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Errata - English

PDF CSV November 24, 2022 through November 24, 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
TERAZOSIN CAPSULES PERFORMANCE TESTS/Dissolution <711>/Test 1/Spectrometric conditions USP36–NF31 5308 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 1 of Analytical wavelength: Change
UV 245 nm
to:
UV 246 nm
AND
Line 3 of Cell length: Change
0.2 cm for Capsules labeled to contain 10 mg
to:
0.5 cm for Capsules labeled to contain 10 mg
POLYISOBUTYLENE IMPURITIES/Lead <251> USP36–NF31 2149 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 1 of Acceptance criteria: Change
NMT 3 mg/g
to:
NMT 3 μg/g
LOPINAVIR AND RITONAVIR TABLETS PERFORMANCE TESTS/Dissolution <711> First Supplement to USP36–NF31 6005 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 1 of Tolerances: Change
80.0%
to:
80%
SORBITAN MONOLAURATE IDENTIFICATION/A. USP36–NF31 2212 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 1 of Sample: Change
1 g of the residue obtained in the Assay for Fatty Acids
to:
Residue obtained in the Assay for Fatty Acids
AND
Line 2 of Acceptance criteria: Change
260–280
to:
260–280 on 1-g sample
POLYMYXIN B SULFATE IMPURITIES/Organic Impurities Second Supplement to USP36–NF31 6686 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 2: Change
Buffer, Mobile phase, Diluent, Sensitivity solution,
to:
Buffer, Mobile phase, Diluent, Standard solution, Sensitivity solution,
AND
Line 1 of Samples in Analysis: Change
Standard solution, Sample solution, and Read More
SORBITAN TRIOLEATE IDENTIFICATION/A. USP36–NF31 2216 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 1 of Sample: Change
1 g of the residue of oleic acid obtained in the Assay for Fatty Acids
to:
Residue obtained in the Assay for Fatty Acids
AND
Line 2 of Acceptance criteria: Change
192–204
to:
192–204 on 1-g sample
CAFFEINE CITRATE ORAL SOLUTION Assay USP36–NF31 2733 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 3 of Chromatographic system: Change
150-cm column
to:
15-cm column
<232> ELEMENTAL IMPURITIES—LIMITS DRUG PRODUCTS/Options for Demonstrating Compliance USP36–NF31 151 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 17 of Summation Option: Change
the manufacturer must validate
to:
the manufacturer must ensure
ETHIODIZED OIL INJECTION Viscosity—Capillary Viscometer Methods <911> and Rotational Rheometer Methods <912> USP36–NF31 3505 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 1: Change
and
to:
or
BETADEX IMPURITIES/Limit of Reducing Sugars USP36–NF31 1905 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 3 of Tartrate solution: Change
20 mg/mL of anhydrous sodium sulfate
to:
200 mg/mL of anhydrous sodium sulfate
OXYMETAZOLINE HYDROCHLORIDE OPHTHALMIC SOLUTION Identification USP36–NF31 4652 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 1: Change
A volume of Ophthalmic Solution, equivalent to about 2.5 mg of oxymetazoline hydrochloride, responds to the Identification test under Oxymetazoline Hydrochloride Nasal Solution.
to:
Place a volume of Ophthalmic Solution, equivalent to about 2.5 mg of… Read More
ETHYL OLEATE SPECIFIC TESTS/Viscosity—Capillary Viscometer Methods <911> and Rotational Rheometer Methods <912> USP36–NF31 2006 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Change:
and
to:
or
RIVASTIGMINE TARTRATE CHEMICAL INFORMATION USP36–NF31 5073 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 1: Change
398.41
to:
400.42
LINOLEOYL POLYOXYLGLYCERIDES IMPURITIES/Limit of Free Glycerol USP36–NF31 2068 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 1 of Mode in Titrimetric system: Change
Direct titration
to:
Residual titration
AND
Line 10 of Analysis: Change
(VSVB)
to:
(VBVS)
AND
Line 11 of Analysis:… Read More
BACLOFEN ASSAY/Procedure/Chromatographic system First Supplement to USP36–NF31 5951 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 1 of Column: Change
250-cm
to:
25.0-cm
POLYSORBATE 80 SPECIFIC TESTS/Viscosity—Capillary Viscometer Methods <911> and Rotational Rheometer Methods <912> USP36–NF31 2163 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 1: Change
and
to:
or
FILGRASTIM ASSAY/Potency Second Supplement to USP36–NF31 6606 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 7 of Preparation of cells for analysis: Change
Column 1 is filled with 50 L of Medium B.
to:
Column 1 is filled with 50 µL of Medium B.
SORBITAN MONOSTEARATE IDENTIFICATION/A. USP36–NF31 2214 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 1 of Sample: Change
1 g of the residue obtained in the Assay for Fatty Acids
to:
Residue obtained in the Assay for Fatty Acids
AND
Line 2 of Acceptance criteria: Change
200–215
to:
200–215 on 1-g sample
BUTABARBITAL SODIUM TABLETS Identification, Infrared Absorption <197K> USP36–NF31 2716 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 5 of Test specimen: Change
Proceed as directed for Column Partition Chromatography under Chromatography <621>, packing the chromatographic tube as follows.
to:
Pack a chromatographic tube as follows.
DROSPIRENONE IMPURITIES/Organic Impurities/Procedure 2 USP36–NF31 3349 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 In footnote b of Table 4: Change
5β,17β-Dihydroxy-6β,7β:15β,16β-dimethylene-17α-pregnan-21-carboxylic acid, γ-lactone.
to:
5β,17-Dihydroxy-6β,7β:15β,16β-dimethylene-3-oxo-17α-pregnan-21-carboxylic acid, γ-lactone.
DILUTED ALCOHOL ADDITIONAL REQUIREMENTS USP36–NF31 1874 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Delete USP Reference Standards <11> section
METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS PERFORMANCE TESTS/Dissolution <711>/Test 2/System suitability USP36–NF31 4327 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 1 of Capacity factor: Change
NMT 2
to:
NLT 2
CETYL ALCOHOL SPECIFIC TESTS/Fats and Fixed Oils, Hydroxyl Value <401> USP36–NF31 1956 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 1 of Mode in Titrimetric system: Change
Direct titration
to:
Residual titration
AND
Line 9 of Analysis: Change
Result = [(VSVB) × F]/W
to:
Result = [(VB Read More
RIFAMPIN, ISONIAZID, PYRAZINAMIDE, AND ETHAMBUTOL HYDROCHLORIDE TABLETS Assay for rifampin, isoniazid, and pyrazinamide USP36–NF31 5047 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 12 of Procedure: Change
the Standard preparation and the Assay preparation, respectively.
to:
the Assay preparation and the Standard preparation, respectively.
HYDROXYETHYL CELLULOSE SPECIFIC TESTS/Viscosity—Capillary Viscometer Methods <911> and Rotational Rheometer Methods <912> USP36–NF31 2038 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 1: Change
and
to:
or
COMPOUND UNDECYLENIC ACID OINTMENT Assay for zinc undecylenate USP36–NF31 5516 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 15 of Procedure: Change
431.94 is the molecular weight of zinc undecylenate;
to:
Mr is the molecular weight of zinc undecylenate, 431.94;
AND
Line 16 of Procedure: Change
65.39 is the atomic weight of zinc;
to:
Ar… Read More
POLYOXYL 10 OLEYL ETHER SPECIFIC TESTS/Average Polymer Length USP36–NF31 2150 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 9 of Analysis: Change
Result = [(31 A2/A1 − 3)]/4
to:
Result = [(31 × A2/A1) − 3]/4
QUININE SULFATE TABLETS ASSAY/Procedure First Supplement to USP36–NF31 6046 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 4 of Analysis: Change
dihydroquinone sulfate
to:
dihydroquinine sulfate
SORBITAN MONOOLEATE IDENTIFICATION/A. USP36–NF31 2213 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 1 of Sample: Change
1 g of the residue obtained in the Assay for Fatty Acids
to:
Residue obtained in the Assay for Fatty Acids
AND
Line 2 of Acceptance criteria: Change
192–204
to:
192–204 on 1-g sample
STEAROYL POLYOXYLGLYCERIDES IMPURITIES/Limit of Free Glycerol USP36–NF31 2250 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 11 of Analysis: Change
(VSVB)
to:
(VBVS)
AND
Line 12 of Analysis: Change
VS = Titrant volume consumed by the Sample… Read More
CARISOPRODOL, ASPIRIN, AND CODEINE PHOSPHATE TABLETS USP Reference standards <11> USP36–NF31 2813 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 2 of USP Codeine N-Oxide RS: Change
C18H21O4
to:
C18H21NO4
<232> ELEMENTAL IMPURITIES—LIMITS ANALYTICAL TESTING USP36–NF31 151 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 2: Change
If, by validated processes and supply-chain control,
to:
If, by process monitoring and supply-chain control,
FERUMOXSIL ORAL SUSPENSION Viscosity—Capillary Viscometer Methods <911> and Rotational Rheometer Methods <912> USP36–NF31 3572 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 1: Change
and
to:
or
CAPRYLOCAPROYL POLYOXYLGLYCERIDES IMPURITIES/Limit of Free Glycerol USP36–NF31 1922 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 1 of Mode in Titrimetric system: Change
Direct titration
to:
Residual titration
AND
Line 10 of Analysis: Change
(VTVB)
to:
(VBVS)
AND… Read More
POLYVINYL ALCOHOL SPECIFIC TESTS/Viscosity—Capillary Viscometer Methods <911>, Rotational Rheometer Methods <912>, and Rolling Ball Viscometer Method <913> USP36–NF31 4830 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 2: Change
and
to:
or
FERROSOFERRIC OXIDE IMPURITIES USP36–NF31 2018 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 1 of Sample solution C in Limit of Lead (Pb): Change
Sample solution
to:
Sample stock solution
AND
Line 1 of Sample solution D in Limit of Lead (Pb): Change
Sample solution
to:
Sample stock solution
AND
Line… Read More
SALICYLIC ACID USP Reference standards <11> USP36–NF31 5098 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 3 of USP Salicylic Acid Related Compound A RS: Change
[CAS-99-96-7].
to:
[99-96-7].
AND
Line 3 of USP Salicylic Acid Related Compound B RS: Change
C8H6O4
to:
C8H6O5
OLEOYL POLYOXYLGLYCERIDES IMPURITIES/Limit of Free Glycerol USP36–NF31 2112 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 1 of Mode in Titrimetric system: Change
Direct titration
to:
Residual titration
AND
Line 10 of Analysis: Change
(VSVB)
to:
(VBVS)
AND
Line 11 of Analysis:… Read More
ISOSORBIDE MONONITRATE EXTENDED-RELEASE TABLETS IMPURITIES/Organic Impurities, Procedure 2 First Supplement to USP36–NF31 5996 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 3: Change the section head
Isosorbide mononitrate related compound A stock solution:
to:
Isosorbide mononitrate related compound A standard stock solution:
AND
Line 7: Change the section head
Isosorbide dinitrate stock solution:
to:
Isosorbide… Read More
POTASSIUM METAPHOSPHATE SPECIFIC TESTS/Viscosity—Capillary Viscometer Methods <911> and Rotational Rheometer Methods <912> USP36–NF31 2172 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 1: Change
and
to:
or
PANCURONIUM BROMIDE INJECTION IMPURITIES/Organic Impurities Second Supplement to USP36–NF31 6677 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Footnote a of Table 1: Change
Piperidinium, 1-[(2,3,5,16,17)-17-acetyloxy-3-hydroxy-2-(1-piperidinyl)androstan-16-yl]-1-methyl bromide.
to:
Piperidinium, 1-[(2,3,5,16,17)-17-acetyloxy-3-hydroxy-2-(1-piperidinyl)androstan-16-yl]-1-methyl.
SORBITAN SESQUIOLEATE IDENTIFICATION/A. USP36–NF31 2215 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 1 of Sample: Change
1 g of the residue obtained in the Assay for Fatty Acids
to:
Residue obtained in the Assay for Fatty Acids
AND
Line 2 of Acceptance criteria: Change
192–204
to:
192–204 on 1-g sample
CAFFEINE CITRATE INJECTION Assay USP36–NF31 2732 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 3 of Chromatographic system: Change
150-cm column
to:
15-cm column
ESOMEPRAZOLE MAGNESIUM SPECIFIC TESTS/Color of Solution USP36–NF31 3464 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 1 of Sample solution: Change
20 mg/mL of Esomeprazole Magnesium in methanol
to:
20 mg/mL of Esomeprazole Magnesium in methanol, filtered
BEHENOYL POLYOXYLGLYCERIDES IMPURITIES/Limit of Free Glycerol/Titrimetric system USP36–NF31 1892 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 1 of Mode: Change
Direct titration
to:
Residual titration
OCTOCRYLENE Identification, Ultraviolet Absorption <197U> USP36–NF31 4557 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 4: Change
Absorptivities, calculated on the as-is basis,
to:
Absorptivity at 303 nm, calculated on the as-is basis,
EGG PHOSPHOLIPIDS ASSAY/Content of Phospholipids USP36–NF31 2000 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 2 of Solution A: Change
acetic acid
to:
glacial acetic acid
AND
Line 2 of Solution B: Change
acetic acid
to:
glacial acetic acid
RIMEXOLONE OPHTHALMIC SUSPENSION Viscosity—Capillary Viscometer Methods <911> and Rotational Rheometer Methods <912> USP36–NF31 5053 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 1: Change
and
to:
or
LAUROYL POLYOXYLGLYCERIDES IMPURITIES/Limit of Free Glycerol USP36–NF31 2064 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 1 of Mode in Titrimetric system: Change
Direct titration
to:
Residual titration
AND
Line 10 of Analysis: Change
(VSVB)
to:
(VBVS)
AND
Line 11 of Analysis:… Read More
URSODIOL TABLETS IMPURITIES/Organic Impurities/Procedure USP36–NF31 5520 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 2 of Sample solution: Change
Tablets, equivalent to about 25 mg of ursodiol,
to:
Tablets, equivalent to about 250 mg of ursodiol,