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PDF CSV August 24, 2017 through August 24, 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
VALGANCICLOVIR HYDROCHLORIDE Related compounds USP42–NF37 4528 1-Aug-2019 NA NA In Column 2 of Table 3: Change
Bis-valine easter of ganciclovir
to:
Bis-valine ester of ganciclovir
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
TIAGABINE HYDROCHLORIDE IMPURITIES/Limit of (S)-(+) Isomer/Mobile phase First Supplement to USP42–NF37 8823 1-Aug-2019 NA NA Change
Hexane,
to:
n-Hexane,
AND
Change
hexane
to:
n-hexane
OXALIPLATIN INJECTION IMPURITIES/Limit of Oxalic Acid/Chromatographic system First Supplement to USP42–NF37 8781 1-Aug-2019 NA NA In Column: Change
L31
to:
L81
POWDERED MILK THISTLE EXTRACT COMPOSITION/Content of Silymarin USP42–NF37 5102 1-Aug-2019 NA NA In Table 2: Change
Tsosilybin B
to:
Isosilybin B
LOVASTATIN TABLETS PERFORMANCE TESTS/Dissolution <711> First Supplement to USP42–NF37 8727 1-Aug-2019 NA NA In Mobile phase: Change
Processed as directed in the Assay
to:
Proceed as directed in the Assay.
LAMOTRIGINE TABLETS FOR ORAL SUSPENSION PERFORMANCE TESTS/Dissolution <711>/Chromatographic procedure 1 First Supplement to USP42–NF37 8720 1-Aug-2019 NA NA In Buffer: Change
glacial acetic acid acid
to:
glacial acetic acid
IOVERSOL CHEMICAL INFORMATION USP42–NF37 2345 1-Aug-2019 NA NA Change
N,N′-Bis(2,3-dihydroxypropyl)-5-N-(2-hydroxyethyl)glycol amido]-2,4,6-triiodoisophthalamide.
to:
N,N’-Bis(2,3-dihydroxypropyl)-5-[N-(2-hydroxyethyl)glycolamido]-2,4,6-triiodoisophthalamide.
EPHEDRINE HYDROCHLORIDE CHEMICAL INFORMATION First Supplement to USP42–NF37 8682 1-Aug-2019 NA NA Add
(1R,2S)-2-(Methylamino)-1-phenylpropan-1-ol hydrochloride;
CHLOROTHIAZIDE Selenium <291> USP42–NF37 942 1-Aug-2019 NA NA Change
0.003%.
to:
NMT 0.003%.
BUSPIRONE HYDROCHLORIDE TABLETS IDENTIFICATION/B. USP42–NF37 621 1-Aug-2019 NA NA Change
relative retention time
to:
retention time
BUSPIRONE HYDROCHLORIDE IDENTIFICATION/B. USP42–NF37 618 1-Aug-2019 NA NA Change
relative retention time
to:
retention time
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
ALUMINA, MAGNESIA, AND SIMETHICONE ORAL SUSPENSION SPECIFIC TESTS/Microbial Enumeration Tests <61> and Tests for Specified Microorganisms <62> USP42–NF37 170 1-Aug-2019 NA NA Change
cfu/g
to:
cfu/mL
ALPROSTADIL ASSAY/Procedure USP42–NF37 151 1-Aug-2019 NA NA In System suitability stock solution: Change
Standard solution
to:
Standard stock solution
<123> GLUCAGON BIOIDENTITY TESTS PROCEDURE/B. In Vitro Cell-Based Bioidentity Test USP42–NF37 6478 1-Aug-2019 NA NA In Standard stock solution: Change
0.4 µg/mL
to:
4 µg/mL
<41> BALANCES REPEATABILITY First Supplement to USP42–NF37 9011 1-Aug-2019 NA NA In all instances in paragraph 2: Change
sr
to:
s
AND
In paragraph 2: Change
is found to be 0.0015, then Mmin must be ≥ 0.3000 g or 300 mg.
to:
is found to be 0.00015, then M… 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)
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
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… Read More
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… 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… Read More
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)… 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 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.
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.
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
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)
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.
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]… Read More
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-(… Read More
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-(… 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
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
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 · H3PO… 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)
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
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
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;
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
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%
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.
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
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.
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
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)
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)
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
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… Read More