Skip to main content

Errata - English

PDF CSV October 31, 2022 through October 31, 2024 All Errata for USP–NF How to use
Enter the title of the monograph
Monograph Title Section Source Publication Page Number Errata Official Date Target Errata Print Publication Target Online Fix Publication Description
DICLOXACILLIN SODIUM CAPSULES PERFORMANCE TESTS USP42–NF37 1330 1-Mar-2020 NA NA In Dissolution <711>: Change
Sample solution: Sample per the chapter. Dilute with Medium to a concentration that is similar to the Standard solution.
Tolerances: NLT 75% (Q) of the labeled amount of… Read More
ALFADEX CHEMICAL INFORMATION USP42–NF37 5561 1-Feb-2020 NA NA Change
972.84
to:
972.85
MEROPENEM FOR INJECTION ASSAY/Procedure Second Supplement to USP42–NF37 9216 1-Feb-2020 NA NA In Mobile phase: Change
Solution A
to:
Buffer
POLYETHYLENE GLYCOL CHEMICAL INFORMATION USP42–NF37 5882 1-Feb-2020 NA NA See https://www.uspnf.com/sites/default/files/usp_pdf/EN/january-2020-errata-with-image.pdf for correction
CYPROHEPTADINE HYDROCHLORIDE ORAL SOLUTION IMPURITIES/Organic Impurities USP42–NF37 1195 1-Jan-2020 NA NA In Standard solution: Change
in Solution B
to:
in Diluent
<121> INSULIN ASSAYS ASSAY/Rabbit Blood Sugar Method—Quantitative Revision Bulletin (Official May 01, 2019) Online 1-Jan-2020 NA NA In Standard stock solution: Change
of USP Insulin RS of the appropriate species
to:
of the USP Insulin Reference Standard of the appropriate species
AND
In Sample stock solution: Change
of USP Insulin RS of the appropriate species.… Read More
CUPRIC CHLORIDE REAGENTS AND REFERENCE TABLES/Reagent Specifications USP42–NF37 6092 1-Jan-2020 NA NA Change
[7447-39-4].
to:
[10125-13-0].
<857> ULTRAVIOLET-VISIBLE SPECTROSCOPY QUALIFICATION OF UV-VIS SPECTROMETERS Second Supplement to USP42–NF37 9570 1-Jan-2020 NA NA In all instances in Table 4: Change
<
to:

AND
In Control of Photometric Response/Acidic Nicotinic Acid Solutions in 0.1 N Hydrochloric Acid/paragraph 1: Change
Using nicotinic acid solutions, the absorbance accuracy… Read More
SIMVASTATIN TABLETS PERFORMANCE TESTS/Dissolution <711> USP42–NF37 4009 1-Dec-2019 NA NA In Standard solution: Change
USP Simvastatin RS in Medium
to:
USP Simvastatin RS in Medium. Transfer a portion of the solution to a centrifuge tube containing about 10 mg of Prewashed manganese dioxide per milliliter of… Read More
<1227> VALIDATION OF MICROBIAL RECOVERY FROM PHARMACOPEIAL ARTICLES VALIDATION OF NEUTRALIZATION METHODS—RECOVERY COMPARISONS Second Supplement to USP42–NF37 9616 1-Dec-2019 NA NA In paragraph 1 in Recovery on Agar Medium: Change
If it is necessary to solubilize the test stample,
to:
If it is necessary to solubilize the test sample,
MEFENAMIC ACID CAPSULES PERFORMANCE TESTS/Dissolution <711> USP42–NF37 2711 1-Dec-2019 NA NA Change
Solution A, Mobile phase, Standard solution, Sample solution, Chromatographic system, and System suitability: Proceed as directed in the Assay, making any necessary volumetric adjustments.
to:
Read More
0.1 N POTASSIUM HYDROXIDE VS REAGENTS AND REFERENCE TABLES/Solutions USP42–NF37 6185 1-Dec-2019 NA NA Change
Standardization: Add 2 drops of phenolphthalein TS to 20 mL of 0.1 N potassium hydroxide VS. Titrate with 0.1 N hydrochloric acid VS until a permanent pale-pink color is produced.
to:
Standardization: Add 2 drops of phenolphthalein TS… Read More
ROPINIROLE EXTENDED-RELEASE TABLETS PERFORMANCE TESTS/Dissolution <711> Revision Bulletin (Official July 01, 2019) Online 1-Dec-2019 NA NA In Test 2 and Test 3 in Analysis: Change
Result1 = C1 × (1/L) × (Mr1/Mr2) × 100
to:
Result1 = C1 × V × (1/L… Read More
ZIPRASIDONE CAPSULES PERFORMANCE TESTS/Dissolution <711>/Test 3/Tier 2 Revision Bulletin (Official October 01, 2019) Online 1-Dec-2019 NA NA In Buffer: Change
6.8 g/L g
to:
6.8 g/L
AND
In Standard stock solution 2: Change
Standard stock solution
to:
Standard stock solution 1
<1430> ANALYTICAL METHODOLOGIES BASED ON SCATTERING PHENOMENA—GENERAL 1. OVERVIEW: GENERAL CHAPTERS BASED ON SCATTERING PHENOMENA Second Supplement to USP42–NF37 9634 1-Dec-2019 NA NA In Row 6 of Column 4 in Table 1: Change
Also properties of condensated phrases
to:
Also properties of condensated phases
AMLODIPINE AND OLMESARTAN MEDOXOMIL TABLETS IMPURITIES/Organic Impurities Second Supplement to USP42–NF37 9101 1-Dec-2019 NA NA In Table 4, Footnote h: Change
0.47,
to:
0.45,
25% TETRABUTYLAMMONIUM HYDROXIDE TS REAGENTS AND REFERENCE TABLES/Solutions Second Supplement to USP42–NF37 9336 1-Dec-2019 NA NA Change
Transfer about 34.82 g
to:
Transfer about 77.1 g
SODIUM BICARBONATE IMPURITIES/Carbonate/Analysis USP42–NF37 Online 1-Dec-2019 NA NA Remove the external reference to a reagent in
Sodium Bicarbonate
2,5-DIHYDROXYBENZOIC ACID REAGENTS AND REFERENCE TABLES/Reagent Specifications USP42–NF37 6097 1-Dec-2019 NA NA Change
[303-07-1].
to:
[490-79-9].
<1430.5> ANALYTICAL METHODOLOGIES BASED ON SCATTERING PHENOMENA—SMALL ANGLE X-RAY SCATTERING AND SMALL ANGLE NEUTRON SCATTERING 6. EXPERIMENTAL CONSIDERATIONS Second Supplement to USP42–NF37 Online 1-Dec-2019 NA NA In 6.2 Resolution/6.2.1 Size resolution: Change
qmin < π/dmax π/dmax
to:
qmin < π/dmax
<1228.4> DEPYROGENATION BY RINSING ROUTINE PROCESS CONTROL USP42–NF37 8067 1-Nov-2019 NA NA In the first paragraph: Change
WFI
to:
Water for Injection
<55> BIOLOGICAL INDICATORS—RESISTANCE PERFORMANCE TESTS D-VALUE DETERMINATION USP42–NF37 6385 1-Nov-2019 NA NA In the third paragraph in Procedure: Change
stated spore filter
to:
stated spore titer
GADOTERIDOL Limit of gadoteridol related compound A USP42–NF37 2020 1-Nov-2019 NA NA In Chromatographic system: Change
packing L21
to:
packing L47
<1229.2> STEAM STERILIZATION OF AQUEOUS LIQUIDS BIOBURDEN/BIOLOGICAL INDICATOR METHOD/Routine Process Control USP42–NF37 8082 1-Nov-2019 NA NA In the first paragraph: Change
calibrartion
to:
calibration
<1222> TERMINALLY STERILIZED PHARMACEUTICAL PRODUCTS—PARAMETRIC RELEASE INTRODUCTION USP42–NF37 8021 1-Nov-2019 NA NA In paragraphs 4 and 5: Change
a probability of a PNSU
to:
a PNSU
HYPROMELLOSE ACETATE SUCCINATE ASSAY USP42–NF37 5772 1-Nov-2019 NA NA In Content of Methoxy and 2-Hydroxypropoxy Groups/Analysis: Change
Result = (rUM/rSM) × (CS/CU) × (Mr1/Mr2)
to:
Result… Read More
<2022> MICROBIOLOGICAL PROCEDURES FOR ABSENCE OF SPECIFIED MICROORGANISMS—NUTRITIONAL AND DIETARY SUPPLEMENTS BUFFER AND MEDIA/Media USP42–NF37 8514 1-Nov-2019 NA NA In Row 5 of Column 2 for L-Cystine in Fluid Selenite–Cystine Medium: Change
10.0 g
to:
10.0 mg
AMIODARONE HYDROCHLORIDE CHEMICAL INFORMATION USP42–NF37 253 1-Oct-2019 NA NA See https://www.uspnf.com/sites/default/files/usp_pdf/EN/september-2019-errata-with-image.pdf for correction.
DESFLURANE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP42–NF37 1230 1-Oct-2019 NA NA In USP Desflurane Related Compound A RS: Change
Bis-(1,2,2,2-tetrafluoroethyl)ether.
to:
Bis-(1,2,2,2-tetrafluoroethyl)ether;
Also known as: 1,1,1,2-Tetrafluoro-2-(1,2,2,2-tetrafluoroethoxy)ethane.
BENZALDEHYDE ASSAY/Procedure USP42–NF37 5586 1-Oct-2019 NA NA In Chromatographic system: Delete
Detector temperature: 25°
BENDAMUSTINE HYDROCHLORIDE FOR INJECTION ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP42–NF37 487 1-Oct-2019 NA NA In USP Bendamustine Related Compound B RS: Change
4-(1-Methyl-5-morpholino-1H-benzimidazol-2-yl)butanoic acid.
C16H21N3O3 303.36
to:
4-(1-Methyl-5-morpholino-1H-benzimidazol-2-yl)… Read More
ZINC SULFATE CHEMICAL INFORMATION USP42–NF37 4649 1-Oct-2019 NA NA Change
Zinc sulfate (1:1) monohydrate 179.46
to:
Zinc sulfate (1:1) monohydrate 179.45
[7446-19-7].
AND
Change
287.56
to:
287.54
ANAGRELIDE CAPSULES PERFORMANCE TESTS/Dissolution <711>/Analysis USP42–NF37 329 1-Oct-2019 NA NA Change
Result = (rU/rS) x (CS/CU) x (Mr1/Mr2) x (V/L) x 100
to:
Result = (rU/rS) x… Read More
HYDROCHLOROTHIAZIDE CAPSULES PERFORMANCE TESTS/Dissolution <711>/Test 2 USP42–NF37 2171 1-Oct-2019 NA NA In Empty capsules solution: Change
Place 10 Capsules
to:
Place 10 empty capsules
PENICILLAMINE CAPSULES PERFORMANCE TESTS/Dissolution <711> Revision Bulletin (Official June 11, 2019) Online 1-Oct-2019 NA NA In Procedure for a pooled sample/Analysis: Change
Result = (AU/AS) × (CS/CU) × V × (1/L) × 100
to:
Result = (AU/AS… Read More
DESFLURANE CHEMICAL INFORMATION USP42–NF37 1230 1-Oct-2019 NA NA Change
(±)-2-Difluoromethyl 1,2,2,2-tetrafluoroethyl ether
to:
(±)-2-Difluoromethyl 1,2,2,2-tetrafluoroethyl ether;
2-(Difluoromethoxy)-1,1,1,2-tetrafluoroethane.
ASHWAGANDHA ROOT DRY EXTRACT COMPOSITION/Content of Withanolides USP42–NF37 4724 1-Oct-2019 NA NA In the first equation in Analysis: Change
CS = concentration of USP Withanoside IV RS in Standard solution A (mg/mL)
to:
CS = concentration of USP Withanolide A RS in Standard solution A (mg/… Read More
BENDAMUSTINE HYDROCHLORIDE FOR INJECTION IMPURITIES/Organic Impurities USP42–NF37 487 1-Oct-2019 NA NA In Table 2: Change
Bendamustine related compound B
to:
Bendamustine related compound Ba
AND
Change
Bendamustine related compound Ca
to:
Bendamustine related compound Cb
AND
Change
Read More
TRIFLUOPERAZINE HYDROCHLORIDE TABLETS Assay USP42–NF37 4473 1-Oct-2019 NA NA Change
2(407.51/480.43)C(rU/rS)
to:
2000(407.51/480.43)C(rU/rS)
PAROXETINE HYDROCHLORIDE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> First Supplement to USP42–NF37 8788 1-Oct-2019 NA NA In USP Paroxetine Related Compound G RS: Change
405.46
to:
441.92
FEXOFENADINE HYDROCHLORIDE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP42–NF37 1828 1-Sep-2019 NA NA In USP Fexofenadine Related Compound A RS: Change
Benzeneacetic acid, 4-[1-oxy-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]butyl]-α,α-dimethyl.
to:
2-(4-{4-[4-(Hydroxydiphenylmethyl)piperidin-1-yl]butanoyl}phenyl)-2-methylpropanoic acid;
Also known as Benzeneacetic… Read More
LEVOFLOXACIN CHEMICAL INFORMATION USP42–NF37 2552 1-Sep-2019 NA NA Change
Anhydrous [100986-85-41].
to:
Anhydrous [100986-85-4].
CHLOROQUINE PHOSPHATE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP42–NF37 939 1-Sep-2019 NA NA In USP Chloroquine Related Compound G RS: Change
C18H26Cl3NO · H2SO4
to:
C18H26ClN3O · H2SO4
FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE EXTENDED-RELEASE TABLETS ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Revision Bulletin (Official August 01, 2018) Online 1-Sep-2019 NA NA In USP Fexofenadine Related Compound A RS: Change
Benzeneacetic acid, 4-[1-oxy-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]butyl]-α,α-dimethyl.
to:
2-(4-{4-[4-(Hydroxydiphenylmethyl)piperidin-1-yl]butanoyl}phenyl)-2-methylpropanoic acid;
Also known as Benzeneacetic… Read More
OLMESARTAN MEDOXOMIL TABLETS IMPURITIES/Organic Impurities Revision Bulletin (Official March 19, 2019) Online 1-Sep-2019 NA NA In the Analysis: Change
CS = concentration of in the Standard solution (mg/mL)
to:
CS = concentration of USP Olmesartan Medoxomil RS in the Standard solution (mg/mL)
FEXOFENADINE HYDROCHLORIDE CAPSULES ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP42–NF37 1830 1-Sep-2019 NA NA In USP Fexofenadine Related Compound A RS: Change
Benzeneacetic acid, 4-[1-oxy-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]butyl]-α,α-dimethyl.
C32H37NO4 538.12
to:
2-(4-{4-[4-(Hydroxydiphenylmethyl)piperidin-1-yl]butanoyl}phenyl… Read More
SILDENAFIL CITRATE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP42–NF37 4002 1-Sep-2019 NA NA In USP Sildenafil Related Compound A RS: Change
5-[2-Ethoxy-5-[(4-methylpiperazin-1-yl)sulfonyl]phenyl]-1-methyl-3-(2-methylpropyl)-1,6-dihydro-7H-pyrazolo[4,3-d]pyrimidin-7-one.
C23H32N6O4S… Read More
CIDOFOVIR INJECTION IMPURITIES/Organic Impurities USP42–NF37 981 1-Sep-2019 NA NA In Table 1: Change
0.56
to:
0.59
MECLOFENAMATE SODIUM CHEMICAL INFORMATION USP42–NF37 2706 1-Sep-2019 NA NA Change
336.15
to:
336.14
AND
Change
[6385-02-0];
to:
[67254-91-5];
AND
Change
UNII: 9MMQ0YER4E.
to:
UNII: 94NJ818U2W.
MORPHINE SULFATE EXTENDED-RELEASE CAPSULES IMPURITIES/Organic Impurities USP42–NF37 Online 1-Sep-2019 NA NA Change
Diluent, Solution A, System suitability solution, Chromatographic system, and Sample solution: Proceed as directed in the Assay.
to:
Diluent, Buffer solution, Solution A, Read More