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PDF CSV September 19, 2022 through September 19, 2024 See all Errata for USP–NF How to use
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Monograph Title Section Source Publication Sort descending Page Number Errata Official Date Target Errata Print Publication Target Online Fix Publication Description
<621> CHROMATOGRAPHY ADJUSTMENT OF CHROMATOGRAPHIC CONDITIONS USPNF Online Online 1-Dec-2022 NA NA In Liquid Chromatography: Isocratic Elution/Injection volume: Change
L2 = internal diameter of the column used (mm)
dc1 = particle size indicated in the monograph (µm)
dc2 =… Read More
<659> PACKAGING AND STORAGE REQUIREMENTS GENERAL DEFINITIONS/Packaging Definitions Second Supplement to USP43–NF38 Online 1-Dec-2025 NA NA In Light-resistant container: Change
〈661.2〉, Functionality, Spectral Transmission Requirements for Light-Resistant Components and Systems.
to:
〈661.2〉, Functionality Test Method, Spectral Transmission Requirements for Light-… Read More
DOXORUBICIN HYDROCHLORIDE INJECTION IMPURITIES/Organic Impurities USPNF 2022 Online Online 1-Nov-2022 NA NA In Analysis: Change
P = potency of doxorubicin in USP Doxorubicin Hydrochloride RS (µg/mg)
to:
P = potency of doxorubicin hydrochloride in USP Doxorubicin Hydrochloride RS (µg/mg)
DIAZOXIDE IMPURITIES/Organic Impurities USPNF Online Online 1-Nov-2022 NA NA In footnote a in Table 2: Change
7-Chloro-2H-benzothiadiazin-3(4H)-one 1,1-dioxide.
to:
7-Chloro-2H-1,2,4-benzothiadiazin-3(4H)-one 1,1-dioxide.
<251> LEAD REQUIREMENTS FOR PROCEDURE VALIDATION USPNF Online Online 1-Jun-2023 NA NA Change
• Precision Repeatability
to:
• Precision
ROSEMARY LEAF DRY AQUEOUS EXTRACT COMPOSITION/Content of Rosmarinic Acid USPNF Online Online 1-May-2023 NA NA In Standard solution B: Change
Before injection, pass through a membrane filter of 0.45-µL or finer pore size,
to:
Before injection, pass through a membrane filter of 0.45-µm or finer pore size,
AND
In Sample solution: Change
Read More
CALCIUM ASCORBATE ASSAY/Procedure USPNF Online Online 1-Aug-2023 NA NA In Analysis: Change
Mr1 = molecular weight of calcium ascorbate dihydrate, 426.43
to:
Mr1 = molecular weight of calcium ascorbate dihydrate, 426.34
AZITHROMYCIN CHEMICAL INFORMATION USPNF Online Online 1-Sep-2023 NA NA Change
748.98
to:
749.00
AND
Change
767.00
to:
767.01
AND
Change
785.02
to:
785.03
CEFDINIR CAPSULES ADDITIONAL REQUIREMENTS USPNF Online Online 1-Dec-2023 NA NA 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
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
DOXAZOSIN MESYLATE IMPURITIES/Organic Impurities USPNF Online Online 1-Nov-2022 NA NA In Analysis: Change
CS = concentration of the corresponding USP Doxazosin Related Compound RS or USP Doxazosin Mesylate RS (for calculating unspecified impurities) in the Standard solution (mg/mL)
to:
CS… Read More
ISOBUTYL ALCOHOL ASSAY/Procedure USPNF Online Online 1-Feb-2023 NA NA In Analysis: Change
rS = sum of all the peaks except those each of which with an area less than 0.1 times the area of the major peak from the Reference solution
to:
rT = sum of all the peaks except those… Read More
RISEDRONATE SODIUM DELAYED-RELEASE TABLETS ASSAY USPNF Online Online 1-May-2023 NA NA Delete
[Note—Use a non-metallic liquid chromatography system for analysis.]
ATORVASTATIN CALCIUM TABLETS IMPURITIES/Organic Impurities USPNF Online Online 1-Jul-2023 NA NA In Analysis: Change
Mr1 = molecular weight of atorvastatin, 558.64
Mr2 = molecular weight of atorvastatin calcium, 1155.34
to:
Mr1 = molecular weight of atorvastatin, 558.65
M… Read More
AZITHROMYCIN IMPURITIES USPNF Online Online 1-Sep-2023 NA NA In Organic Impurities/Table 2: Change:
3′-N-{[4-(Acetylamino)phenyl]sulfonyl}-3′-demethylazithromycinm
to:
3’-N-Demethyl-3’-N-[(4-methylphenyl)sulfonyl]azithromycinm
AND
In Organic Impurities… Read More
CEFDINIR FOR ORAL SUSPENSION ADDITIONAL REQUIREMENTS USPNF Online Online 1-Dec-2023 NA NA 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
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
CALCIUM UNDECYLENATE ASSAY/Procedure USPNF Online Online 1-Nov-2022 NA NA In Solution A: Change
0.15 N hydrochloric acid in water prepared as follows. Transfer 150 mL of hydrochloric acid to a 500-mL volumetric flask, dilute with water to volume, and mix well.
to:
0.15 N hydrochloric acid in water prepared as follows.… Read More
POLYETHYLENE GLYCOL STANDARDS WITH MOLECULAR WEIGHTS OF 1000, 2000, 3000, 4000, AND 6000 DALTONS (G/MOL) CHEMICAL INFORMATION USPNF Online Online 1-Feb-2023 NA NA Change
CAS RN®: 25332-68-3.
to:
CAS RN®: 25322-68-3.
ACARBOSE TABLETS IDENTIFICATION/B. USPNF Online Online 1-May-2023 NA NA Change
The spectrum obtained from the Sample solution shows IR maxima in the regions of 3500–3200, 2950–2890, 1653–1633, and 1070–1000 cm–1.
to:
The spectrum obtained from the sample preparation shows IR maxima in the regions of 3500–3200… Read More
<3> TOPICAL AND TRANSDERMAL DRUG PRODUCTS—PRODUCT QUALITY TESTS SPECIFIC TESTS FOR TDS USPNF Online Online 1-Dec-2023 NA NA In Release Liner Peel Test: Change
The product fails the test if the mean peel force is outside the acceptable range determined during product development.
to:
The product fails the test if the overall mean peel force is outside the acceptable range… Read More
AZITHROMYCIN ADDITIONAL REQUIREMENTS USPNF Online Online 1-Sep-2023 NA NA 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
<81> ANTIBIOTICS—MICROBIAL ASSAYS APPENDICES USPNF Online Online 1-Jan-2024 NA NA In two instances in Appendix 1 equations: Change
14.020
to:
14.022
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
ANETHOLE DEFINITION USPNF Online Online 1-Nov-2022 NA NA Change
(E)-1-methyl-4-(1-propenyl) benzene
to:
(E)-1-methoxy-4-(1-propenyl) benzene
Methyl Acetate CHEMICAL INFORMATION USPNF Online Online 1-Feb-2023 NA NA Change
CAS RN®: 74-20-9.
to:
CAS RN®: 79-20-9.
BISOPROLOL FUMARATE CHEMICAL INFORMATION USPNF Online Online 1-May-2023 NA NA Change
(±)-1-[[α-(2-Isoproproxyethoxy)-p-tolyl]oxy]-3-(isopropyl amino)-2-propanol fumarate (2:1) (salt)
to:
(±)-1-[[α-(2-Isoproproxyethoxy)-p-tolyl]oxy]-3-(isopropylamino)-2-propanol fumarate (2:1) (salt)
VALGANCICLOVIR HYDROCHLORIDE IMPURITIES USPNF Online Online 1-Sep-2023 NA NA In Organic Impurities/Table 3/footnote c: Change
2-[(2-Amino-6-oxo-1,6-dihydro-9H-purin-9-yl)methoxy]-2-hydroxypropyl methyl-L-valinate hydrochloride.
to:
3-[(2-Amino-6-oxo-1,6-dihydropurin-9-yl)methoxy]-2-hydroxypropyl L… Read More
ACARBOSE IMPURITIES USPNF Online Online 1-Jan-2024 NA NA In Chromatographic Purity/Analysis: Change
Result = (rU/rA) × (1/F) × 100
to:
Result = (rU/rA) × (1/F)
PROCAINAMIDE HYDROCHLORIDE ASSAY USPNF Online Online 1-Jun-2024 NA NA In Resolution solution: Change
p-aminoben zoic acid
to:
p-aminobenzoic acid
NALOXONE HYDROCHLORIDE IMPURITIES USPNF Online Online 1-Dec-2022 NA NA In Limit of Naloxone Related Compound D: Delete
Sensitivity solution: 1.25 µg/mL of USP Naloxone Related Compound D RS in 0.1 N hydrochloric acid
AND
In System suitability/Samples: Delete
Sensitivity solution,… Read More
METARAMINOL BITARTRATE SPECIFIC TESTS/Content of Tartaric Acid USPNF Online Online 1-Feb-2023 NA NA In Analysis: Change
Result = {[(VSVB) × N × F]/2 × W} × 100
to:
Result = {[(VSVB) × N × F]/(2 × W)} × 100
ISOFLURANE IMPURITIES/Organic Impurities USPNF Online Online 1-May-2023 NA NA In Analysis: Change
Result = (rU/rS) × CS × (1/F)
to:
Result = (rU/rS) × CF × (1/F)
AND
Change
CS… Read More
PURIFIED SILICEOUS EARTH IMPURITIES USPNF Online Online 1-Aug-2023 NA NA In Leachable Arsenic/Analysis: Change
A 3.0-mL portion of the Sample solution meets the requirements in Arsenic 〈211〉, Procedures, Procedure.
to:
A 3.0-mL portion of the Sample solution meets the… Read More
DIGOXIN TABLETS ASSAY USPNF Online Online 1-Oct-2023 NA NA 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)
GLUCAGON PROCESS-RELATED IMPURITIES AND OTHER COMPONENTS USPNF Online Online 1-Jan-2024 NA NA 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
TYLOSIN INJECTION SPECIFIC TESTS USPNF Online Online 1-Jun-2024 NA NA Change
pH 〈921〉
to:
pH 〈791〉
MAGNESIUM OXIDE IMPURITIES/Limit of Calcium USPNF Online Online 1-Dec-2022 NA NA In Analysis: Change
CU = concentration of Magnesium Hydroxide in the Sample solution (mg/mL)
to:
CU = concentration of Magnesium Oxide in the Sample solution (mg/mL)
FELODIPINE IMPURITIES/Organic Impurities USPNF Online Online 1-Dec-2022 NA NA Change
Buffer, Mobile phase, System suitability solution, Standard solution, Sample solution, and Chromatographic system: Proceed as directed in the Assay.
to:
Buffer, Mobile phase… Read More
METARAMINOL BITARTRATE ADDITIONAL REQUIREMENTS/USP Reference Standards 〈11〉 USPNF Online Online 1-Feb-2023 NA NA In USP Metaraminol Enantiomer RS: Change
3-[(1S,2R)-2-Amino-1-hydroxypropyl]phenol.
C9H13NO2 167.21
to:
3-[(1S,2R)-2-Amino-1-hydroxypropyl]phenol D-tartrate.
C9H Read More
BUPIVACAINE HYDROCHLORIDE INJECTION ASSAY/Procedure USPNF Online Online 1-May-2023 NA NA In Chromatographic system/Column: Change
4-mm × 30-cm; packing L1
to:
3.9-mm × 30-cm; packing L1
AND
In System suitability: Change
[Note—The relative retention times for bupivacaine hydrochloride and dibutyl phthalate are… Read More
REAGENTS AND REFERENCE TABLES Reagent Specifications/Tosylchloramide Sodium USPNF Online Online 1-Aug-2023 NA NA Change
127-65-1
to:
7080-50-4
DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS PERFORMANCE TESTS USPNF Online Online 1-Oct-2023 NA NA 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
SECOBARBITAL SODIUM OTHER REQUIREMENTS USPNF Online Online 1-Jan-2024 NA NA 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
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.
<621> CHROMATOGRAPHY SYSTEM SUITABILITY USPNF Online Online 1-Dec-2022 NA NA Change
System Repeatability—Assay of an Active Substance or an Excipient
to:
System Repeatability
ZINC UNDECYLENATE ASSAY/Procedure USPNF Online Online 1-Dec-2022 NA NA In Solution A: Change
0.15 N hydrochloric acid in water prepared as follows. Transfer 150 mL of hydrochloric acid to a 500-mL volumetric flask, dilute with water to volume, and mix well.
to:
0.15 N hydrochloric acid in water prepared as follows.… Read More
FLUTICASONE PROPIONATE NASAL SPRAY IMPURITIES/Organic Impurities USPNF Online Online 1-Feb-2023 NA NA In Analysis: Change
Samples: System suitability solution, Identification solution, and Sample solution
to:
Samples: Identification solution and Sample solution
PINDOLOL ASSAY/Procedure USPNF Online Online 1-May-2023 NA NA In Standard stock solution: Change
1 mg/mL of USP Pindolol RS in Mobile phase prepared as follows. To a suitable amount of USP Pindolol RS add Mobile phase to fill about 90% of the total volume, and sonicate for about 5 min to… Read More
TRIAZOLAM TABLETS PERFORMANCE TESTS/Dissolution 〈711〉 USPNF Online Online 1-Aug-2023 NA NA In Standard solution: Change
Tablet/mg
to:
mg/Tablet