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Errata - English

PDF CSV November 24, 2022 through November 24, 2024 All Errata for USP–NF How to use
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Monograph Title Section Source Publication Page Number Errata Official Date Target Errata Print Publication Target Online Fix Publication Description
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
TIAGABINE HYDROCHLORIDE ASSAY/Procedure First Supplement to USP42–NF37 8823 1-Aug-2019 NA NA In Analysis: Change
Result = (RU/RS) × (CS/CU) × (Mr1/Mr2) ×▲ (USP 1-Aug-2019) 100
to:
Read More
SODIUM BICARBONATE IMPURITIES/Carbonate USP42–NF37 4019 1-Jul-2019 NA NA In Analysis: Change
and promptly add 10 g of sodium bicarbonate
to:
and promptly add 10 g of Sodium Bicarbonate
SAW PALMETTO EXTRACT COMPOSITION/Content of Long-Chain Alcohols and Sterols USP42–NF37 5196 1-Jul-2019 NA NA In System suitability stock solution B: Change
2 mg/mL each of campesterol, stigmasterol, and USP β-Sitosterol RS and 0.37 mg/mL of stigmastanol
to:
0.37 mg/mL of stigmastanol and 2 mg/mL each of campesterol, stigmasterol, and USP β-Sitosterol RS in… Read More
ETIDRONATE DISODIUM SPECIFIC TESTS/Water Determination <921> USP42–NF37 1745 1-Jul-2019 NA NA In Sample solution: Change
acetic acid
to:
glacial acetic acid
CHOLINE BITARTRATE IMPURITIES/Limit of Total Amines/System suitability USP42–NF37 4839 1-Jul-2019 NA NA In Suitability requirements: Change
μg/L.
to:
μg/mL.
ACETAMINOPHEN ORAL SUSPENSION ASSAY Second Supplement to USP41–NF36 Online 1-Jul-2019 NA NA In the first Procedure: Change
90.0%–110.0%▲(Postponed on 1-Aug-2018)
to:
90.0%–110.0%▲(RB 1-Aug-2018)
VORICONAZOLE IMPURITIES/Voriconazole Related Compounds C and D USP42–NF37 4601 1-Jul-2019 NA NA In System suitability solution: Change
0.25 µg/mL of USP Voriconazole RS
to:
0.25 µg/mL of USP Voriconazole RS in Mobile phase
SAW PALMETTO CAPSULES IDENTIFICATION/B. Presence of Sterols USP42–NF37 5198 1-Jul-2019 NA NA In System suitability stock solution B: Change
2 mg/mL each of campesterol, stigmasterol, and USP β-Sitosterol RS, and 0.37 mg/mL of stigmastanol
to:
0.37 mg/mL of stigmastanol and 2 mg/mL each of campesterol, stigmasterol, and USP β-Sitosterol RS in… Read More
POLYVINYL ALCOHOL IDENTIFICATION USP42–NF37 3566 1-Jul-2019 NA NA In B: Change
It meets the requirements in the test Viscosity—Capillary Methods <911>, Viscosity—Rotational Methods <912>, and Viscosity—Rolling Ball Method <913>.
to:
It meets the requirements in the… Read More
CHOLINE CHLORIDE IMPURITIES/Limit of Total Amines/System suitability USP42–NF37 4841 1-Jul-2019 NA NA In Suitability requirements: Change
μg/L.
to:
μg/mL.
MORPHINE SULFATE EXTENDED-RELEASE CAPSULES PERFORMANCE TESTS/Dissolution <711> Revision Bulletin (Official November 01, 2018) Online 1-Jul-2019 NA NA In Test 1/Tolerances and Test 3/Tolerances: Change
[(C17H19NO3)2 · H2SO4 · 5H2O)]
to:
[(C17H19NO3)2… Read More
ZONISAMIDE IMPURITIES/Organic Impurities USP42–NF37 4675 1-Jul-2019 NA NA In Analysis: Change
CU = concentration of zonisamide related compound A in the Sample solution (mg/mL)
to:
CU = concentration of zonisamide in the Sample solution (mg/mL)
CHITOSAN ASSAY/Degree of Deacetylation USP42–NF37 5663 1-Jul-2019 NA NA In the Analysis: Change
Result = {1 − [(7 × A2)/(3 × A1)] × 100
to:
Result = {1 − [(7 × A2)/(3 × A1)]} × 100
GUANABENZ ACETATE IMPURITIES/Limit of 2,6-Dichlorobenzaldehyde/Chromatographic system USP42–NF37 2129 1-Jun-2019 NA NA In Column: Change
1.8-mm × 3-mm;
to:
1.8-m × 3-mm;
SUMATRIPTAN SUCCINATE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP42–NF37 4145 1-Jun-2019 NA NA In USP Sumatriptan Succinate Related Impurities RS: Change
Mixture of sumatriptan succinate, [3-[2-(methylamino) ethyl]-1H-indol-5-yl]-N-methylmethanesulfonamide maleate salt, sumatriptan succinate related compound C, [3-[2-(dimethylamino… Read More
BACILLUS COAGULANS CAPSULES ASSAY/Enumeration USP42–NF37 4749 1-Jun-2019 NA NA In Peptone diluent: Change
Dispense into sterile containers as needed for preparing samples. Trace mineral solution. Prepare a solution containing
to:
Dispense into sterile containers as needed for preparing samples.
Trace mineral solution… Read More
SALMETEROL INHALATION POWDER IMPURITIES/Organic Impurities USP42–NF37 Online 1-Jun-2019 NA NA In Row 8 of Column 1 of Table 3: Change
Hyrdoxynaphthoic acid
to:
Hydroxynaphthoic acid
CLOMIPHENE CITRATE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP42–NF37 1068 1-Jun-2019 NA NA In USP Clomiphene Related Compound A RS: Change
(E,Z)-2-[4-(1,2-Diphenylethyl)phenoxy]-N,N-diethylethanamine hydrochloride.
to:
(E,Z)-2-[4-(1,2-Diphenylvinyl)phenoxy]-N,N-diethylethanamine… Read More
DOXORUBICIN HYDROCHLORIDE ASSAY/Procedure USP42–NF37 1481 1-Jun-2019 NA NA In the Analysis: Change
P = potency of doxorubicin in USP Doxorubicin Hydrochloride RS (µg/mg)
to:
P = potency of doxorubicin hydrochloride in USP Doxorubicin Hydrochloride RS (µg/mg)
DULOXETINE DELAYED-RELEASE CAPSULES IMPURITIES/Organic Impurities/Table 2 USP42–NF37 1527 1-Jun-2019 NA NA In footnote a: Change
This is a process impurity that is included in Table 1 for identification purposes only.
to:
This is a process impurity that is included for identification purposes only.
PIPERAZINE PHOSPHATE Assay USP42–NF37 3549 1-Jun-2019 NA NA Change
Each mL of 0.1 N perchloric acid is equivalent to 7.953 mg of C4H10N2 · 2HCl.
to:
Each mL of 0.1 N perchloric acid is equivalent to 9.207 mg of C4H10N2 · H3PO4… Read More
BACILLUS COAGULANS ASSAY/Enumeration USP42–NF37 4746 1-Jun-2019 NA NA In Peptone diluent: Change
Dispense into sterile containers as needed for preparing samples. Trace mineral solution. Prepare a solution containing
to:
Dispense into sterile containers as needed for preparing samples.
Trace mineral solution… Read More
REAGENTS AND REFERENCE TABLES SOLUTIONS/0.02 M Edetate Disodium VS USP42–NF37 6179 1-Jun-2019 NA NA In Standardization: Change
previously dried at 100°
to:
previously dried at 110°
CEFTIOFUR SODIUM IMPURITIES/High Molecular Weight Impurities USP42–NF37 859 1-Jun-2019 NA NA In Analysis: Change
rC = peak response of ceftiofur from the Sample solution (mg/mL)
rA = sum of the responses of all peaks that elute after ceftiofur from the Sample solution (mg/mL)
to:… Read More
DIPHENHYDRAMINE HYDROCHLORIDE AND IBUPROFEN CAPSULES ASSAY/Procedure/Chromatographic system/Detectors USP42–NF37 1402 1-Jun-2019 NA NA Change
Identification test A: Diode array, UV 200–400 nm
to:
Identification B: Diode array, UV 200–400 nm
DULOXETINE DELAYED-RELEASE CAPSULES ASSAY/Procedure USP42–NF37 1527 1-Jun-2019 NA NA In Buffer A: Change
monobasic sodium phosphate
to:
monobasic potassium phosphate
AND
In Buffer B: Change
monobasic sodium phosphate
to:
monobasic ammonium phosphate
LEVOCARNITINE IMPURITIES/Enantiomeric Purity USP42–NF37 2541 1-Jun-2019 NA NA In the second equation in Analysis: Change
Result = (RLPB)/(PAPB)
to:
Result = (RLPB)/(PA Read More
TELMISARTAN TABLETS ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP42–NF37 4206 1-Jun-2019 NA NA In USP Telmisartan Related Compound A RS: Change
1,7’-Dimethyl-2’-propyl-1H,3’H-2,5’-bibenzo[d]imidazole.
C19H20N4 304.39
to:
1,7’-Dimethyl-2’-propyl-1H,3’H-2,5’-bibenzo[d]imidazole… Read More
LIQUID GLUCOSE ASSAY/Reducing Sugars USP42–NF37 5741 1-Jun-2019 NA NA In the variable definition list in Analysis: Change
CU = concentration of dextrose equivalent
to:
CU = concentration of Liquid Glucose
ROSUVASTATIN TABLETS PERFORMANCE TESTS/Dissolution <711>/Test 3 Revision Bulletin (Official April 01, 2019) Online 1-Jun-2019 NA NA In Medium: Change
(dissolve 63.0 of citric acid
to:
(dissolve 63.0 g of citric acid
DACTINOMYCIN IDENTIFICATION/A. Ultraviolet Absorption <197U>/Acceptance criteria USP42–NF37 1203 1-Jun-2019 NA NA In Absorptivity: Change
The absorptivity of the Sample solution at 445 nm is NLT 95.0% and NMT 103.0% that of the Standard solution.
to:
The absorptivity, calculated on the dried basis, of the Sample solution at 445… Read More
DOXORUBICIN HYDROCHLORIDE IMPURITIES/Organic Impurities USP42–NF37 1481 1-Jun-2019 NA NA In the fourth equation in Analysis: Change
P = potency of doxorubicin in USP Doxorubicin Hydrochloride RS (µg/mg)
to:
P = potency of doxorubicin hydrochloride in USP Doxorubicin Hydrochloride RS (µg/mg)
EPRINOMECTIN IMPURITIES/Organic Impurities/Acceptance criteria USP42–NF37 1627 1-Jun-2019 NA NA In Total unknown impurities: Change
NMT 1.0
to:
NMT 1.0%
SUMATRIPTAN ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP42–NF37 4139 1-Jun-2019 NA NA In USP Sumatriptan Succinate Related Impurities RS: Change
Mixture of sumatriptan succinate, [3-[2-(methylamino) ethyl]-1H-indol-5-yl]-N-methylmethanesulfonamide maleate salt, sumatriptan succinate related compound C, [3-[2-(dimethylamino… Read More
BACILLUS COAGULANS ASSAY/Enumeration USP42–NF37 4746 1-Jun-2019 NA NA In Sample preparation and Analysis: Change
peptone water
to:
Peptone diluent
<561> ARTICLES OF BOTANICAL ORIGIN TEST FOR AFLATOXINS/Method I USP42–NF37 6701 1-Jun-2019 NA NA In Aflatoxin standard solution: Change
ε = molecular absorptivity
to:
ε = molar absorptivity
AND
in paragraph 2 of Aflatoxin standard solution: Change
transfer an accurate volume of each aflatoxin standard stock solution
to:… Read More
CETIRIZINE HYDROCHLORIDE ORALLY DISINTEGRATING TABLETS ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP42–NF37 897 1-Jun-2019 NA NA In USP Cetirizine Related Compound A RS: Change
2-(2-{4-[(4-Chlorophenyl)phenylmethyl]piperazin-1-yl}ethoxy)acetic acid, ethyl ester dihydrochloride.
C23H29ClN2O3 · 2HCl 489.86
to:
(RS)-2-[2… Read More
DIPHENHYDRAMINE HYDROCHLORIDE AND IBUPROFEN CAPSULES PERFORMANCE TESTS/Dissolution <711>/Analysis USP42–NF37 1402 1-Jun-2019 NA NA Change
CS = concentration of USP Diphenhydramine Hydrochloride RS and USP Ibuprofen RS in the Standard solution (mg/mL)
to:
CS = concentration of USP Diphenhydramine Hydrochloride RS or USP Ibuprofen RS in… Read More
DULOXETINE DELAYED-RELEASE CAPSULES PERFORMANCE TESTS/Dissolution <711> USP42–NF37 1527 1-Jun-2019 NA NA In Test 3/Procedure: Change
1 N sodium hydroxide VS.
to:
0.1 N hydrochloric acid VS.
MILRINONE ASSAY/Procedure USP42–NF37 2922 1-Jun-2019 NA NA In Buffer: Change
72.44 g of sodium tetraborate
to:
72.44 g of sodium tetraborate, anhydrous
TILETAMINE HYDROCHLORIDE Identification/B. Ultraviolet Absorption <197U> USP42–NF37 4347 1-Jun-2019 NA NA In Solution: Change
0.3 mg per mL.
to:
0.03 mg per mL.
REAGENTS AND REFERENCE TABLES SOLUTIONS/0.01 M Edetate Disodium VS USP42–NF37 6179 1-Jun-2019 NA NA In Standardization: Change
previously dried at 100°
to:
previously dried at 110°
CEFTIOFUR HYDROCHLORIDE IMPURITIES/High Molecular Weight Impurities USP42–NF37 857 1-Jun-2019 NA NA In Analysis: Change
rC = peak response of ceftiofur from the Sample solution (mg/mL)
rA = sum of the responses of all peaks that elute after ceftiofur from the Sample solution (mg/mL)
to:… Read More
PHENYLBUTAZONE INJECTION Assay USP42–NF37 3487 1-Jun-2019 NA NA Change
350(C/V)(RU/RS)
to:
714.3(C/V)(RU/RS)
DIDANOSINE IMPURITIES/Related Compounds USP42–NF37 1336 1-Jun-2019 NA NA In System suitability solution: Change
0.5 mg/mL of of didanosine from USP Didanosine System Suitability Mixture RS in Diluent
to:
0.5 mg/mL of USP Didanosine System Suitability Mixture RS in Diluent
DRONEDARONE TABLETS PERFORMANCE TESTS/Dissolution <711> USP42–NF37 1519 1-Jun-2019 NA NA In Tolerances/30 min: Change
20.0%–60.0% (Q) of the labeled amount of dronedarone free base
to:
20.0%–60.0% of the labeled amount of dronedarone free base
LEVALBUTEROL INHALATION SOLUTION IMPURITIES/Limit of S-Albuterol USP42–NF37 Online 1-May-2019 NA NA In Mobile phase: Change
Acetonitrile, methanol, and acetic acid (50:50). To each liter of the solution add 3 mL of acetic acid and 1 mL of triethylamine.▲ (USP 1-May-2019)
to:
Acetonitrile and methanol (50:50… Read More
SODIUM BICARBONATE COMPOUNDED INJECTION ASSAY/Procedure for Sodium Bicarbonate USP42–NF37 4023 1-May-2019 NA NA In Analysis: Change
Result = [(VSVB) x NA x F] x 100
to:
Result = [(VSVB) x NA x F x 100]/W
AND… Read More
REAGENTS AND REFERENCE TABLES REAGENT SPECIFICATIONS USP42–NF37 6079 1-May-2019 NA NA In Beef Extract/Microbial Content: Change
MT
to:
NMT