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PDF CSV October 5, 2022 through October 5, 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
<1160> PHARMACEUTICAL CALCULATIONS IN PHARMACY PRACTICE 19. MEAN KINETIC TEMPERATURE USP42–NF37 7831 1-Sep-2019 NA NA In 19.4 Example Calculations of MKT for CRT Storage Evaluation/Example 3—Calculation of Annual MKTStep 3: Change
3.354
to:
3.340
AND
In Step 4: Change
2.795
to:
2.783
AND
In Step 5:… Read More
G49 CHROMATOGRAPHIC COLUMNS/Packings First Supplement to USP40–NF35 8127 20-Apr-2019 USP42–NF37 First Supplement to USP41–NF36 Add
G49—Dimethylpolysiloxane with chiral building block containing D- or L-valine as chiral agent (for amino acids).
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
BUSPIRONE HYDROCHLORIDE TABLETS IDENTIFICATION/B. USP42–NF37 621 1-Aug-2019 NA NA Change
relative retention time
to:
retention time
<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
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
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
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
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
<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 MminRead More
CHLOROTHIAZIDE Selenium <291> USP42–NF37 942 1-Aug-2019 NA NA Change
0.003%.
to:
NMT 0.003%.
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
BUSPIRONE HYDROCHLORIDE IDENTIFICATION/B. USP42–NF37 618 1-Aug-2019 NA NA Change
relative retention time
to:
retention time
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.
ALPROSTADIL ASSAY/Procedure USP42–NF37 151 1-Aug-2019 NA NA In System suitability stock solution: Change
Standard solution
to:
Standard stock solution
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;
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
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
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.