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PDF CSV April 18, 2019 through April 18, 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
TRIHEXYPHENIDYL HYDROCHLORIDE TABLETS IMPURITIES/Organic Impurities USP43–NF38 4519 1-Apr-2021 NA NA In Sample solution: Change
Nominally 1 mg/mL of trihexyphenidyl hydrochloride in Diluent prepared as follows.
to:
Nominally 1 mg/mL of trihexyphenidyl hydrochloride prepared as follows.
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… 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… 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… Read More
SERTRALINE HYDROCHLORIDE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USPNF 2021 ISSUE 1 Online 1-May-2021 NA NA In USP Sertraline Hydrochloride Racemic Mixture RS: Change
C17H17Cl2 · HCl
to:
C17H17Cl2N · HCl
RILUZOLE TABLETS ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP43–NF38 3883 1-Apr-2021 NA NA In USP Riluzole Related Compound A RS: Change
4-Trifluoromethoxyaniline.
C7H6F3NO 177.12
to:
4-(Trifluoromethoxy)aniline.
C7H6F3NO 177.13
MIRTAZAPINE TABLETS 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… 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
GENERAL NOTICES AND REQUIREMENTS 2. OFFICIAL STATUS AND LEGAL RECOGNITION USPNF 2021 ISSUE 1 Online 1-May-2021 NA NA In 2.10. Official Text: Change
http://www.uspnf.com.
to:
https://online.uspnf.com.
CARBOMER COPOLYMER CHEMICAL INFORMATION USPNF 2021 ISSUE 1 Online 1-May-2021 NA NA See online.uspnf.com for correction
GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLETS ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP43–NF38 2128 1-Apr-2021 NA NA In USP Glyburide Related Compound A RS: Change
368.84
to:
368.83
AMPICILLIN ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP43–NF38 316 1-Apr-2021 NA NA In USP Amoxicillin Related Compound A RS: Change
(2S,5R,6R)-6-Amino-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid.
C16H14N2O2 266.29
to:
(2S… Read More
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.
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 =… 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
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… Read More
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
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
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
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
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
<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
<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〉.
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
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
<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
<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
<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
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)