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CSV December 15, 2016 through December 15, 2018 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
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)
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE ACETATE OPHTHALMIC SUSPENSION Assay for hydrocortisone acetate USP41–NF36 2904 1-Nov-2018 USP43–NF38 Second Supplement to USP41–NF36 Line 1: Change
Proceed with Ophthalmic Suspension as directed in the Assay under Hydrocortisone Acetate Injectable Suspension.
to:
Standard preparation—Prepare as directed for Assay… Read More
LEVODOPA IMPURITIES/Organic Impurities USP41–NF36 2392 1-Nov-2018 USP43–NF38 Second Supplement to USP41–NF36 Footnote a of Table 1: Change
3-(3,4,6-Trihydroxyphenyl)alanine.
to:
3-(3,4,6-Trihydroxyphenyl)alanine; also known as 3-(2,4,5-Trihydroxyphenyl)-L-alanine.
GUAIFENESIN IMPURITIES/Organic Impurities USP41–NF36 2001 1-Nov-2018 USP43–NF38 Second Supplement to USP41–NF36 In the equation in Analysis: Change
Result = (rU/rS) × (1/F) × 100
to:
Result = (rU/rS) × (C… Read More
DROSPIRENONE AND ETHINYL ESTRADIOL TABLETS ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP41–NF36 1447 1-Nov-2018 USP43–NF38 Second Supplement to USP41–NF36 Line 2 of USP Ethinyl Estradiol Related Compound B RS: Change
19-Nor-17ɑ-pregna-1,3,5(10),9(11)-tetraen-20-yne-3,17-diol.
C20H22O2 294.39
to:
19-Nor-17ɑ-pregna-1,3,5(10),9(11)-tetraen-20-yne-3… Read More
AMOXICILLIN IDENTIFICATION/A. First Supplement to USP41–NF36 Online 1-Nov-2018 USP43–NF38 Second Supplement to USP41–NF36 This erratum applies to the new USP-NF ONLINE platform only.
Line 1: Change
Infrared Absorption <197>
to:
Infrared Absorption <197K>
TRIAMTERENE IMPURITIES/Organic Impurities First Supplement to USP41–NF36 Online 1-Oct-2018 USP43–NF38 Second Supplement to USP41–NF36 This erratum applies to the new USP-NF ONLINE platform only.
Line 1 of Standard stock solution 2: Change
0.1 mg/mL of in Diluent.
to:
0.1 mg/mL of USP Triamterene Related Compound A RS in Diluent.
AND
Read More
TRIAMTERENE ADDITIONAL REQUIREMENTS First Supplement to USP41–NF36 Online 1-Oct-2018 USP43–NF38 Second Supplement to USP41–NF36 This erratum applies to the new USP-NF ONLINE platform only.
Line 4 of USP Reference Standards <11>: Change
USP Doxazosin Related Compound A RS
to:
USP Triamterene Related Compound A RS
TRANYLCYPROMINE TABLETS ASSAY/Procedure First Supplement to USP41–NF36 Online 1-Oct-2018 USP43–NF38 Second Supplement to USP41–NF36 This erratum applies to the new USP-NF ONLINE platform only.
Change
Mobile phase: Methanol and Buffer (30:70)
Diluent: Methanol, water, and 0.05 N sulfuric acid VS1S (USP41)… Read More
TRANYLCYPROMINE TABLETS PERFORMANCE TESTS/Dissolution <711> First Supplement to USP41–NF36 Online 1-Oct-2018 USP43–NF38 Second Supplement to USP41–NF36 This erratum applies to the new USP-NF ONLINE platform only.
Change
System suitability
▲1S (USP41)
Sample: Standard solution
Suitability requirements
Read More
TRANEXAMIC ACID INJECTION SPECIFIC TESTS First Supplement to USP41–NF36 Online 1-Oct-2018 USP43–NF38 Second Supplement to USP41–NF36 This erratum applies to the new USP-NF ONLINE platform only.
Change
Dissolution <711>: Meets the requirements
to:
Sterility Tests <71>: Meets the requirements
SUMATRIPTAN NASAL SPRAY ASSAY/Procedure First Supplement to USP41–NF36 Online 1-Oct-2018 USP43–NF38 Second Supplement to USP41–NF36 This erratum applies to the new USP-NF ONLINE platform only.
In the variable definition in Analysis: Change
CS = concentration of USP Sumatriptan Succinate Related Compound A RS
to:
CS =… Read More
PRAVASTATIN SODIUM ADDITIONAL REQUIREMENTS First Supplement to USP41–NF36 Online 1-Oct-2018 USP43–NF38 Second Supplement to USP41–NF36 This erratum applies to the new USP-NF ONLINE platform only.
Line 2 of USP Reference Standards <11>: Change
USP Pravastatin Related Compound A RS
to:
USP Pravastatin 1,1,3,3-Tetramethylbutylamine RS
PIOGLITAZONE AND GLIMEPIRIDE TABLETS IMPURITIES/Organic Impurities: Glimepiride USP41–NF36 3314 1-Oct-2018 USP43–NF38 Second Supplement to USP41–NF36 Change
Table 3
to:
Table 4
AND
Change
Table 4
to:
Table 5
AND
Line 1 of Mobile phase: Change
Table 3
to:
Table 4
AND
In the variable… Read More
NIFEDIPINE EXTENDED-RELEASE TABLETS PERFORMANCE TESTS/Dissolution <711>/Test 5 First Supplement to USP41–NF36 8369 1-Oct-2018 USP43–NF38 Second Supplement to USP41–NF36 Line 1 of Standard stock solution: Change
50 mg of USP Nifedipine RS in Diluent A and water (50:50)
to:
0.50 mg/mL of USP Nifedipine RS prepared as follows. Transfer a suitable amount of USP Nifedipine RS to an appropriate volumetric… Read More
NAPROXEN TABLETS IMPURITIES/Organic Impurities USP41–NF36 2865 1-Oct-2018 USP43–NF38 Second Supplement to USP41–NF36 Line 3 of System suitability solution: Change
0.5 mg/mL of USP Naproxen 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:
0… Read More
METHADONE HYDROCHLORIDE INJECTION ASSAY/Procedure USP41–NF36 2628 1-Oct-2018 USP43–NF38 Second Supplement to USP41–NF36 In the Analysis: Change
Result = (RU/RS) × W × 100
to:
Result = (RU/RS) × W
MEPIVACAINE HYDROCHLORIDE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP41–NF36 2580 1-Oct-2018 USP43–NF38 Second Supplement to USP41–NF36 Line 2 of Bupivacaine Related Compound B: Change
N-(2,6-Dimethylphenyl)piperidine-2-carboxamide.
C14H20N2O 232.32
to:
N-(2,6-Dimethylphenyl)piperidine-2-carboxamide hydrochloride.
C… Read More
LOXAPINE SUCCINATE IMPURITIES/Organic Impurities/Procedure USP41–NF36 2486 1-Oct-2018 USP43–NF38 Second Supplement to USP41–NF36 In the variable definition list in Analysis: Add
F = relative response factor (see Impurity Table 1)