Skip to main content

Errata - English

PDF CSV May 14, 2022 through May 14, 2024 All Errata for USP–NF How to use
Enter the title of the monograph
Monograph Title Sort descending Section Source Publication Page Number Errata Official Date Target Errata Print Publication Target Online Fix Publication Description
BENAZEPRIL HYDROCHLORIDE TABLETS ADDITIONAL REQUIREMENTS/USP References Standards <11> USP43–NF38 Online 1-Jul-2021 NA NA In USP Benazepril Related Compound B RS: Change
(3S)-3-[[(1R)-1-(Ethoxycarbonyl)-3-phenylpropyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-benzazepine-1-acetic acid, monohydrochloride;
Also known as 2-[(SR)-3-{[(RS)-1-… Read More
BENAZEPRIL HYDROCHLORIDE TABLETS PERFORMANCE TESTS/Dissolution <711>/Test 1 First Supplement to USP42–NF37 8644 1-Aug-2019 NA NA In the Standard solution: Change
µg/mL
to:
µg/µL
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
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
BENTONITE IDENTIFICATION/A. X-Ray Diffraction <941> USP35–NF30 1705 1-Oct-2012 USP37–NF32 First Supplement to USP36–NF31 Line 4 of Acceptance criteria: Change
from the pattern of Sample B is 1.492 and 1.504 Å.
to:
from the pattern of Sample B is between 1.492 and 1.504 Å.
BENZALDEHYDE ASSAY/Procedure USP42–NF37 5586 1-Oct-2019 NA NA In Chromatographic system: Delete
Detector temperature: 25°
BENZETHONIUM CHLORIDE IMPURITIES/Organic Impurities/Acceptance criteria First Supplement to USP41–NF36 8297 1-Feb-2019 NA NA In Total impurities: Change
1.0%
to:
NMT 1.0%
BENZOYL PEROXIDE GEL IMPURITIES/Organic Impurities USP38–NF33 2399 1-Jun-2015 USP39–NF34 USP39–NF34 Line 18 of Standard solution D: Change
hydrous benzoyl peroxide (C14H10O4).
to:
anhydrous benzoyl peroxide (C14H10O4).
BENZTROPINE MESYLATE CHEMICAL INFORMATION USP36–NF31 2628 1-Apr-2013 USP37–NF32 USP37–NF32 Line 2: Change
8-Azabicyclo[3.2.1]octane, 3-(diphenylmethoxy)-, endo-, methanesulfonate;
to:
8-Azabicyclo[3.2.1]octane, 3-(diphenylmethoxy)-N-methyl-, endo-, methanesulfonate;
BETADEX IMPURITIES/Limit of Reducing Sugars USP36–NF31 1905 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 3 of Tartrate solution: Change
20 mg/mL of anhydrous sodium sulfate
to:
200 mg/mL of anhydrous sodium sulfate
BETAMETHASONE DIPROPIONATE ASSAY/Procedure USP37–NF32 1961 1-Apr-2015 USP39–NF34 USP39–NF34 Line 2 of Sample solution: Change
5.0 mL each of the Internal standard solution and the Standard stock solution
to:
5.0 mL each of the Internal standard solution and the Sample stock solution
BETAMETHASONE ORAL SOLUTION Identification/A: USP35–NF30 2336 1-Apr-2013 USP37–NF32 USP37–NF32 Line 1: Change
A:
to:
A: Thin-Layer Chromatographic Identification Test <201>—
BETAMETHASONE SODIUM PHOSPHATE IMPURITIES/Limit of Free Betamethasone USP37–NF32 1965 1-Oct-2014 USP39–NF34 First Supplement to USP38–NF33 Line 1 of Sample stock solution: Change
1.0 mg/mL of Betamethasone Sodium Phosphate in water
to:
1.0 mg/mL of Betamethasone Sodium Phosphate in water, prepared as follows. Dissolve 25.0 mg of Betamethasone Sodium Phosphate in water to make 25.0 mL.
BETAMETHASONE SODIUM PHOSPHATE Identification/B. Thin-Layer Chromatographic Identification Test <201> USP36–NF31 2645 1-Aug-2013 USP38–NF33 First Supplement to USP37–NF32 Line 1 of Test solution: Change
1 mg per mL.
to:
1 mg per mL in methanol.
BETAXOLOL OPHTHALMIC SOLUTION IMPURITIES/Organic Impurities USP39–NF34 2749 1-Dec-2016 USP41–NF36 Second Supplement to USP40–NF35 Line 14 of Analysis: Change
Mr1 = molecular weight of betaxolol hydrochloride, 343.89
Mr2 = molecular weight of betaxolol, 307.43
to:
Mr1 = molecular weight of betaxolol, 307.43
Mr2… Read More
BETHANECHOL CHLORIDE IMPURITIES/Heavy Metals, Method 1 <231> Second Supplement to USP36–NF31 6568 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 1 of Test preparation: Change
Bethacholine Chloride
to:
Bethanechol Chloride
BIFIDOBACTERIUM LONGUM SUBSP. LONGUM DEFINITION USPNF 2021 ISSUE 1 Online 1-Jun-2021 NA NA Change
Bifidobacteriumlongum subsp. longum comprises
to:
Bifidobacterium longum subsp. longum comprises
BISMUTH SUBCARBONATE IMPURITIES/Limit of Lead USP38–NF33 2449 1-Apr-2015 USP39–NF34 USP39–NF34 Line 1 of Acceptance criteria: Change
Meets the requirements
to:
NMT 0.002%
BISOCTRIZOLE IMPURITIES/Organic Impurities First Supplement to USP39–NF34 8008 1-Aug-2016 USP41–NF36 First Supplement to USP40–NF35 Footnote b of Table 2: Change
Phenol, 2,2-methylenebis[6-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)].
to:
Phenol, 2,2′-methylenebis[6-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)].
BISOCTRIZOLE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> First Supplement to USP39–NF34 8008 1-Aug-2016 USP41–NF36 First Supplement to USP40–NF35 Line 2 of USP Bisoctrizole Resolution Mixture RS: Change
A mixture of approximately 1.5% of bisoctrizole isomer [phenol, 2,2-methylenebis[6-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)]] in a matrix of bisoctrizole.
to:
A mixture of approximately 1.5% of bisoctrizole isomer… Read More
BISOPROLOL FUMARATE CHEMICAL INFORMATION USPNF Online Online 1-May-2023 NA NA Change
(±)-1-[[α-(2-Isoproproxyethoxy)-p-tolyl]oxy]-3-(isopropyl amino)-2-propanol fumarate (2:1) (salt)
to:
(±)-1-[[α-(2-Isoproproxyethoxy)-p-tolyl]oxy]-3-(isopropylamino)-2-propanol fumarate (2:1) (salt)
BLACK CUMIN SEED THYMOQUINONE OIL DEFINITION USPNF Online Online 1-Sep-2023 NA NA Change
carvacol
to:
carvacrol
BLACK CUMIN SEED THYMOQUINONE OIL SPECIFIC TESTS USPNF Online Online 1-Sep-2023 NA NA In Fats and Fixed Oils 〈401〉, Procedures, Fatty Acid Composition/Table 2: Change
Linoleic
to:
Linoleic acid
BOSWELLIA SERRATA COMPOSITION/Content of Keto-Derivatives of β-Boswellic Acids/System suitability/Suitability requirements USP36–NF31 1366 1-Dec-2013 USP38–NF33 Second Supplement to USP37–NF32 Line 1 of Tailing factor: Change
11-keto-β-boswellic acid peak
to:
3-acetyl-11-keto-β-boswellic acid peak
BOSWELLIA SERRATA EXTRACT COMPOSITION/Content of Keto-Derivatives of β-Boswellic Acids/System suitability/Suitability requirements USP36–NF31 1367 1-Dec-2013 USP38–NF33 Second Supplement to USP37–NF32 Line 1 of Tailing factor: Change
11-keto-β-boswellic acid peak
to:
3-acetyl-11-keto-β-boswellic acid peak
BRETYLIUM TOSYLATE IN DEXTROSE INJECTION Identification USP40–NF35 3049 1-Feb-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 1 of B: Change
It responds to the Identification test under Dextrose.
to:
Add a few drops of a solution (1 in 20) to 5 mL of hot alkaline cupric tartrate TS. A copious red precipitate of cuprous oxide is formed.
BRINZOLAMIDE Related compounds/Test 2 USP35–NF30 2385 1-Apr-2013 USP37–NF32 USP37–NF32 Line 15 of Procedure: Change
relative retention time greater than 6.
to:
relative retention greater than 6.
BRINZOLAMIDE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP39–NF34 2788 1-Feb-2017 USP41–NF36 Second Supplement to USP40–NF35 Line 2 of USP Brinzolamide Related Compound B RS: Change
(R-4-Amino)-2,3-dihydro-2-(3-methoxypropyl)-4H-thieno[3,2,-e]-thiazine-6-sulfonamide-1,1-dioxide ethandioate 1:1.
to:
(R)-4-Amino-2-(3-methoxypropyl)-3,4-dihydro-2H-thieno[3,2-e][1,2]thiazine-6-… Read More
BRINZOLAMIDE OPHTHALMIC SUSPENSION ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP39–NF34 2789 1-Feb-2017 USP41–NF36 Second Supplement to USP40–NF35 Line 2 of USP Brinzolamide Related Compound B RS: Change
(R-4-Amino)-2,3-dihydro-2-(3-methoxypropyl)-4H-thieno[3,2,-e]-thiazine-6-sulfonamide-1,1-dioxide ethandioate 1:1.
to:
(R)-4-Amino-2-(3-methoxypropyl)-3,4-dihydro-2H-thieno[3,2-e][1,2]thiazine-6-… Read More
BROMOCRIPTINE MESYLATE CAPSULES PERFORMANCE TESTS/Dissolution <711> USPNF Online Online 1-May-2022 NA NA In Analysis: Change
bromocriptine mesylate (C32H40BrN5O5 · CH4SO3)
to:
bromocriptine (C32H40BrN5O5)
AND
In… Read More
BROMPHENIRAMINE MALEATE SPECIFIC TESTS/Optical Rotation, Specific Rotation <781> USP38–NF33 2475 1-Oct-2015 USP40–NF35 First Supplement to USP39–NF34 Line 1: Delete
Specific Rotation
AND
Line 1 of Sample: Change
100 mg/mL in water
to:
100 mg/mL in water at 20°
BROMPHENIRAMINE MALEATE SPECIFIC TESTS USPNF Online Online 1-May-2024 NA NA Change
Optical Rotation 〈781〉
to:
Optical Rotation, Angular Rotation 〈781A〉
Budesonide ASSAY/Procedure USP35–NF30 2394 1-Dec-2012 USP37–NF32 Second Supplement to USP36–NF31 Line 2 of Acceptance criteria: Change
Epimer A: 40.0%–51.0% on the dried basis
to:
Epimer A: 40.0%–51.0%
BUDESONIDE IMPURITIES/Organic Impurities USP43–NF38 604 1-May-2020 NA NA In footnote k in Table 2: Change
16α,17-[Butylidenebis(oxy)]-11β,21-dihydroxypregna-1,4-diene-3,20-dione-21-acetate.
to:
16α,17-[Butylidenebis(oxy)]-11β-hydroxypregna-1,4-diene-3,20-dione-21-yl acetate.
BUFFER SOLUTIONS 4. Standard Buffer Solutions/4.1 Preparation Second Supplement to USP36–NF31 6244 1-Dec-2013 USP38–NF33 Second Supplement to USP37–NF32 Line 1 of 4. Boric Acid and Potassium Chloride 0.2 M: Change
12.73 g/L of boric acid
to:
12.37 g/L of boric acid
BUMETANIDE IMPURITIES USP37–NF32 2024 1-Aug-2014 USP39–NF34 First Supplement to USP38–NF33 Row 4 of Column 1 of Table 1: Change
Paroxetine butyl 3-(butylamino)-4-phenoxy-5-sulfamoylbenzoate
to:
Butyl 3-(butylamino)-4-phenoxy-5-sulfamoylbenzoate
BUMETANIDE TABLETS IMPURITIES/Organic Impurities/Chromatographic system First Supplement to USP41–NF36 Online 1-Oct-2018 USP43–NF38 Second Supplement to USP41–NF36 Line 1 of Developing solvent system: Change
Methanol, cyclohexane, methanol, glacial acetic acid, and chloroform (2.5: 10: 10: 80)
to:
Methanol, cyclohexane, glacial acetic acid, and chloroform (2.5: 10: 10: 80)
BUMETANIDE TABLETS ASSAY/Procedure Second Supplement to USP41–NF36 Online 1-Apr-2019 NA NA In Sample solution: Change
Nominally 0.05 mg/mL of bumetanide prepared as follows.
to:
Nominally 125 µg/mL of bumetanide prepared as follows.
BUPIVACAINE HYDROCHLORIDE INJECTION ASSAY/Procedure USPNF Online Online 1-May-2023 NA NA In Chromatographic system/Column: Change
4-mm × 30-cm; packing L1
to:
3.9-mm × 30-cm; packing L1
AND
In System suitability: Change
[Note—The relative retention times for bupivacaine hydrochloride and dibutyl phthalate are… Read More
BUPROPION HYDROCHLORIDE IDENTIFICATION/C. Identification Tests—General <191>, Chloride USP41–NF36 573 1-Aug-2018 USP43–NF38 Second Supplement to USP41–NF36 Line 1 of Acceptance criteria: Change
Meets the requirements of test
to:
Meets the requirements of test A
BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS IMPURITIES/Organic Impurities Revision Bulletin (Official October 01, 2014) Online 1-Feb-2015 USP39–NF34 Second Supplement to USP38–NF33 Row 4 of Column 1 of Table 16: Change
R,S,S,-Thiomorpholine derivativec
to:
S,R,R,-Thiomorpholine derivativec
BUSPIRONE HYDROCHLORIDE IDENTIFICATION/B. USP42–NF37 618 1-Aug-2019 NA NA Change
relative retention time
to:
retention time
BUSPIRONE HYDROCHLORIDE TABLETS IDENTIFICATION/B. USP42–NF37 621 1-Aug-2019 NA NA Change
relative retention time
to:
retention time
BUTABARBITAL SODIUM ORAL SOLUTION ASSAY/Procedure USP38–NF33 2500 1-Feb-2015 USP39–NF34 Second Supplement to USP38–NF33 Line 17 of Analysis: Change
CU = nominal concentration of butabarbital sodium in the Sample solution (µg/mL)
to:
CU = nominal concentration of butabarbital sodium in the Sample solution (mg/mL)
BUTABARBITAL SODIUM TABLETS PERFORMANCE TESTS/Uniformity of Dosage Units <905>/Procedure for content uniformity USP38–NF33 2501 1-Feb-2015 USP39–NF34 Second Supplement to USP38–NF33 Line 18 of Analysis: Change
CU = nominal concentration of butabarbital sodium in the Sample solution
to:
CU = nominal concentration of butabarbital sodium in the Sample solution (mg/mL)
BUTABARBITAL SODIUM TABLETS Identification, Infrared Absorption <197K> USP36–NF31 2716 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 5 of Test specimen: Change
Proceed as directed for Column Partition Chromatography under Chromatography <621>, packing the chromatographic tube as follows.
to:
Pack a chromatographic tube as follows.
BUTORPHANOL TARTRATE NASAL SOLUTION IMPURITIES/Organic Impurities First Supplement to USP37–NF32 6596 1-Apr-2015 USP39–NF34 USP39–NF34 Row 3 of Column 1 of Table 1: Change
6-Butorphanol
to:
Δ6-Butorphanol
BUTYLPARABEN IMPURITIES/Related Substances/Chromatographic system Second Supplement to USP36–NF31 6551 1-Apr-2014 USP38–NF33 USP38–NF33 After the Column section: Add
Column temperature: 35°
CAFFEINE CITRATE INJECTION ASSAY/Procedure USP38–NF33 2520 1-Feb-2015 USP39–NF34 Second Supplement to USP38–NF33 Line 5 of Analysis: Change
Result = (rU/rS) × CS × (Mr1/Mr2) × 100
to:
Result = (rU/rS) × C Read More
CAFFEINE CITRATE INJECTION Assay USP36–NF31 2732 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 3 of Chromatographic system: Change
150-cm column
to:
15-cm column