How to Use the USP–NF Errata Table

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Monograph Title Section Source Publication Page Number Errata Post Date Errata Official Datesort icon Target Errata Print Publication Target Online Fix Publication Description
AZITHROMYCIN IMPURITIES/Organic Impurities/Procedure 2 USP35–NF30 2279 29-Mar-2013 01-Apr-2013 USP37–NF32 USP37–NF32
Line 15 of Analysis: Change
CS = concentration of USP Azithromycin RS in the Standard solution (µg/mL)
to:
CS = concentration of USP Azithromycin RS in the Standard solution (mg/mL)
AND
Add after CU:
P = potency of USP Azithromycin RS (µg/mg of azithromycin)

Line 15 of Analysis: Change
CS = concentration of USP Azithromycin RS in the Standard solution (µg/mL)
to:
CS = concentration of USP Azithromycin RS in the Standard solution (mg/mL)
AND
Add after CU:
P = potency of USP Azithromycin RS (µg/mg of azithromycin)
DIETHYL SEBACATE DEFINITION USP36–NF31 1994 29-Mar-2013 01-Apr-2013 USP37–NF32 USP37–NF32
Line 2: Change
Diethyl Sebacate consists of the diester of alcohol and sebacic acid.
to:
Diethyl Sebacate consists of the diester of alcohol (ethanol) and sebacic acid.

Line 2: Change
Diethyl Sebacate consists of the diester of alcohol and sebacic acid.
to:
Diethyl Sebacate consists of the diester of alcohol (ethanol) and sebacic acid.
HYMETELLOSE IMPURITIES/Chloride and Sulfate, Chloride <221> USP36–NF31 2044 29-Mar-2013 01-Apr-2013 USP37–NF32 USP37–NF32
Change the subsection title
Standard solution
to:
Control solution
AND
Line 4 of Analysis: Change
Standard solution
to:
Control solution
AND
Line 2 of Acceptance criteria: Change
Standard solution
to:
Control solution

Change the subsection title
Standard solution
to:
Control solution
AND
Line 4 of Analysis: Change
Standard solution
to:
Control solution
AND
Line 2 of Acceptance criteria: Change
Standard solution
to:
Control solution
INOSITOL SPECIFIC TESTS/Conductivity USP36–NF31 2049 29-Mar-2013 01-Apr-2013 USP37–NF32 USP37–NF32
Line 1 of Sample solution: Change
Transfer 10.0 g of Inositol, weighed and calculated on the dried basis, to a 50-mL volumetric flask, and dissolve in and dilute with water (previously boiled and cooled to room temperature) to volume.
to:
0.2 g/mL of Inositol in water (previously boiled and cooled to room temperature).

Line 1 of Sample solution: Change
Transfer 10.0 g of Inositol, weighed and calculated on the dried basis, to a 50-mL volumetric flask, and dissolve in and dilute with water (previously boiled and cooled to room temperature) to volume.

to:
0.2 g/mL of Inositol in water (previously boiled and cooled to room temperature).
HYDROGENATED POLYDECENE ASSAY/Content of Decene Oligomer USP36–NF31 2133 29-Mar-2013 01-Apr-2013 USP37–NF32 USP37–NF32
Line 3 of System suitability: Change
[Note—The retention time for squalene is about 18 min; the relative retention times for tetradecane, hexadecane, and squalene are about 0.5, 0.6, and 1.0, respectively.]
to:
[Note—The retention time for squalane is about 18 min; the relative retention times for tetradecane, hexadecane, and squalane are about 0.5, 0.6, and 1.0, respectively.]

Line 3 of System suitability: Change
[Note—The retention time for squalene is about 18 min; the relative retention times for tetradecane, hexadecane, and squalene are about 0.5, 0.6, and 1.0, respectively.]

to:
[Note—The retention time for squalane is about 18 min; the relative retention times for tetradecane, hexadecane, and squalane are about 0.5, 0.6, and 1.0, respectively.]
POLYVINYL ACETATE PHTHALATE IMPURITIES/Free Phthalic Acid USP36–NF31 2168 29-Mar-2013 01-Apr-2013 USP37–NF32 USP37–NF32
Line 1 of Sample solution: Change
6 mg/mL of polyvinyl acetate
to:
6 mg/mL of polyvinyl acetate phthalate

Line 1 of Sample solution: Change
6 mg/mL of polyvinyl acetate
to:
6 mg/mL of polyvinyl acetate phthalate
PROPYLENE GLYCOL MONOLAURATE IMPURITIES/Limit of Propylene Glycol USP36–NF31 2180 29-Mar-2013 01-Apr-2013 USP37–NF32 USP37–NF32
Line 8 of Analysis: Change
Calculate the percentage of free propylene glycol in the portion of Propylene Glycol Monocaprylate taken:
to:
Calculate the percentage of free propylene glycol in the portion of Propylene Glycol Monolaurate taken:

Line 8 of Analysis: Change
Calculate the percentage of free propylene glycol in the portion of Propylene Glycol Monocaprylate taken:

to:
Calculate the percentage of free propylene glycol in the portion of Propylene Glycol Monolaurate taken:
TAPIOCA STARCH Limit of oxidizing substances USP35–NF30 1987 29-Mar-2013 01-Apr-2013 USP37–NF32 USP37–NF32
Line 8: Change
Add 1 mL of starch TS, and titrate with 0.002 N sodium thiosulfate VS to the disappearance of the starch–iodide color.
to:
Add 1 mL of starch TS, and titrate with 0.002 N sodium thiosulfate VS to the disappearance of the starch–iodine color.

Line 8: Change
Add 1 mL of starch TS, and titrate with 0.002 N sodium thiosulfate VS to the disappearance of the starch–iodide color.
to:
Add 1 mL of starch TS, and titrate with 0.002 N sodium thiosulfate VS to the disappearance of the starch–iodine color.
ATROPINE SULFATE TABLETS Assay USP35–NF30 2272 29-Mar-2013 01-Apr-2013 USP37–NF32 USP37–NF32
Line 9 of Procedure: Change
RU and RS are as defined therein.
to:
RU and RS are the peak area ratios of atropine to homatropine.

Line 9 of Procedure: Change
RU and RS are as defined therein.
to:
RU and RS are the peak area ratios of atropine to homatropine.
BETAMETHASONE ORAL SOLUTION Identification/A: USP35–NF30 2336 29-Mar-2013 01-Apr-2013 USP37–NF32 USP37–NF32
Line 1: Change
A:
to:
A: Thin-Layer Chromatographic Identification Test <201>—

Line 1: Change
A:

to:
A:
Thin-Layer Chromatographic Identification Test <201>—
BRINZOLAMIDE Related compounds/Test 2 USP35–NF30 2385 29-Mar-2013 01-Apr-2013 USP37–NF32 USP37–NF32
Line 15 of Procedure: Change
relative retention time greater than 6.
to:
relative retention greater than 6.

Line 15 of Procedure: Change
relative retention time greater than 6.
to:
relative retention greater than 6.
ATRACURIUM BESYLATE INJECTION IMPURITIES/Organic Impurities/Acceptance criteria/Table 2 Second Supplement to USP35–NF30 5909 29-Mar-2013 01-Apr-2013 USP37–NF32 USP37–NF32
Footnote b: Change
cis isomer of the hydroxy compound.
to:
trans isomer of the hydroxy compound.
AND
Footnote c: Change
trans isomer of the hydroxy compound.
to:
cis isomer of the hydroxy compound.
AND
Footnote d: Change
cis isomer of the monoacrylate.
to:
trans isomer of the monoacrylate.
AND
Footnote e: Change
trans isomer of the monoacrylate.
to:
cis isomer of the monoacrylate.

Footnote b: Change
cis isomer of the hydroxy compound.
to:
trans isomer of the hydroxy compound.
AND
Footnote c: Change
trans isomer of the hydroxy compound.
to:
cis isomer of the hydroxy compound.
AND
Footnote d: Change

cis isomer of the monoacrylate.
to:
trans isomer of the monoacrylate.
AND
Footnote e: Change
trans isomer of the monoacrylate.
to:
cis isomer of the monoacrylate.
LEVETIRACETAM ADDITIONAL REQUIREMENTS USP35–NF30 3659 29-Mar-2013 01-Apr-2013 USP37–NF32 USP37–NF32
Line 9 of USP Reference Standards <11>: Change
C8H14ClNO3 207.65
to:
C8H15ClN2O2 206.67

Line 9 of USP Reference Standards <11>: Change

C8H14ClNO3 207.65

to:

C8H15ClN2O2 206.67
VANCOMYCIN INJECTION SPECIFIC TESTS/Composition of Vancomycin USP35–NF30 5003 29-Mar-2013 01-Apr-2013 USP37–NF32 USP37–NF32
Line 16 of Analysis: Change
D = dilution factor, Sample stock solution to Sample solution, 25
to:
D = dilution factor, Sample stock solution to Sample solution
AND
Line 29 of Analysis: Change
D = dilution factor, Sample stock solution to Sample solution, 25
to:
D = dilution factor, Sample stock solution to Sample solution

Line 16 of Analysis: Change
D = dilution factor, Sample stock solution to Sample solution, 25
to:
D = dilution factor, Sample stock solution to Sample solution
AND
Line 29 of Analysis: Change
D = dilution factor, Sample stock solution to Sample solution, 25
to:
D = dilution factor, Sample stock solution to Sample solution
VINORELBINE INJECTION Related compounds USP35–NF30 5028 29-Mar-2013 01-Apr-2013 USP37–NF32 USP37–NF32
Delete the subsection Standard solution and Diluted standard solution.
Replace with:
Standard solution—Dissolve an accurately weighed quantity of USP Vinorelbine Tartrate RS in Mobile phase to obtain a solution having a known concentration of about 1.4 mg per mL.
Diluted standard solution—Transfer 1.0 mL of the Standard solution to a 50-mL volumetric flask, and dilute with Mobile phase to volume. Pipet 1.0 mL of this solution into a 100-mL volumetric flask, and dilute with Mobile phase to volume.
AND
Line 1 of Procedure: Change
Proceed as directed for Procedure in the test for Related compounds under Vinorelbine Tartrate.
to:
Separately inject equal volumes (about 20 µL) of the Test solution and the Diluted standard solution into the chromatograph, record the chromatograms, and measure the areas for the major peaks. Record the chromatograms for three times the retention time of the vinorelbine peak. Disregard any peaks with an area less than or equal to one-half of the area of the peak obtained for vinorelbine in the Diluted standard solution. Calculate the percentage of each impurity in the portion of Injection taken by the formula:
100(ri/rs)
in which ri is the peak response for each impurity obtained from the Test solution; and rs is the sum of the responses of all the peaks.

Delete the subsection Standard solution and Diluted standard solution.
Replace with:
Standard solution—Dissolve an accurately weighed quantity of USP Vinorelbine Tartrate RS in Mobile phase to obtain a solution having a known concentration of about 1.4 mg per mL.
Diluted standard solution—Transfer 1.0 mL of the Standard solution to a 50-mL volumetric flask, and dilute with Mobile phase to volume. Pipet 1.0 mL of this solution into a 100-mL volumetric flask, and dilute with Mobile phase to volume.
AND

 Read More
VINORELBINE INJECTION Assay USP35–NF30 5028 29-Mar-2013 01-Apr-2013 USP37–NF32 USP37–NF32
Line 1: Change
Phosphate buffer, Mobile phase, and System suitability solution—Proceed as directed in the Assay under Vinorelbine Tartrate.
to:
Phosphate buffer—Dissolve 6.9 g of monobasic sodium phosphate in 900 mL of water. Adjust with phosphoric acid to a pH of 4.2, dilute with water to 1000 mL, and mix.
Mobile phase—Dissolve 1.22 g of sodium 1-decanesulfonate in 620 mL of methanol. Add 380 mL of Phosphate buffer, mix, filter, and degas. Make adjustments if necessary (see System Suitability under Chromatography <621>).
System suitability solution—Dissolve accurately weighed quantities of USP Vinorelbine Tartrate RS and USP Vinorelbine Related Compound A RS in water, and dilute quantitatively, and stepwise if necessary, with water to obtain a solution having known concentrations of about 1.4 mg per mL and 0.01 mg per mL, respectively. Expose a portion of this solution in a suitable xenon lamp apparatus capable of supplying a dose of 1600 KJ/m2 between 310 and 800 nm at a power of 500 W/m2 for about 1 h, in order to generate an additional degradation product 3,6-epoxy vinorelbine having a relative retention time of about 0.8.

Line 1: Change
Phosphate buffer, Mobile phase, and System suitability solution—Proceed as directed in the Assay under Vinorelbine Tartrate.
to:
Phosphate buffer—Dissolve 6.9 g of monobasic sodium phosphate in 900 mL of water. Adjust with phosphoric acid to a pH of 4.2, dilute with water to 1000 mL, and mix.

 Read More
ZINC SULFATE TABLETS Identification/B. Zinc USP35–NF30 5077 29-Mar-2013 01-Apr-2013 USP37–NF32 USP37–NF32
Line 1 of Sodium hydroxide solution: Change
42 mg/mL of sodium hydroxide
to:
420 mg/mL of sodium hydroxide

Line 1 of Sodium hydroxide solution: Change
42 mg/mL of sodium hydroxide

to:
420 mg/mL of sodium hydroxide
DULOXETINE DELAYED-RELEASE CAPSULES PERFORMANCE TESTS/Dissolution <711>/Chromatographic system Second Supplement to USP35–NF30 5940 29-Mar-2013 01-Apr-2013 USP37–NF32 USP37–NF32
Line 1 of Column: Change
4.6-mm x 7.5-cm; 3-µm packing L7
to:
4.6-mm x 7.5-cm; 3- or 3.5-µm packing L7

Line 1 of Column: Change
4.6-mm x 7.5-cm; 3-µm packing L7
to:
4.6-mm x 7.5-cm; 3- or 3.5-µm packing L7
SUMATRIPTAN INJECTION SPECIFIC TESTS/Osmolality and Osmolarity <785> Second Supplement to USP35–NF30 5996 29-Mar-2013 01-Apr-2013 USP37–NF32 USP37–NF32
Line 1: Change
270–330 mOsmol
to:
270–330 mOsmol/kg

Line 1: Change
270–330 mOsmol

to:
270–330 mOsmol/kg
<1079> GOOD STORAGE AND DISTRIBUTION PRACTICES FOR DRUG PRODUCTS QUALITY MANAGEMENT SYSTEM/Storage Management System/Receiving and Transferring Drug Products USP36–NF31 693 29-Mar-2013 01-Apr-2013 USP37–NF32 USP37–NF32
Line 1 of footnote 1: Change
JP Edmond,
to:
JP Emond,

Line 1 of footnote 1: Change
JP Edmond,
to:
JP Emond,
POWDERED BLACK PEPPER EXTRACT DEFINITION USP36–NF31 1365 29-Mar-2013 01-Apr-2013 USP37–NF32 USP37–NF32
Line 5: Change
It contains NLT 90.0% and NMT 110.0% of the labeled amount of piperine.
to:
It contains NLT 90.0% and NMT 110.0% of the labeled amount of piperine, calculated on the dried basis.

Line 5: Change
It contains NLT 90.0% and NMT 110.0% of the labeled amount of piperine.
to:
It contains NLT 90.0% and NMT 110.0% of the labeled amount of piperine, calculated on the dried basis.
BENZTROPINE MESYLATE CHEMICAL INFORMATION USP36–NF31 2628 29-Mar-2013 01-Apr-2013 USP37–NF32 USP37–NF32
Line 2: Change
8-Azabicyclo[3.2.1]octane, 3-(diphenylmethoxy)-, endo-, methanesulfonate;
to:
8-Azabicyclo[3.2.1]octane, 3-(diphenylmethoxy)-N-methyl-, endo-, methanesulfonate;

Line 2: Change
8-Azabicyclo[3.2.1]octane, 3-(diphenylmethoxy)-, endo-, methanesulfonate;
to:
8-Azabicyclo[3.2.1]octane, 3-(diphenylmethoxy)-N-methyl-, endo-, methanesulfonate;
CLONAZEPAM ORAL SUSPENSION ASSAY/Procedure USP36–NF31 3053 29-Mar-2013 01-Apr-2013 USP37–NF32 USP37–NF32
Line 6 of Sample solution: Change
Pipet 2.5 mL of the Sample solution
to:
Pipet 2.5 mL of the sample

Line 6 of Sample solution: Change
Pipet 2.5 mL of the Sample solution
to:
Pipet 2.5 mL of the sample
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM ASSAY/Procedure USP36–NF31 3075 29-Mar-2013 01-Apr-2013 USP37–NF32 USP37–NF32
Line 3 of Betamethasone dipropionate stock solution: Change
J being the ratio (in mg/g) of betamethasone to clotrimazole in the Cream
to:
J being the ratio of the labeled amount of betamethasone (in mg/g) to the labeled amount of clotrimazole (in mg/g) in the Cream

Line 3 of Betamethasone dipropionate stock solution: Change
J being the ratio (in mg/g) of betamethasone to clotrimazole in the Cream

to:
J being the ratio of the labeled amount of betamethasone (in mg/g) to the labeled amount of clotrimazole (in mg/g) in the Cream
DILTIAZEM HYDROCHLORIDE ORAL SUSPENSION ASSAY/Procedure USP36–NF31 3263 29-Mar-2013 01-Apr-2013 USP37–NF32 USP37–NF32
Line 6 of Sample solution: Change
Pipet 1.0 mL of the sample solution
to:
Pipet 1.0 mL of the sample

Line 6 of Sample solution: Change
Pipet 1.0 mL of the sample solution
to:
Pipet 1.0 mL of the sample
GLUCONOLACTONE IDENTIFICATION/A. USP36–NF31 3742 29-Mar-2013 01-Apr-2013 USP37–NF32 USP37–NF32
Line 5 of Analysis: Change
crystals of the phenylhydrazine of gluconic acid
to:
crystals of the phenylhydrazide of gluconic acid

Line 5 of Analysis: Change
crystals of the phenylhydrazine of gluconic acid
to:
crystals of the phenylhydrazide of gluconic acid
LORAZEPAM TABLETS IMPURITIES/Organic Impurities/System suitability/Suitability requirements USP36–NF31 4153 29-Mar-2013 01-Apr-2013 USP37–NF32 USP37–NF32
Line 1 of Tailing factor: Change
2.0, Standard solution
to:
NMT 2.0, Standard solution

Line 1 of Tailing factor: Change
2.0, Standard solution
to:
NMT 2.0, Standard solution
METHENAMINE ORAL SOLUTION ASSAY/Procedure USP36–NF31 4288 29-Mar-2013 01-Apr-2013 USP37–NF32 USP37–NF32
Line 10 of Analysis: Change
BS = absorbance of the Sample blank
to:
BS = absorbance of the Standard blank

Line 10 of Analysis: Change
BS = absorbance of the Sample blank
to:
BS = absorbance of the Standard blank
CALCIUM SULFATE SPECIFIC TESTS/Loss on Drying <731> USP35–NF30 1724 29-Mar-2013 01-Apr-2013 USP37–NF32 USP37–NF32
Line 1 of Acceptance criteria: Change
NMT 1.5% for the anhydrous form and NMT 19.0%–23.0% for the dihydrate
to:
NMT 1.5% for the anhydrous form and 19.0%–23.0% for the dihydrate

Line 1 of Acceptance criteria: Change
NMT 1.5% for the anhydrous form and NMT 19.0%–23.0% for the dihydrate
to:
NMT 1.5% for the anhydrous form and 19.0%–23.0% for the dihydrate
IFOSFAMIDE Chloroform-insoluble phosphorus USP35–NF30 3477 29-Mar-2013 01-Apr-2013 USP37–NF32 USP37–NF32
Line 18 of Test preparation: Change
ammonium hydroxide solution.
to:
ammonium hydroxide.

Line 18 of Test preparation: Change
ammonium hydroxide solution.
to:
ammonium hydroxide.
METHOTREXATE IMPURITIES/Organic Impurities/Procedure 1: Related Compounds USP35–NF30 3855 29-Mar-2013 01-Apr-2013 USP37–NF32 USP37–NF32
Footnote b of Impurity Table 1: Change
(S)-2-{4-[(2-Amino-4-oxo-1,4-dihydropteridin-6-yl)methylamino]-N-methylbenzamido}pentanedioic acid.
to:
(S)-2-(4-{[(2-Amino-4-oxo-1,4-dihydropteridin-6-yl)methyl](methyl)amino}benzamido)pentanedioic acid.

Footnote b of Impurity Table 1: Change
(S)-2-{4-[(2-Amino-4-oxo-1,4-dihydropteridin-6-yl)methylamino]-N-methylbenzamido}pentanedioic acid.

to:
(S)-2-(4-{[(2-Amino-4-oxo-1,4-dihydropteridin-6-yl)methyl](methyl)amino}benzamido)pentanedioic acid.
<621> CHROMATOGRAPHY SYSTEM SUITABILITY/Stationary Phase USP35–NF30 258 31-Jan-2013 01-Feb-2013 USP37–NF32 Second Supplement to USP36–NF31
Line 3 of Flow Rate (HPLC): Change
Monograph Image
in which F1 is the flow rate indicated in the monograph, in mL/min; F2 is the adjusted flow rate, in mL/min; l1 is the length of the column indicated in the monograph; l2 is the length of the column used; d1 is the column inner diameter indicated in the monograph; and d2 is the internal diameter of the column used. Additionally, the flow rate can be adjusted by ±50%.
to:
Monograph Image
in which F1 is the flow rate indicated in the monograph, in mL/min; F2 is the adjusted flow rate, in mL/min; d1 is the column inner diameter indicated in the monograph; and d2 is the internal diameter of the column used. Additionally, the flow rate can be adjusted by ±50%.

Line 3 of Flow Rate (HPLC): Change

 Read More
<1050> VIRAL SAFETY EVALUATION OF BIOTECHNOLOGY PRODUCTS DERIVED FROM CELL LINES OF HUMAN OR ANIMAL ORIGIN VI. Evaluation and Characterization of Viral Clearance Procedures USP35–NF30 553 31-Jan-2013 01-Feb-2013 USP37–NF32 Second Supplement to USP36–NF31
Row 10 (Reovirus 3) of Column 5 (Genome) of Table A-1: Change
DNA
to:
RNA

Row 10 (Reovirus 3) of Column 5 (Genome) of Table A-1: Change
DNA
to:
RNA
ACESULFAME POTASSIUM IMPURITIES/Limit of Fluoride USP35–NF30 1680 31-Jan-2013 01-Feb-2013 USP37–NF32 Second Supplement to USP36–NF31
Line 25 of Analysis: Change
C = concentration of fluoride in the Sample solution, from the standard curve (mg/mL)
to:
C = concentration of fluoride in the Sample solution, from the standard curve (µg/mL)

Line 25 of Analysis: Change
C = concentration of fluoride in the Sample solution, from the standard curve (mg/mL)
to:
C = concentration of fluoride in the Sample solution, from the standard curve (µg/mL)
GLYCERYL BEHENATE IMPURITIES USP35–NF30 1811 31-Jan-2013 01-Feb-2013 USP37–NF32 Second Supplement to USP36–NF31
Line 34 of Content of 1-Monoglycerides/Analysis: Change
F = equivalency factor of glyceryl monobehenate, 207.3 mg/mEq
to:
F = equivalency factor of glyceryl monobehenate, 0.2073 g/mEq
AND
Line 19 of Limit of Free Glycerin/Analysis: Change
F = equivalency factor of glycerin, 23.0 mg/mEq
to:
F = equivalency factor of glycerin, 0.023 g/mEq

Line 34 of Content of 1-Monoglycerides/Analysis: Change
F = equivalency factor of glyceryl monobehenate, 207.3 mg/mEq

to:
F = equivalency factor of glyceryl monobehenate, 0.2073 g/mEq

AND
Line 19 of Limit of Free Glycerin/Analysis: Change
F = equivalency factor of glycerin, 23.0 mg/mEq
to:
F = equivalency factor of glycerin, 0.023 g/mEq
GLYCERYL MONOOLEATE SPECIFIC TESTS/Fats and Fixed Oils, Fatty Acid Composition <401> USP35–NF30 1814 31-Jan-2013 01-Feb-2013 USP37–NF32 Second Supplement to USP36–NF31
Column 3 of Table 1: Change in Row 1
Percentage, NMT (%)
to:
Percentage (%)
Change in Row 2
12.0
to:
NMT 12.0
Change in Row 3
6.0
to:
NMT 6.0
Change in Row 4
60.0
to:
NLT 60.0
Change in Row 5
35.0
to:
NMT 35.0
Change in Row 6
2.0
to:
NMT 2.0
Change in Row 7
2.0
to:
NMT 2.0
Change in Row 8
2.0
to:
NMT 2.0

Column 3 of Table 1: Change in Row 1
Percentage, NMT (%)
to:
Percentage (%)
Change in Row 2
12.0
to:
NMT 12.0
Change in Row 3
6.0
to:
NMT 6.0
Change in Row 4
60.0
to:
NLT 60.0
Change in Row 5
35.0
to:
NMT 35.0
Change in Row 6
2.0
to:
NMT 2.0
Change in Row 7
2.0
to:
NMT 2.0
Change in Row 8
2.0
to:
NMT 2.0
ONDANSETRON INJECTION USP Reference Standards USP35–NF30 4120 31-Jan-2013 01-Feb-2013 USP37–NF32 Second Supplement to USP36–NF31
Line 7: Delete
USP Ondansetron Related Compound B RS
6,6´-Methylene bis-[(1,2,3,9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)-methyl]-4H-carbazol-4-one.

Line 7: Delete
USP Ondansetron Related Compound B RS

6,6´-Methylene bis-[(1,2,3,9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)-methyl]-4H-carbazol-4-one.
OXYBUTYNIN CHLORIDE EXTENDED-RELEASE TABLETS PERFORMANCE TESTS/Dissolution <711>/Test 2 USP35–NF30 4167 31-Jan-2013 01-Feb-2013 USP37–NF32 Second Supplement to USP36–NF31
Line 3 of Working standard solution: Change
or transfer 10 mL for Tablets labeled to contain 10 mg, to a 100-mL volumetric flask.
to:
transfer 10 mL for Tablets labeled to contain 10 mg, or transfer 15 mL for Tablets labeled to contain 15 mg to a 100-mL volumetric flask.

Line 3 of Working standard solution: Change
or transfer 10 mL for Tablets labeled to contain 10 mg, to a 100-mL volumetric flask.
to:
transfer 10 mL for Tablets labeled to contain 10 mg, or transfer 15 mL for Tablets labeled to contain 15 mg to a 100-mL volumetric flask.
PHENYLALANINE IMPURITIES USP35–NF30 4296 31-Jan-2013 01-Feb-2013 USP37–NF32 Second Supplement to USP36–NF31
Line 1 of Heavy Metals, Method I <231>: Change
Method I
to:
Method II

Line 1 of Heavy Metals, Method I <231>: Change
Method I
to:
Method II
TRIAZOLAM TABLETS Assay USP35–NF30 4936 31-Jan-2013 01-Feb-2013 USP37–NF32 Second Supplement to USP36–NF31
Line 2: Change
Mobile phase and Chromatographic system—Proceed as directed in the Assay under Triazolam.
to:
Mobile phase—Prepare a filtered and degassed mixture of acetonitrile, chloroform, butyl alcohol, water, and glacial acetic acid (850:80:50:20:0.5). Make adjustments if necessary (see System Suitability under Chromatography <621>).
AND
After the Assay preparation subsection: Add a new subsection
Chromatographic system (see Chromatography <621>)—The liquid chromatograph is equipped with a 254-nm detector and a 4.6-mm × 30-cm column that contains packing L3. The flow rate is about 2.0 mL per minute. Chromatograph the Standard preparation, and record the peak responses as directed under Procedure: the relative retention times are 1 for triazolam and about 1.4 for the internal standard, the resolution, R, between the internal standard and triazolam is not less than 2.0, and the relative standard deviation for replicate injections is not more than 2.0%.
AND
Line 4 of Procedure: Change
Calculate the quantity, in mg, of C17H12Cl2N4 in the portion of Triazolam taken by the formula:
to:
Calculate the quantity, in mg, of C17H12Cl2N4 in the portion of Tablets taken by the formula:
AND
Line 9 of Procedure: Change
RU and RS are the ratios of the internal standard peak area to the triazolam peak area obtained from the Assay preparation and the Standard preparation, respectively.
to:
RU and RS are the ratios of the triazolam peak area to the internal standard peak area obtained from the Assay preparation and the Standard preparation, respectively.

Line 2: Change
Mobile phase and Chromatographic system—Proceed as directed in the Assay under Triazolam.
to:
Mobile phase—Prepare a filtered and degassed mixture of acetonitrile, chloroform, butyl alcohol, water, and glacial acetic acid (850:80:50:20:0.5). Make adjustments if necessary (see System Suitability under Chromatography <621>).
AND
After the Assay preparation subsection: Add a new subsection

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VINCRISTINE SULFATE IMPURITIES/Organic Impurities USP35–NF30 5022 31-Jan-2013 01-Feb-2013 USP37–NF32 Second Supplement to USP36–NF31
Line 5 of Analysis: Change
Result = [rUA/(ΣrUA + 25rUB)] × 100
to:
Result = [rUA/(ΣrUA + 30rUB)] × 100
AND
Change line 12 of Analysis:
Result = [ΣrUA/(ΣrUA + 25rUB)] × 100
to:
Result = [ΣrUA/(ΣrUA + 30rUB)] × 100

Line 5 of Analysis: Change
Result = [rUA/(ΣrUA + 25rUB)] × 100
to:
Result = [rUA/(ΣrUA + 30rUB)] × 100
AND
Change line 12 of Analysis:
Result = [ΣrUA/(ΣrUA + 25rUB)] × 100
to:
Result = [ΣrUA/(ΣrUA + 30rUB)] × 100
ZINC GLUCONATE IMPURITIES/Limit of Cadmium USP35–NF30 5070 31-Jan-2013 01-Feb-2013 USP37–NF32 Second Supplement to USP36–NF31
Line 22 of Analysis: Change
W = weight of Calcium Gluconate taken to prepare Sample solution A (g)
to:
W = weight of Zinc Gluconate taken to prepare Sample solution A (g)

Line 22 of Analysis: Change
W = weight of Calcium Gluconate taken to prepare Sample solution A (g)
to:
W = weight of Zinc Gluconate taken to prepare Sample solution A (g)
ALLANTOIN IDENTIFICATION First Supplement to USP35–NF30 5429 31-Jan-2013 01-Feb-2013 USP37–NF32 Second Supplement to USP36–NF31
Line 1 of B. Thin-Layer Chromatographic Identification Test <201>: Change
The RF value of the principal spot from Sample solution A corresponds to that from Standard solution A, as described in the test for Organic Impurities.
to:
The RF value of the principal spot from Sample solution B corresponds to that from Standard solution A, as described in the test for Organic Impurities.

Line 1 of B. Thin-Layer Chromatographic Identification Test <201>: Change
The RF value of the
principal spot from Sample solution A corresponds to that from Standard solution A, as
described in the test for Organic Impurities.
to:
The RF value of the
principal spot from Sample solution B corresponds to that from Standard solution A, as
described in the test for Organic Impurities.
<232> ELEMENTAL IMPURITIES--LIMITS Drug Products/Large Volume Parenterals Second Supplement to USP35–NF30 5633 31-Jan-2013 01-Feb-2013 USP37–NF32 Second Supplement to USP36–NF31
Row 16 of Column 4 of Table 1: Change
70
to:
100
AND
Row 16 of Column 5 of Table 1: Change
25
to:
10

Row 16 of Column 4 of Table 1: Change
70
to:
100
AND
Row 16 of Column 5 of Table 1: Change
25
to:
10
AZITHROMYCIN FOR INJECTION IMPURITIES/Limit of Aminoazithromycin, Formamido Analog, Methylformamido Analog, and 3’-De(dimethylamino)-3’-oxoazithromycin (if present) Second Supplement to USP35–NF30 5910 31-Jan-2013 01-Feb-2013 USP37–NF32 Second Supplement to USP36–NF31
Line 1 of Buffer: Change
3.5 g/mL
to:
3.5 g/L

Line 1 of Buffer: Change
3.5 g/mL
to:
3.5 g/L
ADAPALENE IMPURITIES/Residual Solvent: Limit of Triethylamine Revision Bulletin (Official December 01, 2012) Online 31-Jan-2013 01-Feb-2013 USP37–NF32 Second Supplement to USP36–NF31
Line 1 of Diluent: Change
Dimethyl sulfoxide and 1 N sodium hydroxide solution (4:1)
to:
Dimethyl sulfoxide
AND
Line 1 of Standard solution: Change
3.2 μg/mL of USP Triethylamine RS in Diluent
to:
4.0 μg/mL of USP Triethylamine RS in Diluent. Transfer 4.0 mL of this solution to a 20-mL headspace vial, and add 1.0 mL of 1 N NaOH solution.
AND
Line 1 of Sample solution: Change
40 mg/mL of Adapalene in Diluent
to:
50 mg/mL of Adapalene in Diluent. Transfer 4.0 mL of this solution to a 20-mL headspace vial, and add 1.0 mL of 1 N NaOH solution.

Line 1 of Diluent: Change
Dimethyl sulfoxide and 1 N sodium hydroxide solution (4:1)

to:
Dimethyl sulfoxide
AND
Line 1 of Standard solution: Change
3.2 μg/mL of USP Triethylamine RS in Diluent
to:
4.0 μg/mL of USP Triethylamine RS in Diluent. Transfer 4.0 mL of this solution to a 20-mL headspace vial, and add 1.0 mL of 1 N NaOH solution.
AND
Line 1 of Sample solution: Change
40 mg/mL of Adapalene in Diluent
to:

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TACROLIMUS ORAL SUSPENSION ASSAY/Chromatographic system USP36–NF31 5261 31-Jan-2013 01-Feb-2013 USP37–NF32 Second Supplement to USP36–NF31
After line 1 of Column: Add a new section
Column temperature: 70°

After line 1 of Column: Add a new section
Column temperature: 70°
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE Assay USP35–NF30 1822 31-Jan-2013 01-Feb-2013 USP37–NF32 Second Supplement to USP36–NF31
Line 2: Change
Hypromellose 2906, except to substitute Low-Substituted Hydroxypropyl Cellulose for Hypromellose 2906 throughout.
to:
Hypromellose, except to substitute Low-Substituted Hydroxypropyl Cellulose for Hypromellose throughout.

Line 2: Change
Hypromellose 2906, except to substitute Low-Substituted Hydroxypropyl Cellulose for Hypromellose 2906 throughout.

to:
Hypromellose, except to substitute Low-Substituted Hydroxypropyl Cellulose for Hypromellose throughout.
MYRISTYL ALCOHOL SPECIFIC TESTS/Fats and Fixed Oils, Hydroxyl Value <401> USP35–NF30 1873 31-Jan-2013 01-Feb-2013 USP37–NF32 Second Supplement to USP36–NF31
Line 7 of Analysis: Change
Result = [(VU − VB) × F]/W
VU = volume of 1 N sodium hydroxide consumed by the Sample (mL)
VB = volume of 1 N sodium hydroxide consumed by the Blank (mL)
to:
Result = [(VB − VU) × F]/W
VB = volume of 1 N sodium hydroxide consumed by the Blank (mL)
VU = volume of 1 N sodium hydroxide consumed by the Sample (mL)

Line 7 of Analysis: Change
Result = [(VU − VB) × F]/W
VU = volume of 1 N sodium hydroxide consumed by the Sample (mL)
VB = volume of 1 N sodium hydroxide consumed by the Blank (mL)
to:
Result = [(VB − VU) × F]/W
VB = volume of 1 N sodium hydroxide consumed by the Blank (mL)
VU = volume of 1 N sodium hydroxide consumed by the Sample (mL)
AMANTADINE HYDROCHLORIDE CAPSULES PERFORMANCE TESTS/Dissolution <711>/Test 2 USP35–NF30 2153 31-Jan-2013 01-Feb-2013 USP37–NF32 Second Supplement to USP36–NF31
Line 5 of Chromatographic system: Change
Column: 0.32-mm × 30-cm, 0.25-μm film, phase G1
to:
Column: 0.32-mm × 30-m, 0.25-μm film, phase G1

Line 5 of Chromatographic system: Change
Column: 0.32-mm × 30-cm, 0.25-μm film, phase G1

to:
Column: 0.32-mm × 30-m, 0.25-μm film, phase G1
XLS CSV