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CSV June 19, 2016 through June 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/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.
REPOSITORY CORTICOTROPIN INJECTION ADDITIONAL REQUIREMENTS USP41–NF36 1097 1-May-2018 USP42–NF37 Second Supplement to USP41–NF36 In USP Reference Standards <11>: Add
USP Ascorbic Acid RS
COLCHICINE IMPURITIES/Limit of Ethyl Acetate/System suitability/Suitability requirements First Supplement to USP41–NF36 8314 1-May-2018 USP42–NF37 Second Supplement to USP41–NF36 Delete
Tailing factor: NMT 2.0 for the menthol peak
ARGATROBAN IMPURITIES/Organic Impurities USP41–NF36 346 1-May-2018 USP42–NF37 Second Supplement to USP41–NF36 Footnote b of Table 2: Change
Ethyl (2R,4R)-1-[N8-nitro-L-arginyl]-4-methylpiperidine-2-carboxylate hydrochloride.
to:
Ethyl (4R)-1-[N8-nitro-L-arginyl]-4-methylpiperidine-2-… Read More
ARGATROBAN ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP41–NF36 346 1-May-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 2 of USP Argatroban Related Compound B RS: Change
Ethyl (2R,4R)-1-[N8-nitro-L-arginyl]-4-methylpiperidine-2-carboxylate hydrochloride.
C15H28N6O5 ∙ HCl 408.88
to… Read More
<1210> STATISTICAL TOOLS FOR PROCEDURE VALIDATION 3. ACCURACY AND PRECISION USP41–NF36 7622 1-May-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 4 of paragraph 3 of 3.2 Combined Validation of Accuracy and Precision: Change
validate evaluate
to:
validate
AND
Variable definition in paragraph 6 of 3.2 Combined Validation of Accuracy and Precision… Read More
<724> DRUG RELEASE GENERAL DRUG RELEASE STANDARDS USP41–NF36 6471 1-May-2018 USP42–NF37 Second Supplement to USP41–NF36 Figure 5: Change
O
to:
Ø
REAGENTS/INDICATORS AND SOLUTIONS SOLUTIONS/Volumetric Solutions/0.01 M Sodium Thiosulfate VS USP41–NF36 5772 1-May-2018 USP42–NF37 Second Supplement to USP41–NF36 In the equation in Standardization: Change
N = mg K2Cr2O7/49.04 x mL Na2S2O3
to:
M = mg K2Cr2O7/49.04 x mL Na2… Read More
REAGENTS SOLUTIONS/Volumetric Solutions USP41–NF36 5769 1-May-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 1 of 0.1 N Potassium Hydroxide VS: Change
Transfer 100 mL of potassium hydroxide to a 1000-mL volumetric flask.
to:
Transfer 100 mL of 1 N Potassium Hydroxide VS to a 1000-mL volumetric flask.
REAGENTS REAGENT SPECIFICATIONS USP41–NF36 5680 1-May-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 1 of Carbon Disulfide, CS: Change
Carbon Disulfide, CS
to:
Carbon Disulfide, CS2
SALMETEROL INHALATION POWDER ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP40–NF35 6096 1-Apr-2018 USP42–NF37 USP42–NF37 Line 2 of USP Salmeterol Related Compound H RS: Change
1-Hydroxy-4-[2-hydroxy-5-(1-hydroxy-2-{[6-(4-phenylbutoxy)hexyl]amino}ethyl)benzyl]-2-naphthoic acid.
C36H43NO6 585.73
to:
1-Hydroxy-4-[2-hydroxy-5-(1-… Read More
PERINDOPRIL ERBUMINE IMPURITIES/Limit of Perindopril Related Compound I/System suitability USP40–NF35 5644 1-Apr-2018 USP42–NF37 USP42–NF37 Line 3: Add
[Note—The relative retention times for perindopril and perindopril related compound I are 1.0 and 1.6, respectively.]
FLUTICASONE PROPIONATE AND SALMETEROL INHALATION POWDER ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP40–NF35 4309 1-Apr-2018 USP42–NF37 USP42–NF37 Line 2 of USP Salmeterol Related Compound H RS: Change
1-Hydroxy-4-[2-hydroxy-5-(1-hydroxy-2-{[6-(4-phenylbutoxy)hexyl]amino}ethyl)benzyl]-2-naphthoic acid.
C36H43NO6 585.73
to:
1-Hydroxy-4-[2-hydroxy-5-(1-… Read More
<661.1> PLASTIC MATERIALS OF CONSTRUCTION TEST METHODS/Tin in Non-Tin-Stabilized Materials USP41–NF36 6403 1-Apr-2018 USP42–NF37 USP42–NF37 Line 3 of Sample solution: Change
If the solution is not colorless, add the sodium sulfate
to:
If the solution is not colorless, add the sodium sulfite
PIPERACILLIN AND TAZOBACTAM FOR INJECTION IMPURITIES/Organic Impurities, Procedure 2/Table 3 USP40–NF35 5728 1-Mar-2018 USP42–NF37 Second Supplement to USP41–NF36 Footnote m: Change
(2S,5R,6R)-Ethyl 6-((R)-2-{(2S,5R,6R)-6-[(R)-2-(4-ethyl-2,3-dioxopiperazine-1-carboxamido)-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxamido}-2-phenylacetamido)-3,3-dimethyl-7-… Read More
PAROXETINE HYDROCHLORIDE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> First Supplement to USP40–NF35 Online 1-Mar-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 1 of USP Paroxetine Related Compound F RS: Change
trans(−)-1-Methyl-3-[1,3-benzodioxol-5-yloxy)methyl]-4-(fluorophenyl)piperidine.
to:
(3S,4R)-3-[(Benzodioxol-5-yloxy)methyl]-4-(4-fluorophenyl)-1-methylpiperidine.
NOREPINEPHRINE BITARTRATE ASSAY/Procedure USP40–NF35 5380 1-Mar-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 1 of Sample solution: Change
25 mg/mL of Norepinephrine Bitartrate in glacial acetic acid. If necessary warm slightly to effect solution.
to:
Dissolve 500 mg of Norepinephrine Bitartrate in 20 mL of glacial acetic acid, warming slightly if necessary to… Read More
NOREPINEPHRINE BITARTRATE IDENTIFICATION/B. Procedure USP40–NF35 5380 1-Mar-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 1 of Analysis: Change
Add 1 drop of ferric chloride TS.
to:
Add 1 drop of ferric chloride TS to 2 mL of Sample solution.
CHLORHEXIDINE GLUCONATE ORAL RINSE Identification USP40–NF35 3367 1-Mar-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 1 of C: Change
Undiluted Oral Rinse used as the test solution meets the requirements for Identification test B under Calcium Gluconate, except that a Standard solution containing about 0.6 mg of USP Potassium Gluconate RS per mL is used and 15 μL… Read More
AMLODIPINE AND ATORVASTATIN TABLETS PERFORMANCE TESTS/Dissolution <711> First Supplement to USP41–NF36 8270 1-Mar-2018 USP42–NF37 Second Supplement to USP41–NF36 In the variable definition list of the second equation in Analysis: Change
Mr2 = molecular weight of atorvastatin calcium, 1209.39
to:
Mr2 = molecular weight of atorvastatin calcium, 1155.34
AMLODIPINE AND ATORVASTATIN TABLETS ASSAY/Procedure First Supplement to USP41–NF36 8270 1-Mar-2018 USP42–NF37 Second Supplement to USP41–NF36 In the variable definition list of the second equation in Analysis: Change
Mr2 = molecular weight of atorvastatin calcium, 1209.39
to:
Mr2 = molecular weight of atorvastatin calcium, 1155.34
AMLODIPINE AND ATORVASTATIN TABLETS IMPURITIES/Organic Impurities Related to Atorvastatin First Supplement to USP41–NF36 8270 1-Mar-2018 USP42–NF37 Second Supplement to USP41–NF36 In the variable definition list in Analysis: Change
Mr2 = molecular weight of atorvastatin calcium, 1209.39
to:
Mr2 = molecular weight of atorvastatin calcium, 1155.34
<1210> STATISTICAL TOOLS FOR PROCEDURE VALIDATION 3. ACCURACY AND PRECISION/3.1 Methods for Estimating Accuracy and Precision USP41–NF36 7622 1-Mar-2018 USP42–NF37 Second Supplement to USP41–NF36 Paragraph 4: Change
For example, with ɑ = 0.05 and n = 9, t0.95:8 = 1.860 provides a 100(1− 2 × 1.05)%
to:
For example, with ɑ = 0.05 and n = 9, t0.95:8 = 1.860 provides a 100(1 − 2 × 0.05)%
<601> INHALATION AND NASAL DRUG PRODUCTS: AEROSOLS, SPRAYS, AND POWDERS—PERFORMANCE QUALITY TESTS C. AERODYNAMIC SIZE DISTRIBUTION—INHALATION AEROSOLS, SPRAYS, AND POWDERS USP41–NF36 6327 1-Mar-2018 USP42–NF37 Second Supplement to USP41–NF36 Figure 6: Change
Boquilla del Inhalador
to:
Inhaler Mouthpiece
AND
Change
Tubo de Admisión
to:
Induction Port
AND
Change
Cono de Ingreso
to:
Entrance Cone