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PDF CSV November 14, 2017 through November 14, 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
HYPROMELLOSE ACETATE SUCCINATE ASSAY USP42–NF37 5772 1-Nov-2019 NA NA In Content of Methoxy and 2-Hydroxypropoxy Groups/Analysis: Change
Result = (rUM/rSM) × (CS/CU) × (Mr1/Mr2)
to:
Read More
GADOTERIDOL Limit of gadoteridol related compound A USP42–NF37 2020 1-Nov-2019 NA NA In Chromatographic system: Change
packing L21
to:
packing L47
<2022> MICROBIOLOGICAL PROCEDURES FOR ABSENCE OF SPECIFIED MICROORGANISMS—NUTRITIONAL AND DIETARY SUPPLEMENTS BUFFER AND MEDIA/Media USP42–NF37 8514 1-Nov-2019 NA NA In Row 5 of Column 2 for L-Cystine in Fluid Selenite–Cystine Medium: Change
10.0 g
to:
10.0 mg
<1229.2> STEAM STERILIZATION OF AQUEOUS LIQUIDS BIOBURDEN/BIOLOGICAL INDICATOR METHOD/Routine Process Control USP42–NF37 8082 1-Nov-2019 NA NA In the first paragraph: Change
calibrartion
to:
calibration
<1228.4> DEPYROGENATION BY RINSING ROUTINE PROCESS CONTROL USP42–NF37 8067 1-Nov-2019 NA NA In the first paragraph: Change
WFI
to:
Water for Injection
<1222> TERMINALLY STERILIZED PHARMACEUTICAL PRODUCTS—PARAMETRIC RELEASE INTRODUCTION USP42–NF37 8021 1-Nov-2019 NA NA In paragraphs 4 and 5: Change
a probability of a PNSU
to:
a PNSU
<55> BIOLOGICAL INDICATORS—RESISTANCE PERFORMANCE TESTS D-VALUE DETERMINATION USP42–NF37 6385 1-Nov-2019 NA NA In the third paragraph in Procedure: Change
stated spore filter
to:
stated spore titer
ZINC SULFATE CHEMICAL INFORMATION USP42–NF37 4649 1-Oct-2019 NA NA Change
Zinc sulfate (1:1) monohydrate 179.46
to:
Zinc sulfate (1:1) monohydrate 179.45
[7446-19-7].
AND
Change
287.56
to:
287.54
TRIFLUOPERAZINE HYDROCHLORIDE TABLETS Assay USP42–NF37 4473 1-Oct-2019 NA NA Change
2(407.51/480.43)C(rU/rS)
to:
2000(407.51/480.43)C(rU/rS)
PENICILLAMINE CAPSULES PERFORMANCE TESTS/Dissolution <711> Revision Bulletin (Official June 11, 2019) Online 1-Oct-2019 NA NA In Procedure for a pooled sample/Analysis: Change
Result = (AU/AS) × (CS/CU) × V × (1/L) × 100
to:
Result = (AU/A… Read More
PAROXETINE HYDROCHLORIDE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> First Supplement to USP42–NF37 8788 1-Oct-2019 NA NA In USP Paroxetine Related Compound G RS: Change
405.46
to:
441.92
HYDROCHLOROTHIAZIDE CAPSULES PERFORMANCE TESTS/Dissolution <711>/Test 2 USP42–NF37 2171 1-Oct-2019 NA NA In Empty capsules solution: Change
Place 10 Capsules
to:
Place 10 empty capsules
DESFLURANE CHEMICAL INFORMATION USP42–NF37 1230 1-Oct-2019 NA NA Change
(±)-2-Difluoromethyl 1,2,2,2-tetrafluoroethyl ether
to:
(±)-2-Difluoromethyl 1,2,2,2-tetrafluoroethyl ether;
2-(Difluoromethoxy)-1,1,1,2-tetrafluoroethane.
DESFLURANE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP42–NF37 1230 1-Oct-2019 NA NA In USP Desflurane Related Compound A RS: Change
Bis-(1,2,2,2-tetrafluoroethyl)ether.
to:
Bis-(1,2,2,2-tetrafluoroethyl)ether;
Also known as: 1,1,1,2-Tetrafluoro-2-(1,2,2,2-tetrafluoroethoxy)ethane.
BENZALDEHYDE ASSAY/Procedure USP42–NF37 5586 1-Oct-2019 NA NA In Chromatographic system: Delete
Detector temperature: 25°
BENDAMUSTINE HYDROCHLORIDE FOR INJECTION IMPURITIES/Organic Impurities USP42–NF37 487 1-Oct-2019 NA NA In Table 2: Change
Bendamustine related compound B
to:
Bendamustine related compound Ba
AND
Change
Bendamustine related compound Ca
to:
Bendamustine related compound Cb
Read More
BENDAMUSTINE HYDROCHLORIDE FOR INJECTION ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP42–NF37 487 1-Oct-2019 NA NA In USP Bendamustine Related Compound B RS: Change
4-(1-Methyl-5-morpholino-1H-benzimidazol-2-yl)butanoic acid.
C16H21N3O3 303.36
to:
4-(1-Methyl-5-morpholino-1H-benzimidazol-2-… Read More
ASHWAGANDHA ROOT DRY EXTRACT COMPOSITION/Content of Withanolides USP42–NF37 4724 1-Oct-2019 NA NA In the first equation in Analysis: Change
CS = concentration of USP Withanoside IV RS in Standard solution A (mg/mL)
to:
CS = concentration of USP Withanolide A RS in Standard solution A… Read More
ANAGRELIDE CAPSULES PERFORMANCE TESTS/Dissolution <711>/Analysis USP42–NF37 329 1-Oct-2019 NA NA Change
Result = (rU/rS) x (CS/CU) x (Mr1/Mr2) x (V/L) x 100
to:
Result = (rU/rS Read More
AMIODARONE HYDROCHLORIDE CHEMICAL INFORMATION USP42–NF37 253 1-Oct-2019 NA NA See https://www.uspnf.com/sites/default/files/usp_pdf/EN/september-2019-errata-with-image.pdf for correction.
SILDENAFIL CITRATE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP42–NF37 4002 1-Sep-2019 NA NA In USP Sildenafil Related Compound A RS: Change
5-[2-Ethoxy-5-[(4-methylpiperazin-1-yl)sulfonyl]phenyl]-1-methyl-3-(2-methylpropyl)-1,6-dihydro-7H-pyrazolo[4,3-d]pyrimidin-7-one.
C23H32N6O4S… Read More
OLMESARTAN MEDOXOMIL TABLETS IMPURITIES/Organic Impurities Revision Bulletin (Official March 19, 2019) Online 1-Sep-2019 NA NA In the Analysis: Change
CS = concentration of in the Standard solution (mg/mL)
to:
CS = concentration of USP Olmesartan Medoxomil RS in the Standard solution (mg/mL)
MORPHINE SULFATE EXTENDED-RELEASE CAPSULES IMPURITIES/Organic Impurities USP42–NF37 Online 1-Sep-2019 NA NA Change
Diluent, Solution A, System suitability solution, Chromatographic system, and Sample solution: Proceed as directed in the Assay.
to:
Diluent, Buffer solution, Solution A,… Read More
MECLOFENAMATE SODIUM CHEMICAL INFORMATION USP42–NF37 2706 1-Sep-2019 NA NA Change
336.15
to:
336.14
AND
Change
[6385-02-0];
to:
[67254-91-5];
AND
Change
UNII: 9MMQ0YER4E.
to:
UNII: 94NJ818U2W.
LEVOFLOXACIN CHEMICAL INFORMATION USP42–NF37 2552 1-Sep-2019 NA NA Change
Anhydrous [100986-85-41].
to:
Anhydrous [100986-85-4].
FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE EXTENDED-RELEASE TABLETS ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Revision Bulletin (Official August 01, 2018) Online 1-Sep-2019 NA NA In USP Fexofenadine Related Compound A RS: Change
Benzeneacetic acid, 4-[1-oxy-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]butyl]-α,α-dimethyl.
to:
2-(4-{4-[4-(Hydroxydiphenylmethyl)piperidin-1-yl]butanoyl}phenyl)-2-methylpropanoic acid;
Also known as… Read More
FEXOFENADINE HYDROCHLORIDE TABLETS ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Revision Bulletin (Official November 01, 2018) Online 1-Sep-2019 NA NA In USP Fexofenadine Related Compound A RS: Change
Benzeneacetic acid, 4-[1-oxy-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]butyl]-α,α-dimethyl.
to:
2-(4-{4-[4-(Hydroxydiphenylmethyl)piperidin-1-yl]butanoyl}phenyl)-2-methylpropanoic acid;
Also known as… Read More
FEXOFENADINE HYDROCHLORIDE CAPSULES ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP42–NF37 1830 1-Sep-2019 NA NA In USP Fexofenadine Related Compound A RS: Change
Benzeneacetic acid, 4-[1-oxy-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]butyl]-α,α-dimethyl.
C32H37NO4 538.12
to:
2-(4-{4-[4-(Hydroxydiphenylmethyl)piperidin-1-yl]… Read More
FEXOFENADINE HYDROCHLORIDE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP42–NF37 1828 1-Sep-2019 NA NA In USP Fexofenadine Related Compound A RS: Change
Benzeneacetic acid, 4-[1-oxy-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]butyl]-α,α-dimethyl.
to:
2-(4-{4-[4-(Hydroxydiphenylmethyl)piperidin-1-yl]butanoyl}phenyl)-2-methylpropanoic acid;
Also known as… Read More
CIDOFOVIR INJECTION IMPURITIES/Organic Impurities USP42–NF37 981 1-Sep-2019 NA NA In Table 1: Change
0.56
to:
0.59
CHLOROQUINE PHOSPHATE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP42–NF37 939 1-Sep-2019 NA NA In USP Chloroquine Related Compound G RS: Change
C18H26Cl3NO · H2SO4
to:
C18H26ClN3O · H2SO4
CALCIUM CARBONATE IMPURITIES/Limit of Magnesium and Alkali Salts USP42–NF37 666 1-Sep-2019 NA NA Change
Sample solution: 1.0 g
to:
Sample: 1.0 g
<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
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