Errata - English

PDF CSV January 30, 2023 through January 30, 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
<232> ELEMENTAL IMPURITIES—LIMITS ANALYTICAL TESTING Second Supplement to USP35–NF30 5633 28-Sep-2012 1-Oct-2012 USP37–NF32 First Supplement to USP36–NF31 Line 6: Change
Pd
to:
Pb
ACETAZOLAMIDE FOR INJECTION ASSAY USP35–NF30 2063 28-Sep-2012 1-Oct-2012 USP37–NF32 First Supplement to USP36–NF31 Line 19: Change
25C(AU/AS)
to:
250C(AU/AS)
AZITHROMYCIN FOR INJECTION IMPURITIES/Limit of Azithromycin N-Oxide, Desosaminylazithromycin, and N-Demethylazithromycin Second Supplement to USP35–NF30 5910 28-Sep-2012 1-Oct-2012 USP37–NF32 First Supplement to USP36–NF31 Line 5 of Analysis: Change
Result = (rU/rS) × (CS/CU) × P × F × 100
to:
Result = (rU/rS) × (CS/C… Read More
FLUTICASONE PROPIONATE IMPURITIES/Organic Impurities USP35–NF30 3261 28-Sep-2012 1-Oct-2012 USP37–NF32 First Supplement to USP36–NF31 Line 1 of the Sample solution: Change
2.0 mg/mL
to:
0.2 mg/mL
NAFTIFINE HYDROCHLORIDE GEL Content of alcohol USP35–NF30 3983 28-Sep-2012 1-Oct-2012 USP37–NF32 First Supplement to USP36–NF31 Line 4 of Procedure: Change
Calculate the quantity, in mg, of C2H5OH in the portion of Gel taken by the formula:
to:
Calculate the percentage of C2H5OH in the portion of Gel taken by the formula:
RIBAVIRIN TABLETS ASSAY/Procedure USP35–NF30 4544 28-Sep-2012 1-Oct-2012 USP37–NF32 First Supplement to USP36–NF31 Line 5 of System suitability in subsection Tailing factor: Change
NLT 2.0
to:
NMT 2.0
BENTONITE IDENTIFICATION/A. X-Ray Diffraction <941> USP35–NF30 1705 28-Sep-2012 1-Oct-2012 USP37–NF32 First Supplement to USP36–NF31 Line 4 of Acceptance criteria: Change
from the pattern of Sample B is 1.492 and 1.504 Å.
to:
from the pattern of Sample B is between 1.492 and 1.504 Å.
DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS PERFORMANCE TESTS/Dissolution <711>/Test 3 First Supplement to USP35–NF30 5460 28-Sep-2012 1-Oct-2012 USP37–NF32 First Supplement to USP36–NF31 Line 2 of Analysis: Change
Samples: Acid stage standard solution, Buffer stage standard solution, Acid stage sample solutions, and Buffer stage sample solutions
to:
Samples: Acid stage standard solution, Buffer stage standard… Read More
METHYL ALCOHOL ASSAY/Procedure USP35–NF30 1865 28-Sep-2012 1-Oct-2012 USP37–NF32 First Supplement to USP36–NF31 Line 9 of System suitability: Change
Tailing factor: NLT 1.5 for methyl alcohol, System suitability solution
to:
Tailing factor: NMT 1.5 for methyl alcohol, System suitability solution
TACROLIMUS CAPSULES IMPURITIES/Procedure 2 First Supplement to USP35–NF30 5541 28-Sep-2012 1-Oct-2012 USP37–NF32 First Supplement to USP36–NF31 Footnote j of Table 5: Change
(3S,4R,5S,8S,9E,12S,14S,15R,16S,18R,19R,26aS)-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-{(E)-2-[(1R,3R,4R)-4-… Read More
TREHALOSE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP35–NF30 2007 28-Sep-2012 1-Oct-2012 USP37–NF32 First Supplement to USP36–NF31 Line 2: Delete
USP Glycerin RS
<233> ELEMENTAL IMPURITIES—PROCEDURES INTRODUCTION/Definition Second Supplement to USP35–NF30 5634 28-Sep-2012 1-Oct-2012 USP37–NF32 First Supplement to USP36–NF31 Line 2 of Target Elements: Change
Pd
to:
Pb
AMOXICILLIN TABLETS PERFORMANCE TESTS USP35–NF30 2202 28-Sep-2012 1-Oct-2012 USP37–NF32 First Supplement to USP36–NF31 Line 4 of Analysis: Change
Result = (rU/rS) × (CS/L) × (D/V) × P × F × 100
to:
Result = (rU/rS) × (CS/L) × V × D × P × F × 100
AND
Transpose lines 12 and 13 of the variable definition list to match the order… Read More
METFORMIN HYDROCHLORIDE TABLETS Dissolution <711>/Test 3 USP35–NF30 3830 28-Sep-2012 1-Oct-2012 USP37–NF32 First Supplement to USP36–NF31 Lines 6 and 7 of Procedure: Change
rU × CS × 900 × 100/rS × D × LC
to:
rU × CS × 1000 × 100/rS × D × LC
AND
Line 11 of Procedure:… Read More
POVIDONE IMPURITIES/Vinylpyrrolidinone USP35–NF30 4379 28-Sep-2012 1-Oct-2012 USP37–NF32 First Supplement to USP36–NF31 Line 2 of the Note in Column, Analytical in Chromatographic system: Change
4.0- × 30-mm or a 4.6- × 30-mm guard column
to:
4.0-mm × 30-mm or a 4.6-mm × 30-mm guard column
ZINC CARBONATE IMPURITIES/Iron <241> USP35–NF30 5068 28-Sep-2012 1-Oct-2012 USP37–NF32 First Supplement to USP36–NF31 Line 1 of Sample solution: Change
Sample solution: Dissolve 1.0 g in 20 mL of water and 3 mL of hydrochloric acid.
to:
Test preparation: Dissolve 0.5 g in 20 mL of water and 3 mL of hydrochloric acid.
MICROCRYSTALLINE CELLULOSE IDENTIFICATION/B. Procedure USP35–NF30 1746 28-Sep-2012 1-Oct-2012 USP37–NF32 First Supplement to USP36–NF31 4th formula of Analysis: Change
Result = (95) × [η]c/WS × [(100 − %LOD)/100]
to:
Result = [(95) × [η]c]/{WS × [(100 − %LOD)/100]}
OMEGA-3-ACID ETHYL ESTERS CAPSULES SPECIFIC TESTS/Microbial Enumeration Tests <61> and Tests for Specified Microorganisms <62> First Supplement to USP35–NF30 5524 28-Sep-2012 1-Oct-2012 USP37–NF32 First Supplement to USP36–NF31 Line 2: Change
103
to:
103 cfu/mL
AND
Line 3: Change
102
to:
102 cfu/mL
AND
Line 6: Change
Salmonella in 10 g.
to:
Salmonella species in 10 g.
POLYSORBATE 60 SPECIFIC TESTS/Acid Value USP35–NF30 1920 28-Sep-2012 1-Oct-2012 USP37–NF32 First Supplement to USP36–NF31 Line 1 of Sample: Change
10.0
to:
10.0 g
<232> ELEMENTAL IMPURITIES—LIMITS DRUG SUBSTANCE AND EXCIPIENTS Second Supplement to USP35–NF30 5633 28-Sep-2012 1-Oct-2012 USP37–NF32 First Supplement to USP36–NF31 Row 13 of Column 4 of Table 2: Change
25
to:
1.0
ADENOSINE IDENTIFICATION/Infrared Absorption <197M> USP35–NF30 2079 28-Sep-2012 1-Oct-2012 USP37–NF32 First Supplement to USP36–NF31 Line 1:
Delete NMT 0.1%
GANCICLOVIR ORAL SUSPENSION ASSAY USP35–NF30 3319 28-Sep-2012 1-Oct-2012 USP37–NF32 First Supplement to USP36–NF31 Line 1 of Internal standard solution: Change
4 mg per mL
to:
0.4 mg per mL
POLYVINYL ALCOHOL Identification test C USP35–NF30 4351 28-Sep-2012 1-Oct-2012 USP37–NF32 First Supplement to USP36–NF31 Line 5: Change
Add 10 mL of alcohol to the remaining 5 mL of the polyvinyl alcohol solution, and mix
to:
Add 10 mL of alcohol to the remaining 2 mL of the polyvinyl alcohol solution, and mix.
TYROSINE IMPURITIES/Heavy Metals <231> USP35–NF30 4976 28-Sep-2012 1-Oct-2012 USP37–NF32 First Supplement to USP36–NF31 Line 1: Change
Method I
to:
Method II
TRIBASIC CALCIUM PHOSPHATE IDENTIFICATION/Test A USP35–NF30 1719 28-Sep-2012 1-Oct-2012 USP37–NF32 First Supplement to USP36–NF31 Line 1 of the Sample solution: Change
Dissolve 100 mg in 5 mL of diluted nitric acid.
to:
A solution in a slight excess of nitric acid
ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES PERFORMANCE TESTS/Dissolution <711> First Supplement to USP35–NF30 5473 28-Sep-2012 1-Oct-2012 USP37–NF32 First Supplement to USP36–NF31 Line 4 of Medium: Change
and adjust with 2 N hydrochloric acid or 2 N sodium, if necessary, to a pH
to:
and adjust with 2 N hydrochloric acid or 2 N sodium hydroxide, if necessary, to a pH
POLYETHYLENE OXIDE IMPURITIES/Organic Impurities/Procedure: Limit of Free Ethylene Oxide USP35–NF30 1906 28-Sep-2012 1-Oct-2012 USP37–NF32 First Supplement to USP36–NF31 Line 2 of System suitability: Change
Samples: Standard stock solution and Standard solution C
to:
Sample: Standard solution C
<232> ELEMENTAL IMPURITIES—LIMITS DRUG SUBSTANCE AND EXCIPIENTS Second Supplement to USP35–NF30 5633 28-Sep-2012 1-Oct-2012 USP37–NF32 First Supplement to USP36–NF31 Rows 11 and 15 of Column 2 of Table 2: Change
100
to:
10
AND
Rows 11 and 15 of Column 3 of Table 2: Change
10
to:
1.0
AND
Row 11 of Column 4 of Table 2: Change
1.5
to:
0.15
AND
Row 15 of Column 4 of Table 2:… Read More
ZEIN IDENTIFICATION/C. SDS-Polyacrylamide Gel Electrophoresis USP35–NF30 2019 28-Sep-2012 1-Oct-2012 USP37–NF32 First Supplement to USP36–NF31 Lines 1 and 2 of the Acceptance criteria: Change
Zein has two major bands: the α band is at 21–25 kDa, and the β band is at 17–18 kDa.
to:
Zein has two major bands for α-zein at 19–26 kDa.
AZITHROMYCIN FOR INJECTION IMPURITIES/Limit of Aminoazithromycin, Formamido Analog, Methylformamido Analog, and 3′-De(dimethylamino)-3′-oxoazithromycin Second Supplement to USP35–NF30 5910 28-Sep-2012 1-Oct-2012 USP37–NF32 First Supplement to USP36–NF31 Row 11 of Table 2: Change
3′-Demethyl-3′-N-[(4-methylphenyl)sulfonyl]azithromycin
to:
3′-N-Demethyl-3′-N-[(4-methylphenyl)sulfonyl]azithromycin
CHLOROPHYLLIN COPPER COMPLEX SODIUM SPECIFIC TESTS/Loss on Drying <231> USP35–NF30 2628 28-Sep-2012 1-Oct-2012 USP37–NF32 First Supplement to USP36–NF31 Line 1: Change
150°
to:
105°
METRONIDAZOLE Related compounds USP35–NF30 3905 28-Sep-2012 1-Oct-2012 USP37–NF32 First Supplement to USP36–NF31 Line 19 of Procedure: Change
ri is the peak response for any unspecified degradation product peak in the Test solution
to:
ri is the peak response for any single unspecified impurity in the Test solution
PRILOCAINE AND EPINEPHRINE INJECTION Assay for epinephrine USP35–NF30 4411 28-Sep-2012 1-Oct-2012 USP37–NF32 First Supplement to USP36–NF31 Line 7 of Procedure: Change
183.21/333.30
to:
183.20/333.29
AND
Line 8 of Procedure: Change
183.21 and 333.30
to:
183.20 and 333.29