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CSV February 19, 2017 through February 19, 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
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
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
SALIX SPECIES BARK POWDER INTRODUCTION USP42–NF37 5189 1-Feb-2019 NA NA Delete
(This monograph is postponed indefinitely.)
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
SALIX SPECIES BARK DRY EXTRACT INTRODUCTION USP42–NF37 5187 1-Feb-2019 NA NA Delete
(This monograph is postponed indefinitely.)
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
SALIX SPECIES BARK INTRODUCTION USP42–NF37 5185 1-Feb-2019 NA NA Delete
(This monograph is postponed indefinitely.)
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
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
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%
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
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
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
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
OLEYL OLEATE CHEMICAL INFORMATION USP41–NF36 5471 1-Jan-2019 NA NA Change
532.92
to:
532.94
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
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.
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,
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
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
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
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
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
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
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
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
AZEOTROPIC ISOPROPYL ALCOHOL ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP41–NF36 2257 1-Dec-2018 USP43–NF38 USP42–NF37 Line 1 of USP 2-Propanol System Suitability RS: Change
It contains 0.1% of each of the following: ethyl ether, acetone, isopropyl alcohol, diisopropyl ether, 1-propanol, and 2-butanol.
to:
It is a mixture of the following: ethyl ether (0.1%), acetone… Read More
GLUTARAL CONCENTRATE ASSAY/Procedure USP41–NF36 1960 1-Dec-2018 USP43–NF38 USP42–NF37 In the variable definition list in Analysis: Change
W = weight of Concentrate taken (g)
to:
W = nominal weight of glutaral taken (g)
FLUTICASONE PROPIONATE INHALATION POWDER IMPURITIES/Organic Impurities/System suitability USP41–NF36 1836 1-Dec-2018 USP43–NF38 USP42–NF37 In the Tailing factor: Change
NLT 1.3
to:
NMT 1.3
CUPRIC SULFATE INJECTION Assay USP41–NF36 1112 1-Dec-2018 USP43–NF38 USP42–NF37 Line 8 of Assay preparation: Change
to bring the total sodium content of this flask to 13.5 mg.
to:
to bring the total sodium chloride content of this flask to 13.5 mg.
CUPRIC CHLORIDE INJECTION ASSAY/Procedure USP41–NF36 1111 1-Dec-2018 USP43–NF38 USP42–NF37 Line 3 of Sample solution: Change
to bring the total sodium content of this flask to 13.5 mg.
to:
to bring the total sodium chloride content of this flask to 13.5 mg.
CUPRIC CHLORIDE ASSAY/Procedure USP41–NF36 1109 1-Dec-2018 USP43–NF38 USP42–NF37 Line 1 of Analysis: Change
To the Sample solution
to:
To 50 mL of the Sample solution
CIPROFLOXACIN AND DEXAMETHASONE OTIC SUSPENSION IMPURITIES USP41–NF36 951 1-Dec-2018 USP43–NF38 USP42–NF37 In the variable definition list of Ciprofloxacin Related Compounds/Analysis: Change
CU = nominal concentration of ciprofloxacin in the Otic Suspension (mg/mL)
to:
CU = nominal… Read More
AMLODIPINE AND ATORVASTATIN TABLETS ASSAY/Procedure First Supplement to USP41–NF36 8270 1-Dec-2018 USP43–NF38 USP42–NF37 In the second Calculate statement in Analysis: Change
(C33H34FN2O5)
to:
(C33H35FN2O5)
AMLODIPINE AND ATORVASTATIN TABLETS DEFINITION First Supplement to USP41–NF36 8270 1-Dec-2018 USP43–NF38 USP42–NF37 Line 4: Change
(C33H34FN2O5)
to:
(C33H35FN2O5)
AMLODIPINE AND ATORVASTATIN TABLETS PERFORMANCE TESTS/Dissolution <711> First Supplement to USP41–NF36 8270 1-Dec-2018 USP43–NF38 USP42–NF37 In the second Calculate statement in Analysis: Change
(C33H34FN2O5)
to:
(C33H35FN2O5)
AND
In Tolerances: Change
(C33… Read More
ALLOPURINOL ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP41–NF36 121 1-Dec-2018 USP43–NF38 USP42–NF37 Line 3 of USP Allopurinol Related Compound A RS: Change
(C5H6N4O)2 · H2SO4 350.32
to:
(C4H6N4O)2 · H2SO4 350.31
ACAMPROSATE CALCIUM IMPURITIES/Limit of Acamprosate Related Compound A First Supplement to USP41–NF36 8263 1-Dec-2018 USP43–NF38 USP42–NF37 In the variable definition list in Analysis: Change
CS = concentration of USP Acamprosate Calcium Related Compound A RS in the Standard solution (µg/mL)
to:
CS = concentration of USP Acamprosate… Read More
ZOLMITRIPTAN TABLETS IMPURITIES/Organic Impurities Revision Bulletin (Official November 01, 2017) Online 1-Nov-2018 USP43–NF38 Second Supplement to USP41–NF36 Line 2 of Analysis: Change
Sample: Sample solution
to:
Samples: Standard solution and Sample solution
PURE STEAM ADDITIONAL REQUIREMENTS USP41–NF36 4348 1-Nov-2018 USP43–NF38 Second Supplement to USP41–NF36 Delete
USP Reference Standards <11>
USP 1,4-Benzoquinone RS
STERILE PURIFIED WATER ADDITIONAL REQUIREMENTS USP41–NF36 4348 1-Nov-2018 USP43–NF38 Second Supplement to USP41–NF36 Delete
USP Reference Standards <11>
USP 1,4-Benzoquinone RS
PURIFIED WATER ADDITIONAL REQUIREMENTS USP41–NF36 4347 1-Nov-2018 USP43–NF38 Second Supplement to USP41–NF36 Delete
USP Reference Standards <11>
USP 1,4-Benzoquinone RS
STERILE WATER FOR IRRIGATION ADDITIONAL REQUIREMENTS USP41–NF36 4347 1-Nov-2018 USP43–NF38 Second Supplement to USP41–NF36 Delete
USP Reference Standards <11>
USP 1,4-Benzoquinone RS
STERILE WATER FOR INJECTION ADDITIONAL REQUIREMENTS USP41–NF36 4346 1-Nov-2018 USP43–NF38 Second Supplement to USP41–NF36 Delete
USP Reference Standards <11>
USP 1,4-Benzoquinone RS
STERILE WATER FOR INHALATION ADDITIONAL REQUIREMENTS USP41–NF36 4346 1-Nov-2018 USP43–NF38 Second Supplement to USP41–NF36 Delete
USP Reference Standards <11>
USP 1,4-Benzoquinone RS
WATER FOR INJECTION ADDITIONAL REQUIREMENTS USP41–NF36 4345 1-Nov-2018 USP43–NF38 Second Supplement to USP41–NF36 Delete
USP Reference Standards <11>
USP 1,4-Benzoquinone RS
WATER FOR HEMODIALYSIS ADDITIONAL REQUIREMENTS USP41–NF36 4345 1-Nov-2018 USP43–NF38 Second Supplement to USP41–NF36 Delete
USP Reference Standards <11>
USP 1,4-Benzoquinone RS
VINORELBINE INJECTION ASSAY/Procedure/System suitability/Suitability requirements USP41–NF36 4326 1-Nov-2018 USP43–NF38 Second Supplement to USP41–NF36 Line 1 of Relative standard deviation: Change
NLT 2.0%, Standard solution
to:
NMT 2.0%, Standard solution
RIZATRIPTAN BENZOATE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP41–NF36 3662 1-Nov-2018 USP43–NF38 Second Supplement to USP41–NF36 Line 6 of USP Rizatriptan Benzoate System Suitability Mixture RS: Change
269.34)
to:
269.35)
RITONAVIR CAPSULES PERFORMANCE TESTS/Dissolution <711>/Test 2 Revision Bulletin (Official April 01, 2018) Online 1-Nov-2018 USP43–NF38 Second Supplement to USP41–NF36 Row 1 of Column 3 of Table 1: Change
Tolerances (Q)
to:
Tolerances
AND
Row 3 of Column 3 of Table 1: Change
NLT 80%
to:
NLT 80% (Q)