Skip to main content

Errata - English

PDF CSV October 18, 2023 through October 18, 2025 All Errata for USP–NF How to use
Enter the title of the monograph
Monograph Title Section Source Publication Page Number Errata Official Date Target Errata Print Publication Target Online Fix Publication Description
ZANAMIVIR IMPURITIES/Organic Impurities/Chromatographic system USP37–NF32 5197 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
SAW PALMETTO EXTRACT COMPOSITION/Content of Long-Chain Alcohols and Sterols USP37–NF32 5545 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.
TRIBASIC CALCIUM PHOSPHATE ASSAY/Procedure USP37–NF32 5883 1-Dec-2014 USP39–NF34 Second Supplement to USP38–NF33 Delete the subsection
Blank: Proceed as directed in the Analysis, omitting the test specimen.
AND
Equation in Analysis: Change
Result = {[VSVB) × M × F]/W} × 100
to:
Result = [(VRead More
TRIBASIC CALCIUM PHOSPHATE IMPURITIES/Dibasic Salt and Calcium Oxide USP37–NF32 5883 1-Dec-2014 USP39–NF34 Second Supplement to USP38–NF33 Delete the subsection
Blank: 25.0 mL of Titrant
COPOVIDONE IMPURITIES/Limit of Monomers (1-Vinyl-2-Pyrrolidone, Vinyl Acetate, and 2-Pyrrolidone) USP37–NF32 5938 1-Dec-2014 USP39–NF34 Second Supplement to USP38–NF33 Line 29 of Analysis: Change
Calculate the content of 2-pyrrolidinone
to:
Calculate the content of 2-pyrrolidone
CHLORPHENIRAMINE MALEATE SPECIFIC TESTS/Optical Rotation, Specific Rotation <781> First Supplement to USP37–NF32 6617 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°
ERYTHROMYCIN DELAYED-RELEASE TABLETS PERFORMANCE TESTS/Dissolution <711>/Test 1/Buffer stage First Supplement to USP37–NF32 6633 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
TRAZODONE HYDROCHLORIDE IMPURITIES/Limit of Trazodone Related Compound F and Cyclophosphamide Related Compound A/Chromatographic system/MS conditions First Supplement to USP37–NF32 6708 1-Dec-2014 USP39–NF34 Second Supplement to USP38–NF33 Line 4 of Acquisition mode:Change
272
to:
273
TRAZODONE HYDROCHLORIDE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> First Supplement to USP37–NF32 6708 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.
GLYCERYL BEHENATE DEFINITION Second Supplement to USP37–NF32 7077 1-Dec-2014 USP39–NF34 Second Supplement to USP38–NF33 Line 7: Change
behenic (docosanic) acid
to:
behenic (docosanoic) acid
HYDROXYPROPYL CELLULOSE ASSAY Second Supplement to USP37–NF32 7080 1-Dec-2014 USP39–NF34 Second Supplement to USP38–NF33 Line 1 of Internal standard solution: Change
Methycyclohexane
to:
Methylcyclohexane
POLYSORBATE 80 SPECIFIC TESTS/Fats and Fixed Oils, Acid Value <401> Second Supplement to USP37–NF32 7089 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
MEBENDAZOLE ASSAY/Procedure Second Supplement to USP37–NF32 7199 1-Dec-2014 USP39–NF34 Second Supplement to USP38–NF33 Line 3 of Analysis: Change
Calculate the percentage of each impurity in the portion of Oral Suspension taken:
to:
Calculate the percentage of mebendazole (C16H13N3O3) in the portion of Mebendazole taken:
SODIUM PICOSULFATE CHEMICAL INFORMATION Second Supplement to USP37–NF32 7253 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
GANODERMA LUCIDUM FRUITING BODY COMPOSITION/Content of Triterpenoic Acids Revision Bulletin (Official August 01, 2014) Online 1-Dec-2014 USP39–NF34 Second Supplement to USP38–NF33 Line 1 of Standard solution A: Change
USP Ganoderic Acid RS
to:
USP Ganoderic Acid A RS
AND
Line 3 of variable definition list in Analysis: Change
rS = peak area of ganoderic acid in Standard solution A
to:
rS… Read More
GANODERMA LUCIDUM FRUITING BODY SPECIFIC TESTS/Botanical Characteristics Revision Bulletin (Official August 01, 2014) Online 1-Dec-2014 USP39–NF34 Second Supplement to USP38–NF33 Line 6 of Macroscopic: Change
concentrically culcate
to:
concentrically sulcate
GANODERMA LUCIDUM FRUITING BODY POWDER COMPOSITION/Content of Triterpenoic Acids Revision Bulletin (Official August 01, 2014) Online 1-Dec-2014 USP39–NF34 Second Supplement to USP38–NF33 Line 1 of Standard solution A: Change
USP Ganoderic Acid RS
to:
USP Ganoderic Acid A RS
AND
Line 3 of variable definition list in Analysis: Change
rS = peak area of ganoderic acid in Standard solution A
to:
rS… Read More
FENTANYL ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Second Supplement to USP37–NF32 Online 1-Dec-2014 USP39–NF34 Second Supplement to USP38–NF33 Delete
USP Fentanyl Related Compound C RS
AND
Delete
USP Fentanyl Related Compound F RS
NIFEDIPINE EXTENDED-RELEASE TABLETS PERFORMANCE TESTS/Dissolution <711>/Test 2 Second Supplement to USP37–NF32 Online 1-Dec-2014 USP38–NF33 USP38–NF33 Line 1 of Solution A: Change
sodium phosphate
to:
dibasic sodium phosphate
BETAMETHASONE SODIUM PHOSPHATE IMPURITIES/Limit of Free Betamethasone USP37–NF32 1965 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.
CALCIUM GLUCONATE INJECTION Identification USP37–NF32 2089 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
DACARBAZINE USP Reference standards <11> USP37–NF32 2504 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
ESCITALOPRAM ORAL SOLUTION IMPURITIES/Organic Impurities USP37–NF32 2580 1-Oct-2014 USP39–NF34 First Supplement to USP38–NF33 Row 6 of Column 1 of Table 3: Change
Desfluorocitalopramf
to:
Desfluorocitalopramf,c
DIDANOSINE DELAYED-RELEASE CAPSULES PERFORMANCE TESTS/Dissolution <711>/Analysis USP37–NF32 2603 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
DROSPIRENONE AND ETHINYL ESTRADIOL TABLETS IMPURITIES/Organic Impurities/Chromatographic system USP37–NF32 2739 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).
IRINOTECAN HYDROCHLORIDE INJECTION IMPURITIES/Organic Impurities USP37–NF32 3403 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
KETOPROFEN EXTENDED-RELEASE CAPSULES ASSAY/Procedure/System suitability/Suitability requirements USP37–NF32 3469 1-Oct-2014 USP39–NF34 First Supplement to USP38–NF33 Line 1 of Tailing factor: Change
NLT 1.5
to:
NMT 1.5
KETOPROFEN EXTENDED-RELEASE CAPSULES PERFORMANCE TESTS/Uniformity of Dosage Units <905>/System suitability/Suitability requirements USP37–NF32 3469 1-Oct-2014 USP39–NF34 First Supplement to USP38–NF33 Line 1 of Tailing factor: Change
NLT 1.5
to:
NMT 1.5
OXYBUTYNIN CHLORIDE SPECIFIC TESTS/Loss on Drying <731> USP37–NF32 4129 1-Oct-2014 USP39–NF34 First Supplement to USP38–NF33 Line 1 of Acceptance criteria: Change
NMT 3.0%
to:
NMT 3%
PSEUDOEPHEDRINE HYDROCHLORIDE ASSAY/Procedure USP37–NF32 4481 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
WATER FOR HEMODIALYSIS CHEMICAL INFORMATION USP37–NF32 5173 1-Oct-2014 USP39–NF34 First Supplement to USP38–NF33 Add the chemical formula and molecular weight:
H2O 18.02
WATER FOR INJECTION CHEMICAL INFORMATION USP37–NF32 5173 1-Oct-2014 USP39–NF34 First Supplement to USP38–NF33 Add the chemical formula and molecular weight:
H2O 18.02
STERILE WATER FOR INHALATION CHEMICAL INFORMATION USP37–NF32 5174 1-Oct-2014 USP39–NF34 First Supplement to USP38–NF33 Add the chemical formula and molecular weight:
H2O 18.02
STERILE WATER FOR INHALATION ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP37–NF32 5174 1-Oct-2014 USP39–NF34 First Supplement to USP38–NF33 Add:
USP 1,4-Benzoquinone RS
AND
USP Sucrose RS
STERILE WATER FOR INJECTION CHEMICAL INFORMATION USP37–NF32 5175 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 1-Oct-2014 USP39–NF34 First Supplement to USP38–NF33 Add:
USP 1,4-Benzoquinone RS
AND
USP Sucrose RS
STERILE WATER FOR IRRIGATION CHEMICAL INFORMATION USP37–NF32 5175 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 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 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 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
CELLACEFATE ASSAY/Content of Acetyl USP37–NF32 5919 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)
POWDERED CELLULOSE IDENTIFICATION/B. Procedure USP37–NF32 5923 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]}
ETHYLCELLULOSE DISPERSION TYPE B ASSAY/Procedure USP37–NF32 5981 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:
CHLORPHENIRAMINE MALEATE IMPURITIES/Organic Impurities First Supplement to USP37–NF32 6617 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,
DEXCHLORPHENIRAMINE MALEATE IMPURITIES/Organic Impurities First Supplement to USP37–NF32 6626 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,
DACARBAZINE FOR INJECTION IMPURITIES/Limit of 2-Azahypoxanthine Second Supplement to USP37–NF32 Online 1-Oct-2014 USP39–NF34 First Supplement to USP38–NF33 Line 2 of Analysis: Change
2-azahypoxanthine monohydrate
to:
2-azahypoxanthine
GENERAL NOTICES TO USP-NF 6. TESTING PRACTICES AND PROCEDURES/6.50. Preparation of Solutions First Supplement to USP37–NF32 6291 1-Aug-2014 USP38–NF33 USP38–NF33 Line 6 of 6.50.20. Solutions: Change
An expression such as “(1 in 10)” means that 1 part by volume of a liquid shall be diluted with a sufficient quantity of the diluent or solvent to make the volume of the finished solution 10 parts by volume. An expression such as “(20:5:2… Read More
<795> PHARMACEUTICAL COMPOUNDING—NONSTERILE PREPARATIONS DEFINITIONS USP37–NF32 403 1-Aug-2014 USP39–NF34 First Supplement to USP38–NF33 Line 1 of Beyond-Use Date (BUD): Change
The date after which a compounded preparation should not to be used;
to:
The date after which a compounded preparation shall not be used;
<1788> METHODS FOR THE DETERMINATION OF PARTICULATE MATTER IN INJECTIONS AND OPHTHALMIC SOLUTIONS LIGHT OBSCURATION PARTICLE COUNT TEST/Instrument Standardization Tests/Particle Counting Accuracy—System Suitability USP37–NF32 1301 1-Aug-2014 USP39–NF34 First Supplement to USP38–NF33 Line 26 of Method 1—MWHC Instruments: Change
PB is the average particle count obtained from the suspension;
to:
PS is the average particle count obtained from the suspension;
ALLOPURINOL USP Reference standards <11> USP37–NF32 1649 1-Aug-2014 USP39–NF34 First Supplement to USP38–NF33 Line 2 of USP Allopurinol Related Compound C RS: Change
N-(4H-1,2,4-Triazol-4-yl)-1H-pyrazole-4-carboxamide.
to:
5-(4H-1,2,4-Triazol-4-yl)-1H-pyrazole-4-carboxamide.