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 Publication Description
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)

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°

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.

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.

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

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%)

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

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

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

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]}

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:

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.

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

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

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

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
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

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

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%

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.

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.

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