Skip to main content

Errata - English

PDF CSV October 4, 2022 through October 4, 2024 All Errata for USP–NF How to use
Enter the title of the monograph
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