-Mar-2024 |
NA
|
NA
|
In USP Reference Standards 〈11〉/USP Iodixanol Related Compound E RS: Change 5-[[3-[[3-[[(2,3-Dihydroxypropyl)amino]carbonyl]-5- [[amino]carbonyl]-2,4,6-triiodophenyl](acetylimino)]-2-hydroxypropyl]-(acetylimino)]-N,N′-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-1,3-… Read More
In USP Reference Standards 〈11〉/USP Iodixanol Related Compound E RS: Change 5-[[3-[[3-[[(2,3-Dihydroxypropyl)amino]carbonyl]-5- [[amino]carbonyl]-2,4,6-triiodophenyl](acetylimino)]-2-hydroxypropyl]-(acetylimino)]-N,N′-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-1,3-benzenedicarboxamide. to: 5-{N-[3-(N-{3-Carbamoyl-5-[(2,3-dihydroxypropyl)carbamoyl]-2,4,6-triiodophenyl}acetamido)-2-hydroxypropyl]acetamido}-N1,N3-bis(2,3-dihydroxypropyl)-2,4,6-triiodoisophthalamide.
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FLURAZEPAM HYDROCHLORIDE |
USP REFERENCE STANDARDS 〈11〉 |
USPNF Online
|
Online |
23-Feb-2024 |
1-Mar-2024 |
NA
|
NA
|
In USP Flurazepam Related Compound C RS: Change 5-Chloro-2-(2-diethylaminoethyl(amino)-2′-fluorobenzophenone hydrochloride. to: 5-Chloro-2-(2-diethylaminoethylamino)-2′-fluorobenzophenone hydrochloride. |
THEOPHYLLINE CAPSULES |
IDENTIFICATION |
USPNF Online
|
Online |
26-Jan-2024 |
1-Feb-2024 |
NA
|
NA
|
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
|
Online |
26-Jan-2024 |
1-Feb-2024 |
NA
|
NA
|
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
|
NA
|
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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LINEZOLID TABLETS |
PERFORMANCE TESTS |
USPNF Online
|
Online |
26-Jan-2024 |
1-Feb-2024 |
NA
|
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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CARVEDILOL TABLETS |
PERFORMANCE TESTS |
USPNF Online
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Online |
26-Jan-2024 |
1-Feb-2024 |
NA
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NA
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In Dissolution <711>/Test 3/Chromatographic system/Column: Change 4.6-mm × 15-mm; 5-μm packing L7 to: 4.6-mm × 15-cm; 5-μm packing L7 |
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) |
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 |
<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
|
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
|
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. |