Sorry, you need to enable JavaScript to visit this website.

Errata - English

PDF CSV November 24, 2022 through November 24, 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
GLYCERYL TRISTEARATE IDENTIFICATION/Fatty Acid Composition USP36–NF31 2033 31-Jan-2014 1-Feb-2014 USP38–NF33 Second Supplement to USP37–NF32 Line 19 of Analysis: Change
Result = [(FMC × PFA1 × AMC)/(PMC × AFA1)] × 100
to:
Result = (FMC × PFA1 ×… Read More
DICLOFENAC SODIUM DELAYED-RELEASE TABLETS IMPURITIES/Organic Impurities/Procedure USP36–NF31 3221 31-Jan-2014 1-Feb-2014 USP38–NF33 Second Supplement to USP37–NF32 Line 22 of Analysis: Change
rS = peak response for each impurity from the Standard solution
to:
rS = peak response of diclofenac related compound A from the Standard solution
TIZANIDINE TABLETS IMPURITIES/Organic Impurities/Procedure USP36–NF31 5408 31-Jan-2014 1-Feb-2014 USP38–NF33 Second Supplement to USP37–NF32 Line 9 of Sample solution: Change
45-µm or finer pore size
to:
0.45-µm or finer pore size
OXALIPLATIN INJECTION IMPURITIES/Limit of Oxalic Acid First Supplement to USP36–NF31 6033 31-Jan-2014 1-Feb-2014 USP38–NF33 Second Supplement to USP37–NF32 Line 3 of Analysis: Change
Calculate the percentage of each impurity
to:
Calculate the percentage of oxalic acid
WATER-SOLUBLE VITAMINS WITH MINERALS CAPSULES STRENGTH/Molybdenum, Method 1 Second Supplement to USP36–NF31 6479 31-Jan-2014 1-Feb-2014 USP38–NF33 Second Supplement to USP37–NF32 Line 2 of Standard solutions: Change
2.0
to:
5.0
CEFTAZIDIME FOR INJECTION Assay USP36–NF31 2887 31-Jan-2014 1-Feb-2014 USP38–NF33 Second Supplement to USP37–NF32 Line 6 of Procedure: Change
250,000[C/W (100 − m − s)](rU / rS)
to:
25,000{C/[W (100 − m − s)]}(rU / rS)
RIBOFLAVIN 5′-PHOSPHATE SODIUM IMPURITIES/Free Riboflavin and Riboflavin Diphosphates USP36–NF31 5037 31-Jan-2014 1-Feb-2014 USP38–NF33 Second Supplement to USP37–NF32 Line 1 of Emission wavelength: Change
530 nm
to:
530 nm (monochromator-based detector) or 470 nm (filtered-type detector)
CYCLOMETHICONE ASSAY/Procedure/System suitability First Supplement to USP36–NF31 5909 31-Jan-2014 1-Feb-2014 USP38–NF33 Second Supplement to USP37–NF32 Line 2 of Suitability requirements: Change
Relative standard deviation: NMT 2.0% for cyclomethicone 4, cyclomethicone 5, and cyclomethicone 6, Standard solution A, Standard solution B, and Standard solution C
to:
Relative standard deviation: NMT… Read More
OIL- AND WATER-SOLUBLE VITAMINS WITH MINERALS ORAL SOLUTION STRENGTH/Chromium Second Supplement to USP36–NF31 6399 31-Jan-2014 1-Feb-2014 USP38–NF33 Second Supplement to USP37–NF32 Line 13 of Analysis: Change
C = concentration of chromium in the Standard solution (µg/mL)
to:
C = concentration of chromium in the Sample solution (µg/mL)
ANAGRELIDE HYDROCHLORIDE ASSAY/Procedure/Chromatographic system/System suitability USP36–NF31 2500 31-Jan-2014 1-Feb-2014 USP38–NF33 Second Supplement to USP37–NF32 Line 2 of Suitability requirements: Change
Column efficiency: NMT
to:
Column efficiency: NLT
DILTIAZEM HYDROCHLORIDE IMPURITIES/Organic Impurities USP36–NF31 3258 31-Jan-2014 1-Feb-2014 USP38–NF33 Second Supplement to USP37–NF32 Line 21 of Analysis: Change
rS = response of each impurity peak from the Standard solution
to:
rS = peak response of desacetyl diltiazem from the Standard solution
VANCOMYCIN HYDROCHLORIDE SPECIFIC TESTS/Composition of Vancomycin USP36–NF31 5543 31-Jan-2014 1-Feb-2014 USP38–NF33 Second Supplement to USP37–NF32 Line 28 of Analysis: Change
Result = [(rI/(D × rB) + rA)] × 100
to:
Result = {rI/[(D × rB) + rA]} × 100
<1660> CONTAINERS GLASS-EVALUATION OF INNER SURFACE DURABILITY EVALUATION OF THE INNER SURFACE DURABILITY/Aggressive Screening Conditions Second Supplement to USP36–NF31 6221 31-Jan-2014 1-Feb-2014 USP38–NF33 Second Supplement to USP37–NF32 Row 1 of Column 3 of Table 4: Change
3% Citric Acid pH 8.0
to:
3% Sodium Citrate pH 8.0
ISOPROPYL ALCOHOL ASSAY/Procedure Second Supplement to USP36–NF31 6638 31-Jan-2014 1-Feb-2014 USP38–NF33 Second Supplement to USP37–NF32 Line 17 of Chromatographic system: Change
Linear velocity: 35 cm/s
to:
Flow rate: 2.3 mL/min
AND
Row 2 of Column 1 of Table 2: Change
Diethyl ether
to:
Ethyl ether
BOSWELLIA SERRATA EXTRACT COMPOSITION/Content of Keto-Derivatives of β-Boswellic Acids/System suitability/Suitability requirements USP36–NF31 1367 22-Nov-2013 1-Dec-2013 USP38–NF33 Second Supplement to USP37–NF32 Line 1 of Tailing factor: Change
11-keto-β-boswellic acid peak
to:
3-acetyl-11-keto-β-boswellic acid peak
CARVEDILOL IMPURITIES/Organic Impurities, Procedure 3: Carvedilol Related Compound F USP36–NF31 2822 22-Nov-2013 1-Dec-2013 USP38–NF33 Second Supplement to USP37–NF32 Line 2 of Sample solution: Change
Use about 1.9 mL of Diluent per mg of the Carvedilol, and sonicate briefly to facilitate dissolution.
to:
Initially add Diluent to fill about 80% of the total volume. Sonicate briefly to facilitate dissolution. Cool, and dilute with… Read More
LEVALBUTEROL INHALATION SOLUTION ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP36–NF31 4080 22-Nov-2013 1-Dec-2013 USP38–NF33 Second Supplement to USP37–NF32 Line 35: Delete
USP Levalbuterol Related Compound H RS
4-[2-(tert-Butylamino)-1-methoxyethyl]-2-(hydroxymethyl)phenol.
C14H23NO3 253.34
RISPERIDONE ORALLY DISINTEGRATING TABLETS ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP36–NF31 5067 22-Nov-2013 1-Dec-2013 USP38–NF33 Second Supplement to USP37–NF32 Line 2 of USP Risperidone Related Compounds Mixture RS: Change
Contains a 98.9/0.5/0.3/0.3 (area %) mixture of the following four compounds:
Risperidone (98.9%)
Risperidone cis-N-oxide (0.5%): cis-3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9… Read More
VALERIAN TINCTURE STRENGTH/Content of Valerenic Acids Second Supplement to USP36–NF31 6352 22-Nov-2013 1-Dec-2013 USP38–NF33 Second Supplement to USP37–NF32 Line 1 of Acceptance criteria: Change
90.0%–120.0%
to:
NLT 0.015% of valerenic acids, calculated as the sum of hydroxyvalerenic acid, acetoxyvalerenic acid, and valerenic acid
PARICALCITOL INJECTION IMPURITIES/Organic Impurities/Chromatographic system/Columns Second Supplement to USP36–NF31 6678 22-Nov-2013 1-Dec-2013 USP38–NF33 Second Supplement to USP37–NF32 Line 1 of Guard: Change
4.6-mm × 7.5-cm
to:
4.6-mm × 7.5-mm
FERRIC AMMONIUM CITRATE Mercury USP36–NF31 2469 22-Nov-2013 1-Dec-2013 USP38–NF33 Second Supplement to USP37–NF32 Line 5 of Standard solutions: Change
2.5, 5.0, 10.0, and 35.0 µg
to:
2.5, 5.0, 10.0, and 35.0 ng
GRANISETRON HYDROCHLORIDE INJECTION Assay USP36–NF31 3772 22-Nov-2013 1-Dec-2013 USP38–NF33 Second Supplement to USP37–NF32 Line 10 of Procedure: Change
100(312.41 / 348.87)(C/L)(rU / rS)
to:
100(312.41 / 348.87)(C/CU)(rU / rS)
AND
Line of 14 of Procedure: Change
L is… Read More
LACTATED RINGER'S INJECTION Definition USP36–NF31 5055 22-Nov-2013 1-Dec-2013 USP38–NF33 Second Supplement to USP37–NF32 Line 13: Change
408.0 mg of chloride
to:
428.0 mg of chloride
BUFFER SOLUTIONS 4. Standard Buffer Solutions/4.1 Preparation Second Supplement to USP36–NF31 6244 22-Nov-2013 1-Dec-2013 USP38–NF33 Second Supplement to USP37–NF32 Line 1 of 4. Boric Acid and Potassium Chloride 0.2 M: Change
12.73 g/L of boric acid
to:
12.37 g/L of boric acid
DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS PERFORMANCE TESTS/Dissolution <711>/Test 5 Second Supplement to USP36–NF31 6592 22-Nov-2013 1-Dec-2013 USP38–NF33 Second Supplement to USP37–NF32 Line 3 of Acid stage sample solution: Change
suitable filter of 45-µm pore size.
to:
suitable filter of 0.45-µm pore size.
AND
Line 3 of Buffer stage sample solution: Change
suitable filter of 45-µm pore size.
to:
suitable filter of 0.45-µm pore size.
ALMOND OIL SPECIFIC TESTS/Sterol Composition USP36–NF31 1877 22-Nov-2013 1-Dec-2013 USP38–NF33 Second Supplement to USP37–NF32 Row 9 of Table 2: Change
Δ7-Stigmastenol ≥3.0%
to:
Δ7-Stigmastenol ≤3.0%
FLUOCINONIDE TOPICAL SOLUTION Alcohol content USP36–NF31 3618 22-Nov-2013 1-Dec-2013 USP38–NF33 Second Supplement to USP37–NF32 Line 1 of Standard solution: Change
Dilute 20.0 mL of USP Alcohol
to:
Dilute 20.0 mL of alcohol
MINERAL OIL SPECIFIC TESTS USP36–NF31 4372 22-Nov-2013 1-Dec-2013 USP38–NF33 Second Supplement to USP37–NF32 Line 1 of Viscosity—Capillary Viscometer Methods <911>: Change
34.5 and 150.0 mm2· s−1
to:
34.5–150.0 mm2· s−1
ATROPINE SULFATE SPECIFIC TESTS/Optical Rotation, Specific Rotation <781> First Supplement to USP36–NF31 5948 22-Nov-2013 1-Dec-2013 USP38–NF33 Second Supplement to USP37–NF32 Line 1 of Sample solution: Change
0.1 mg/mL in water
to:
0.1 g/mL of Atropine Sulfate in water
CAPSICUM OLEORESIN SPECIFIC TESTS/Limit of Nonivamide Second Supplement to USP36–NF31 6577 22-Nov-2013 1-Dec-2013 USP38–NF33 Second Supplement to USP37–NF32 Line 1 of Acceptance criteria: Change
on the dried basis
to:
on the anhydrous basis
RISPERIDONE ORAL SOLUTION ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Second Supplement to USP36–NF31 6690 22-Nov-2013 1-Dec-2013 USP38–NF33 Second Supplement to USP37–NF32 Line 2 of USP Risperidone Related Compounds Mixture RS: Change
Contains a 98.9: 0.5: 0.30: 0.3 (area %) mixture of four compounds:
98.9% of Risperidone.
0.5% of Risperidone cis-N-oxide: cis-3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-… Read More
BOSWELLIA SERRATA COMPOSITION/Content of Keto-Derivatives of β-Boswellic Acids/System suitability/Suitability requirements USP36–NF31 1366 22-Nov-2013 1-Dec-2013 USP38–NF33 Second Supplement to USP37–NF32 Line 1 of Tailing factor: Change
11-keto-β-boswellic acid peak
to:
3-acetyl-11-keto-β-boswellic acid peak
APROTININ Limit of des-Ala-aprotinin and des-Ala-des-Gly-aprotinin USP36–NF31 2522 22-Nov-2013 1-Dec-2013 USP38–NF33 Second Supplement to USP37–NF32 Change the subsection head
Capillary zone electrophoresis system (see Capillary Electrophoresis under Biotechnology-Derived Articles—Test <1047>)—
to:
Capillary zone electrophoresis system—
KETOROLAC TROMETHAMINE TABLETS IMPURITIES/Organic Impurities USP36–NF31 4042 22-Nov-2013 1-Dec-2013 USP38–NF33 Second Supplement to USP37–NF32 Line 1 of Sample solution: Change
Proceed as directed for the Sample stock solution in the Assay.
to:
Proceed as directed for the Sample solution in the Assay.
RISPERIDONE USP Reference standards <11> USP36–NF31 5063 22-Nov-2013 1-Dec-2013 USP38–NF33 Second Supplement to USP37–NF32 Line 7 of USP Risperidone System Suitability Mixture RS: Change
9-Hydroxyrisperidone-(6RS)-3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]ethyl]-2,6-dimethyl-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]pyrimidin-4-one.
to:
9-Hydroxyrisperidone: (9RS)-3-{2-[4-(6… Read More
CHINESE SALVIA COMPOSITION/Content of Salvianolic Acid B Second Supplement to USP36–NF31 6331 22-Nov-2013 1-Dec-2013 USP38–NF33 Second Supplement to USP37–NF32 Line 16 of Analysis: Change
W = weight of Chinese Salvia used to prepare the Sample solution (mg)
to:
W = weight of Chinese Salvia used to prepare the Sample stock solution (mg)
LORATADINE IMPURITIES/Organic Impurities, Procedure 1 Second Supplement to USP36–NF31 6650 22-Nov-2013 1-Dec-2013 USP38–NF33 Second Supplement to USP37–NF32 Line 3 of Note: Change
4,8-dichloro-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-one
to:
4,8-dichloro-5,6-dihydro-11H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-one
POLYETHYLENE GLYCOL MONOMETHYL ETHER IMPURITIES/Limit of 2-Methoxyethanol USP36–NF31 2142 22-Nov-2013 1-Dec-2013 USP38–NF33 Second Supplement to USP37–NF32 Line 11 of Calibration: Change
On the two Calibration plots,
to:
On the Calibration plot,
GADOTERIDOL INJECTION Bacterial endotoxins <85> USP36–NF31 3701 22-Nov-2013 1-Dec-2013 USP38–NF33 Second Supplement to USP37–NF32 Line 2: Change
gadoteridol.
to:
Gadoteridol Injection.
OCTINOXATE Assay USP36–NF31 4556 22-Nov-2013 1-Dec-2013 USP38–NF33 Second Supplement to USP37–NF32 Line 3 of Chromatographic system: Change
a 0.32-mm × 25-m column that contains coating G1,
to:
a 0.32-mm × 25-m column with 0.25-µm thickness of phase G1 coating,
ISOTRETINOIN CAPSULES PERFORMANCE TESTS/Dissolution <711>/Test 4 First Supplement to USP36–NF31 6000 22-Nov-2013 1-Dec-2013 USP38–NF33 Second Supplement to USP37–NF32 Line 13 of System suitability: Add section heads before "Calculate the percentage....":
Analysis
Samples: Standard solution and Sample solution
CYCLOBENZAPRINE HYDROCHLORIDE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Second Supplement to USP36–NF31 6585 22-Nov-2013 1-Dec-2013 USP38–NF33 Second Supplement to USP37–NF32 Line 2 of USP Cyclobenzaprine Related Compound A RS: Change
5-[3-(Dimethylamino)propyl]-10,11-dihydro-5H-dibenzo[a,d]-cyclohepten-5-ol.
to:
5-[3-(Dimethylamino)propyl]-5H-dibenzo[a,d]-cyclohepten-5-ol.
TRAMADOL HYDROCHLORIDE ASSAY/Procedure Second Supplement to USP36–NF31 6715 22-Nov-2013 1-Dec-2013 USP38–NF33 Second Supplement to USP37–NF32 Line 2 of System suitability solution: Change
USP Tramadol Hydrochloride Related Compound A RS
to:
USP Tramadol Related Compound A RS
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
ACETYLTRIBUTYL CITRATE IDENTIFICATION/B. USP36–NF31 1869 27-Sep-2013 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 2: Change
USP Acetyltriethyl Citrate RS
to:
USP Acetyltributyl Citrate RS
CLAVULANATE POTASSIUM IMPURITIES/Organic Impurities/Procedure 3: Limit of Aliphatic Amines USP36–NF31 3022 27-Sep-2013 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 In the definition list in Analysis: Change
CU = nominal concentration of Clavulanate Potassium in the Standard solution
to:
CU = nominal concentration of Clavulanate Potassium in the Sample solution
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
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.
GLYCERYL MONOLINOLEATE ASSAY/Procedure USP36–NF31 2030 27-Sep-2013 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 13 of Chromatographic system: Change
Column temperature: 40°
to:
Temperatures
Detector: 40°
Column: 40°
QUININE SULFATE IMPURITIES/Dihydroquinine Sulfate USP36–NF31 4995 27-Sep-2013 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 5 of Analysis: Change
Result = (rU/rS) × 100
to:
Result = rU/(rU + rS) × 100