Monograph Title | Section | Source Publication Sort descending | Page Number | Errata Post Date | Errata Official Date | Target Errata Print Publication | Target Online Fix Publication | Description |
---|---|---|---|---|---|---|---|---|
<621> CHROMATOGRAPHY | ADJUSTMENT OF CHROMATOGRAPHIC CONDITIONS | USPNF Online | Online | 26-Aug-2022 | 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 | 26-Aug-2022 | 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 | 31-Jan-2013 | 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 | 30-Nov-2012 | 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 | 30-Nov-2012 | 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 | 30-Nov-2012 | 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 | 28-Sep-2012 | 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 | 28-Sep-2012 | 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 | 30-Nov-2012 | 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 | 28-Sep-2012 | 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 | 30-Nov-2012 | 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 | 28-Sep-2012 | 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 | 30-Nov-2012 | 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 | 28-Sep-2012 | 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 | 28-Sep-2012 | 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 | 28-Sep-2012 | 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 | 27-Sep-2013 | 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 | 27-Sep-2013 | 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 | 27-Sep-2013 | 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 | 26-Jul-2013 | 1-Aug-2013 | USP38–NF33 | First Supplement to USP37–NF32 | Line 2 of Adsorbent: Change 5m to: 5 µm |
POWDERED GYMNEMA | IDENTIFICATION/B. Thin-Layer Chromatography/Chromatographic system | First Supplement to USP36–NF31 | 5883 | 26-Jul-2013 | 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 | 28-Mar-2014 | 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 |
NORTRIPTYLINE HYDROCHLORIDE | IMPURITIES/Organic Impurities | First Supplement to USP36–NF31 | 6027 | 31-May-2013 | 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 | 26-Jul-2013 | 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 | 26-Jul-2013 | 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 | 26-Jul-2013 | 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 | 28-Mar-2014 | 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 | 26-Jul-2013 | 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 | 26-Jul-2013 | 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 | 31-Jan-2014 | 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 | 31-Jan-2014 | 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 | 31-Jan-2014 | 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 | 22-Nov-2013 | 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 | 22-Nov-2013 | 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 | 27-Sep-2013 | 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 | 27-Mar-2015 | 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 | 27-Mar-2015 | 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 | 30-Jan-2015 | 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 | 21-Nov-2014 | 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 | 21-Nov-2014 | 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 | 25-Jul-2014 | 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 | 21-Nov-2014 | 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 | 30-May-2014 | 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 | 25-Jul-2014 | 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 | 21-Nov-2014 | 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 | 30-May-2014 | 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 | 25-Jul-2014 | 1-Aug-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Line 3 of Sample solution: Change USP Cefadroxil RS to: Cefadroxil |
PHENYTOIN SODIUM INJECTION | OTHER COMPONENTS/Alcohol and Propylene Glycol Content | First Supplement to USP37–NF32 | 6684 | 30-May-2014 | 1-Jun-2014 | USP38–NF33 | USP38–NF33 | Line 3 of Standard solution: Change Internal standard stock solution to: Internal standard solution |
CEFADROXIL CAPSULES | ADDITIONAL REQUIREMENTS/USP Reference Standards <11> | First Supplement to USP37–NF32 | 6604 | 25-Jul-2014 | 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 | 26-Sep-2014 | 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, |