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PDF CSV October 31, 2022 through October 31, 2024 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
RILUZOLE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP43–NF38 3882 1-Apr-2021 NA NA In USP Riluzole Related Compound A RS: Change
4-Trifluoromethoxyphenylamine; 4-trifluoromethoxyanaline.
C7H6F3NO 177.12
to:
4-(Trifluoromethoxy)aniline.
C7H6F3NO 177.… Read More
MIRTAZAPINE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP43–NF38 Online 1-Apr-2021 NA NA In USP Mirtazapine Resolution Mixture RS: Change
Impurity D: 1,2,3,4,10,14b-Hexahydropyrazino[2,1-a]pyrido[2,3-c][2]benzazepine.
to:
Impurity D: [Note–This impurity may be available either as the free base form or as the hydrochloride salt… Read More
<659> PACKAGING AND STORAGE REQUIREMENTS GENERAL DEFINITIONS/Packaging Definitions Second Supplement to USP43–NF38 Online 1-Apr-2021 NA NA In Light-resistant container: Change
〈671〉, Spectral Transmission
to:
〈671〉, Spectral Transmission for Light-Resistant Packaging Components or Systems
NADOLOL AND BENDROFLUMETHIAZIDE TABLETS IMPURITIES USPNF 2021 ISSUE 1 Online 1-May-2021 NA NA In Organic Impurities, Procedure 2: Bendroflumethiazide Related Impurities/Acceptance criteria: Change
The reporting threshold is NMT 0.05%.
to:
The reporting threshold is 0.05%.
ZILEUTON USP Reference standards <11> USP43–NF38 4679 1-Apr-2021 NA NA In USP Zileuton Related Compound A RS: Change
N-(1-Benzo-[b]thien-2-ylethyl)urea.
C11H12N2OS 220.30
to:
N-(1-Benzo-[b]thien-2-ylethyl)urea;
Also known as 1-[1-(Benzo… Read More
AMLODIPINE AND OLMESARTAN MEDOXOMIL TABLETS ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP43–NF38 Online 1-Mar-2021 NA NA In USP Amlodipine Related Compound A RS: Change
522.93
to:
522.94
STRONTIUM CHLORIDE Sr 89 INJECTION CHEMICAL INFORMATION USP43–NF38 4126 1-Mar-2021 NA NA Change
89SrC12
to:
89SrCl2
FENTANYL CITRATE CHEMICAL INFORMATION USPNF 2021 ISSUE 1 Online 1-May-2021 NA NA Change
528.59
to:
528.60
PACLITAXEL INJECTION TITLE USPNF 2021 ISSUE 1 Online 1-May-2021 NA NA Change
Paclit 1axel Injection
to:
Paclitaxel Injection
<643> TOTAL ORGANIC CARBON PROCEDURES/2. Sterile Water USPNF 2021 ISSUE 1 Online 1-May-2021 NA NA In Column 2 in Table 2: Change
1,4-Benzoquinone (mL/L)
to:
1,4-Benzoquinone (mg/L)
AND
In Column 2 and 4 in Table 3: Change
Sucrose Concentration (mg/mL)
to:
Sucrose Concentration (mg/L)
COPOVIDONE IMPURITIES/Limit of Monomers (1-Vinyl-2-Pyrrolidone and Vinyl Acetate) Harmonization (Official May 01, 2021) Online 1-May-2021 NA NA In Standard solution: Change
0.25 μg/mL of 1-vinyl-2-pyrrolidone and 5 μg/mL of vinyl acetate, respectively, diluted from the Standard stock solution in Mobile phase
to:
0.25 μg/mL of 1-vinyl-2-pyrrolidone and 0.25 μg/mL of vinyl… Read More
AMITRIPTYLINE HYDROCHLORIDE ASSAY/Procedure USP43–NF38 261 1-Mar-2021 NA NA In System suitability solution: Change
0.5 µg/mL of USP Amitriptyline Related Compound A RS, 1 µg/mL of USP Amitriptyline Hydrochloride RS, and 1.5 µg/mL each of USP Amitriptyline Related Compound B RS, USP Cyclobenzaprine Hydrochloride RS, and USP… Read More
VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES PERFORMANCE TESTS/Dissolution <711> USP43–NF38 4598 1-Mar-2021 NA NA In Test 2/Analysis: Change
Resulti = (rU/rS) × CS × (Mr1/Mr2)
to:
Resulti = (AU/AS Read More
FENTANYL CITRATE IMPURITIES/Organic Impurities USPNF 2021 ISSUE 1 Online 1-May-2021 NA NA In both variable definition lists in Analysis: Change
Mr1 = molecular weight of fentanyl citrate, 528.59
Mr2 = molecular weight of fentanyl, 336.47
to:
Mr1 = molecular… Read More
AMLODIPINE AND OLMESARTAN MEDOXOMIL TABLETS IMPURITIES/Organic Impurities USP43–NF38 Online 1-Mar-2021 NA NA In the first variable definition list in Analysis: Change
522.93
to:
522.94
CLONIDINE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP43–NF38 1100 1-Mar-2021 NA NA In USP Clonidine Related Compound A RS: Change
1-Acetyl-2-(2,6-dichlorophenylamino)-2-(4,5-dihydroimidazol).
to:
1-Acetyl-2-(2,6-dichlorophenylimino)imidazolidine.
CLOZAPINE IMPURITIES/Organic Impurities USPNF 2021 ISSUE 1 Online 1-May-2021 NA NA In System suitability/Suitability requirements/Resolution: Change
NLT 2.5 between demethyl clozapine and clozapine
to:
NLT 2.5 between demethyl clozapine and clozapine, System suitability solution
<1051> CLEANING GLASS APPARATUS CLEANING VALIDATION BEST PRACTICES USPNF 2021 ISSUE 1 Online 1-May-2021 NA NA Change
Quantitative Assessment of Cleaning Procedure
to:
Quantitative Assessment of Cleaning Process
<1430.6> ANALYTICAL METHODOLOGIES BASED ON SCATTERING PHENOMENA—PARTICLE COUNTING VIA LIGHT SCATTERING 4. FACTORS THAT AFFECT THE TESTING Second Supplement to USP43–NF38 Online 1-May-2021 NA NA In paragraph 1: Change
an airborne liquid counter.
to:
an airborne counter.
FEXOFENADINE HYDROCHLORIDE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP43–NF38 1869 1-Feb-2021 NA NA In USP Fexofenadine Related Compound B RS: Change
3-[1-Hydroxy-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]butyl]-α,α-dimethyl benzeneacetic acid hydrochloride.
C32H39NO4 · HCl 538.12
to:
3-[1-Hydroxy-4-[4-(… Read More
HYDROMORPHONE HYDROCHLORIDE ORAL SOLUTION IMPURITIES/Organic Impurities USP43–NF38 2252 1-Feb-2021 NA NA In footnote g of Table 3: Change
2,2′-Bihydromorphone.
to:
(5α)-3-Hydroxy-2-[(5α)-3-hydroxy-17-methyl-6-oxo-4,5-epoxymorphinan-2-yl]-17-methyl-4,5-epoxymorphinan-6-one dihydrochloride.
<1079> RISKS AND MITIGATION STRATEGIES FOR THE STORAGE AND TRANSPORTATION OF FINISHED DRUG PRODUCTS 4. RISK MITIGATION CATEGORIES AS QMS ELEMENTS Second Supplement to USP43–NF38 Online 1-Feb-2021 NA NA In 4.1 Documentation and Procedures/4.1.3 Labels: Change
The use of symbols that are recognized by international organizations is strongly recommended.
to:
The use of symbols that are recognized by international organizations is strongly… Read More
DOPAMINE HYDROCHLORIDE AND DEXTROSE INJECTION Limit of 5-hydroxymethylfurfural and related substances USP43–NF38 1495 1-Jan-2021 NA NA In Cation-exchange column: Change
Proceed as directed under Column Partition Chromatography (see Chromatography 〈621〉),
to:
Proceed as directed under Chromatography 〈621〉, General Procedures, Column… Read More
CARVEDILOL IMPURITIES/Organic Impurities, Procedure 2 USP43–NF38 Online 1-Jan-2021 NA NA In Table 3/footnote b: Change
1-(2-(2-Methoxyphenoxy)ethylamino)-3-(6,7,8,9-tetrahydro-5H-carbazol-4-yloxy)propan-2-ol.
to:
1-(2-(2-Methoxyphenoxy)ethylamino)-3-(2,3,4,9-tetrahydro-1H-carbazol-5-yloxy)propan-2-ol.
NOREPINEPHRINE BITARTRATE IDENTIFICATION/C. Procedure USP43–NF38 Online 1-Jan-2021 NA NA In Sample solution: Change
0.01 µg/mL
to:
0.1 mg/mL
<382> ELASTOMERIC COMPONENT FUNCTIONAL SUITABILITY IN PARENTERAL PRODUCT PACKAGING/DELIVERY SYSTEMS 5. NEEDLE AND SPIKE ACCESS FUNCTIONAL SUITABILITY TESTS Second Supplement to USP43–NF38 Online 1-Jan-2021 NA NA In paragraph 4 of 5.1 Fragmentation/Cartridge systems/Procedure A: Change
graticlule
to:
graticule
PINDOLOL TABLETS ASSAY/Procedure Second Supplement to USP43–NF38 Online 1-Jan-2021 NA NA In Chromatographic system/Run time: Change
NLT 2 times the retention time of the nortriptytine peak
to:
NLT 2 times the retention time of the nortriptyline peak
FENTANYL CHEMICAL INFORMATION USP43–NF38 Online 1-Jan-2021 NA NA Change
336.47
to:
336.48
DOBUTAMINE IN DEXTROSE INJECTION ASSAY/Procedure 1: Dextrose USP43–NF38 1470 1-Jan-2021 NA NA In Analysis: Change
Result = [(100 × a) × (l/α)] × (1/CU) × (Mr1/Mr2) × 100
to:
Result = [(100 × a)/(l × α)] × (1/CU) × (Mr1… Read More
CARVEDILOL ADDITIONAL REQUIREMENTS/USP Reference Standards USP43–NF38 Online 1-Jan-2021 NA NA In USP Carvedilol Related Compound A RS: Change
629.74
to:
629.75
AND
In USP Carvedilol Related Compound B RS: Change
645.74
to:
645.76
AND
In USP Carvedilol Related Compound C RS: Change
496.60
to:
496.61
AND
In USP… Read More
NALOXONE HYDROCHLORIDE INJECTION IMPURITIES/Limit of 2,2′-Bisnaloxone Revision Bulletin (Official September 01, 2020) Online 1-Jan-2021 NA NA In Analysis: Change
[Note—The relative retention times for naloxone and 2,2′-bisnaloxone (4,5′:4′,5″-diepoxy-3,3′,14,14′-tetrahydroxy-17,17′-bis(prop-2-enyl)-2,2′-bimorphinanyl-6,6′-dione) are 1.0 and 2.8, respectively.]
to:
[Note—The relative… Read More
FENTANYL CITRATE INJECTION Assay USP43–NF38 1849 1-Jan-2021 NA NA In Procedure: Change
(336.48/528.59)CD(rU/rS)
in which 336.48 and 528.59 are the molecular weights
to:
(336.48/528.60)CD(rU/rS)
in… Read More
TRYPSIN CHEMICAL INFORMATION Second Supplement to USP43–NF38 Online 1-Dec-2020 NA NA Change
C1012H1555N279O324S14 23,293 (for bovine β-Trypsin)
to:
C1012H1585N279O324S14 23,293 (for bovine β-Trypsin)
TIAGABINE HYDROCHLORIDE ASSAY/Procedure USP43–NF38 4365 1-Dec-2020 NA NA In the Standard solution: Change
Transfer suitable volumes of the Standard stock solution and Internal standard solution into a suitable volumetric flask and dilute with Diluent to volume.
to:
0.1 mg/mL of USP Tiagabine… Read More
AMIODARONE HYDROCHLORIDE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP43–NF38 Online 1-Dec-2020 NA NA In USP Amiodarone Related Compound H RS: Change
2-Chloro-N,N-diethylethanamine.
C6H14ClN 135.64
to:
2-Chloro-N,N-diethylethanamine hydrochloride.
C6H14ClN · HCl 172.09
<1092> THE DISSOLUTION PROCEDURE: DEVELOPMENT AND VALIDATION 1. PRELIMINARY ASSESSMENT Second Supplement to USP43–NF38 Online 1-Dec-2020 NA NA In paragraph 4 of 1.4 Choosing an apparatus: Change
peak vessels
to:
apex vessels
<661.1> PLASTIC MATERIALS OF CONSTRUCTION POLYAMIDE 6 First Supplement to USP43–NF38 Online 1-Dec-2020 NA NA In Related Substances/Chromatographic system/Column: Change
0.25-mm × 0.25-µm; phase G25
to:
30-m × 0.25-mm; 0.25-µm phase G25
ORBIFLOXACIN Related compounds USP43–NF38 3275 1-Dec-2020 NA NA In Procedure: Change
20,000(CS)(ri/rS)(1/F)
in which CS is the concentration, in mg per mL, of orbifloxacin in the Standard solution; ri is… Read More
GOSERELIN ACETATE IMPURITIES/Organic Impurities: Related Compounds Interim Revision Announcement (Official May 01, 2020) Online 1-Dec-2020 NA NA In Table 1: Change
Goserelinare
to:
Goserelin
AMLODIPINE AND ATORVASTATIN TABLETS ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP43–NF38 265 1-Dec-2020 NA NA In USP Atorvastatin Related Compound H RS: Change
540.62
to:
540.64
<467> RESIDUAL SOLVENTS APPENDICES/Appendix 3 Interim Revision Announcement (Official December 01, 2020) Online 1-Dec-2020 NA NA In the denominator in the equation in the final paragraph: Change
at mK−1
to:
atm K−1
<1467> RESIDUAL SOLVENTS—VERIFICATION OF COMPENDIAL PROCEDURES AND VALIDATION OF ALTERNATIVE PROCEDURES VERIFICATION OF COMPENDIAL PROCEDURES USP43–NF38 8404 1-Dec-2020 NA NA In Limit Procedures: Procedure A and Procedure B/Verification when solvents likely to be present (LTBP) are not known/Specificity: Change
or acetonitrile and cis-dichloroethene
to:
or methylisobutylketone and cis-dichloroethene
MIRTAZAPINE TABLETS ADDITIONAL REQUIREMENTS USP43–NF38 2978 1-Dec-2020 NA NA In USP Reference Standards <11>/USP Mirtazapine Resolution Mixture RS: Change
This resolution mixture contains approximately 0.1% w/w each of the following:
Impurity A: 1,2,3,4,10,14b-Hexahydro-2-methylpyrazino[2,1-a]pyrido[2,3-c… Read More
EFAVIRENZ TABLETS IMPURITIES/Organic Impurities USP43–NF38 1591 1-Dec-2020 NA NA In the footnotes in Table 2: Change
d(S,E)-6-Chloro-4-(pent-3-en-1-ynyl)-4-(trifluoromethyl)-2H-3,1-benzoxazin-2-one.
e(S,Z)-6-Chloro-4-(pent-3-en-1-ynyl)-4-(trifluoromethyl)-2H-3,1-benzoxazin-2-one.
to:
d… Read More
ATORVASTATIN CALCIUM ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP43–NF38 414 1-Dec-2020 NA NA In USP Atorvastatin Related Compound C RS: Change
Difluoro impurity, or (3R,5R)-7-[3-(phenylcarbamoyl)-4,5-bis(4-fluorophenyl)-2-isopropyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic acid, calcium salt.
to:
Calcium (3R,5R… Read More
<661.2> PLASTIC PACKAGING SYSTEMS FOR PHARMACEUTICAL USE SCOPE/Table 1 First Supplement to USP43–NF38 Online 1-Dec-2020 NA NA Change
If light protection is necessaryc
to:
If light protection is necessary
AND
Change Row 11
Chemical Suitability for Use Assessment Risk-based testing Risk-based testing
to:
Chemical Suitability for Use
Assessment Risk-… Read More
FENOPROFEN CALCIUM CHEMICAL INFORMATION USP43–NF38 1843 1-Dec-2020 NA NA Change
[53746-45-5];
to:
[71720-56-4];
MEBENDAZOLE ORAL SUSPENSION Identification USP43–NF38 2744 1-Dec-2020 NA NA Change
Mix a quantity of Oral Suspension, equivalent to about 200 mg of mebendazole, with 20 mL of a mixture of chloroform and 96 percent formic acid (19:1). Proceed as directed for Identification under Mebendazole Tablets, beginning with “Warm the… Read More
<1092> THE DISSOLUTION PROCEDURE: DEVELOPMENT AND VALIDATION 6. ACCEPTANCE CRITERIA Second Supplement to USP43–NF38 Online 1-Dec-2020 NA NA In Row 1 of Table 5 and Table 6: Align Times with Acceptance Criteria
ATORVASTATIN CALCIUM TABLETS ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP43–NF38 418 1-Dec-2020 NA NA In USP Atorvastatin Related Compound H RS: Change
540.62
to:
540.64