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PDF CSV January 27, 2019 through January 27, 2021 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
FENTANYL CHEMICAL INFORMATION USP43–NF38 Online 1-Jan-2021 NA NA Change
336.47
to:
336.48
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.
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:
Read More
<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
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
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
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
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) × (M… Read More
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
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
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,5… 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 ·… Read More
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
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
<1085> GUIDELINES ON THE ENDOTOXINS TEST METHOD SUITABILITY USP43–NF38 7665 1-Dec-2020 NA NA In Row 2 of Column 3 of Table 3: Change
hydrochloride
to:
hydrochloric acid
AND
In paragraph 2 of Method Suitability Testing/Common Test Interferences: Change
hydrochloride
to:
hydrochloric acid
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:
Read More
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
<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
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
MIRTAZAPINE ADDITIONAL REQUIREMENTS USP43–NF38 2976 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
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
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)
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… Read More
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; riRead More
TIAMULIN IMPURITIES/Organic Impurities USP43–NF38 4368 1-Dec-2020 NA NA In the equation in Analysis: Change
Result = (rU/rT) x 100
to:
Result = (rU/rT) x D x 100
AND
Add
D = dilution factor for… Read More
<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-… Read More
<1092> THE DISSOLUTION PROCEDURE: DEVELOPMENT AND VALIDATION 2. METHOD DEVELOPMENT Second Supplement to USP43–NF38 Online 1-Dec-2020 NA NA In paragraph 2 of 2.4 Study Design/2.4.1 Time Points: Change
Assessment of Drug Product Performance—Bioavailability, Bioequivalence, and Dissolution 〈1090〉.
to:
Assessment of Solid Oral Drug Product Performance and… Read More
FENOPROFEN CALCIUM CHEMICAL INFORMATION USP43–NF38 1843 1-Dec-2020 NA NA Change
[53746-45-5];
to:
[71720-56-4];
<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
<661.1> PLASTIC MATERIALS OF CONSTRUCTION INTRODUCTION First Supplement to USP43–NF38 Online 1-Dec-2020 NA NA Delete
An example of an extractable elements testing strategy is provided in Evaluation of Plastic Packaging Systems and Their Materials of Construction with Respect to Their User Safety Impact 〈1661〉.
<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
<1671> THE APPLICATION OF MOISTURE VAPOR TRANSMISSION RATES FOR SOLID ORAL DOSAGE FORMS IN PLASTIC PACKAGING SYSTEMS EQUIVALENCY AND APPLICATION OF MVTR DETERMINATION METHOD Second Supplement to USP43–NF38 Online 1-Dec-2020 NA NA In Application/paragraph 3: Change
≤0.8/day/tablet
to:
≤0.8 mg/day/tablet
<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
Read More
<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
PRAZIQUANTEL TABLETS PERFORMANCE TESTS/Dissolution <711> USP43–NF38 3650 1-Nov-2020 NA NA In For products for veterinary use/Apparatus 2: Change
peak vessels
to:
apex vessels
APREPITANT CAPSULES PERFORMANCE TESTS/Dissolution <711> USP43–NF38 362 1-Nov-2020 NA NA In Test 3/Apparatus 2: Change
peak vessels.
to:
apex vessels.
GALANTAMINE TABLETS PERFORMANCE TESTS/Dissolution <711> USP43–NF38 2081 1-Nov-2020 NA NA In Test 3/Apparatus 2: Change
peak vessels
to:
apex vessels
NATEGLINIDE CHEMICAL INFORMATION USP43–NF38 Online 1-Nov-2020 NA NA This erratum applies to the USP-NF ONLINE platform only.
See http://uspnf.com/nateglinide-err-img-20201030 for correction
METHYLENE BLUE CHEMICAL INFORMATION First Supplement to USP43–NF38 Online 1-Nov-2020 NA NA Change
Phenothiazin-5-ium, 3,7-bis(dimethylamino)-, chloride;
3,7-Bis(dimethylamino)phenothiazin-5-ium chloride;
to:
Phenothiazin‐5‐ium, 3,7‐bis(dimethylamino)‐, chloride, hydrate (1:1:x);
3,7‐Bis(dimethylamino)phenothiazin‐5‐ium chloride… Read More
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLETS ASSAY/Procedure First Supplement to USP43–NF38 Online 1-Nov-2020 NA NA In Buffer A: Change
monobasic potassium phosphate
to:
monobasic sodium phosphate
HYDROXYPROPYL BETADEX CHEMICAL INFORMATION USP43–NF38 5818 1-Nov-2020 NA NA Change
[94035-02-6].
to:
[128446-35-5].
GALANTAMINE EXTENDED-RELEASE CAPSULES ADDITIONAL REQUIREMENTS/USP Reference Standards <11> First Supplement to USP43–NF38 Online 1-Nov-2020 NA NA In USP Galantamine Hydrobromide Related Compounds Mixture RS: Change
Anhydrogalantamine;
(4aS,8aS)-3-Methoxy-11-methyl-9,10,11,12-tetrahydro-4aH-benzo[2,3]benzofuro[4,3-cd]azepine.
C17H19NO2
Read More
GELATIN SPECIFIC TESTS/Sulfur Dioxide Harmonization (Official May 01, 2020) 5783 1-Nov-2020 NA NA In three instances in Analysis: Change
0.1 M sodium hydroxide
to:
Titrant
AND
In the equation: Change
M
to:
N
AND
In the variable definition list: Change
M = actual… Read More
VERAPAMIL HYDROCHLORIDE IMPURITIES/Organic Impurities USP43–NF38 4604 1-Nov-2020 NA NA Change
Buffer, Mobile phase, and Chromatographic system: Proceed as directed in the Assay.
to:
Buffer and Mobile phase: Prepare as directed in the Assay.
OXYGEN IMPURITIES USP43–NF38 3347 1-Nov-2020 NA NA Change
Impurities Testing in Medical Gases Assay 〈413〉
to:
Impurities Testing in Medical Gases 〈413〉
MEDICAL AIR IMPURITIES USP43–NF38 100 1-Nov-2020 NA NA Change
Impurities Testing in Medical Gases Assay 〈413〉
to:
Impurities Testing in Medical Gases 〈413〉
OXYGEN 93 PERCENT IMPURITIES USP43–NF38 3347 1-Nov-2020 NA NA Change
Impurities Testing in Medical Gases Assay 〈413〉
to:
Impurities Testing in Medical Gases 〈413〉
CLOMIPHENE CITRATE TABLETS ADDITIONAL REQUIREMENTS/USP Reference Standards <11> First Supplement to USP43–NF38 Online 1-Nov-2020 NA NA In USP Clomiphene Related Compound A RS: Change
(E,Z)-2-[4-(1,2-Diphenylethyl)phenoxy]-N,N-diethylethanamine hydrochloride.
to:
(E,Z)-2-[4-(1,2-Diphenylethenyl)phenoxy]-N,N-diethylethanamine hydrochloride.
ANISE OIL IDENTIFICATION/A. Chromatographic Identity First Supplement to USP43–NF38 Online 1-Nov-2020 NA NA In Acceptance criteria/Chromatographic similarity: Change
[Note—The chromatogram of the Standard is similar to the reference chromatogram provided with the lot of being used.]
to:
[Note—The chromatogram of the Standard is… Read More
<733> LOSS ON IGNITION INTRODUCTION USP43–NF38 Online 1-Nov-2020 NA NA In paragraph 3: Change
Upon completion of each ignition, cover the crucible, and allow it to cool in a desiccator to room temperature before weighing.
to:
Upon completion of each ignition, cover the crucible, and allow it to cool in a desiccator to… Read More