Errata - English

PDF CSV February 19, 2023 through February 19, 2025 All Errata for USP–NF How to use
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Monograph Title Section Source Publication Page Number Errata Post Date Errata Official Date Target Errata Print Publication Target Online Fix Publication Description
ZANAMIVIR IMPURITIES/Organic Impurities/Chromatographic system USP37–NF32 5197 21-Nov-2014 1-Dec-2014 USP39–NF34 Second Supplement to USP38–NF33 Line 1 of Column: Change
5-μm packing L##1
to:
5-μm packing L82
CHLORPHENIRAMINE MALEATE SPECIFIC TESTS/Optical Rotation, Specific Rotation <781> First Supplement to USP37–NF32 6617 21-Nov-2014 1-Dec-2014 USP39–NF34 Second Supplement to USP38–NF33 Line 1 of Sample: Change
100 mg/mL in water
to:
100 mg/mL in water at 20°
HYDROXYPROPYL CELLULOSE ASSAY Second Supplement to USP37–NF32 7080 21-Nov-2014 1-Dec-2014 USP39–NF34 Second Supplement to USP38–NF33 Line 1 of Internal standard solution: Change
Methycyclohexane
to:
Methylcyclohexane
CEFADROXIL FOR ORAL SUSPENSION IDENTIFICATION/Thin-Layer Chromatography/Chromatographic system USP37–NF32 2182 21-Nov-2014 1-Dec-2014 USP39–NF34 Second Supplement to USP38–NF33 Line 2 of Developing solvent system: Change
(60:40:15)
to:
(60: 40: 1.5)
GANODERMA LUCIDUM FRUITING BODY SPECIFIC TESTS/Botanical Characteristics Revision Bulletin (Official August 01, 2014) Online 21-Nov-2014 1-Dec-2014 USP39–NF34 Second Supplement to USP38–NF33 Line 6 of Macroscopic: Change
concentrically culcate
to:
concentrically sulcate
LAMIVUDINE AND ZIDOVUDINE TABLETS IMPURITIES/Organic Impurities USP37–NF32 3484 21-Nov-2014 1-Dec-2014 USP39–NF34 Second Supplement to USP38–NF33 Row 17 of Column 1 of Table 2: Change
(the limit includes individual unidentified impurities)
to:
(the limit includes individual unspecified impurities)
WHITE PETROLATUM IMPURITIES/Organic Impurities/Procedure: Organic Acids USP37–NF32 4254 21-Nov-2014 1-Dec-2014 USP39–NF34 Second Supplement to USP38–NF33 Line 1 of Sample solution: Change
20.0 g in 100 mL of neutralized alcohol and water (1:2).
to:
20.0 g of White Petrolatum in 100 mL of a 1 in 2 mixture of neutralized alcohol and water.
SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLETS ASSAY/Procedure USP37–NF32 4787 21-Nov-2014 1-Dec-2014 USP39–NF34 Second Supplement to USP38–NF33 Line 3 of Standard solution: Change
in Mobile phase from Sample stock solution
to:
in Mobile phase from Standard stock solution
TRIBASIC CALCIUM PHOSPHATE IMPURITIES/Dibasic Salt and Calcium Oxide USP37–NF32 5883 21-Nov-2014 1-Dec-2014 USP39–NF34 Second Supplement to USP38–NF33 Delete the subsection
Blank: 25.0 mL of Titrant
TRAZODONE HYDROCHLORIDE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> First Supplement to USP37–NF32 6708 21-Nov-2014 1-Dec-2014 USP39–NF34 Second Supplement to USP38–NF33 Line 2 of USP Trazodone Related Compound D RS: Change
(2-{3-[4-(4-Bromophenyl)piperazin-1-yl]propyl}-[1,2,4]triazolo[4,3-α]pyridin-3(2H)-one hydrochloride.
to:
2-{3-[4-(3-Bromophenyl)piperazin-1-yl]propyl}-[1,2,4]triazolo[4,3-α]pyridin-3(2H)-one hydrochloride.
<659> PACKAGING AND STORAGE REQUIREMENTS GENERAL DEFINITIONS USP37–NF32 315 21-Nov-2014 1-Dec-2014 USP39–NF34 Second Supplement to USP38–NF33 Line 1 of Single-Dose (see also Injections <1>, Containers for Injections): Change
A single-unit package for an article intended for parenteral administration. Examples of single-dose containers include prefilled syringes, cartridges, fusion-sealed containers, and closure-… Read More
SODIUM PICOSULFATE CHEMICAL INFORMATION Second Supplement to USP37–NF32 7253 21-Nov-2014 1-Dec-2014 USP39–NF34 Second Supplement to USP38–NF33 Line 5: Change
Disodium 4,4′-(pyridin-2-ylmethanediyl)dibenzenesulfonate
to:
Disodium 4,4′-(pyridin-2-ylmethanediyl)dibenzenesulfate
FLUDARABINE PHOSPHATE IMPURITIES/Limit of Sodium USP37–NF32 3003 21-Nov-2014 1-Dec-2014 USP39–NF34 Second Supplement to USP38–NF33 Line 1 of Standard solution: Change
1 µg/mL of sodium chloride in water
to:
1 µg/mL of sodium in water
NIFEDIPINE EXTENDED-RELEASE TABLETS PERFORMANCE TESTS/Dissolution <711>/Test 2 Second Supplement to USP37–NF32 Online 21-Nov-2014 1-Dec-2014 USP38–NF33 USP38–NF33 Line 1 of Solution A: Change
sodium phosphate
to:
dibasic sodium phosphate
MINOCYCLINE FOR INJECTION IMPURITIES USP37–NF32 3843 21-Nov-2014 1-Dec-2014 USP39–NF34 Second Supplement to USP38–NF33 Line 6 of Limit of Epiminocycline: Change
[Note—The relative retention times for epiminocycline and minocycline are 0.86 and 1.0, respectively.]
to:
[Note—The relative retention times for epiminocycline and minocycline are 0.7 and 1.0, respectively.]
SULFAMETHOXAZOLE AND TRIMETHOPRIM INJECTION ASSAY/Procedure USP37–NF32 4784 21-Nov-2014 1-Dec-2014 USP39–NF34 Second Supplement to USP38–NF33 Line 3 of Standard solution: Change
in Mobile phase from Sample stock solution
to:
in Mobile phase from Standard stock solution
SAW PALMETTO EXTRACT COMPOSITION/Content of Long-Chain Alcohols and Sterols USP37–NF32 5545 21-Nov-2014 1-Dec-2014 USP39–NF34 Second Supplement to USP38–NF33 Line 3 of Acceptance criteria:Add
The lipophilic Extract contains 0.15%–0.35% of long-chain alcohols, and the hydroalcoholic Extract contains 0.01%–0.15% of long-chain alcohols on the anhydrous basis.
ERYTHROMYCIN DELAYED-RELEASE TABLETS PERFORMANCE TESTS/Dissolution <711>/Test 1/Buffer stage First Supplement to USP37–NF32 6633 21-Nov-2014 1-Dec-2014 USP39–NF34 Second Supplement to USP38–NF33 Line 1 of Standard solution: Change
0.28 mg/mL of USP Erythromycin RS in Medium
to:
Dissolve USP Erythromycin RS in Medium to obtain a concentration similar to that of the Sample solution.
AND
Line 1 of Sample solution: Change
Pass portions of… Read More
POLYSORBATE 80 SPECIFIC TESTS/Fats and Fixed Oils, Acid Value <401> Second Supplement to USP37–NF32 7089 21-Nov-2014 1-Dec-2014 USP39–NF34 Second Supplement to USP38–NF33 Line 1 of Analysis: Change
with 0.1 N potassium hydroxide or 0.1 N sodium hydroxide
to:
with 0.1 N potassium hydroxide VS or 0.1 N sodium hydroxide VS
ESCITALOPRAM ORAL SOLUTION IMPURITIES/Organic Impurities USP37–NF32 2580 26-Sep-2014 1-Oct-2014 USP39–NF34 First Supplement to USP38–NF33 Row 6 of Column 1 of Table 3: Change
Desfluorocitalopramf
to:
Desfluorocitalopramf,c
KETOPROFEN EXTENDED-RELEASE CAPSULES PERFORMANCE TESTS/Uniformity of Dosage Units <905>/System suitability/Suitability requirements USP37–NF32 3469 26-Sep-2014 1-Oct-2014 USP39–NF34 First Supplement to USP38–NF33 Line 1 of Tailing factor: Change
NLT 1.5
to:
NMT 1.5
STERILE WATER FOR INHALATION CHEMICAL INFORMATION USP37–NF32 5174 26-Sep-2014 1-Oct-2014 USP39–NF34 First Supplement to USP38–NF33 Add the chemical formula and molecular weight:
H2O 18.02
STERILE WATER FOR IRRIGATION ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP37–NF32 5175 26-Sep-2014 1-Oct-2014 USP39–NF34 First Supplement to USP38–NF33 Add:
USP 1,4-Benzoquinone RS
AND
USP Sucrose RS
ETHYLCELLULOSE DISPERSION TYPE B ASSAY/Procedure USP37–NF32 5981 26-Sep-2014 1-Oct-2014 USP39–NF34 First Supplement to USP38–NF33 Line 3 of Analysis: Change
Calculate the percentage of ethylcellulose in the portion of Ethylcellulose Dispersion Type B taken:
to:
Calculate the percentage of the labeled amount of ethylcellulose in the portion of Ethylcellulose Dispersion Type B taken:
CALCIUM GLUCONATE INJECTION Identification USP37–NF32 2089 26-Sep-2014 1-Oct-2014 USP39–NF34 First Supplement to USP38–NF33 Line 1 of Identification test A: Change
A volume of Injection diluted, if necessary, with water to obtain a test solution of calcium gluconate (1 in 100) responds to Identification test B under Calcium Gluconate.
to:
Dissolve a quantity of it in water to… Read More
IRINOTECAN HYDROCHLORIDE INJECTION IMPURITIES/Organic Impurities USP37–NF32 3403 26-Sep-2014 1-Oct-2014 USP39–NF34 First Supplement to USP38–NF33 Row 3 of Column 1 of Table 2: Change
Camptothecinb
to:
Camptothecinb,d
AND
Row 5 of Column 1: Change
7-Ethylcamptothecinc
to:
7-Ethylcamptothecinc,d
AND
Add a footnote:
dThese process impuritiesare… Read More
WATER FOR HEMODIALYSIS CHEMICAL INFORMATION USP37–NF32 5173 26-Sep-2014 1-Oct-2014 USP39–NF34 First Supplement to USP38–NF33 Add the chemical formula and molecular weight:
H2O 18.02
STERILE WATER FOR INJECTION ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP37–NF32 5175 26-Sep-2014 1-Oct-2014 USP39–NF34 First Supplement to USP38–NF33 Add:
USP 1,4-Benzoquinone RS
AND
USP Sucrose RS
CELLACEFATE ASSAY/Content of Acetyl USP37–NF32 5919 26-Sep-2014 1-Oct-2014 USP39–NF34 First Supplement to USP38–NF33 Line 12 of Analysis:
Result = {[(P − 0.5182 × B)/(100 − B)] − (0.5772 × C)} × 100
to:
Result = 100 × [P − (0.5182 × B)]/(100 − B) − (0.5772 × C)
DACARBAZINE FOR INJECTION IMPURITIES/Limit of 2-Azahypoxanthine Second Supplement to USP37–NF32 Online 26-Sep-2014 1-Oct-2014 USP39–NF34 First Supplement to USP38–NF33 Line 2 of Analysis: Change
2-azahypoxanthine monohydrate
to:
2-azahypoxanthine
DIDANOSINE DELAYED-RELEASE CAPSULES PERFORMANCE TESTS/Dissolution <711>/Analysis USP37–NF32 2603 26-Sep-2014 1-Oct-2014 USP39–NF34 First Supplement to USP38–NF33 Line 11 of the variable definition list: Change
CS = concentration of didanosine in the Standard solution (mg/mL)
to:
CS = concentration of USP Didanosine Related Compound A RS in the Standard solution for the Acid stage or… Read More
OXYBUTYNIN CHLORIDE SPECIFIC TESTS/Loss on Drying <731> USP37–NF32 4129 26-Sep-2014 1-Oct-2014 USP39–NF34 First Supplement to USP38–NF33 Line 1 of Acceptance criteria: Change
NMT 3.0%
to:
NMT 3%
STERILE WATER FOR INHALATION ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP37–NF32 5174 26-Sep-2014 1-Oct-2014 USP39–NF34 First Supplement to USP38–NF33 Add:
USP 1,4-Benzoquinone RS
AND
USP Sucrose RS
PURE STEAM CHEMICAL INFORMATION USP37–NF32 5176 26-Sep-2014 1-Oct-2014 USP39–NF34 First Supplement to USP38–NF33 Add the chemical formula and molecular weight:
H2O 18.02
CHLORPHENIRAMINE MALEATE IMPURITIES/Organic Impurities First Supplement to USP37–NF32 6617 26-Sep-2014 1-Oct-2014 USP39–NF34 First Supplement to USP38–NF33 Line 1 of Standard solution: Change
1.1 μg/mL of USP Chlorpheniramine Maleate RS in Diluent,
to:
1.4 μg/mL of USP Chlorpheniramine Maleate RS in Diluent,
DACARBAZINE USP Reference standards <11> USP37–NF32 2504 26-Sep-2014 1-Oct-2014 USP39–NF34 First Supplement to USP38–NF33 Line 3 of USP Dacarbazine Related Compound B RS: Change
C4H3N5O 137.10
to:
C4H3N5O · H2O 155.12
KETOPROFEN EXTENDED-RELEASE CAPSULES ASSAY/Procedure/System suitability/Suitability requirements USP37–NF32 3469 26-Sep-2014 1-Oct-2014 USP39–NF34 First Supplement to USP38–NF33 Line 1 of Tailing factor: Change
NLT 1.5
to:
NMT 1.5
WATER FOR INJECTION CHEMICAL INFORMATION USP37–NF32 5173 26-Sep-2014 1-Oct-2014 USP39–NF34 First Supplement to USP38–NF33 Add the chemical formula and molecular weight:
H2O 18.02
STERILE WATER FOR IRRIGATION CHEMICAL INFORMATION USP37–NF32 5175 26-Sep-2014 1-Oct-2014 USP39–NF34 First Supplement to USP38–NF33 Add the chemical formula and molecular weight:
H2O 18.02
POWDERED CELLULOSE IDENTIFICATION/B. Procedure USP37–NF32 5923 26-Sep-2014 1-Oct-2014 USP39–NF34 First Supplement to USP38–NF33 Fourth equation in Analysis: Change
Result = 95 × [η]c/WS × [(100 − %LOD)/100]
to:
Result = [95 × [η]c]/{WS × [(100 − %LOD)/100]}
BETAMETHASONE SODIUM PHOSPHATE IMPURITIES/Limit of Free Betamethasone USP37–NF32 1965 26-Sep-2014 1-Oct-2014 USP39–NF34 First Supplement to USP38–NF33 Line 1 of Sample stock solution: Change
1.0 mg/mL of Betamethasone Sodium Phosphate in water
to:
1.0 mg/mL of Betamethasone Sodium Phosphate in water, prepared as follows. Dissolve 25.0 mg of Betamethasone Sodium Phosphate in water to make 25.0 mL.
DROSPIRENONE AND ETHINYL ESTRADIOL TABLETS IMPURITIES/Organic Impurities/Chromatographic system USP37–NF32 2739 26-Sep-2014 1-Oct-2014 USP39–NF34 First Supplement to USP38–NF33 Line 2 of Detector 2: Change
Monitor the signal at 344 nm between 37 and 42 min.
to:
Monitor the signal at 344 nm for ethinyl estradiol related compound B (typically between 37 and 42 min).
PSEUDOEPHEDRINE HYDROCHLORIDE ASSAY/Procedure USP37–NF32 4481 26-Sep-2014 1-Oct-2014 USP39–NF34 First Supplement to USP38–NF33 Line 2 of System suitability solution: Change
0.02 mg/mL of USP Ephedrine Sulfate RS
to:
0.002 mg/mL of USP Ephedrine Sulfate RS
STERILE WATER FOR INJECTION CHEMICAL INFORMATION USP37–NF32 5175 26-Sep-2014 1-Oct-2014 USP39–NF34 First Supplement to USP38–NF33 Add the chemical formula and molecular weight:
H2O 18.02
STERILE PURIFIED WATER ADDITIONAL REQUIREMENTS USP37–NF32 5176 26-Sep-2014 1-Oct-2014 USP39–NF34 First Supplement to USP38–NF33 Add a section:
USP Reference Standards <11>
USP 1,4-Benzoquinone RS
USP Sucrose RS
DEXCHLORPHENIRAMINE MALEATE IMPURITIES/Organic Impurities First Supplement to USP37–NF32 6626 26-Sep-2014 1-Oct-2014 USP39–NF34 First Supplement to USP38–NF33 Line 1 of Standard solution:
2.2 μg/mL of USP Dexchlorpheniramine Maleate RS in Diluent,
to:
2.8 μg/mL of USP Dexchlorpheniramine Maleate RS in Diluent,
AMIFOSTINE ASSAY/Procedure/System suitability/Suitability requirements USP37–NF32 1717 25-Jul-2014 1-Aug-2014 USP39–NF34 First Supplement to USP38–NF33 Line 1 of Column efficiency: Change
NLT 100
to:
NLT 1000
TIZANIDINE TABLETS ASSAY/Procedure/System suitability Second Supplement to USP37–NF32 Online 25-Jul-2014 1-Aug-2014 USP39–NF34 First Supplement to USP38–NF33 Change
Sample: Standard solution
to:
Samples: System suitability solution and Standard solution
AND
Change
Resolution: NLT 4.0 between tizanidine and tizanidine related compound C; NLT 4.0 between tizanidine and tizanidine related compound… Read More
CEFUROXIME FOR INJECTION Constituted solution USP37–NF32 2246 25-Jul-2014 1-Aug-2014 USP39–NF34 First Supplement to USP38–NF33 Line 3: Change
meets the requirements for Constituted Solutions under Labeling under Injections <1>.
to:
meets the requirements for Constituted Solutions under Injections <1>.
DULOXETINE DELAYED-RELEASE CAPSULES IDENTIFICATION USP37–NF32 2743 25-Jul-2014 1-Aug-2014 USP39–NF34 First Supplement to USP38–NF33 Change
A. Infrared Absorption <197S>
to:
A. Infrared Absorption <197F>