Errata - English

PDF CSV April 29, 2022 through April 29, 2024 All Errata for USP–NF How to use
Enter the title of the monograph
Monograph Title Section Source Publication Page Number Errata Post Date Errata Official Date Target Errata Print Publication Target Online Fix Publication Description
FELBAMATE TABLETS IMPURITIES/Organic Impurities/System suitability/Suitability requirements USP36–NF31 3537 26-Jul-2013 1-Aug-2013 USP38–NF33 First Supplement to USP37–NF32 Line 1 of Resolution: Change
NMT 2
to:
NLT 2
RIMEXOLONE OPHTHALMIC SUSPENSION Viscosity—Capillary Viscometer Methods <911> and Rotational Rheometer Methods <912> USP36–NF31 5053 27-Sep-2013 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 27-Sep-2013 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
(VS − VB)
to:
(VB − VS)
AND
Line 11 of Analysis:… Read More
GYMNEMA IDENTIFICATION/B. Thin-Layer Chromatography/Chromatographic system First Supplement to USP36–NF31 5880 26-Jul-2013 1-Aug-2013 USP38–NF33 First Supplement to USP37–NF32 Line 2 of Adsorbent: Change
5m
to:
5 µm
FILGRASTIM ASSAY/Potency Second Supplement to USP36–NF31 6606 27-Sep-2013 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 27-Sep-2013 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
BEHENOYL POLYOXYLGLYCERIDES IMPURITIES/Limit of Free Glycerol/Titrimetric system USP36–NF31 1892 27-Sep-2013 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 1 of Mode: Change
Direct titration
to:
Residual titration
CEFDINIR CAPSULES IMPURITIES/Organic Impurities/Table 2 USP36–NF31 2850 26-Jul-2013 1-Aug-2013 USP38–NF33 First Supplement to USP37–NF32 Row 16 of Column 1: Change
Cefdinir impurity 2e
to:
Cefdinir impurity 2f
AND
Row 21 of Column 1: Change
Cefdinir impurity 3e
to:
Cefdinir impurity 3f
ESOMEPRAZOLE MAGNESIUM SPECIFIC TESTS/Color of Solution USP36–NF31 3464 27-Sep-2013 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
FEXOFENADINE HYDROCHLORIDE TABLETS ASSAY/Procedure USP36–NF31 3576 26-Jul-2013 1-Aug-2013 USP38–NF33 First Supplement to USP37–NF32 Line 6 of Sample stock solution: Change
(equivalent to 80% of the total flask volume)
to:
(sufficient to fill the flask to 80% of its volume)
RIVASTIGMINE TARTRATE CHEMICAL INFORMATION USP36–NF31 5073 27-Sep-2013 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 27-Sep-2013 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
(VS − VB)
to:
(VB − VS)
AND
Line 11 of Analysis:… Read More
POWDERED GYMNEMA IDENTIFICATION/B. Thin-Layer Chromatography/Chromatographic system First Supplement to USP36–NF31 5883 26-Jul-2013 1-Aug-2013 USP38–NF33 First Supplement to USP37–NF32 Line 2 of Adsorbent: Change
5m
to:
5 µm
PANCURONIUM BROMIDE INJECTION IMPURITIES/Organic Impurities Second Supplement to USP36–NF31 6677 27-Sep-2013 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 27-Sep-2013 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
BETADEX IMPURITIES/Limit of Reducing Sugars USP36–NF31 1905 27-Sep-2013 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
CLARITHROMYCIN FOR ORAL SUSPENSION ASSAY/Procedure USP36–NF31 3018 26-Jul-2013 1-Aug-2013 USP38–NF33 First Supplement to USP37–NF32 Change the subsection head
Buffer:
to:
Buffer A:
AND
After the Buffer A subsection: Add
Buffer B: 0.067 M dibasic potassium phosphate
AND
Line 1 of Mobile phase: Change
Methanol and Buffer
to:
Methanol and Buffer A… Read More
ETHIODIZED OIL INJECTION Viscosity—Capillary Viscometer Methods <911> and Rotational Rheometer Methods <912> USP36–NF31 3505 27-Sep-2013 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 1: Change
and
to:
or
FLUPHENAZINE DECANOATE INJECTION Assay USP36–NF31 3639 26-Jul-2013 1-Aug-2013 USP38–NF33 First Supplement to USP37–NF32 Line 11 of Standard preparation: Delete
(1:5)
AND
Line 8 of Assay preparation: Delete
(1:5)
SALICYLIC ACID USP Reference standards <11> USP36–NF31 5098 27-Sep-2013 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 27-Sep-2013 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
(VS − VB)
to:
(VB − VS)
AND
Line 11 of Analysis:… Read More
PURIFIED GYMNEMA EXTRACT COMPOSITION/Content of Gymnemic Acids First Supplement to USP36–NF31 5884 26-Jul-2013 1-Aug-2013 USP38–NF33 First Supplement to USP37–NF32 Line 1 of Acceptance criteria: Change
90%–110% of the labeled amount
to:
90.0%–110.0% of the labeled amount on the dried basis
POLYMYXIN B SULFATE IMPURITIES/Organic Impurities Second Supplement to USP36–NF31 6686 27-Sep-2013 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 27-Sep-2013 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
CAPRYLOCAPROYL POLYOXYLGLYCERIDES IMPURITIES/Limit of Free Glycerol USP36–NF31 1922 27-Sep-2013 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
(VT − VB)
to:
(VB − VS)
AND… Read More
CLARITHROMYCIN EXTENDED-RELEASE TABLETS PERFORMANCE TESTS/Dissolution <711>/Test 4 USP36–NF31 3019 26-Jul-2013 1-Aug-2013 USP38–NF33 First Supplement to USP37–NF32 Line 2 of Standard solution: Change
and Medium (96:4).
to:
and Medium (4:96).
FERUMOXSIL ORAL SUSPENSION Viscosity—Capillary Viscometer Methods <911> and Rotational Rheometer Methods <912> USP36–NF31 3572 27-Sep-2013 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 1: Change
and
to:
or
LAMOTRIGINE TABLETS PERFORMANCE TESTS/Dissolution <711>/Test 1 USP36–NF31 4056 26-Jul-2013 1-Aug-2013 USP38–NF33 First Supplement to USP37–NF32 Line 3 of Standard solution: Change
0.028 µg/mL
to:
0.028 mg/mL
TERAZOSIN CAPSULES PERFORMANCE TESTS/Dissolution <711>/Test 1/Spectrometric conditions USP36–NF31 5308 27-Sep-2013 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 27-Sep-2013 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
GENTAMICIN SULFATE IMPURITIES/Limit of Methanol First Supplement to USP36–NF31 5990 26-Jul-2013 1-Aug-2013 USP38–NF33 First Supplement to USP37–NF32 Line 11 of Analysis: Change
Result = (RU/RS) × (CS/CU) × D × F × 100
to:
Result = (RU/RS) × (CS… Read More
STINGING NETTLE COMPOSITION/Content of Total Amino Acids USP36–NF31 1604 26-Jul-2013 1-Aug-2013 USP38–NF33 First Supplement to USP37–NF32 Line 1 of Reagent solution: Change
Solution containing 1.00 g of ninhydrin, 1.50 g of hydrindantin,
to:
Solution containing 1.00 g of ninhydrin, 150 mg of hydrindantin,
STEAROYL POLYOXYLGLYCERIDES IMPURITIES/Limit of Free Glycerol USP36–NF31 2250 27-Sep-2013 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 11 of Analysis: Change
(VS − VB)
to:
(VB − VS)
AND
Line 12 of Analysis: Change
VS = Titrant volume consumed by the Sample… Read More
CETOSTEARYL ALCOHOL SPECIFIC TESTS/Fats and Fixed Oils, Hydroxyl Value <401> USP36–NF31 1954 27-Sep-2013 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 16 of Analysis: Change
Result = [(VS − VB) × F]/W
to:
Result = [(VB… Read More
DACARBAZINE FOR INJECTION USP Reference standards <11> USP36–NF31 3137 26-Jul-2013 1-Aug-2013 USP38–NF33 First Supplement to USP37–NF32 Line 3 of USP Dacarbazine Related Compound B RS: Change
C4H3N5O 137.10
to:
C4H3N5O · H2O 155.12
MERCAPTOPURINE TABLETS IMPURITIES/Organic Impurities/Procedure USP36–NF31 4249 27-Sep-2013 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 6 of Sample stock solution: Change
Dilute with water to volume.
to:
Dilute with Solution A to volume.
LEVOFLOXACIN ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP36–NF31 4099 26-Jul-2013 1-Aug-2013 USP38–NF33 First Supplement to USP37–NF32 Line 2 of USP Levofloxacin Related Compound A RS: Change
(S)-9-Fluoro-3-methyl-10-(piperazin-1-yl)-7-oxo-2,3-dihydro-7H-pyrido[1,2,3-de][1,4-benzoxazine-6-carbocylic acid.
to:
(S)-9-Fluoro-3-methyl-10-(piperazin-1-yl)-7-oxo-2,3-dihydro-7H-pyrido[1,2,3-… Read More
COMPOUND UNDECYLENIC ACID OINTMENT Assay for zinc undecylenate USP36–NF31 5516 27-Sep-2013 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 27-Sep-2013 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
MEPROBAMATE TABLETS ASSAY/Procedure First Supplement to USP36–NF31 6015 26-Jul-2013 1-Aug-2013 USP38–NF33 First Supplement to USP37–NF32 Line 4 of Standard solution: Change
Dissolve in 30% of the final flask volume, and dilute with water to volume.
to:
Dissolve in 30% of the final flask volume of acetonitrile, and dilute with water to volume.
POWDERED STINGING NETTLE COMPOSITION/Content of Total Amino Acids USP36–NF31 1606 26-Jul-2013 1-Aug-2013 USP38–NF33 First Supplement to USP37–NF32 Line 1 of Reagent solution: Change
Solution containing 1.00 g of ninhydrin, 1.50 g of hydrindantin,
to:
Solution containing 1.00 g of ninhydrin, 150 mg of hydrindantin,
STEARYL ALCOHOL SPECIFIC TESTS/Fats and Fixed Oils, Hydroxyl Value <401> USP36–NF31 2252 27-Sep-2013 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 14 of Analysis: Change
[(VS − VB) × N × F]/W
to:
[(VB − VS) × N × Mr]/W
AND
Line 15 of Analysis: Change… Read More
CETYL ALCOHOL SPECIFIC TESTS/Fats and Fixed Oils, Hydroxyl Value <401> USP36–NF31 1956 27-Sep-2013 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 = [(VS − VB) × F]/W
to:
Result = [(VB… Read More
CRYOPRESERVED HUMAN FIBROBLAST-DERIVED DERMAL SUBSTITUTE Total collagen content USP36–NF31 3155 26-Jul-2013 1-Aug-2013 USP38–NF33 First Supplement to USP37–NF32 Line 7 of Collagen calibration standards: Change
by adding 25 mL, 50 mL, 100 mL, and 200 mL,
to:
by adding 25 μL, 50 μL, 100 μL, and 200 μL,
METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS PERFORMANCE TESTS/Dissolution <711>/Test 2/System suitability USP36–NF31 4327 27-Sep-2013 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 1 of Capacity factor: Change
NMT 2
to:
NLT 2
MOXIFLOXACIN OPHTHALMIC SOLUTION Related compounds USP36–NF31 4414 26-Jul-2013 1-Aug-2013 USP38–NF33 First Supplement to USP37–NF32 Row 1 of Column 3 of Table 2: Change
Relative Retention Time vs. Moxifloxacin
to:
Relative Retention vs. Moxifloxacin
AND
Row 1 of Column 3 of Table 3: Change
Relative Retention Time vs. Moxifloxacin
to:
Relative Retention vs. Moxifloxacin
URSODIOL TABLETS IMPURITIES/Organic Impurities/Procedure USP36–NF31 5520 27-Sep-2013 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,
POLYOXYL 20 CETOSTEARYL ETHER SPECIFIC TESTS/Average Polymer Length USP36–NF31 2155 27-Sep-2013 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 16 of Analysis: Change
Result = [32 × A2/(A1 − 3)]/4
to:
Result = [(32 × A2/A1) − 3]/4
OXCARBAZEPINE IMPURITIES/Organic Impurities, Procedure 1 First Supplement to USP36–NF31 6035 26-Jul-2013 1-Aug-2013 USP38–NF33 First Supplement to USP37–NF32 Row 4 of Column 1 of Table 1: Change
Dibenzazepinoneb
to:
Oxcarbazepine related compound E
AND
Delete footnote b
AND
Reletter the following footnotes in both the table and footnote definitions:
c to b
d to c
e to d
POWDERED STINGING NETTLE EXTRACT COMPOSITION/Content of Total Amino Acids USP36–NF31 1608 26-Jul-2013 1-Aug-2013 USP38–NF33 First Supplement to USP37–NF32 Line 1 of Reagent solution: Change
Solution containing 1.00 g of ninhydrin, 1.50 g of hydrindantin,
to:
Solution containing 1.00 g of ninhydrin, 150 mg of hydrindantin,