How to Use the USP–NF Errata Table

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Monograph Title Section Source Publicationsort icon Page Number Errata Official Date Target Errata Print Publication Target Online Fix Publication Description
<660> Containers—Glass SPECIFIC TESTS/Hydrolytic Resistance/Method First Supplement to USP35–NF30 5150 01-Dec-2012 USP37–NF32 Second Supplement to USP36–NF31
In the Note in line 11 of Titration: Change
Rinse the grains by swirling with three 15-mL portions of Purified Water, and add the washings to the main solution.
to:
Rinse the grains by swirling with three 15-mL portions of Carbon Dioxide-Free Water, and add the washings to the main solution.

In the Note in line 11 of Titration: Change
Rinse the grains by swirling with three 15-mL portions of Purified Water, and add the washings to the main solution.
to:
Rinse the grains by swirling with three 15-mL portions of Carbon Dioxide-Free Water, and add the washings to the main solution.

Esomeprazole Magnesium Delayed-Release Capsules ASSAY/Procedure First Supplement to USP35–NF30 5473 01-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.

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.

Esomeprazole Magnesium Delayed-Release Capsules PERFORMANCE TESTS/Dissolution <711> First Supplement to USP35–NF30 5473 01-Dec-2012 USP37–NF32 Second Supplement to USP36–NF31
Change
Buffer, Diluent, Mobile phase, System suitability, and Chromatographic system: Proceed as directed in the Assay.
to:
Buffer, Mobile phase, System suitability, and Chromatographic system: Proceed as directed in the Assay.

Change
Buffer, Diluent, Mobile phase, System suitability, and Chromatographic system: Proceed as directed in the Assay.

to:
Buffer, Mobile phase, System suitability, and Chromatographic system: Proceed as directed in the Assay.

Esterified Estrogens Tablets ASSAY/Procedure First Supplement to USP35–NF30 5485 01-Dec-2012 USP37–NF32 Second Supplement to USP36–NF31
Line 3 of Analysis: Change
Separately calculate the percentage of the labeled amount of sodium estrone sulfate and sodium equilin sulfate in the portion of Conjugated Estrogens taken:
to:
Separately calculate the percentage of the labeled amount of sodium estrone sulfate and sodium equilin sulfate in the portion of Tablets taken:

Line 3 of Analysis: Change
Separately calculate the percentage of the labeled amount of sodium estrone sulfate and sodium equilin sulfate in the portion of Conjugated Estrogens taken:

to:
Separately calculate the percentage of the labeled amount of sodium estrone sulfate and sodium equilin sulfate in the portion of Tablets taken:

Itraconazole IMPURITIES/Organic Impurities First Supplement to USP35–NF30 5508 01-Dec-2012 USP37–NF32 Second Supplement to USP36–NF31
Line 1 of Standard solution: Change
1.0 µg/mL of USP Itraconazole RS in Diluent
to:
10.0 µg/mL of USP Itraconazole RS in Diluent

Line 1 of Standard solution: Change
1.0 µg/mL of USP Itraconazole RS in Diluent
to:
10.0 µg/mL of USP Itraconazole RS in Diluent

Omega-3-Acid Ethyl Esters Capsules SPECIFIC TESTS/Microbial Enumeration <61> First Supplement to USP35–NF30 5524 01-Dec-2012 USP37–NF32 First Supplement to USP36–NF31
Line 2: Change
103
to:
103 cfu/g
AND
Line 3: Change
102
to:
102 cfu/g

Line 2: Change
103
to:
103 cfu/g
AND
Line 3: Change
102
to:
102 cfu/g

ALLANTOIN IDENTIFICATION First Supplement to USP35–NF30 5429 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.

<698> DELIVERABLE VOLUME ACCEPTANCE CRITERIA/For Multiple-Unit Containers First Supplement to USP35–NF30 5154 01-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

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

DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS PERFORMANCE TESTS/Dissolution <711>/Test 3 First Supplement to USP35–NF30 5460 01-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 solution, and Sample solutions

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 solution
, and Sample solutions

ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES PERFORMANCE TESTS/Dissolution <711> First Supplement to USP35–NF30 5473 01-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

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

ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES IMPURITIES/Organic Impurities First Supplement to USP35–NF30 5473 01-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), from the Capsule content, to a 200-mL volumetric flask, add 20 mL of methanol, and shake for 30 s.

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), from the Capsule content, to a 200-mL volumetric flask, add 20 mL of methanol, and shake for 30 s.

OMEGA-3-ACID ETHYL ESTERS CAPSULES SPECIFIC TESTS/Microbial Enumeration Tests <61> and Tests for Specified Microorganisms <62> First Supplement to USP35–NF30 5524 01-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.

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.

TACROLIMUS IMPURITIES/Procedure 2 First Supplement to USP35–NF30 5538 01-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-hydroxy-3-methoxycyclohexyl]-1-methylvinyl}-14,16-dimethoxy-4,10,12,18-tetramethyl-15,19-epoxy-8-propyl-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone.
to:
(3S,4R,5S,8R,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-hydroxy-3-methoxycyclohexyl]-1-methylvinyl}-14,16-dimethoxy-4,10,12,18-tetramethyl-15,19-epoxy-8-propyl-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone.

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-hydroxy-3-methoxycyclohexyl]-1-methylvinyl}-14,16-dimethoxy-4,10,12,18-tetramethyl-15,19-epoxy-8-propyl-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone.

to:

Read More
TACROLIMUS CAPSULES IMPURITIES/Procedure 2 First Supplement to USP35–NF30 5541 01-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-hydroxy-3-methoxycyclohexyl]-1-methylvinyl}-14,16-dimethoxy-4,10,12,18-tetramethyl-15,19-epoxy-8-propyl-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone.
to:
(3S,4R,5S,8R,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-hydroxy-3-methoxycyclohexyl]-1-methylvinyl}-14,16-dimethoxy-4,10,12,18-tetramethyl-15,19-epoxy-8-propyl-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20, 21(4H,23H)-tetrone.

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-hydroxy-3-methoxycyclohexyl]-1-methylvinyl}-14,16-dimethoxy-4,10,12,18-tetramethyl-15,19-epoxy-8-propyl-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone.

to:

Read More
ADAPALENE IMPURITIES/Residual Solvent: Limit of Triethylamine Revision Bulletin (Official December 01, 2012) Online 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:

Read More
Olanzapine Tablets ASSAY/Procedure Revision Bulletin (Official July 01, 2012) Online 01-Dec-2012 USP37–NF32 Second Supplement to USP36–NF31
Line 10 of Analysis: Change
CU = concentration of olanzapine in the Sample solution (mg/mL)
to:
CU = nominal concentration of olanzapine in the Sample solution (mg/mL)

Line 10 of Analysis: Change
CU = concentration of olanzapine in the Sample solution (mg/mL)
to:
CU = nominal concentration of olanzapine in the Sample solution (mg/mL)

Olanzapine Tablets IMPURITIES/Organic Impurities Revision Bulletin (Official July 01, 2012) Online 01-Dec-2012 USP37–NF32 Second Supplement to USP36–NF31
Line 11 of Analysis: Change
CU = concentration of olanzapine in the Sample solution (mg/mL)
to:
CU = nominal concentration of olanzapine in the Sample solution (mg/mL)

Line 11 of Analysis: Change
CU = concentration of olanzapine in the Sample solution (mg/mL)
to:
CU = nominal concentration of olanzapine in the Sample solution (mg/mL)

Olanzapine Tablets ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Revision Bulletin (Official July 01, 2012) Online 01-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-Methyl-2-((2-nitrophenyl)amino)-3-thiophenecarbonitrile.
C12H9N3O2S 259.28
USP Olanzapine Related Compound B RS
2-Methyl-10H-thieno-[2,3-b][1,5]benzodiazepin-4[5H]-one.
C12H10N2OS 230.29

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-Methyl-2-((2-nitrophenyl)amino)-3-thiophenecarbonitrile.

C12H9N3O2S 259.28
USP Olanzapine Related Compound B RS
2-Methyl-10H-thieno-[2,3-b][1,5]benzodiazepin-4[5H]-one.

Read More
Carisoprodol Tablets ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Second Supplement to USP35–NF30 5921 01-Dec-2012 USP37–NF32 Second Supplement to USP36–NF31
Line 5: At end of USP Reference Standards, add
USP Meprobamate RS

Line 5: At end of USP Reference Standards, add
USP Meprobamate RS

Cefepime Hydrochloride IMPURITIES/Organic Impurities/Procedure 1: Limit of N-Methylpyrrolidine Second Supplement to USP35–NF30 5923 01-Dec-2012 USP37–NF32 Second Supplement to USP36–NF31
Line 5 of Chromatographic system: Change
Column: 4.0-mm x 25-cm; 5-µm packing L##1
to:
Column: 4.0-mm x 25-cm; 5-µm packing L76
AND
Delete corresponding footnote: "Available as Metrosep C4-250."

Line 5 of Chromatographic system: Change
Column: 4.0-mm x 25-cm; 5-µm packing L##1
to:
Column: 4.0-mm x 25-cm; 5-µm packing L76
AND
Delete corresponding footnote: "Available as Metrosep C4-250."

Cefepime for Injection IMPURITIES/Organic Impurities/Procedure 1: Limit of N-Methylpyrrolidine Second Supplement to USP35–NF30 5925 01-Dec-2012 USP37–NF32 Second Supplement to USP36–NF31
Line 5 of Chromatographic system: Change
Column: 4.0-mm x 25-cm; 5-µm packing L##1
to:
Column: 4.0-mm x 25-cm; 5-µm packing L76
AND
Delete corresponding footnote: Available as Metrosep C4-250.

Line 5 of Chromatographic system: Change
Column: 4.0-mm x 25-cm; 5-µm packing L##1
to:
Column: 4.0-mm x 25-cm; 5-µm packing L76
AND
Delete corresponding footnote: Available as Metrosep C4-250.

<232> ELEMENTAL IMPURITIES--LIMITS Drug Products/Large Volume Parenterals Second Supplement to USP35–NF30 5633 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 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

<232> ELEMENTAL IMPURITIES--LIMITS Drug Substance and Excipients Second Supplement to USP35–NF30 5633 01-Feb-2013 USP37–NF32 Second Supplement to USP36–NF31
Row 16 of Column 4 of Table 2: Change
7
to:
10

Row 16 of Column 4 of Table 2: Change
7
to:
10

<232> ELEMENTAL IMPURITIES—LIMITS DRUG SUBSTANCE AND EXCIPIENTS Second Supplement to USP35–NF30 5633 01-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: Change
30
to:
3.0

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: Change
30
to:
3.0

<232> ELEMENTAL IMPURITIES—LIMITS ANALYTICAL TESTING Second Supplement to USP35–NF30 5633 01-Oct-2012 USP37–NF32 First Supplement to USP36–NF31
Line 6: Change
Pd
to:
Pb

Line 6: Change
Pd
to:
Pb

<232> ELEMENTAL IMPURITIES—LIMITS DRUG SUBSTANCE AND EXCIPIENTS Second Supplement to USP35–NF30 5633 01-Oct-2012 USP37–NF32 First Supplement to USP36–NF31
Row 13 of Column 4 of Table 2: Change
25
to:
1.0

Row 13 of Column 4 of Table 2: Change
25
to:
1.0

<232> ELEMENTAL IMPURITIES—LIMITS DRUG PRODUCTS/Large Volume Parenterals Second Supplement to USP35–NF30 5633 01-Oct-2012 USP37–NF32 First Supplement to USP36–NF31
Row 13 of Column 4 of Table 1: Change
250
to:
10

Row 13 of Column 4 of Table 1: Change
250
to:
10

<233> ELEMENTAL IMPURITIES—PROCEDURES INTRODUCTION/Definition Second Supplement to USP35–NF30 5634 01-Oct-2012 USP37–NF32 First Supplement to USP36–NF31
Line 2 of Target Elements: Change
Pd
to:
Pb

Line 2 of Target Elements: Change
Pd
to:
Pb

AZITHROMYCIN FOR INJECTION IMPURITIES/Limit of Aminoazithromycin, Formamido Analog, Methylformamido Analog, and 3′-De(dimethylamino)-3′-oxoazithromycin Second Supplement to USP35–NF30 5910 01-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

Row 11 of Table 2: Change
3′-Demethyl-3′-N-[(4-methylphenyl)sulfonyl]azithromycin
to:
3′-N-Demethyl-3′-N-[(4-methylphenyl)sulfonyl]azithromycin

AZITHROMYCIN FOR INJECTION IMPURITIES/Limit of Azithromycin N-Oxide, Desosaminylazithromycin, and N-Demethylazithromycin Second Supplement to USP35–NF30 5910 01-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/CU) × P × 100

Line 5 of Analysis: Change
Result = (rU/rS) × (CS/CU) × P × F × 100
to:
Result = (rU/rS) × (CS/CU) × P × 100

ATRACURIUM BESYLATE INJECTION IMPURITIES/Organic Impurities/Acceptance criteria/Table 2 Second Supplement to USP35–NF30 5909 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.

DULOXETINE DELAYED-RELEASE CAPSULES PERFORMANCE TESTS/Dissolution <711>/Chromatographic system Second Supplement to USP35–NF30 5940 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 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

Polysorbate 80 SPECIFIC TESTS/Fats and Fixed Oils, Saponification Value <401> USP35–NF30 1920 01-Dec-2012 USP37–NF32 Second Supplement to USP36–NF31
Line 3 of Analysis: Change
0.5 N alcoholic potassium hydroxide
to:
0.5 N alcoholic potassium hydroxide VS

Line 6 of Analysis: Change
0.5 N hydrochloric acid
to:
0.5 N hydrochloric acid VS

Line 3 of Analysis: Change
0.5 N alcoholic potassium hydroxide
to:
0.5 N alcoholic potassium hydroxide VS

Line 6 of Analysis: Change
0.5 N hydrochloric acid

to:
0.5 N hydrochloric acid VS

Aminosalicylate Sodium Limit of m-aminophenol USP35–NF30 2177 01-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. Add 10.0 mL of Internal standard solution, dilute with Mobile phase to volume, and mix.

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. Add 10.0 mL of Internal standard solution, dilute with Mobile phase to volume, and mix.

Aminosalicylate Sodium Tablets Limit of m-aminophenol USP35–NF30 2178 01-Dec-2012 USP37–NF32 Second Supplement to USP36–NF31
Line 1 of Test solution: Change
Use the Assay preparation, prepared as directed in the Assay.
to:
Weigh and finely powder not fewer than 20 Tablets. Transfer an accurately weighed portion of the powder, equivalent to about 690 mg of aminosalicylate sodium, to a 100-mL low-actinic volumetric flask. Add 50 mL of Mobile phase, and shake for about 5 minutes. Dilute with Mobile phase to volume, and mix. Filter, and transfer 10.0 mL of the clear filtrate to a low-actinic, 100-mL volumetric flask containing 10.0 mL of Internal standard solution, dilute with Mobile phase to volume, and mix.

Line 1 of Test solution: Change
Use the Assay preparation, prepared as directed in the Assay.
to:

Read More
Aminosalicylic Acid Tablets Limit of m-aminophenol USP35–NF30 2179 01-Dec-2012 USP37–NF32 Second Supplement to USP36–NF31
Change the subsection:
Mobile phase and Internal standard solution—Prepare as directed in the Assay under Aminosalicylic Acid.
to:
Mobile phase—Prepare as directed in the Assay under Aminosalicylic Acid.
Internal standard solution—Prepare a solution of sulfanilamide in Mobile phase having a concentration of about 5 µg per mL.

Line 1 of Test solution: Change
Use the Assay preparation, prepared as directed in the Assay.
to:
Weigh and finely powder not fewer than 20 Tablets. Transfer an accurately weighed portion of the powder, equivalent to about 500 mg of aminosalicylic acid, to a 100-mL low-actinic volumetric flask. Add 50 mL of Mobile phase, and shake for about 5 minutes. Dilute with Mobile phase to volume, and mix. Filter, and transfer 10.0 mL of the clear filtrate to a 100-mL low-actinic volumetric flask containing 10.0 mL of Internal standard solution, dilute with Mobile phase to volume, and mix.

Change the subsection:
Mobile phase and Internal standard solution—Prepare as directed in the Assay under Aminosalicylic Acid.
to:

Mobile phase—Prepare as directed in the Assay under
Aminosalicylic Acid.
Internal standard solution—Prepare a solution of sulfanilamide
in Mobile phase having a concentration of
about 5 µg per mL.

Line 1 of Test solution: Change
Use the Assay preparation, prepared as directed in
the Assay.
to:

Read More
Moxifloxacin Ophthalmic Solution Related compounds/Test 1 USP35–NF30 3960 01-Dec-2012 USP37–NF32 Second Supplement to USP36–NF31
Line 4 of Chromatographic system: Delete
The flow rate is about 0.5 mL per minute.

Line 4 of Chromatographic system: Delete
The flow rate is about 0.5 mL per minute.

Tramadol Hydrochloride Tablets IMPURITIES/Organic Impurities/Procedure USP35–NF30 4905 01-Dec-2012 USP37–NF32 Second Supplement to USP36–NF31
Line 5 of Analysis: Change
Result = (rU/rS) × (CS/CU) × (1/F) × 0.1
to:
Result = (rU/rS) × (CS/CU) × (1/F) × 100

Line 5 of Analysis: Change
Result = (rU/rS) × (CS/CU) × (1/F) × 0.1
to:
Result = (rU/rS) × (CS/CU) × (1/F) × 100

Triclosan Related compounds USP35–NF30 4939 01-Dec-2012 USP37–NF32 Second Supplement to USP36–NF31
Line 1 of Procedure: Change
Inject a volume (about 0.5 µL)
to:
Inject a volume (about 2.0 µL)

Line 1 of Procedure: Change
Inject a volume (about 0.5 µL)
to:
Inject a volume (about 2.0 µL)

Compound Undecylenic Acid Ointment Assay for zinc undecylenate USP35–NF30 4978 01-Dec-2012 USP37–NF32 Second Supplement to USP36–NF31
Line 17 of Procedure: Change
AU, AH, and AL
to:
AU, AS1, and AS2

Line 17 of Procedure: Change
AU, AH, and AL
to:
AU, AS1, and AS2

Ampicillin Sodium SPECIFIC TESTS/pH <791> USP35–NF30 2213 01-Dec-2012 USP37–NF32 Second Supplement to USP36–NF31
Line 2: Change text of Sample solution from
10.0 mg/mL
to:
10.0 mg/mL of ampicillin

Line 2: Change text of Sample solution from
10.0 mg/mL
to:
10.0 mg/mL of ampicillin

Budesonide ASSAY/Procedure USP35–NF30 2394 01-Dec-2012 USP37–NF32 Second Supplement to USP36–NF31
Line 2 of Acceptance criteria: Change
Epimer A: 40.0%–51.0% on the dried basis
to:
Epimer A: 40.0%–51.0%

Line 2 of Acceptance criteria: Change
Epimer A: 40.0%–51.0% on the dried basis

to:
Epimer A: 40.0%–51.0%

Dibasic Calcium Phosphate Dihydrate ASSAY USP35–NF30 2463 01-Dec-2012 USP37–NF32 Second Supplement to USP36–NF31
Line 14 of Analysis: Change
W = Sample weight (mg)
to:
W = Sample weight (mg) in 20.0 mL of the Sample solution

Line 14 of Analysis: Change
W = Sample weight (mg)
to:
W = Sample weight (mg) in 20.0 mL of the Sample solution

Dibasic Calcium Phosphate Dihydrate IMPURITIES/Heavy Metals, Method I <231> USP35–NF30 2463 01-Dec-2012 USP37–NF32 Second Supplement to USP36–NF31
Line 1 of Test preparation: Change
Warm 1.3 g with 3 mL of 3 N hydrochloric acid to completely dissolve.
to:
Warm 1.3 g with 3 mL of 3 N hydrochloric acid until no more dissolves.

Line 1 of Test preparation: Change
Warm 1.3 g with 3 mL of 3 N hydrochloric acid to completely dissolve.
to:
Warm 1.3 g with 3 mL of 3 N hydrochloric acid until no more dissolves.

Anhydrous Dibasic Calcium Phosphate ASSAY USP35–NF30 2464 01-Dec-2012 USP37–NF32 Second Supplement to USP36–NF31
In line 14 of Analysis: Change
W = Sample weight (mg)
to:
W = Sample weight (mg) in 20.0 mL of the Sample solution

In line 14 of Analysis: Change
W = Sample weight (mg)
to:
W = Sample weight (mg) in 20.0 mL of the Sample solution

Anhydrous Dibasic Calcium Phosphate IMPURITIES/Heavy Metals, Method I <231> USP35–NF30 2464 01-Dec-2012 USP37–NF32 Second Supplement to USP36–NF31
Line 1 of Test preparation: Change
Warm 1.3 g with 3 mL of 3 N hydrochloric acid to completely dissolve.
to:
Warm 1.3 g with 3 mL of 3 N hydrochloric acid until no more dissolves.

Line 1 of Test preparation: Change
Warm 1.3 g with 3 mL of 3 N hydrochloric acid to completely dissolve.

to:
Warm 1.3 g with 3 mL of 3 N hydrochloric acid until no more dissolves.

Cod Liver Oil ASSAY/Vitamin D USP35–NF30 2756 01-Dec-2012 USP37–NF32 Second Supplement to USP36–NF31
Line 1 of Aqueous potassium hydroxide solution: Change
Dissolve 800 mg of potassium hydroxide in 1000 mL of freshly boiled water, mix, and cool.
to:
Dissolve 800 g of potassium hydroxide in 1000 mL of freshly boiled water, mix, and cool.

Line 1 of Aqueous potassium hydroxide solution: Change
Dissolve 800 mg of potassium hydroxide in 1000 mL of freshly boiled water, mix, and cool.
to:
Dissolve 800 g of potassium hydroxide in 1000 mL of freshly boiled water, mix, and cool.

Glimepiride Tablets PERFORMANCE TESTS/Dissolution/Test 1 USP35–NF30 3335 01-Dec-2012 USP37–NF32 Second Supplement to USP36–NF31
Line 3 of Analysis: Change
Result = (rU/rS) × (CS/L) × V × 100
to:
Result = (rU/rS) × (CS/L) × V × D x 100
AND after Line 8 of Analysis: Add
D = dilution factor of the Sample solution

Line 3 of Analysis: Change

Result = (rU/rS) × (CS/L) × V × 100

to:
Result = (rU/rS) × (CS/L) × V × D x 100

AND after Line 8 of Analysis: Add
D = dilution factor of the Sample solution

XLS CSV