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PDF CSV May 14, 2022 through May 14, 2024 All Errata for USP–NF How to use
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Monograph Title Section Source Publication Sort descending Page Number Errata Official Date Target Errata Print Publication Target Online Fix Publication Description
<621> CHROMATOGRAPHY ADJUSTMENT OF CHROMATOGRAPHIC CONDITIONS USPNF Online Online 1-Dec-2022 NA NA In Liquid Chromatography: Isocratic Elution/Injection volume: Change
L2 = internal diameter of the column used (mm)
dc1 = particle size indicated in the monograph (µm)
dc2 =… Read More
METHYLENE BLUE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USPNF Online Online 1-Sep-2022 NA USPNF 2023 Issue 2 In USP Azure B RS: Change
3-(Dimethylamino)-7-(methylamino)-phenothiazine-5-ium chloride.
to:
3-(Dimethylamino)-7-(methylamino)phenothiazin-5-ium chloride.
ALLANTOIN IDENTIFICATION First Supplement to USP35–NF30 5429 1-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… Read More
<660> Containers—Glass SPECIFIC TESTS/Hydrolytic Resistance/Method First Supplement to USP35–NF30 5150 1-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… Read More
Esomeprazole Magnesium Delayed-Release Capsules ASSAY/Procedure First Supplement to USP35–NF30 5473 1-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.
Esomeprazole Magnesium Delayed-Release Capsules PERFORMANCE TESTS/Dissolution <711> First Supplement to USP35–NF30 5473 1-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.
<698> DELIVERABLE VOLUME ACCEPTANCE CRITERIA/For Multiple-Unit Containers First Supplement to USP35–NF30 5154 1-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
DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS PERFORMANCE TESTS/Dissolution <711>/Test 3 First Supplement to USP35–NF30 5460 1-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… Read More
Esterified Estrogens Tablets ASSAY/Procedure First Supplement to USP35–NF30 5485 1-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… Read More
ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES PERFORMANCE TESTS/Dissolution <711> First Supplement to USP35–NF30 5473 1-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
Itraconazole IMPURITIES/Organic Impurities First Supplement to USP35–NF30 5508 1-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
ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES IMPURITIES/Organic Impurities First Supplement to USP35–NF30 5473 1-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… Read More
Omega-3-Acid Ethyl Esters Capsules SPECIFIC TESTS/Microbial Enumeration <61> First Supplement to USP35–NF30 5524 1-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
OMEGA-3-ACID ETHYL ESTERS CAPSULES SPECIFIC TESTS/Microbial Enumeration Tests <61> and Tests for Specified Microorganisms <62> First Supplement to USP35–NF30 5524 1-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.
TACROLIMUS IMPURITIES/Procedure 2 First Supplement to USP35–NF30 5538 1-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-… Read More
TACROLIMUS CAPSULES IMPURITIES/Procedure 2 First Supplement to USP35–NF30 5541 1-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-… Read More
ISOSORBIDE MONONITRATE EXTENDED-RELEASE TABLETS IMPURITIES/Organic Impurities, Procedure 2 First Supplement to USP36–NF31 5996 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 3: Change the section head
Isosorbide mononitrate related compound A stock solution:
to:
Isosorbide mononitrate related compound A standard stock solution:
AND
Line 7: Change the section head
Isosorbide dinitrate stock solution:
to:
Isosorbide… Read More
LOPINAVIR AND RITONAVIR TABLETS PERFORMANCE TESTS/Dissolution <711> First Supplement to USP36–NF31 6005 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 1 of Tolerances: Change
80.0%
to:
80%
QUININE SULFATE TABLETS ASSAY/Procedure First Supplement to USP36–NF31 6046 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 4 of Analysis: Change
dihydroquinone sulfate
to:
dihydroquinine sulfate
GYMNEMA IDENTIFICATION/B. Thin-Layer Chromatography/Chromatographic system First Supplement to USP36–NF31 5880 1-Aug-2013 USP38–NF33 First Supplement to USP37–NF32 Line 2 of Adsorbent: Change
5m
to:
5 µm
ATROPINE SULFATE INJECTION ASSAY/Procedure First Supplement to USP36–NF31 5950 1-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
POWDERED GYMNEMA IDENTIFICATION/B. Thin-Layer Chromatography/Chromatographic system First Supplement to USP36–NF31 5883 1-Aug-2013 USP38–NF33 First Supplement to USP37–NF32 Line 2 of Adsorbent: Change
5m
to:
5 µm
NORTRIPTYLINE HYDROCHLORIDE IMPURITIES/Organic Impurities First Supplement to USP36–NF31 6027 1-Jun-2013 USP37–NF32 USP37–NF32 Line 3 of Acceptance criteria: Change
Standard solution
to:
Sample solution
PURIFIED GYMNEMA EXTRACT COMPOSITION/Content of Gymnemic Acids First Supplement to USP36–NF31 5884 1-Aug-2013 USP38–NF33 First Supplement to USP37–NF32 Line 1 of Acceptance criteria: Change
90%–110% of the labeled amount
to:
90.0%–110.0% of the labeled amount on the dried basis
GENTAMICIN SULFATE IMPURITIES/Limit of Methanol First Supplement to USP36–NF31 5990 1-Aug-2013 USP38–NF33 First Supplement to USP37–NF32 Line 11 of Analysis: Change
Result = (RU/RS) × (CS/CU) × D × F × 100
to:
Result = (RU/RS) × (CS Read More
MEPROBAMATE TABLETS ASSAY/Procedure First Supplement to USP36–NF31 6015 1-Aug-2013 USP38–NF33 First Supplement to USP37–NF32 Line 4 of Standard solution: Change
Dissolve in 30% of the final flask volume, and dilute with water to volume.
to:
Dissolve in 30% of the final flask volume of acetonitrile, and dilute with water to volume.
CALCIUM SULFATE ASSAY/Procedure First Supplement to USP36–NF31 Online 1-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… Read More
OXCARBAZEPINE IMPURITIES/Organic Impurities, Procedure 1 First Supplement to USP36–NF31 6035 1-Aug-2013 USP38–NF33 First Supplement to USP37–NF32 Row 4 of Column 1 of Table 1: Change
Dibenzazepinoneb
to:
Oxcarbazepine related compound E
AND
Delete footnote b
AND
Reletter the following footnotes in both the table and footnote definitions:
c to b
d to c
e to d
OXCARBAZEPINE IMPURITIES/Organic Impurities, Procedure 2 First Supplement to USP36–NF31 6035 1-Aug-2013 USP38–NF33 First Supplement to USP37–NF32 Row 9 of Column 1 of Table 3: Change
Oxcarbazepine related compound Eg
to:
Oxcarbazepine related compound E
AND
Delete footnote g
CYCLOMETHICONE ASSAY/Procedure/System suitability First Supplement to USP36–NF31 5909 1-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… Read More
ATOMOXETINE HYDROCHLORIDE IMPURITIES/Organic Impurities, Procedure 2 First Supplement to USP36–NF31 5947 1-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,
OXALIPLATIN INJECTION IMPURITIES/Limit of Oxalic Acid First Supplement to USP36–NF31 6033 1-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
ATROPINE SULFATE SPECIFIC TESTS/Optical Rotation, Specific Rotation <781> First Supplement to USP36–NF31 5948 1-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
ISOTRETINOIN CAPSULES PERFORMANCE TESTS/Dissolution <711>/Test 4 First Supplement to USP36–NF31 6000 1-Dec-2013 USP38–NF33 Second Supplement to USP37–NF32 Line 13 of System suitability: Add section heads before "Calculate the percentage....":
Analysis
Samples: Standard solution and Sample solution
BACLOFEN ASSAY/Procedure/Chromatographic system First Supplement to USP36–NF31 5951 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 1 of Column: Change
250-cm
to:
25.0-cm
BUTORPHANOL TARTRATE NASAL SOLUTION IMPURITIES/Organic Impurities First Supplement to USP37–NF32 6596 1-Apr-2015 USP39–NF34 USP39–NF34 Row 3 of Column 1 of Table 1: Change
6-Butorphanol
to:
Δ6-Butorphanol
RIVASTIGMINE TARTRATE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> First Supplement to USP37–NF32 Online 1-Apr-2015 USP39–NF34 USP39–NF34 Line 2 of USP Rivastigmine Related Compound A RS: Change
Di-p-toluoyl-D-(+)-tartaric acid monohydrate.
C20H20O9 404.37
to:
(+)-Di-(p-toluoyl)-D-tartaric acid.
C20H18O8 386.35
EXTENDED PHENYTOIN SODIUM CAPSULES IDENTIFICATION/A. Infrared Absorption—General <197> First Supplement to USP37–NF32 6681 1-Feb-2015 USP39–NF34 Second Supplement to USP38–NF33 Line 1 of Sample: Change
6 mg/mL of phenytoin sodium in water from a suitable number of Capsules prepared as follows. Nominally transfer 300 mg of the powder into 50 mL of water in a separator.
to:
300 mg of phenytoin sodium from the contents of Capsules in 50 mL of water in a… Read More
CHLORPHENIRAMINE MALEATE SPECIFIC TESTS/Optical Rotation, Specific Rotation <781> First Supplement to USP37–NF32 6617 1-Dec-2014 USP39–NF34 Second Supplement to USP38–NF33 Line 1 of Sample: Change
100 mg/mL in water
to:
100 mg/mL in water at 20°
ERYTHROMYCIN DELAYED-RELEASE TABLETS PERFORMANCE TESTS/Dissolution <711>/Test 1/Buffer stage First Supplement to USP37–NF32 6633 1-Dec-2014 USP39–NF34 Second Supplement to USP38–NF33 Line 1 of Standard solution: Change
0.28 mg/mL of USP Erythromycin RS in Medium
to:
Dissolve USP Erythromycin RS in Medium to obtain a concentration similar to that of the Sample solution.
AND
Line 1 of Sample solution: Change
Pass portions of… Read More
<551> VITAMIN E ASSAY ASSAY/Procedure 4/Chromatographic system First Supplement to USP37–NF32 6338 1-Aug-2014 USP39–NF34 First Supplement to USP38–NF33 Line 1 of Flow rate: Change
1.5 mL/min
to:
1 mL/min
TRAZODONE HYDROCHLORIDE IMPURITIES/Limit of Trazodone Related Compound F and Cyclophosphamide Related Compound A/Chromatographic system/MS conditions First Supplement to USP37–NF32 6708 1-Dec-2014 USP39–NF34 Second Supplement to USP38–NF33 Line 4 of Acquisition mode:Change
272
to:
273
ATROPINE SULFATE IMPURITIES First Supplement to USP37–NF32 6591 1-Jun-2014 USP38–NF33 USP38–NF33 Row 6 of Column 1 of Table 2: Change
Hyoscyamine related compound Ae
to:
Hyoscyamine related compound A
AND
Delete footnote e
AND
Reletter the following footnotes in both the table and footnote definitions:
f to e
g to f
ATROPINE SULFATE ASSAY/Procedure/System suitability/Suitability requirements First Supplement to USP37–NF32 6591 1-Aug-2014 USP39–NF34 First Supplement to USP38–NF33 Line 1of Relative standard deviation: Change
NMT 1.0
to:
NMT 1.0%
TRAZODONE HYDROCHLORIDE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> First Supplement to USP37–NF32 6708 1-Dec-2014 USP39–NF34 Second Supplement to USP38–NF33 Line 2 of USP Trazodone Related Compound D RS: Change
(2-{3-[4-(4-Bromophenyl)piperazin-1-yl]propyl}-[1,2,4]triazolo[4,3-α]pyridin-3(2H)-one hydrochloride.
to:
2-{3-[4-(3-Bromophenyl)piperazin-1-yl]propyl}-[1,2,4]triazolo[4,3-α]pyridin-3(2H)-one hydrochloride.
CIPROFLOXACIN EXTENDED-RELEASE TABLETS PERFORMANCE TESTS/Dissolution <711>/Test 2 First Supplement to USP37–NF32 6619 1-Jun-2014 USP38–NF33 USP38–NF33 Line 1 of Standard solution: Change
0.56 mg/mL of USP Ciprofloxacin Hydrochloride RS in Medium
to:
0.62 mg/mL of USP Ciprofloxacin Hydrochloride RS in Medium
AND
Line 8 of Analysis: Change
CS = concentration of ciprofloxacin in the… Read More
CEFADROXIL ASSAY/Procedure First Supplement to USP37–NF32 6602 1-Aug-2014 USP39–NF34 First Supplement to USP38–NF33 Line 3 of Sample solution: Change
USP Cefadroxil RS
to:
Cefadroxil
CEFADROXIL CAPSULES ADDITIONAL REQUIREMENTS/USP Reference Standards <11> First Supplement to USP37–NF32 6604 1-Aug-2014 USP39–NF34 First Supplement to USP38–NF33 Line 2 of USP Cefadroxil Related Compound I RS: Change
(6R,7R)-7-[(R)-2-Amino-2-(4-hydroxyphenyl)acetamido]-3-methyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid monohydrate.
to:
(6R,7R)-7-[(R)-2-Amino-2-(4-hydroxyphenyl)acetamido… Read More
CHLORPHENIRAMINE MALEATE IMPURITIES/Organic Impurities First Supplement to USP37–NF32 6617 1-Oct-2014 USP39–NF34 First Supplement to USP38–NF33 Line 1 of Standard solution: Change
1.1 μg/mL of USP Chlorpheniramine Maleate RS in Diluent,
to:
1.4 μg/mL of USP Chlorpheniramine Maleate RS in Diluent,
PHENYTOIN SODIUM INJECTION OTHER COMPONENTS/Alcohol and Propylene Glycol Content First Supplement to USP37–NF32 6684 1-Jun-2014 USP38–NF33 USP38–NF33 Line 3 of Standard solution: Change
Internal standard stock solution
to:
Internal standard solution