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PDF CSV April 21, 2017 through April 21, 2019 See all Errata for USP–NF How to use
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Monograph Title Section Source Publication Page Number Errata Official Date Sort ascending Target Errata Print Publication Target Online Fix Publication Description PHP Field
SCOPOLAMINE HYDROBROMIDE IDENTIFICATION/B. First Supplement to USP41–NF36 8420 1-Apr-2019 NA NA In Sample solution: Change
50 mg/mL of alcohol
to:
50 mg/mL in water
0
RUTIN CHEMICAL INFORMATION USP41–NF36 4841 1-Apr-2019 NA NA Change
3-Rhamnoglucoside of 5,7,3',4'-tetrahydroxyflavonol;
2-(3,4-Dihydroxyphenyl)-5,7-dihydroxy-4H-chromen-4-one-3-yl 6-O-α-L-rhamnopyranosyl-β-D-glucoside [250249-75-3].
to:
3-Rhamnoglucoside of 5,7,3',4'-… Read More
0
PREDNISOLONE SODIUM PHOSPHATE Related compounds USP41–NF36 3416 1-Apr-2019 NA NA In Table 1: Add
Prednisolone sodium phosphate 1.00 — —
0
METAXALONE IDENTIFICATION/B. USP41–NF36 2611 1-Apr-2019 NA NA Change
The retention time of the major peak of the Sample solution corresponds to that of the Sample solution, as obtained in the Assay.
to:
The retention time of the major peak of the Sample solution corresponds to… Read More
0
MERCAPTOPURINE IMPURITIES/Organic Impurities USP41–NF36 2587 1-Apr-2019 NA NA Change
Sample solution: 0.12 mg/mL of Mercaptopurine in Solution A. [NOTE—Inject the Sample solution within 1 h of preparation.]
to:
Sample stock solution: 0.5 mg/mL of mercaptopurine in a mixture of methanol and… Read More
0
ISOPHANE INSULIN HUMAN SUSPENSION ASSAY/Procedure Interim Revision Announcement (Official January 01, 2019) Online 1-Apr-2019 NA NA In Standard solution: Change
USP Insulin Beef RS
to:
USP Insulin Human RS
0
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.
0
PRAZOSIN HYDROCHLORIDE COMPOUNDED ORAL SUSPENSION ASSAY/Procedure Second Supplement to USP41–NF36 8945 1-Mar-2019 NA NA In the Mobile phase: Change
tetramethylammonium hydrochloride
to:
tetramethylammonium hydroxide
0
OXANDROLONE Related compounds USP41–NF36 3072 1-Mar-2019 NA NA In footnote 4 of the second table: Change
Methyl-(1,17β-dihydroxy-17α-methyl-1,3-seco-2-nor-5α-androstane-3-oate.
to:
Methyl 1,17β-dihydroxy-17α-methyl-1,3-seco-2-nor-5α-androstan-3-oate.
0
METHYLDOPA SPECIFIC TESTS/Optical Rotation <781S> USP41–NF36 2666 1-Mar-2019 NA NA In the Sample solution: Change
aluminum chloride
to:
aluminum chloride hexahydrate
0
MESNA TABLETS ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Second Supplement to USP41–NF36 8906 1-Mar-2019 NA NA In USP Mesna Related Compound A RS: Change
2-(Acetylthio)ethane-1-sulfonic acid.
C4H8O4S2 184.22
to:
2-(Acetylthio)ethane-1-sulfonic acid, potassium salt, crystal adduct with potassium chloride.… Read More
0
MESNA ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Second Supplement to USP41–NF36 8904 1-Mar-2019 NA NA In USP Mesna Related Compound A RS: Change
2-(Acetylthio)ethane-1-sulfonic acid.
C4H8O4S2 184.22
to:
2-(Acetylthio)ethane-1-sulfonic acid, potassium salt, crystal adduct with potassium chloride.… Read More
0
FLUDROCORTISONE ACETATE TABLETS IMPURITIES/Organic Impurities/Table 1 Second Supplement to USP41–NF36 8843 1-Mar-2019 NA NA In footnote a: Change
9-Fluoro-11β,17,21-trihydroxypregn-4-ene-3,20-dione 21-acetate.
to:
9-Fluoro-11β,17,21-trihydroxypregn-4-ene-3,20-dione.
0
DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS ASSAY/Procedure USP41–NF36 1358 1-Mar-2019 NA NA In Buffer: Change
0.5 g/L of citric acid and 0.4 g/L of dibasic sodium phosphate in water
to:
0.5 g/L of anhydrous citric acid and 0.4 g/L of anhydrous dibasic sodium phosphate in water
0
DEXMEDETOMIDINE HYDROCHLORIDE CHEMICAL INFORMATION USP41–NF36 Online 1-Mar-2019 NA NA This erratum applies to the USP-NF ONLINE platform only.
See https://www.uspnf.com/sites/default/files/usp_pdf/EN/february_2019_errata_image1.pdf for correction
0
CARBINOXAMINE MALEATE TABLETS IMPURITIES/Organic Impurities Second Supplement to USP41–NF36 8788 1-Mar-2019 NA NA In the Standard stock solution: Change
USP Carbinoxamine Maleate RS free base)
to:
carbinoxamine)
AND
In the Standard solution: Change
USP Carbinoxamine Maleate RS free base)
to:
carbinoxamine)
AND
In… Read More
0
CARBINOXAMINE MALEATE IMPURITIES/Organic Impurities Second Supplement to USP41–NF36 8786 1-Mar-2019 NA NA In Standard stock solution: Change
(equivalent to 0.05 mg/mL of USP Carbinoxamine Maleate RS free base) and 0.05 mg/mL each of USP Carbinoxamine Related Compound A RS, USP Carbinoxamine Related Compound B RS, and USP Carbinoxamine Related Compound C RS… Read More
0
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE TABLETS ASSAY/Procedure/Chromatographic system Second Supplement to USP41–NF36 8781 1-Mar-2019 NA NA In Column: Change
[Note—Conditioning of the Column with Solution A and Solution B (80:20)
to:
[Note—Conditioning of the Column with Solution A and Solution B (90:10)
0
CALCIUM SILICATE IMPURITIES/Limit of Lead USP41–NF36 5240 1-Mar-2019 NA NA In Lead standard solution: Change
1000 mg of lead/mL4
to:
1000 mg of lead/L4
0
ARGATROBAN CHEMICAL INFORMATION USP41–NF36 346 1-Mar-2019 NA NA See https://www.uspnf.com/sites/default/files/usp_pdf/EN/february_2019_errata_image1.pdf for correction 0
AMITRIPTYLINE HYDROCHLORIDE TABLETS IMPURITIES/Organic Impurities Second Supplement to USP41–NF36 8759 1-Mar-2019 NA NA In Analysis: Change
rU = peak response of amitriptyline related compound A, amitriptyline related compound B, or nortriptyline hydrochloride from the Sample solution
rS = peak response of amitriptyline… Read More
0
<1010> ANALYTICAL DATA—INTERPRETATION AND TREATMENT MEASUREMENT PRINCIPLES AND VARIATION USP42–NF37 7129 1-Mar-2019 NA NA See https://www.uspnf.com/sites/default/files/usp_pdf/EN/february_2019_errata_image1.pdf for correction 0
REAGENTS Solutions/Volumetric Solutions/0.01 N Sodium Hydroxide VS USP41–NF36 5770 1-Mar-2019 NA NA See https://www.uspnf.com/sites/default/files/usp_pdf/EN/february_2019_errata_image1.pdf for correction 0
REAGENTS Reagent Specifications/7,8-Dihydrofolic Acid Second Supplement to USP41–NF36 9052 1-Mar-2019 NA NA Change
(L-Glutamic Acid, N-[4-[[(2-Amino-3,4,7,8-tetrahydro-4-pteridinyl)methyl]amino]benzoyl]-),
to:
(L-Glutamic Acid, N-[4-[[(2-Amino-3,4,7,8-tetrahydro-4-oxo-6-pteridinyl)methyl]amino]benzoyl]-),
0
SALMETEROL INHALATION POWDER ASSAY/Procedure/Analysis First Supplement to USP41–NF36 Online 1-Feb-2019 NA NA In the definition list: Change
Mr1 = molecular weight of salmeterol free base, 415.75
to:
Mr1 = molecular weight of salmeterol free base, 415.57
0
SALMETEROL INHALATION POWDER PERFORMANCE TESTS First Supplement to USP41–NF36 Online 1-Feb-2019 NA NA In the definition list in Particle Size Distribution by Cascade Impaction/Analysis: Change
Mr1 = molecular weight of salmeterol free base, 415.75
to:
Mr1 = molecular weight of… Read More
0
SALIX SPECIES BARK POWDER INTRODUCTION USP42–NF37 5189 1-Feb-2019 NA NA Delete
(This monograph is postponed indefinitely.)
0
SALIX SPECIES BARK POWDER ADDITIONAL REQUIREMENTS USP42–NF37 5189 1-Feb-2019 NA NA In Labeling: Change
The label states the Latin binomial(s) of one or several Salix species included in the article.
to:
The label states the Latin binomial(s) of one or several Salix species included in the article. Dosage forms… Read More
0
SALIX SPECIES BARK DRY EXTRACT INTRODUCTION USP42–NF37 5187 1-Feb-2019 NA NA Delete
(This monograph is postponed indefinitely.)
0
SALIX SPECIES BARK DRY EXTRACT ADDITIONAL REQUIREMENTS USP42–NF37 5187 1-Feb-2019 NA NA In Labeling: Change
It meets the labeling requirements of Botanical Extracts <565>.
to:
It meets the labeling requirements of Botanical Extracts <565>. Dosage forms prepared with this article should bear the… Read More
0
SALIX SPECIES BARK INTRODUCTION USP42–NF37 5185 1-Feb-2019 NA NA Delete
(This monograph is postponed indefinitely.)
0
SALIX SPECIES BARK ADDITIONAL REQUIREMENTS USP42–NF37 5185 1-Feb-2019 NA NA In Labeling: Change
The label states the Latin binomial(s) of one or several Salix species included in the article.
to:
The label states the Latin binomial(s) of one or several Salix species included in the article. Dosage forms… Read More
0
LEFLUNOMIDE IMPURITIES/Organic Impurities/Procedure 2 USP41–NF36 2353 1-Feb-2019 NA NA Change
Standard solution: 0.5 µg/mL of USP Leflunomide RS, from the Standard solution in Mobile phase
to:
Standard stock solution: Proceed as directed in the Standard solution in the Assay.
Read More
0
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%
0
VITAMIN A ADDITIONAL REQUIREMENTS USP41–NF36 4327 1-Jan-2019 NA NA Change
Delete the following
•USP Reference Standards <11>
USP Retinyl Acetate RS
USP Retinyl Palmitate RS
▲(CN 1-May-2018)
to:
•USP Reference Standards <11>
USP Retinyl… Read More
0
TRIAZOLAM TABLETS Uniformity of dosage units <905> USP41–NF36 4202 1-Jan-2019 NA NA In Mobile phase and Chromatographic system: Change
Proceed as directed in the Assay under Triazolam.
to:
Proceed as directed in the Assay.
AND
In Procedure: Change
Proceed as directed for… Read More
0
TELMISARTAN AND HYDROCHLOROTHIAZIDE TABLETS PERFORMANCE TESTS/Dissolution <711>/Test 1/Chromatographic system Revision Bulletin (Official February 01, 2018) Online 1-Jan-2019 NA NA In Flow rate: Change
The flow rate goes back to 0.6 mL
to:
The flow rate goes back to 0.6 mL/min
0
PANTOPRAZOLE SODIUM IMPURITIES/Organic Impurities/Test 2/Chromatographic system First Supplement to USP41–NF36 8392 1-Jan-2019 NA NA In Column: Change
4.6-mm x 12.5-cm; 5-μm packing L1
to:
4-mm x 12.5-cm; 5-μm packing L1
0
OLEYL OLEATE CHEMICAL INFORMATION USP41–NF36 5471 1-Jan-2019 NA NA Change
532.92
to:
532.94
0
METACRESOL IDENTIFICATION/B. USP41–NF36 2605 1-Jan-2019 NA NA Change
The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.
to:
The retention time of the metacresol peak of the Sample solution corresponds… Read More
0
HOMATROPINE HYDROBROMIDE Limit of tropine USP41–NF36 2038 1-Jan-2019 NA NA In Tropine reference solution: Change
0.4 mg per mL.
to:
0.4 mg per mL in Diluent.
0
ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES PERFORMANCE TESTS/Dissolution <11>/Test 3/Buffer stage Revision Bulletin (Official March 01, 2018) Online 1-Jan-2019 NA NA In the Standard solution: Change
0.25 M sodium hydroxide,
to:
0.25 N sodium hydroxide,
AND
In the Sample solution: Change
0.25sodium hydroxide,
to:
0.25 N sodium hydroxide,
0
PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS PERFORMANCE TESTS/Dissolution Test 1 USP41–NF36 3157 1-Dec-2018 USP43–NF38 USP42–NF37 In the Analysis: Change
Result = (rU/rS) × CS × (Mr1/Mr2) × V × (100/L)
to:
Result = (rU/rS) × CS × (Mr1/Mr2) × V × (100/L) ×… Read More
0
OXYBUTYNIN CHLORIDE EXTENDED-RELEASE TABLETS PERFORMANCE TESTS/Dissolution <711>/Test 8 Revision Bulletin (Official April 01, 2018) Online 1-Dec-2018 USP43–NF38 USP42–NF37 In the variable definition list in Analysis: Change
CS = concentration of oxybutynin chloride in the Standard solution (mg/mL)
to:
CS = concentration of USP Oxybutynin Chloride RS in the Read More
0
OXYBUTYNIN CHLORIDE EXTENDED-RELEASE TABLETS ASSAY/Procedure Revision Bulletin (Official April 01, 2018) Online 1-Dec-2018 USP43–NF38 USP42–NF37 This erratum applies to the Revision Bulletin posted on www.uspnf.com only.
In System suitability: Add
[Note—The relative retention times for oxybutynin and oxybutynin related compound A are about 1.0 and 1.6,… Read More
0
OXYBUTYNIN CHLORIDE EXTENDED-RELEASE TABLETS IMPURITIES/Organic Impurities Revision Bulletin (Official April 01, 2018) Online 1-Dec-2018 USP43–NF38 USP42–NF37 This erratum applies to the Revision Bulletin posted on www.uspnf.com only.
In the variable definition list in Analysis: Change
CU = nominal concentration of the Sample solution… Read More
0
OCTOCRYLENE SPECIFIC TESTS/Acidity First Supplement to USP41–NF36 8379 1-Dec-2018 USP43–NF38 USP42–NF37 Line 1 of Acceptance criteria: Change
NMT 0.18 mL of Titrant is required
to:
NMT 0.18 mL of Titrant/g is required
0
NAPROXEN SODIUM TABLETS IMPURITIES/Organic Impurities First Supplement to USP41–NF36 8363 1-Dec-2018 USP43–NF38 USP42–NF37 In the System suitability solution: Change
0.5 mg/mL of USP Naproxen Sodium RS and 0.5 µg/mL of USP Naproxen Related Compound A RS in Diluent, from Standard stock solution 1 and Standard stock solution 2, respectively
to:… Read More
0
METOPROLOL TARTRATE CHEMICAL INFORMATION USP41–NF36 2712 1-Dec-2018 USP43–NF38 USP42–NF37 Line 4: Change
(±)-1-(Isopropylamino)-3-[p-(2-methoxyethyl)phenoxy]-2-propanol l-(+)-tartrate (2:1) (salt);
1-(Isopropylamino)-3-[p-(2-methoxyethyl)phenoxy]-2-propanol (2:1) dextro-tartrate salt
to:… Read More
0
LIDOCAINE ASSAY/Procedure First Supplement to USP41–NF36 Online 1-Dec-2018 USP43–NF38 USP42–NF37 This erratum applies to the new USP-NF ONLINE platform only.
Line 2 of Standard solution: Change
1 N sodium hydroxide,
to:
1 N hydrochloric acid,
AND
Line 2 of Sample solution: Change
1 N sodium hydroxide,… Read More
0