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
<795> PHARMACEUTICAL COMPOUNDING— NONSTERILE PREPARATIONS STABILITY CRITERIA AND BEYOND-USE DATING/General Guidelines for Assigning Beyond-Use Dates Revision Bulletin (Official January 01, 2014) ONLINE 01-Apr-2014 Second Supplement to USP37–NF32 Second Supplement to USP37–NF32
Line 7 of Paragraph 1: Change
(see the General Notices and Requirements, Preservation, Packaging, Storage, and Labeling)
to:
(see <659>)

Line 7 of Paragraph 1: Change
(see the General Notices and Requirements, Preservation, Packaging, Storage, and Labeling)
to:

(see <659>)

<795> PHARMACEUTICAL COMPOUNDING—NONSTERILE PREPARATIONS COMPOUNDING FACILITIES Revision Bulletin (Official January 01, 2014) ONLINE 01-Apr-2014 Second Supplement to USP37–NF32 Second Supplement to USP37–NF32
Line 4 of Paragraph 4: Change
(see the General Notices and Requirements, Preservation, Packaging, Storage, and Labeling, Storage Temperature and Humidity;
to:
(see Packaging and Storage Requirements <659>;

Line 4 of Paragraph 4: Change
(see the General Notices and Requirements, Preservation, Packaging, Storage, and Labeling, Storage Temperature and Humidity;
to:
(see Packaging and Storage Requirements <659>;

<81> ANTIBIOTICS—MICROBIAL ASSAYS Turbidimetric Method USP36–NF31 76 01-Apr-2014 USP38–NF33 USP38–NF33
Line 9 of Paragraph 2 of Analysis: Change
or a water bath maintained at the temperature specified in Table 8 and for the time specified in Table 11.
to:
or a water bath maintained at 36.0° –37.5° for the time specified in Table 11.

Line 9 of Paragraph 2 of Analysis: Change
or a water bath maintained at the temperature specified in Table 8 and for the time specified in Table 11.
to:
or a water bath maintained at 36.0°
–37.5° for the time specified in Table 11.

ATROPINE SULFATE INJECTION ASSAY/Procedure First Supplement to USP36–NF31 5950 01-Apr-2014 USP38–NF33 USP38–NF33
Line 1 of Buffer: Change
Dissolve 4.1 g of sodium acetate and
to:
Dissolve 4.1 g of anhydrous sodium acetate and

Line 1 of Buffer: Change
Dissolve 4.1 g of sodium acetate and
to:
Dissolve 4.1 g of anhydrous sodium acetate and

BUTYLPARABEN IMPURITIES/Related Substances/Chromatographic system Second Supplement to USP36–NF31 6551 01-Apr-2014 USP38–NF33 USP38–NF33
After the Column section: Add
Column temperature: 35°

After the Column section: Add
Column temperature: 35°

CALCIUM SULFATE ASSAY/Procedure First Supplement to USP36–NF31 ONLINE 01-Apr-2014 USP38–NF33 USP38–NF33
Line 14 of Analysis: Change
Result = [(V × N × F)/W] × 100
to:
Result = [(V × M × F)/W] × 100
AND
Line 15 of Analysis: Change
V = volume of titrant consumed by the Sample (mL)
N = actual normality of the titrant (mEq/mL)
F = equivalency factor, 136.14 mg/mEq
to:
V = volume of Titrant consumed by the Sample (mL)
M = actual molarity of the Titrant (mM/mL)
F = equivalency factor, 136.14 mg/mM

Line 14 of Analysis: Change
Result = [(V ×
N × F)/W] × 100

to:
Result = [(V ×
M × F)/W] × 100

AND
Line 15 of Analysis: Change
V = volume of titrant consumed by the Sample (mL)
N = actual normality of the titrant (mEq/mL)
F = equivalency factor, 136.14 mg/mEq
to:
V = volume of Titrant consumed by the Sample (mL)
M = actual molarity of the Titrant (mM/mL)
F = equivalency factor, 136.14
mg/mM

CARBIDOPA AND LEVODOPA ORALLY DISINTEGRATING TABLETS ASSAY Second Supplement to USP36–NF31 6580 01-Apr-2014 USP38–NF33 USP38–NF33
Line 2 of Procedure: Change
Inject the Sample solution within 2 h of preparation. Protect the volumetric solutions from light.
to:
Protect the volumetric solutions from light.

Line 2 of Procedure: Change
Inject the Sample solution within 2 h of preparation. Protect the volumetric solutions from light.
to:
Protect the volumetric solutions from light.

CLINDAMYCIN PALMITATE HYDROCHLORIDE ASSAY/Procedure USP36–NF31 3031 01-Apr-2014 USP38–NF33 USP38–NF33
Line 1 of Acceptance criteria: Change
NLT 540 μg
to:
NLT 540 μg/mg

Line 1 of Acceptance criteria: Change
NLT 540 μg
to:
NLT 540 μg/mg

MAGNESIUM ALUMINUM SILICATE IMPURITIES/Arsenic, Method I <211> USP36–NF31 2073 01-Apr-2014 USP38–NF33 USP38–NF33
Line 1 of Standard preparation: Change
Prepare as directed in the chapter.
to:
Transfer 5.0 mL (5 μg of arsenic) of the Standard Arsenic Solution to a 25-mL volumetric flask, and add dilute hydrochloric acid (1:25) to volume.
AND
Delete:
Control preparation: Transfer 5.0 mL (5 μg of As) of the Standard preparation to a 25-mL volumetric flask, and add dilute hydrochloric acid (1:25) to volume.
AND
Line 1 of Acceptance criteria: Change
the absorbance due to any red color from the Test preparation does not exceed that produced by the Control preparation.
to:
the absorbance due to any red color from the Test preparation does not exceed that produced by the Standard preparation.

Line 1 of Standard preparation: Change
Prepare as directed in the chapter.

to:
Transfer 5.0 mL (5 μg of arsenic) of the Standard Arsenic Solution to a 25-mL volumetric flask, and add dilute hydrochloric acid (1:25) to volume.

AND
Delete:
Control preparation: Transfer 5.0 mL (5 μg of As) of the Standard preparation to a 25-mL volumetric flask, and add dilute hydrochloric acid (1:25) to volume.

AND
Line 1 of Acceptance criteria: Change

Read more
MELPHALAN TABLETS Dissolution <711> USP36–NF31 4232 01-Apr-2014 USP38–NF33 USP38–NF33
Line 1 of Mobile phase: Change
Prepare a filtered and degassed mixture of water, acetonitrile, ammonium acetate, glacial acetic acid, and triethylamine (1500:500:2:2:0.4). Make adjustments if necessary (see System Suitability under Chromatography <621>).
to:
Transfer 2 grams of ammonium acetate, 2 mL of glacial acetic acid, and 0.4 mL of triethylamine to a suitable flask containing 1500 mL of water and 500 mL of acetonitrile. Stir until all solids are dissolved and well mixed, then filter and degas.

Line 1 of Mobile phase: Change
Prepare a filtered and degassed mixture of water, acetonitrile, ammonium acetate, glacial acetic acid, and triethylamine (1500:500:2:2:0.4). Make adjustments if necessary (see System Suitability under Chromatography <621>).

to:
Transfer 2 grams of ammonium acetate, 2 mL of glacial acetic acid, and 0.4 mL of triethylamine to a suitable flask containing 1500 mL of water and 500 mL of acetonitrile. Stir until all solids are dissolved and well mixed, then filter and degas.

ONDANSETRON INJECTION Assay Second Supplement to USP36–NF31 ONLINE 01-Apr-2014 USP38–NF33 USP38–NF33
Line 7 of Procedure: Change
(293.36 / 329.82)(25C / V)(rU / rS)
to:
(293.36 / 329.83)(25C / V)(rU / rS)
AND
Line 8 of Procedure: Change
329.82
to:
329.83

Line 7 of Procedure: Change
(293.36 / 329.82)(25C / V)(rU / rS)
to:
(293.36 / 329.83)(25C / V)(rU / rS)
AND
Line 8 of Procedure: Change
329.82
to:
329.83

ONDANSETRON ORAL SOLUTION Assay USP36–NF31 4586 01-Apr-2014 USP38–NF33 USP38–NF33
Line 7 of Procedure: Change
(293.36/329.82)100(C/V)(rU / rS)
to:
(293.36 / 329.83)100(C / V)(rU / rS)
AND
Line 8 of Procedure: Change
329.82
to:
329.83

Line 7 of Procedure: Change
(293.36/329.82)100(C/V)(rU / rS)
to:
(293.36
/
329.83)100(C
/
V)(rU / rS)

AND
Line 8 of Procedure: Change
329.82
to:
329.83

ONDANSETRON ORAL SOLUTION Related compounds USP36–NF31 4586 01-Apr-2014 USP38–NF33 USP38–NF33
Line 7 of Procedure: Change
(293.36/329.82)10,000(1 / F)(1 / V)(CS / CA)(ri / rS)
to:
(293.36 / 329.83)10,000(1 / F)(1 / V)(CS / CA)(ri / rS)
AND
Line 8 of Procedure: Change
329.82
to:
329.83

Line 7 of Procedure: Change
(293.36/329.82)10,000(1 / F)(1 / V)(CS / CA)(ri / rS)
to:
(293.36
/
329.83)10,000(1 / F)(1 / V)(CS / CA)(ri / rS)

AND
Line 8 of Procedure: Change
329.82
to:
329.83

SODIUM ACETATE IMPURITIES/Inorganic Impurities/Potassium USP36–NF31 5147 01-Apr-2014 USP38–NF33 USP38–NF33
Line 1 of Sample solution: Change
Equivalent to 600 mg/mL of anhydrous sodium acetate
to:
Dissolve the equivalent of 3 g of anhydrous sodium acetate in 5 mL of water.
AND
Line 1 of Analysis: Change
To 5 mL of Sample solution add
to:
To the Sample solution add

Line 1 of Sample solution: Change
Equivalent to 600 mg/mL of anhydrous sodium acetate

to:
Dissolve the equivalent of 3 g of anhydrous sodium acetate in 5 mL of water.
AND
Line 1 of Analysis: Change
To 5 mL of Sample solution add
to:
To the Sample solution add

Sodium Sulfite, Anhydrous REAGENTS/Reagent Specifications USP36–NF31 1196 01-Apr-2014 USP38–NF33 USP38–NF33
Line 2: Change
[7753-83-7]
to:
[7757-83-7]

Line 2: Change
[7753-83-7]
to:
[7757-83-7]

THALIDOMIDE CAPSULES Dissolution <711> USP36–NF31 5347 01-Apr-2014 USP38–NF33 USP38–NF33
After the Test solution section: Add
to:
Chromatographic system—Prepare as directed in the Assay under Thalidomide.

After the Test solution section: Add
to:
Chromatographic system—Prepare as directed in the Assay under Thalidomide.

THIMEROSAL IMPURITIES/Mercury Ions USP36–NF31 5368 01-Apr-2014 USP38–NF33 USP38–NF33
Line 19 of Analysis:
CS = concentration of mercuric chloride in the Standard solution (mg/mL)
to:
CS = concentration of mercuric chloride in Sample solution B (mg/mL)

Line 19 of Analysis:
CS = concentration of mercuric chloride in the Standard solution (mg/mL)
to:
CS = concentration of mercuric chloride in Sample solution B (mg/mL)

<1660> CONTAINERS GLASS-EVALUATION OF INNER SURFACE DURABILITY EVALUATION OF THE INNER SURFACE DURABILITY/Aggressive Screening Conditions Second Supplement to USP36–NF31 6221 01-Feb-2014 USP38–NF33 Second Supplement to USP37–NF32
Row 1 of Column 3 of Table 4: Change
3% Citric Acid pH 8.0
to:
3% Sodium Citrate pH 8.0

Row 1 of Column 3 of Table 4: Change
3% Citric Acid pH 8.0
to:
3% Sodium Citrate pH 8.0

ANAGRELIDE HYDROCHLORIDE ASSAY/Procedure/Chromatographic system/System suitability USP36–NF31 2500 01-Feb-2014 USP38–NF33 Second Supplement to USP37–NF32
Line 2 of Suitability requirements: Change
Column efficiency: NMT
to:
Column efficiency: NLT

Line 2 of Suitability requirements: Change
Column efficiency: NMT
to:
Column efficiency: NLT

ATOMOXETINE HYDROCHLORIDE IMPURITIES/Organic Impurities, Procedure 2 First Supplement to USP36–NF31 5947 01-Feb-2014 USP38–NF33 Second Supplement to USP37–NF32
Line 5 of System suitability solution: Change
dissolving the Reference Standards in ethanol,
to:
dissolving the Reference Standards in absolute alcohol,
AND
Line 2 of Sample solution: Change
dissolving it in ethanol,
to:
dissolving it in absolute alcohol,

Line 5 of System suitability solution: Change
dissolving the Reference Standards in ethanol,
to:
dissolving the Reference Standards in absolute alcohol,

AND
Line 2 of Sample solution: Change
dissolving it in ethanol,
to:
dissolving it in absolute alcohol,

CANDESARTAN CILEXETIL ASSAY/Procedure USP36–NF31 2774 01-Feb-2014 USP38–NF33 Second Supplement to USP37–NF32
Line 1 of Analysis: Change
Titrate with 8 mL of 0.1 N
to:
Titrate with 0.1 N

Line 1 of Analysis: Change
Titrate with 8 mL of 0.1 N
to:
Titrate with 0.1 N

CEFTAZIDIME FOR INJECTION Assay USP36–NF31 2887 01-Feb-2014 USP38–NF33 Second Supplement to USP37–NF32
Line 6 of Procedure: Change
250,000[C/W (100 − ms)](rU / rS)
to:
25,000{C/[W (100 − ms)]}(rU / rS)

Line 6 of Procedure:
Change
250,000[C/W (100 −

m

s)](rU / rS)

to:
25,000{C/[W (100 − m
s)]}(rU / rS)

CLARITHROMYCIN ASSAY/Procedure/System suitability USP36–NF31 3016 01-Feb-2014 USP38–NF33 Second Supplement to USP37–NF32
Line 1 of Samples: Change
Standard solution 2 and Standard solution 4
to:
Standard solution 1, Standard solution 2, and Standard solution 4
AND
Line 13 of Suitability requirements: Change
Relative standard deviation: NMT 1.5%, Standard solution 2
to:
Relative standard deviation: NMT 1.5%, Standard solution 1

Line 1 of Samples:
Change
Standard solution 2 and Standard solution 4
to:
Standard solution 1, Standard solution 2, and Standard solution 4
AND

Line 13 of Suitability requirements: Change
Relative standard deviation: NMT 1.5%, Standard solution 2
to:
Relative standard deviation: NMT 1.5%, Standard solution 1

CYCLOMETHICONE ASSAY/Procedure/System suitability First Supplement to USP36–NF31 5909 01-Feb-2014 USP38–NF33 Second Supplement to USP37–NF32
Line 2 of Suitability requirements: Change
Relative standard deviation: NMT 2.0% for cyclomethicone 4, cyclomethicone 5, and cyclomethicone 6, Standard solution A, Standard solution B, and Standard solution C
to:
Relative standard deviation: NMT 2.0% for cyclomethicone 4, Standard solution A; NMT 2.0% for cyclomethicone 5, Standard solution B; NMT 2.0% for cyclomethicone 6, Standard solution C

Line 2 of Suitability requirements: Change
Relative standard deviation: NMT 2.0% for cyclomethicone 4, cyclomethicone 5, and cyclomethicone 6, Standard solution A, Standard solution B, and Standard solution C
to:
Relative standard deviation: NMT 2.0% for cyclomethicone 4, Standard solution A; NMT 2.0% for cyclomethicone 5, Standard solution B; NMT 2.0% for cyclomethicone 6, Standard solution C

DICLOFENAC SODIUM DELAYED-RELEASE TABLETS IMPURITIES/Organic Impurities/Procedure USP36–NF31 3221 01-Feb-2014 USP38–NF33 Second Supplement to USP37–NF32
Line 22 of Analysis: Change
rS = peak response for each impurity from the Standard solution
to:
rS = peak response of diclofenac related compound A from the Standard solution

Line 22 of Analysis: Change
rS = peak response for each impurity from the Standard solution
to:
rS = peak response of diclofenac related compound A from the Standard solution

DILTIAZEM HYDROCHLORIDE IMPURITIES/Organic Impurities USP36–NF31 3258 01-Feb-2014 USP38–NF33 Second Supplement to USP37–NF32
Line 21 of Analysis: Change
rS = response of each impurity peak from the Standard solution
to:
rS = peak response of desacetyl diltiazem from the Standard solution

Line 21 of Analysis: Change
rS = response of each impurity peak from the Standard solution
to:
rS = peak response of desacetyl diltiazem from the Standard solution

FENTANYL IMPURITIES/Organic Impurities/Acceptance criteria USP36–NF31 3554 01-Feb-2014 USP38–NF33 Second Supplement to USP37–NF32
Footnote f of Table 2: Change
N-Phenyl-N-[1-(2-phenylethyl)-4-piperidinyl]acetanilide hydrochloride, or acetyl fentanyl.
to:
N-(1-Phenethylpiperidin-4-yl)-N-phenylacetamide.

Footnote f of Table 2: Change
N-Phenyl-N-[1-(2-phenylethyl)-4-piperidinyl]acetanilide hydrochloride, or acetyl fentanyl.
to:
N-(1-Phenethylpiperidin-4-yl)-N-phenylacetamide.

GLYCERYL TRISTEARATE IDENTIFICATION/Fatty Acid Composition USP36–NF31 2033 01-Feb-2014 USP38–NF33 Second Supplement to USP37–NF32
Line 19 of Analysis: Change
Result = [(FMC × PFA1 × AMC)/(PMC × AFA1)] × 100
to:
Result = (FMC × PFA1 × AMC)/(PMC × AFA1)

Line 19 of Analysis: Change
Result = [(FMC × PFA1 × AMC)/(PMC × AFA1)] × 100
to:
Result = (FMC × PFA1 × AMC)/(PMC × AFA1)

ISOPROPYL ALCOHOL ASSAY/Procedure Second Supplement to USP36–NF31 6638 01-Feb-2014 USP38–NF33 Second Supplement to USP37–NF32
Line 17 of Chromatographic system: Change
Linear velocity: 35 cm/s
to:
Flow rate: 2.3 mL/min
AND
Row 2 of Column 1 of Table 2: Change
Diethyl ether
to:
Ethyl ether

Line 17 of Chromatographic system: Change
Linear velocity: 35 cm/s
to:
Flow rate: 2.3 mL/min
AND
Row 2 of Column 1 of Table 2: Change
Diethyl ether
to:
Ethyl ether

OIL- AND WATER-SOLUBLE VITAMINS WITH MINERALS CAPSULES STRENGTH/Molybdenum, Method 1 Second Supplement to USP36–NF31 6372 01-Feb-2014 USP38–NF33 Second Supplement to USP37–NF32
Line 2 of Standard solutions: Change
2.0
to:
5.0

Line 2 of Standard solutions: Change
2.0
to:
5.0

OIL- AND WATER-SOLUBLE VITAMINS WITH MINERALS ORAL SOLUTION CONTAMINANTS Second Supplement to USP36–NF31 6399 01-Feb-2014 USP38–NF33 Second Supplement to USP37–NF32
Add the test:
Absence of Specified Microorganisms <2022>: Meet the requirements of the tests for the absence of Salmonella species, Escherichia coli, and Staphylococcus aureus

Add the test:
Absence of Specified Microorganisms <2022>: Meet the requirements of the tests for the absence of Salmonella species, Escherichia coli, and Staphylococcus aureus

OIL- AND WATER-SOLUBLE VITAMINS WITH MINERALS ORAL SOLUTION STRENGTH/Chromium Second Supplement to USP36–NF31 6399 01-Feb-2014 USP38–NF33 Second Supplement to USP37–NF32
Line 13 of Analysis: Change
C = concentration of chromium in the Standard solution (µg/mL)
to:
C = concentration of chromium in the Sample solution (µg/mL)

Line 13 of Analysis: Change
C = concentration of chromium in the Standard solution (µg/mL)
to:
C = concentration of chromium in the Sample solution (µg/mL)

OXALIPLATIN INJECTION IMPURITIES/Limit of Oxalic Acid First Supplement to USP36–NF31 6033 01-Feb-2014 USP38–NF33 Second Supplement to USP37–NF32
Line 3 of Analysis: Change
Calculate the percentage of each impurity
to:
Calculate the percentage of oxalic acid

Line 3 of Analysis: Change
Calculate the percentage of each impurity

to:
Calculate the percentage of oxalic acid

RIBOFLAVIN 5′-PHOSPHATE SODIUM IMPURITIES/Free Riboflavin and Riboflavin Diphosphates USP36–NF31 5037 01-Feb-2014 USP38–NF33 Second Supplement to USP37–NF32
Line 1 of Emission wavelength: Change
530 nm
to:
530 nm (monochromator-based detector) or 470 nm (filtered-type detector)

Line 1 of Emission wavelength: Change
530 nm
to:
530 nm (monochromator-based detector) or 470 nm (filtered-type detector)

RISPERIDONE TABLETS Dissolution <711> USP36–NF31 5065 01-Feb-2014 USP38–NF33 Second Supplement to USP37–NF32
Line 4 of Chromatographic system: Change
Chromatograph the Standard solution and the Test solution as directed for Procedure:
to:
Chromatograph the Standard solution as directed for Procedure:

Line 4 of Chromatographic system:
Change
Chromatograph the Standard solution and the Test solution as directed for Procedure:
to:
Chromatograph the Standard solution as directed for Procedure:

TIZANIDINE TABLETS IMPURITIES/Organic Impurities/Procedure USP36–NF31 5408 01-Feb-2014 USP38–NF33 Second Supplement to USP37–NF32
Line 9 of Sample solution: Change
45-µm or finer pore size
to:
0.45-µm or finer pore size

Line 9 of Sample solution: Change
45-µm or finer pore size
to:
0.45-µm or finer pore size

VANCOMYCIN HYDROCHLORIDE SPECIFIC TESTS/Composition of Vancomycin USP36–NF31 5543 01-Feb-2014 USP38–NF33 Second Supplement to USP37–NF32
Line 28 of Analysis: Change
Result = [(rI/(D × rB) + rA)] × 100
to:
Result = {rI/[(D × rB) + rA]} × 100

Line 28 of Analysis: Change
Result = [(rI/(D × rB) + rA)] × 100

to:
Result = {rI/[(D × rB) + rA]} × 100

VANCOMYCIN HYDROCHLORIDE FOR INJECTION SPECIFIC TESTS/Content of Vancomycin USP36–NF31 5546 01-Feb-2014 USP38–NF33 Second Supplement to USP37–NF32
Line 27 of Analysis: Change
Result = [rI/(D × rB) + rA] × 100
to:
Result = {rI/[(D × rB) + rA]} × 100

Line 27 of Analysis: Change
Result = [rI/(D × rB) + rA] × 100

to:
Result = {rI/[(D × rB) + rA]} × 100

WATER-SOLUBLE VITAMINS WITH MINERALS CAPSULES STRENGTH/Molybdenum, Method 1 Second Supplement to USP36–NF31 6479 01-Feb-2014 USP38–NF33 Second Supplement to USP37–NF32
Line 2 of Standard solutions: Change
2.0
to:
5.0

Line 2 of Standard solutions: Change
2.0
to:
5.0

ALMOND OIL SPECIFIC TESTS/Sterol Composition USP36–NF31 1877 01-Dec-2013 USP38–NF33 Second Supplement to USP37–NF32
Row 9 of Table 2: Change
Δ7-Stigmastenol ≥3.0%
to:
Δ7-Stigmastenol ≤3.0%

Row 9 of Table 2: Change
Δ7-Stigmastenol ≥3.0%
to:
Δ7-Stigmastenol
≤3.0%

APROTININ Limit of des-Ala-aprotinin and des-Ala-des-Gly-aprotinin USP36–NF31 2522 01-Dec-2013 USP38–NF33 Second Supplement to USP37–NF32
Change the subsection head
Capillary zone electrophoresis system (see Capillary Electrophoresis under Biotechnology-Derived ArticlesTest <1047>)—
to:
Capillary zone electrophoresis system

Change the subsection head
Capillary zone electrophoresis system (see Capillary Electrophoresis under Biotechnology-Derived ArticlesTest <1047>)—
to:
Capillary zone electrophoresis system

ATROPINE SULFATE SPECIFIC TESTS/Optical Rotation, Specific Rotation <781> First Supplement to USP36–NF31 5948 01-Dec-2013 USP38–NF33 Second Supplement to USP37–NF32
Line 1 of Sample solution: Change
0.1 mg/mL in water
to:
0.1 g/mL of Atropine Sulfate in water

Line 1 of Sample solution: Change
0.1 mg/mL in water
to:
0.1 g/mL of Atropine Sulfate in water

BOSWELLIA SERRATA COMPOSITION/Content of Keto-Derivatives of β-Boswellic Acids/System suitability/Suitability requirements USP36–NF31 1366 01-Dec-2013 USP38–NF33 Second Supplement to USP37–NF32
Line 1 of Tailing factor: Change
11-keto-β-boswellic acid peak
to:
3-acetyl-11-keto-β-boswellic acid peak

Line 1 of Tailing factor: Change
11-keto-β-boswellic acid peak

to:
3-acetyl-11-keto-β-boswellic acid peak

BOSWELLIA SERRATA EXTRACT COMPOSITION/Content of Keto-Derivatives of β-Boswellic Acids/System suitability/Suitability requirements USP36–NF31 1367 01-Dec-2013 USP38–NF33 Second Supplement to USP37–NF32
Line 1 of Tailing factor: Change
11-keto-β-boswellic acid peak
to:
3-acetyl-11-keto-β-boswellic acid peak

Line 1 of Tailing factor: Change
11-keto-β-boswellic acid peak
to:
3-acetyl-11-keto-β-boswellic acid peak

BUFFER SOLUTIONS 4. Standard Buffer Solutions/4.1 Preparation Second Supplement to USP36–NF31 6244 01-Dec-2013 USP38–NF33 Second Supplement to USP37–NF32
Line 1 of 4. Boric Acid and Potassium Chloride 0.2 M: Change
12.73 g/L of boric acid
to:
12.37 g/L of boric acid

Line 1 of 4. Boric Acid and Potassium Chloride 0.2 M: Change
12.73 g/L of boric acid
to:
12.37 g/L of boric acid

CAPSICUM OLEORESIN SPECIFIC TESTS/Limit of Nonivamide Second Supplement to USP36–NF31 6577 01-Dec-2013 USP38–NF33 Second Supplement to USP37–NF32
Line 1 of Acceptance criteria: Change
on the dried basis
to:
on the anhydrous basis

Line 1 of Acceptance criteria: Change
on the dried basis
to:
on the anhydrous basis

CARVEDILOL IMPURITIES/Organic Impurities, Procedure 3: Carvedilol Related Compound F USP36–NF31 2822 01-Dec-2013 USP38–NF33 Second Supplement to USP37–NF32
Line 2 of Sample solution: Change
Use about 1.9 mL of Diluent per mg of the Carvedilol, and sonicate briefly to facilitate dissolution.
to:
Initially add Diluent to fill about 80% of the total volume. Sonicate briefly to facilitate dissolution. Cool, and dilute with Diluent to volume.

Line 2 of Sample solution:
Change
Use about 1.9 mL of Diluent per mg of the Carvedilol, and sonicate briefly to facilitate dissolution.
to:
Initially add Diluent to fill about 80% of the total volume. Sonicate briefly to facilitate dissolution. Cool, and dilute with Diluent to volume.

CHINESE SALVIA COMPOSITION/Content of Salvianolic Acid B Second Supplement to USP36–NF31 6331 01-Dec-2013 USP38–NF33 Second Supplement to USP37–NF32
Line 16 of Analysis: Change
W = weight of Chinese Salvia used to prepare the Sample solution (mg)
to:
W = weight of Chinese Salvia used to prepare the Sample stock solution (mg)

Line 16 of Analysis: Change
W = weight of Chinese Salvia used to prepare the Sample solution (mg)
to:
W = weight of Chinese Salvia used to prepare the Sample stock solution (mg)

CYCLOBENZAPRINE HYDROCHLORIDE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Second Supplement to USP36–NF31 6585 01-Dec-2013 USP38–NF33 Second Supplement to USP37–NF32
Line 2 of USP Cyclobenzaprine Related Compound A RS: Change
5-[3-(Dimethylamino)propyl]-10,11-dihydro-5H-dibenzo[a,d]-cyclohepten-5-ol.
to:
5-[3-(Dimethylamino)propyl]-5H-dibenzo[a,d]-cyclohepten-5-ol.

Line 2 of USP Cyclobenzaprine Related Compound A RS: Change
5-[3-(Dimethylamino)propyl]-10,11-dihydro-5H-dibenzo[a,d]-cyclohepten-5-ol.

to:
5-[3-(Dimethylamino)propyl]-5H-dibenzo[a,d]-cyclohepten-5-ol.

DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS PERFORMANCE TESTS/Dissolution <711>/Test 5 Second Supplement to USP36–NF31 6592 01-Dec-2013 USP38–NF33 Second Supplement to USP37–NF32
Line 3 of Acid stage sample solution: Change
suitable filter of 45-µm pore size.
to:
suitable filter of 0.45-µm pore size.
AND
Line 3 of Buffer stage sample solution: Change
suitable filter of 45-µm pore size.
to:
suitable filter of 0.45-µm pore size.

Line 3
of Acid stage sample solution: Change
suitable filter of 45-µm pore size.
to:
suitable filter of 0.45-µm pore size.
AND
Line 3
of Buffer stage sample solution: Change
suitable filter of 45-µm pore size.
to:
suitable filter of 0.45-µm pore size.

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