How to Use the USP–NF Errata Table

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Monograph Title Section Source Publication Page Number Errata Official Date Target Errata Print Publication Target Online Fix Publicationsort icon Description
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

DESCRIPTION AND SOLUBILITY Ethylcellulose Dispersion Type B USP35–NF30 1118 01-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.

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.

BENTONITE IDENTIFICATION/A. X-Ray Diffraction <941> USP35–NF30 1705 01-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.

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.

TRIBASIC CALCIUM PHOSPHATE IDENTIFICATION/Test A USP35–NF30 1719 01-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

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

CALCIUM SULFATE ASSAY/Procedure USP35–NF30 1724 01-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 = [(VB) × N × F × 100]/W
to:
Result = [(V × N × F)/W] × 100
AND
Line 15 of Analysis: Delete
B = volume of titrant consumed by the Blank (mL)

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 = [(VB) × N × F × 100]/W
to:

Result = [(V × N × F)/W] × 100

AND
Line 15 of Analysis: Delete

B = volume of titrant consumed by the Blank (mL)

MICROCRYSTALLINE CELLULOSE IDENTIFICATION/B. Procedure USP35–NF30 1746 01-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]}

4th formula of Analysis: Change

Result = (95) × [η]c/WS × [(100 − %LOD)/100]

to:

Result = [(95) × [η]c]/{WS × [(100 − %LOD)/100]}

MAGNESIUM STEARATE IMPURITIES/Chloride and Sulfate, Sulfate <221> USP35–NF30 1847 01-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%)

Line 3: Change

0.020 N sulfuric acid (1.0%)

to:

0.020 M sulfuric acid (1.0%)

METHYL ALCOHOL ASSAY/Procedure USP35–NF30 1865 01-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

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

POLYETHYLENE OXIDE IMPURITIES/Organic Impurities/Procedure: Limit of Free Ethylene Oxide USP35–NF30 1906 01-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

Line 2 of System suitability: Change

Samples: Standard stock solution and Standard solution
C

to:

Sample: Standard solution C

POLYSORBATE 20 SPECIFIC TESTS/Acid Value USP35–NF30 1919 01-Oct-2012 USP37–NF32 First Supplement to USP36–NF31
Line 1 of Sample: Change
10.0
to:
10.0 g

Line 1 of Sample: Change

10.0

to:

10.0 g

POLYSORBATE 60 SPECIFIC TESTS/Acid Value USP35–NF30 1920 01-Oct-2012 USP37–NF32 First Supplement to USP36–NF31
Line 1 of Sample: Change
10.0
to:
10.0 g

Line 1 of Sample: Change

10.0

to:

10.0 g

SODIUM HYDROXIDE ASSAY/Procedure USP35–NF30 1955 01-Oct-2012 USP37–NF32 First Supplement to USP36–NF31
Line 10 of Analysis: Change
Result = {[(VS1VB) × N × F1]/W} × 100
to:
Result = {[(VS2VB) × N × F1]/W} × 100
AND
Line 11 of Analysis: Change
VS1
to:
VS2

Line 10 of Analysis: Change

Result = {[(VS1VB) × N × F1]/W} × 100

to:

Result = {[(VS2VB) × N × F1]/W} × 100

AND
Line 11 of Analysis: Change

VS1
to:

VS2

TREHALOSE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP35–NF30 2007 01-Oct-2012 USP37–NF32 First Supplement to USP36–NF31
Line 2: Delete
USP Glycerin RS

Line 2: Delete

USP Glycerin RS

ZEIN IDENTIFICATION/C. SDS-Polyacrylamide Gel Electrophoresis USP35–NF30 2019 01-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.

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.

ACETAZOLAMIDE FOR INJECTION ASSAY USP35–NF30 2063 01-Oct-2012 USP37–NF32 First Supplement to USP36–NF31
Line 19: Change
25C(AU/AS)
to:
250C(AU/AS)

Line 19: Change
25C(AU/AS)

to:
250C(AU/AS)

ADENOSINE IDENTIFICATION/Infrared Absorption <197M> USP35–NF30 2079 01-Oct-2012 USP37–NF32 First Supplement to USP36–NF31
Line 1:
Delete NMT 0.1%

Line 1:
Delete
NMT 0.1%

ALPRAZOLAM ORALLY-DISINTEGRATING TABLETS IMPURITIES/Procedure USP35–NF30 2106 01-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.

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.

<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
<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

AMOXICILLIN TABLETS PERFORMANCE TESTS USP35–NF30 2202 01-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 in the equation

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 in the equation

CHLOROPHYLLIN COPPER COMPLEX SODIUM SPECIFIC TESTS/Loss on Drying <231> USP35–NF30 2628 01-Oct-2012 USP37–NF32 First Supplement to USP36–NF31
Line 1: Change
150°
to:
105°

Line 1: Change
150°

to:

105°

FLUTICASONE PROPIONATE IMPURITIES/Organic Impurities USP35–NF30 3261 01-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

Line 1 of the Sample solution: Change

2.0 mg/mL

to:

0.2 mg/mL

GANCICLOVIR ORAL SUSPENSION ASSAY USP35–NF30 3319 01-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

Line 1 of Internal standard solution: Change

4 mg per mL

to:

0.4 mg per mL

INDINAVIR SULFATE OTHER COMPONENTS/Procedure 2: Content of Alcohol USP35–NF30 3489 01-Oct-2012 USP37–NF32 First Supplement to USP36–NF31
Line 6 of Chromatographic system in the subsection Column: Change
G14
to:
G16

Line 6 of Chromatographic system in the subsection Column: Change

G14

to:

G16

METFORMIN HYDROCHLORIDE TABLETS Dissolution <711>/Test 3 USP35–NF30 3830 01-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: Change
900 is the volume
to:
1000 is the volume

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: Change

900 is the volume

to:

1000 is the volume

METRONIDAZOLE Related compounds USP35–NF30 3905 01-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

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

NAFTIFINE HYDROCHLORIDE GEL Content of alcohol USP35–NF30 3983 01-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:

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:

POLYVINYL ALCOHOL Identification test C USP35–NF30 4351 01-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.

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.

POVIDONE IMPURITIES/Limit of Aldehydes USP35–NF30 4379 01-Oct-2012 USP37–NF32 First Supplement to USP36–NF31
Line 15 of Analysis: Change
Result = 10 × (C/W) × {[(AU2AU1) × (AB2AB1)]/[(AS2AS1) − (AB2AB1)]}
to:
Result = 100 × (CS/CU) × {[(AU2AU1) − (AB2AB1)]/[(AS2AS1) − (AB2AB1)]}
AND
Line 17 of Analysis: Change
C = concentration of acetaldehyde in the Standard solution (mg/mL)
W = weight of Povidone taken (g)
to:
CS = concentration of acetaldehyde in the Standard solution (mg/mL)
CU = concentration of Sample solution (mg/mL)

Line 15 of Analysis: Change

Result = 10 × (C/W) × {[(AU2AU1) × (AB2AB1)]/[(AS2AS1) − (AB2AB1)]}

to:

Read More
POVIDONE IMPURITIES/Vinylpyrrolidinone USP35–NF30 4379 01-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

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

PRILOCAINE AND EPINEPHRINE INJECTION Assay for epinephrine USP35–NF30 4411 01-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

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

RIBAVIRIN TABLETS ASSAY/Procedure USP35–NF30 4544 01-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

Line 5 of System suitability in subsection Tailing factor:
Change

NLT 2.0

to:

NMT 2.0

TYROSINE IMPURITIES/Heavy Metals <231> USP35–NF30 4976 01-Oct-2012 USP37–NF32 First Supplement to USP36–NF31
Line 1: Change
Method I
to:
Method II

Line 1: Change
Method I
to:

Method II

VINORELBINE TARTRATE ASSAY/Procedure USP35–NF30 5027 01-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%

Line 1 of Relative standard deviation in System suitability: Change

NLT 2.0%

to:

NMT 2.0%

ZINC CARBONATE IMPURITIES/Iron <241> USP35–NF30 5068 01-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.

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.

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:

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