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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
DESCRIPTION AND SOLUBILITY Ethylcellulose Dispersion Type B USP35–NF30 1118 28-Sep-2012 1-Oct-2012 USP37–NF32 First Supplement to USP36–NF31 Lines 3 and 4: Change
in toluene, in chloroform, and in ethyl acetate; insoluble in water, in glycerin, and in propylene glycol.
to:
in tetrahydrofuran, and in ethyl acetate; insoluble in water and in chloroform.
<698> DELIVERABLE VOLUME ACCEPTANCE CRITERIA/For Multiple-Unit Containers First Supplement to USP35–NF30 5154 28-Sep-2012 1-Oct-2012 USP37–NF32 First Supplement to USP36–NF31 Figure 1, right branch, left box: Change
Volume of 1 more containers is less than 95% LV
to:
Volume of 1 or more containers is less than 95% LV
MAGNESIUM STEARATE IMPURITIES/Chloride and Sulfate, Sulfate <221> USP35–NF30 1847 28-Sep-2012 1-Oct-2012 USP37–NF32 First Supplement to USP36–NF31 Line 3: Change
0.020 N sulfuric acid (1.0%)
to:
0.020 M sulfuric acid (1.0%)
TACROLIMUS IMPURITIES/Procedure 2 First Supplement to USP35–NF30 5538 28-Sep-2012 1-Oct-2012 USP37–NF32 First Supplement to USP36–NF31 Footnote h of Table 3: 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
SODIUM HYDROXIDE ASSAY/Procedure USP35–NF30 1955 28-Sep-2012 1-Oct-2012 USP37–NF32 First Supplement to USP36–NF31 Line 10 of Analysis: Change
Result = {[(VS1 − VB) × N × F1]/W} × 100
to:
Result = {[(VS2 − VB) × N × F1]/W} × 100
AND
Line 11 of … Read More
<232> ELEMENTAL IMPURITIES—LIMITS DRUG PRODUCTS/Large Volume Parenterals 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 1: Change
250
to:
10
ALPRAZOLAM ORALLY-DISINTEGRATING TABLETS IMPURITIES/Procedure USP35–NF30 2106 28-Sep-2012 1-Oct-2012 USP37–NF32 First Supplement to USP36–NF31 Change the subsection
Buffer and Diluent: Prepare as directed in the Assay.
to:
Diluent: Prepare as directed in the Assay.
Buffer: 6.8 g/L of monobasic potassium phosphate in water. Adjust with phosphoric acid to a pH of 3.0.
INDINAVIR SULFATE OTHER COMPONENTS/Procedure 2: Content of Alcohol USP35–NF30 3489 28-Sep-2012 1-Oct-2012 USP37–NF32 First Supplement to USP36–NF31 Line 6 of Chromatographic system in the subsection Column: Change
G14
to:
G16
POVIDONE IMPURITIES/Limit of Aldehydes USP35–NF30 4379 28-Sep-2012 1-Oct-2012 USP37–NF32 First Supplement to USP36–NF31 Line 15 of Analysis: Change
Result = 10 × (C/W) × {[(AU2 − AU1) × (AB2 − AB1)]/[(AS2 − AS1) − (AB2… Read More
VINORELBINE TARTRATE ASSAY/Procedure USP35–NF30 5027 28-Sep-2012 1-Oct-2012 USP37–NF32 First Supplement to USP36–NF31 Line 1 of Relative standard deviation in System suitability: Change
NLT 2.0%
to:
NMT 2.0%
CALCIUM SULFATE ASSAY/Procedure USP35–NF30 1724 28-Sep-2012 1-Oct-2012 USP37–NF32 First Supplement to USP36–NF31 Line 5 of Titrimetric system: Delete the subsection
Blank: 100 mL of water and 4 mL of 3 N hydrochloric acid
AND
Line 11 of Analysis: Delete the sentence
Perform a blank determination.
AND
Line 13 of Analysis: Change
Result = [(V − B… Read More
ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES IMPURITIES/Organic Impurities First Supplement to USP35–NF30 5473 28-Sep-2012 1-Oct-2012 USP37–NF32 First Supplement to USP36–NF31 Line 1 of Sample solution: Change
Transfer a portion of the powdered pellets, from the Capsule content, equivalent to 80–90 mg of esomeprazole, to a 200-mL volumetric flask, add 20 mL of methanol, and shake for 30 s.
to:
Transfer a portion of the powdered pellets (about 80–90 mg… Read More
POLYSORBATE 20 SPECIFIC TESTS/Acid Value USP35–NF30 1919 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 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
Esomeprazole Magnesium Delayed-Release Capsules ASSAY/Procedure First Supplement to USP35–NF30 5473 30-Nov-2012 1-Dec-2012 USP37–NF32 Second Supplement to USP36–NF31 Line 1 of Standard solution: Change
Transfer 10 mg of USP Omeprazole RS to a 250-mL volumetric flask, and dissolve in about 10 mL of methanol.
to:
Transfer 10 mg of USP Omeprazole RS to a 250-mL volumetric flask, and dissolve in about 10 mL of alcohol.
Carisoprodol Tablets ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Second Supplement to USP35–NF30 5921 30-Nov-2012 1-Dec-2012 USP37–NF32 Second Supplement to USP36–NF31 Line 5: At end of USP Reference Standards, add
USP Meprobamate RS
Olanzapine Tablets ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Revision Bulletin (Official July 01, 2012) Online 30-Nov-2012 1-Dec-2012 USP37–NF32 Second Supplement to USP36–NF31 Lines 3 and 6: Change
USP Olanzapine Related Compound A RS
5-Methyl-2-((2-nitrophenyl)amino)-3-thiophenecarbonitrile.
USP Olanzapine Related Compound B RS
2-Methyl-10H-thieno-[2,3-b][1,5]benzodiazepin-4[5H]-one.
to:
USP Olanzapine Related Compound A RS
5… Read More
Aminosalicylate Sodium Limit of m-aminophenol USP35–NF30 2177 30-Nov-2012 1-Dec-2012 USP37–NF32 Second Supplement to USP36–NF31 Line 1 of Test preparation: Change
Use the Assay preparation, prepared as directed in the Assay.
to:
Transfer about 69 mg of Aminosalicylate Sodium, accurately weighed, to a 100-mL low-actinic volumetric flask, add 50 mL of Mobile phase, and swirl to dissolve.… Read More