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PDF CSV October 12, 2022 through October 12, 2024 See all Errata for USP–NF How to use
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Monograph Title Section Source Publication Page Number Errata Official Date Target Errata Print Publication Target Online Fix Publication Description
METHOTREXATE ASSAY USPNF Online Online 1-Oct-2024 NA NA In Procedure/Buffer: Correct the reagent cross reference
1 N sodium hydroxide
to:
1 N sodium hydroxide
RALBUMIN HUMAN IMPURITIES USPNF Online Online 1-Oct-2024 NA NA In Limit of High Molecular Weight Proteins: Change
Acceptance criteria
Individual impurities: NMT 1.0%
to:
Acceptance criteria: NMT 1.0%
AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE CAPSULES ASSAY USPNF Online Online 1-Oct-2024 NA NA In Procedure/Buffer 1: Change
tetrabutyl ammonium
to:
tetrabutylammonium
FLUCONAZOLE TABLETS ADDITIONAL REQUIREMENTS USPNF Online Online 1-Oct-2024 NA NA In USP Reference Standards <11>/USP Fluconazole Related Compound B RS: Change
C13H13FN9O
to:
C13H13FN6O
PHENOXYBENZAMINE HYDROCHLORIDE ASSAY USPNF Online Online 1-Oct-2024 NA NA In Procedure/Solution A: Change
sodium phosphate monobasic
to:
sodium phosphate, monobasic, anhydrous
CETIRIZINE HYDROCHLORIDE IMPURITIES USPNF Online Online 1-Oct-2024 NA NA In Organic Impurities, Procedure 2/Solution A: Change
tetrabutyl ammonium
to:
tetrabutylammonium
MOXIFLOXACIN TABLETS IMPURITIES USPNF Online Online 1-Oct-2024 NA NA In Organic Impurities/Buffer: Change
tetrabutyl ammonium
to:
tetrabutylammonium
AND
In Organic Impurities/Solution C: Change
tetrabutyl ammonium
to:
tetrabutylammonium
CALCITONIN SALMON IMPURITIES USPNF Online Online 1-Oct-2024 NA NA In Procedure: Related Peptides and Other Related Substances/Test 2: Change
Resolution solution:
to:
System suitability solution:
AND
In Procedure: Related Peptides and Other Related Substances/Test 2… Read More
KETOCONAZOLE ASSAY USPNF Online Online 1-Oct-2024 NA NA In Procedure/Buffer: Change
tetrabutyl ammonium
to:
tetrabutylammonium
RALBUMIN HUMAN ASSAY USPNF Online Online 1-Oct-2024 NA NA In Albumin Content/Native stock running buffer: Change
glycerol
to:
glycine
ADENOSINE ASSAY USPNF Online Online 1-Oct-2024 NA NA In Procedure/Buffer: Change
tetrabutyl ammonium
to:
tetrabutylammonium
CETIRIZINE HYDROCHLORIDE TABLETS IMPURITIES USPNF Online Online 1-Oct-2024 NA NA In Organic Impurities/Buffer: Change
tetrabutyl ammonium
to:
tetrabutylammonium
PACLITAXEL IMPURITIES USPNF Online Online 1-Oct-2024 NA NA In Organic Impurities/Table 4: Change
a(2aR,4S,4aS,6R,9S,11S,12S,12aR,12bS)-12b-(Acetyloxy)-12-(benzyloxy)-1,2a,3,4,4a,6,9,10,11,12,12a,12b-dodecahydro-4,6,9,11-tetrahydroxy-4a,8,13,13-… Read More
CALCITONIN SALMON SPECIFIC TESTS USPNF Online Online 1-Oct-2024 NA NA In Bioidentity/Medium B: Change
2 mM RPMI 1640
to:
RPMI 1640
POTASSIUM PHOSPHATES COMPOUNDED INJECTION ASSAY USPNF Online Online 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
NICARDIPINE HYDROCHLORIDE ADDITIONAL REQUIREMENTS USPNF Online Online 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
EXENATIDE INJECTION PRODUCT-RELATED SUBSTANCES AND IMPURITIES USPNF Online Online 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 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
NAPROXEN SODIUM SPECIFIC TESTS USPNF Online Online 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.
EDETATE DISODIUM COMPOUNDED OPHTHALMIC SOLUTION DEFINITION USPNF Online Online 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 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
NEOMYCIN AND POLYMYXIN B SULFATES AND LIDOCAINE CREAM ASSAY USPNF Online Online 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 BRead More
TYLOSIN INJECTION SPECIFIC TESTS USPNF Online Online 1-Jun-2024 NA NA Change
pH 〈921〉
to:
pH 〈791〉
CEFUROXIME AXETIL FOR ORAL SUSPENSION ASSAY USPNF Online Online 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
METRONIDAZOLE CAPSULES IMPURITIES USPNF Online Online 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
PROCAINAMIDE HYDROCHLORIDE ASSAY USPNF Online Online 1-Jun-2024 NA NA In Resolution solution: Change
p-aminoben zoic acid
to:
p-aminobenzoic acid
DOCETAXEL IMPURITIES USPNF Online Online 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
RIVASTIGMINE TARTRATE ADDITIONAL REQUIREMENTS USPNF Online Online 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
DOXORUBICIN HYDROCHLORIDE ASSAY USPNF Online Online 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 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
BROMPHENIRAMINE MALEATE SPECIFIC TESTS USPNF Online Online 1-May-2024 NA NA Change
Optical Rotation 〈781〉
to:
Optical Rotation, Angular Rotation 〈781A〉
RIVASTIGMINE TARTRATE IMPURITIES USPNF Online Online 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 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
DAPSONE TABLETS PERFORMANCE TESTS USPNF Online Online 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
LIDOCAINE, RACEPINEPHRINE AND TETRACAINE HYDROCHLORIDES COMPOUNDED TOPICAL GEL DEFINITION USPNF Online Online 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
IPRATROPIUM BROMIDE INHALATION SOLUTION IMPURITIES USPNF Online Online 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 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
SUCROSE IMPURITIES USPNF Online Online 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
LIDOCAINE ASSAY USPNF Online Online 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
IODIXANOL INJECTION ADDITIONAL REQUIREMENTS USPNF Online Online 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
FLURAZEPAM HYDROCHLORIDE USP REFERENCE STANDARDS 〈11〉 USPNF Online Online 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.
PROPOFOL ASSAY USPNF Online Online 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 1-Mar-2024 NA NA Correct the chemical structure
IODIXANOL INJECTION IMPURITIES USPNF Online Online 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
THALIDOMIDE CAPSULES ASSAY USPNF Online Online 1-Mar-2024 NA NA In Procedure: Change
1000C(RU/RS)
to:
500C(RU/RS)
<1228.1> DRY HEAT DEPYROGENATION INTRODUCTION USPNF Online Online 1-Mar-2024 NA NA Change
parental manufacturing
to:
parenteral manufacturing
COCOYL CAPRYLOCAPRATE SPECIFIC TESTS USPNF Online Online 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 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
LINEZOLID TABLETS PERFORMANCE TESTS USPNF Online Online 1-Feb-2024 NA NA 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
CARVEDILOL TABLETS PERFORMANCE TESTS USPNF Online Online 1-Feb-2024 NA NA 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