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PDF CSV May 24, 2022 through May 24, 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
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
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
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
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
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
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
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
THEOPHYLLINE CAPSULES IDENTIFICATION USPNF Online Online 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
DICYCLOMINE HYDROCHLORIDE IDENTIFICATION USPNF Online Online 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
AMOXICILLIN ORAL SUSPENSION IDENTIFICATION USPNF Online Online 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
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
<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
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
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)
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
Strychnine Sulfate REAGENTS AND REFERENCE TABLES USPNF Online Online 1-Dec-2023 NA NA 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 Online 1-Dec-2023 NA NA 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 1-Dec-2023 NA NA In Dissolution 〈711〉: Move Test 2 after Test 1
PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS PERFORMANCE TESTS USPNF Online Online 1-Dec-2023 NA NA 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
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
AMOXICILLIN INTRAMAMMARY INFUSION IDENTIFICATION USPNF Online Online 1-Dec-2023 NA NA 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
NORFLURANE IMPURITIES USPNF Online Online 1-Dec-2023 NA NA 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 1-Dec-2023 NA NA 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 1-Dec-2023 NA NA 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 1-Dec-2023 NA NA 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
SODIUM SALICYLATE ADDITIONAL REQUIREMENTS USPNF Online Online 1-Dec-2023 NA NA In USP Reference Standards 〈11〉: Add
USP Phenol RS
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
<631> COLOR AND ACHROMICITY METHOD II: INSTRUMENTAL (QUANTITATIVE) ASSESSMENT OF COLOR AND COLOR MATCHES USPNF Online Online 1-Dec-2023 NA NA 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
AZITHROMYCIN IMPURITIES USPNF Online Online 1-Dec-2023 NA NA 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
OLMESARTAN MEDOXOMIL TABLETS PERFORMANCE TESTS USPNF Online Online 1-Dec-2023 NA NA 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 1-Dec-2023 NA NA In USP Reference Standards 〈11〉/USP Cefdinir Related Compound A RS: Change
413.43
to:
413.42
AMOXICILLIN BOLUSES IDENTIFICATION USPNF Online Online 1-Dec-2023 NA NA 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
DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE CAPSULES ADDITIONAL REQUIREMENTS USPNF Online Online 1-Dec-2023 NA NA 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.
<430> PARTICLE SIZE ANALYSIS BY DYNAMIC LIGHT SCATTERING GLOSSARY USPNF Online Online 1-May-2024 NA NA 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 1-Nov-2023 NA NA 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