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Errata - English

CSV August 19, 2016 through August 19, 2018 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
ZIPRASIDONE HYDROCHLORIDE IMPURITIES/Organic Impurities Second Supplement to USP41–NF36 8992 1-Aug-2018 USP43–NF38 Second Supplement to USP41–NF36 In the second variable definition in Analysis: Change
rU = peak response of chloroindolinone or ziprasidone related compound F from the Sample solution
to:
rU = peak response of chloroindolinone,… Read More
SODIUM FLUORIDE AND ACIDULATED PHOSPHATE TOPICAL SOLUTION ASSAY First Supplement to USP41–NF36 8423 1-Aug-2018 USP43–NF38 Second Supplement to USP41–NF36 Line 1 of Sample solution: Change
1.1 µg/mL of sodium fluoride
to:
0.5 µg/mL of fluoride ion
AND
In the variable definition list in Analysis: Change
CU = nominal concentration of sodium fluoride in the… Read More
RACEPINEPHRINE HYDROCHLORIDE USP Reference standards <11> USP41–NF36 3565 1-Aug-2018 USP43–NF38 Second Supplement to USP41–NF36 Add
USP Epinephrine Bitartrate RS
RACEPINEPHRINE INHALATION SOLUTION ADDITIONAL REQUIREMENTS USP41–NF36 3564 1-Aug-2018 USP43–NF38 Second Supplement to USP41–NF36 Add
USP Reference Standards <11>
USP Epinephrine Bitartrate RS
RACEPINEPHRINE USP Reference standards <11> USP41–NF36 3564 1-Aug-2018 USP43–NF38 Second Supplement to USP41–NF36 Add
USP Epinephrine Bitartrate RS
MICONAZOLE NITRATE ASSAY/Procedure First Supplement to USP41–NF36 Online 1-Aug-2018 USP43–NF38 Second Supplement to USP41–NF36 (Note: This errata applies to the new USP-NF ONLINE platform only.)
Line 1 of System suitability solution: Change
0.1 mg/mL of USP Miconazole Nitrate RS and 6 µg/mL of USP Econazole Nitrate RS in Diluent.
to:
0.1 mg/mL of USP… Read More
MICONAZOLE NITRATE IMPURITIES/Organic Impurities First Supplement to USP41–NF36 Online 1-Aug-2018 USP43–NF38 Second Supplement to USP41–NF36 (Note: This errata applies to the new USP-NF ONLINE platform only.)
Line 1 of Standard solution: Change
1.2 µg/mL each of USP Miconazole Nitrate RS, USP Econazole Nitrate RS, USP Doxazosin Related Compound C RSUSP Doxazosin Related Compound C… Read More
MICONAZOLE NITRATE ADDITIONAL REQUIREMENTS First Supplement to USP41–NF36 Online 1-Aug-2018 USP43–NF38 Second Supplement to USP41–NF36 (Note: This errata applies to the new USP-NF ONLINE platform only.)
Line 4 of USP Reference Standards <11>: Change
USP Doxazosin Related Compound C RS
to:
USP Miconazole Related Compound C RS
AND
Line 7 of USP… Read More
FOLIC ACID INJECTION USP Reference standards <11> USP41–NF36 1866 1-Aug-2018 USP43–NF38 Second Supplement to USP41–NF36 Delete
USP Endotoxin RS
FISH OIL CONTAINING OMEGA-3 ACIDS DEFINITION USP41–NF36 4617 1-Aug-2018 USP43–NF38 Second Supplement to USP41–NF36 Line 5: Change
Scombroidae,
to:
Scombridae,
DIVALPROEX SODIUM DELAYED-RELEASE CAPSULES PERFORMANCE TESTS/Dissolution <711>/Test 2 USP41–NF36 1354 1-Aug-2018 USP43–NF38 Second Supplement to USP41–NF36 Line 1 of Tolerances: Change
NMT 20% (Q) of the labeled amount of
to:
NMT 20% of the labeled amount of
DEXAMETHASONE SODIUM PHOSPHATE INJECTION ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP41–NF36 1204 1-Aug-2018 USP43–NF38 Second Supplement to USP41–NF36 Delete
USP Endotoxin RS
BUPROPION HYDROCHLORIDE IDENTIFICATION/C. Identification Tests—General <191>, Chloride USP41–NF36 573 1-Aug-2018 USP43–NF38 Second Supplement to USP41–NF36 Line 1 of Acceptance criteria: Change
Meets the requirements of test
to:
Meets the requirements of test A
<1663> ASSESSMENT OF EXTRACTABLES ASSOCIATED WITH PHARMACEUTICAL PACKAGING/DELIVERY SYSTEMS REFERENCES USP41–NF36 7910 1-Aug-2018 USP43–NF38 Second Supplement to USP41–NF36 Line 2 of reference 7: Delete
http://webstore.ansi.org/RecordDetail.aspx?sku=ASTM%20F1980-07(2011)&source=msn&adgroup=astm. Accessed 19 March 2013.
<661.1> PLASTIC MATERIALS OF CONSTRUCTION TEST METHODS USP41–NF36 6403 1-Aug-2018 USP43–NF38 Second Supplement to USP41–NF36 Line 1 of Plastic Additives/Reference solutions/Reference solution I: Change
0.24 mg/mL of USP Plastic Additive 4 RS prepared in the Solvent mixture
to:
0.24 mg/mL of USP Plastic Additive 4 RS prepared in methylene… Read More
<123> GLUCAGON BIOIDENTITY TESTS PROCEDURE/B. In Vitro Cell-Based Bioidentity Test First Supplement to USP41–NF36 8627 1-Aug-2018 USP43–NF38 Second Supplement to USP41–NF36 Line 1 of Medium B: Change
Kreb's salt solution containing 0.3% (v/v) human serum albumen
to:
Krebs' salt solution containing 0.3% (v/v) human serum albumin
AND
Line 1 of Medium C: change
Kreb's salt solution containing 0.… Read More
REAGENTS CHROMATOGRAPHIC COLUMNS/Packings USP41–NF36 5776 1-Aug-2018 USP43–NF38 Second Supplement to USP41–NF36 Line 2 of L73: Delete
[Note—Available as Jordi-Gel DBV from www.jordiflp.com.]
REAGENTS REAGENTS, INDICATORS, AND SOLUTIONS/Reagent Specifications USP41–NF36 5737 1-Aug-2018 USP43–NF38 Second Supplement to USP41–NF36 Line 4 of N-(2-Tetrahydrofuroyl)piperazine: Change
EMS-DOTTIKON, www.ems-dottikon.ch.
to:
Oakwood Chemical, www.oakwoodchemical.com.
HYDROGENATED POLYDEXTROSE ASSAY/Procedure USP41–NF36 5495 1-Jul-2018 USP42–NF37 Second Supplement to USP41–NF36 Change
Standard solution: 4.0 mg/mL of USP Polydextrose RS, calculated on the anhydrous and ash-free basis, in Mobile phase
Sample solution: 4.0 mg/mL of Hydrogenated Polydextrose, calculated on the anhydrous and ash-free basis, in… Read More
POLYDEXTROSE ASSAY/Procedure First Supplement to USP41–NF36 8491 1-Jul-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 1 of Sample solution: Change
Polydextrose, calculated on the anhydrous and ash-free basis, in Mobile phase
to:
Polydextrose in Mobile phase
AND
Line 1 of Acceptance criteria: Change
NLT 90.0%
to… Read More
CHORIONIC GONADOTROPIN FOR INJECTION ADDITIONAL REQUIREMENTS USP41–NF36 1982 1-Jul-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 2 of USP Reference Standards <11>: Delete
USP Endotoxin RS
CALCIUM CITRATE MALATE IMPURITIES/Limit of Fluoride First Supplement to USP41–NF36 8299 1-Jul-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 1 of Standard solution: Change
Transfer 1.0 mL of Standard stock solution
to:
Transfer 2.0 mL of Standard stock solution
<198> NUCLEAR MAGNETIC RESONANCE SPECTROSCOPY IDENTITY TESTING OF BACTERIAL POLYSACCHARIDES USED IN VACCINE MANUFACTURE 2. PROCEDURE First Supplement to USP41–NF36 8633 1-Jul-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 3 of 2.1 Equipment Requirements/Processing Parameters: Change
adsorption
to:
absorption
ZIPRASIDONE HYDROCHLORIDE IMPURITIES/Organic Impurities/Analysis Second Supplement to USP41–NF36 8993 1-Jun-2018 USP42–NF37 Second Supplement to USP41–NF36 In the second Calculate statement: Change
chloroindolinone and ziprasidone related compound F
to:
chloroindolinone, ziprasidone related compound F, and any individual unspecified impurity
AND
In the second variable definition list:… Read More
COMPRESSIBLE SUGAR IMPURITIES/Limit of Calcium USP41–NF36 5631 1-Jun-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 1: Delete
Proceed as directed in Identification Tests—General <191>, Calcium.
SODIUM METABISULFITE ASSAY/Procedure/Analysis USP41–NF36 5573 1-Jun-2018 USP42–NF37 Second Supplement to USP41–NF36 In the Calculate statement: Change
sodium metabisulfite (Na2S2O5)
to:
sulfur dioxide (SO2)
MICONAZOLE NITRATE TOPICAL POWDER ADDITIONAL REQUIREMENTS/USP Reference Standards <11> First Supplement to USP41–NF36 8355 1-Jun-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 2 of USP Miconazole Related Compound C RS: Change
2-[(2,4-Dichlorobenzyl)oxy]-2-(2,4-dichlorophenyl)ethan-1-amine.
C15H13Cl4NO 365.08
to:
2-[(2,4-Dichlorobenzyl)oxy]-2-(2,4-dichlorophenyl)ethan-1-amine… Read More
LAMIVUDINE ORAL SOLUTION ASSAY/Procedure/Chromatographic system USP41–NF36 2328 1-Jun-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 1 of Flow rate: Change
1 mL/mL
to:
1 mL/min
FLUMAZENIL IMPURITIES/Limit of Flumazenil Related Compound C USP41–NF36 1775 1-Jun-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 2 of Standard solution B: Change
0.12 μg/mL
to:
0.12 μL/mL
ETHYLENE GLYCOL AND VINYL ALCOHOL GRAFT COPOLYMER IMPURITIES/Procedure 2: Vinyl Acetate USP41–NF36 5346 1-Jun-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 6 of Sample solution: Change
Pass through a 0.2-mm membrane filter.
to:
Pass through a 0.2-μm membrane filter.
ESZOPICLONE TABLETS ADDITIONAL REQUIREMENTS/USP Reference Standards Second Supplement to USP41–NF36 Online 1-Jun-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 2 of USP Eszopiclone Related Compound A RS:
[Note—This material may be available in the free base or salt form.]
6-(5-Chloropyridin-2-yl)-7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b]pyrazin-5-yl 4-methylpiperazine-1-carboxylate 4-oxide… Read More
ESZOPICLONE ADDITIONAL REQUIREMENTS/USP Reference Standards Second Supplement to USP41–NF36 Online 1-Jun-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 2 of USP Eszopiclone Related Compound A RS:
[Note—This material may be available in the free base or salt form.]
6-(5-Chloropyridin-2-yl)-7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b]pyrazin-5-yl 4-methylpiperazine-1-carboxylate 4-oxide… Read More
ERYTHRITOL IMPURITIES/Related Compounds/Analysis USP41–NF36 5335 1-Jun-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 2: Change
Samples: Standard solution and Sample solution
to:
Samples: Standard solution A and Sample solution
AND
In the variable definition list: Change
rS… Read More
DOXEPIN HYDROCHLORIDE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP41–NF36 1404 1-Jun-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 2 of USP Doxepin Related Compound C RS: Change
(E,Z)-3-(Dibenzo[b,e]oxepin-11(6H-ylidene)-N-methyl-propoan-1-amine.
to:
(E,Z)-3-(Dibenzo[b,e]oxepin-11(6H)-ylidene)-N-methylpropan-… Read More
CHOLESTEROL IMPURITIES/Limit of Related Sterols and Other Organic Impurities/Analysis USP41–NF36 5296 1-Jun-2018 USP42–NF37 Second Supplement to USP41–NF36 In the second variable definition list: Change
CS2 = concentration of USP Cholesterol RS in the Standard solution (mg/mL)
to:
CS2 = concentration of USP Cholesterol RS in the System… Read More
CARBIDOPA AND LEVODOPA TABLETS ASSAY/Procedure/Chromatographic system USP41–NF36 693 1-Jun-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 1 of Detector: Change
Identification B,
to:
Identification A,
<1661> EVALUATION OF PLASTIC PACKAGING SYSTEMS AND THEIR MATERIALS OF CONSTRUCTION WITH RESPECT TO THEIR USER SAFETY IMPACT APPLICABILITY AND APPLICATION OF <661.1> USP41–NF36 7902 1-Jun-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 3 of Application/4.: Change
proscribed
to:
prescribed
AND
Line 3 of Description of Polymers Contained in <661.1>/Polyethylenes: Change
Low-density polypropylene (LDPE)
to:
Low-density… Read More
<1601> PRODUCTS FOR NEBULIZATION—CHARACTERIZATION TESTS AERODYNAMIC ASSESSMENT OF NEBULIZED AEROSOLS USP41–NF36 7874 1-Jun-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 1 of paragraph 3: Change
general information chapter Aerosols, Nasal Sprays, Metered-Dose Inhalers, and Dry Powder Inhalers <601>),
to:
general chapter Inhalation and Nasal Drug Products: Aerosols, Sprays, and Powders—… Read More
<210> MONOSACCHARIDE ANALYSIS PROCEDURES/Procedure 3: Enzymatic Hydrolysis and Analysis by RP-HPLC of DMB-labeled Sialic Acids First Supplement to USP41–NF36 Online 1-Jun-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 6 of Analysis: Change
Convert the protein concentration from mg/mL to (1 μM = 1 nmol/mL).
to:
Convert the protein concentration from mg/mL to μM (1 μM = 1 nmol/mL).
ZONISAMIDE CAPSULES PERFORMANCE TESTS/Dissolution <711> USP41–NF36 4410 1-May-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 1 of Apparatus 2: Change
75 rpm, with sinkers (see Dissolution <711>, Figure 2a)
to:
75 rpm. Use suitable sinkers, if necessary.
HYDROGENATED VEGETABLE OIL DEFINITION USP41–NF36 5649 1-May-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 2: Change
The melting range, heavy metals limit, iodine value, and saponification value differ,
to:
The melting range, iodine value, and saponification value differ,
PEMETREXED FOR INJECTION ASSAY/Procedure/Analysis First Supplement to USP41–NF36 Online 1-May-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 8 of the variable definition list: Change
Mr2 = molecular weight of pemetrexed disodium (anhydrous), 473.37
to:
Mr2 = molecular weight of pemetrexed disodium (anhydrous), 471.38
ISOSORBIDE DINITRATE SUBLINGUAL TABLETS Assay USP41–NF36 2272 1-May-2018 USP42–NF37 Second Supplement to USP41–NF36 Change
Buffer solution, Mobile phase, Internal standard solution, Standard preparation, and Chromatographic system—Prepare as directed in the Assay under Diluted Isosorbide Dinitrate.
to:
Read More
ISOSORBIDE DINITRATE SUBLINGUAL TABLETS Identification USP41–NF36 2272 1-May-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 1: Change
Tablets respond to the Identification test under Isosorbide Dinitrate Tablets.
to:
Transfer a suitable quantity of finely powdered Tablets to a glass-stoppered centrifuge tube. Add 10 mL of sodium hydroxide solution (1… Read More
ISOSORBIDE DINITRATE CHEWABLE TABLETS Assay USP41–NF36 2270 1-May-2018 USP42–NF37 Second Supplement to USP41–NF36 Change
Buffer solution, Mobile phase, Internal standard solution, Standard preparation, and Chromatographic system—Prepare as directed in the Assay under Diluted Isosorbide Dinitrate.
to:
Buffer solution—… Read More
ISOSORBIDE DINITRATE CHEWABLE TABLETS Identification USP41–NF36 2270 1-May-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 1: Change
Chewable Tablets respond to the Identification test under Isosorbide Dinitrate Tablets.
to:
Transfer a suitable quantity of finely powdered Tablets to a glass-stoppered centrifuge tube. Add 10 mL of sodium hydroxide… Read More
ISOSORBIDE DINITRATE TABLETS Assay USP41–NF36 2270 1-May-2018 USP42–NF37 Second Supplement to USP41–NF36 Change
Buffer solution, Mobile phase, Internal standard solution, Standard preparation, and Chromatographic system—Prepare as directed in the Assay under Diluted Isosorbide Dinitrate.
to:
Read More
ETHYL ACETATE IMPURITIES/Chromatographic Purity USP41–NF36 5336 1-May-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 3 of Acceptance criteria: Change
Ethyl isobutyl ether:
to:
1-Ethoxy-2-methylpropane:
DIDANOSINE FOR ORAL SOLUTION ASSAY/Procedure/Chromatographic system USP41–NF36 1275 1-May-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 1 of Guard column: Change
20-cm;
to:
20-mm;
DESLORATADINE TABLETS IMPURITIES USP41–NF36 1178 1-May-2018 USP42–NF37 Second Supplement to USP41–NF36 Organic Impurities: Add
Protect all solutions containing desloratadine from light.