Monograph Title | Section | Source Publication | Page Number | Errata Post Date Sort ascending | Errata Official Date | Target Errata Print Publication | Target Online Fix Publication | Description |
---|---|---|---|---|---|---|---|---|
MORPHINE SULFATE EXTENDED-RELEASE CAPSULES | IMPURITIES/Organic Impurities | Revision Bulletin (Official November 01, 2018) | Online | 26-Apr-2019 | 1-May-2019 | NA | NA | In Row 4 of Column 1 of Table 5: Change Morphine related compound Bb to: Morphine related compound B (anhydrous)b |
HYPROMELLOSE PHTHALATE | IMPURITIES/Chloride and Sulfate <221>, Chloride | Harmonization (Official May 01, 2019) | Online | 26-Apr-2019 | 1-May-2019 | NA | NA | In Analysis: Change ▲Add 1 mL of silver nitrate TS to the Standard solution and then add a 50-mL portion of the Sample solution. Mix and allow to stand for 5 min protected from direct sunlight. Compare the turbidity of the… Read More |
ISOPHANE INSULIN HUMAN SUSPENSION | ASSAY/Procedure | Interim Revision Announcement (Official January 01, 2019) | Online | 29-Mar-2019 | 1-Apr-2019 | NA | NA | In Standard solution: Change USP Insulin Beef RS to: USP Insulin Human RS |
SCOPOLAMINE HYDROBROMIDE | IDENTIFICATION/B. | First Supplement to USP41–NF36 | 8420 | 29-Mar-2019 | 1-Apr-2019 | NA | NA | In Sample solution: Change 50 mg/mL of alcohol to: 50 mg/mL in water |
PREDNISOLONE SODIUM PHOSPHATE | Related compounds | USP41–NF36 | 3416 | 29-Mar-2019 | 1-Apr-2019 | NA | NA | In Table 1: Add Prednisolone sodium phosphate 1.00 — — |
MERCAPTOPURINE | IMPURITIES/Organic Impurities | USP41–NF36 | 2587 | 29-Mar-2019 | 1-Apr-2019 | NA | NA | Change Sample solution: 0.12 mg/mL of Mercaptopurine in Solution A. [NOTE—Inject the Sample solution within 1 h of preparation.] to: Sample stock solution: 0.5 mg/mL of mercaptopurine in a mixture of methanol and … Read More |
BUMETANIDE TABLETS | ASSAY/Procedure | Second Supplement to USP41–NF36 | Online | 29-Mar-2019 | 1-Apr-2019 | NA | NA | In Sample solution: Change Nominally 0.05 mg/mL of bumetanide prepared as follows. to: Nominally 125 µg/mL of bumetanide prepared as follows. |
RUTIN | CHEMICAL INFORMATION | USP41–NF36 | 4841 | 29-Mar-2019 | 1-Apr-2019 | NA | NA | Change 3-Rhamnoglucoside of 5,7,3',4'-tetrahydroxyflavonol; 2-(3,4-Dihydroxyphenyl)-5,7-dihydroxy-4H-chromen-4-one-3-yl 6-O-α-L-rhamnopyranosyl-β-D-glucoside [250249-75-3]. to: 3-Rhamnoglucoside of 5,7,3',4'-tetrahydroxyflavonol… Read More |
METAXALONE | IDENTIFICATION/B. | USP41–NF36 | 2611 | 29-Mar-2019 | 1-Apr-2019 | NA | NA | Change The retention time of the major peak of the Sample solution corresponds to that of the Sample solution, as obtained in the Assay. to: The retention time of the major peak of the Sample solution corresponds to that of… Read More |
MESNA TABLETS | ADDITIONAL REQUIREMENTS/USP Reference Standards <11> | Second Supplement to USP41–NF36 | 8906 | 22-Feb-2019 | 1-Mar-2019 | NA | NA | In USP Mesna Related Compound A RS: Change 2-(Acetylthio)ethane-1-sulfonic acid. C4H8O4S2 184.22 to: 2-(Acetylthio)ethane-1-sulfonic acid, potassium salt, crystal adduct with potassium chloride. C4… Read More |
DEXMEDETOMIDINE HYDROCHLORIDE | CHEMICAL INFORMATION | USP41–NF36 | Online | 22-Feb-2019 | 1-Mar-2019 | NA | NA | This erratum applies to the USP-NF ONLINE platform only. See https://www.uspnf.com/sites/default/files/usp_pdf/EN/february_2019_errata_image1.pdf for correction |
REAGENTS | Solutions/Volumetric Solutions/0.01 N Sodium Hydroxide VS | USP41–NF36 | 5770 | 22-Feb-2019 | 1-Mar-2019 | NA | NA | See https://www.uspnf.com/sites/default/files/usp_pdf/EN/february_2019_errata_image1.pdf for correction |
FLUDROCORTISONE ACETATE TABLETS | IMPURITIES/Organic Impurities/Table 1 | Second Supplement to USP41–NF36 | 8843 | 22-Feb-2019 | 1-Mar-2019 | NA | NA | In footnote a: Change 9-Fluoro-11β,17,21-trihydroxypregn-4-ene-3,20-dione 21-acetate. to: 9-Fluoro-11β,17,21-trihydroxypregn-4-ene-3,20-dione. |
<1010> ANALYTICAL DATA—INTERPRETATION AND TREATMENT | MEASUREMENT PRINCIPLES AND VARIATION | USP42–NF37 | 7129 | 22-Feb-2019 | 1-Mar-2019 | NA | NA | See https://www.uspnf.com/sites/default/files/usp_pdf/EN/february_2019_errata_image1.pdf for correction |
OXANDROLONE | Related compounds | USP41–NF36 | 3072 | 22-Feb-2019 | 1-Mar-2019 | NA | NA | In footnote 4 of the second table: Change Methyl-(1,17β-dihydroxy-17α-methyl-1,3-seco-2-nor-5α-androstane-3-oate. to: Methyl 1,17β-dihydroxy-17α-methyl-1,3-seco-2-nor-5α-androstan-3-oate. |
CARBINOXAMINE MALEATE | IMPURITIES/Organic Impurities | Second Supplement to USP41–NF36 | 8786 | 22-Feb-2019 | 1-Mar-2019 | NA | NA | In Standard stock solution: Change (equivalent to 0.05 mg/mL of USP Carbinoxamine Maleate RS free base) and 0.05 mg/mL each of USP Carbinoxamine Related Compound A RS, USP Carbinoxamine Related Compound B RS, and USP Carbinoxamine Related Compound C RS… Read More |
PRAZOSIN HYDROCHLORIDE COMPOUNDED ORAL SUSPENSION | ASSAY/Procedure | Second Supplement to USP41–NF36 | 8945 | 22-Feb-2019 | 1-Mar-2019 | NA | NA | In the Mobile phase: Change tetramethylammonium hydrochloride to: tetramethylammonium hydroxide |
DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS | ASSAY/Procedure | USP41–NF36 | 1358 | 22-Feb-2019 | 1-Mar-2019 | NA | NA | In Buffer: Change 0.5 g/L of citric acid and 0.4 g/L of dibasic sodium phosphate in water to: 0.5 g/L of anhydrous citric acid and 0.4 g/L of anhydrous dibasic sodium phosphate in water |
AMITRIPTYLINE HYDROCHLORIDE TABLETS | IMPURITIES/Organic Impurities | Second Supplement to USP41–NF36 | 8759 | 22-Feb-2019 | 1-Mar-2019 | NA | NA | In Analysis: Change rU = peak response of amitriptyline related compound A, amitriptyline related compound B, or nortriptyline hydrochloride from the Sample solution rS = peak response of amitriptyline related… Read More |
MESNA | ADDITIONAL REQUIREMENTS/USP Reference Standards <11> | Second Supplement to USP41–NF36 | 8904 | 22-Feb-2019 | 1-Mar-2019 | NA | NA | In USP Mesna Related Compound A RS: Change 2-(Acetylthio)ethane-1-sulfonic acid. C4H8O4S2 184.22 to: 2-(Acetylthio)ethane-1-sulfonic acid, potassium salt, crystal adduct with potassium chloride. C4… Read More |
ARGATROBAN | CHEMICAL INFORMATION | USP41–NF36 | 346 | 22-Feb-2019 | 1-Mar-2019 | NA | NA | See https://www.uspnf.com/sites/default/files/usp_pdf/EN/february_2019_errata_image1.pdf for correction |
CALCIUM SILICATE | IMPURITIES/Limit of Lead | USP41–NF36 | 5240 | 22-Feb-2019 | 1-Mar-2019 | NA | NA | In Lead standard solution: Change 1000 mg of lead/mL4 to: 1000 mg of lead/L4 |
CARBINOXAMINE MALEATE TABLETS | IMPURITIES/Organic Impurities | Second Supplement to USP41–NF36 | 8788 | 22-Feb-2019 | 1-Mar-2019 | NA | NA | In the Standard stock solution: Change USP Carbinoxamine Maleate RS free base) to: carbinoxamine) AND In the Standard solution: Change USP Carbinoxamine Maleate RS free base) to: carbinoxamine) AND In the Analysis… Read More |
REAGENTS | Reagent Specifications/7,8-Dihydrofolic Acid | Second Supplement to USP41–NF36 | 9052 | 22-Feb-2019 | 1-Mar-2019 | NA | NA | Change (L-Glutamic Acid, N-[4-[[(2-Amino-3,4,7,8-tetrahydro-4-pteridinyl)methyl]amino]benzoyl]-), to: (L-Glutamic Acid, N-[4-[[(2-Amino-3,4,7,8-tetrahydro-4-oxo-6-pteridinyl)methyl]amino]benzoyl]-), |
METHYLDOPA | SPECIFIC TESTS/Optical Rotation <781S> | USP41–NF36 | 2666 | 22-Feb-2019 | 1-Mar-2019 | NA | NA | In the Sample solution: Change aluminum chloride to: aluminum chloride hexahydrate |
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE TABLETS | ASSAY/Procedure/Chromatographic system | Second Supplement to USP41–NF36 | 8781 | 22-Feb-2019 | 1-Mar-2019 | NA | NA | In Column: Change [Note—Conditioning of the Column with Solution A and Solution B (80:20) to: [Note—Conditioning of the Column with Solution A and Solution B (90:10) |
L104 | CHROMATOGRAPHIC COLUMNS/Packings | First Supplement to USP41–NF36 | 8503 | 26-Jan-2019 | 1-Feb-2019 | USP42–NF37 | Second Supplement to USP41–NF36 | Add L104—Triazol groups chemically bonded to porous silica particles, 1.5–10 μm in diameter. |
LEFLUNOMIDE | IMPURITIES/Organic Impurities/Procedure 2 | USP41–NF36 | 2353 | 25-Jan-2019 | 1-Feb-2019 | NA | NA | Change Standard solution: 0.5 µg/mL of USP Leflunomide RS, from the Standard solution in Mobile phase to: Standard stock solution: Proceed as directed in the Standard solution in the Assay. … Read More |
SALIX SPECIES BARK DRY EXTRACT | INTRODUCTION | USP42–NF37 | 5187 | 25-Jan-2019 | 1-Feb-2019 | NA | NA | Delete (This monograph is postponed indefinitely.) |
SALIX SPECIES BARK | INTRODUCTION | USP42–NF37 | 5185 | 25-Jan-2019 | 1-Feb-2019 | NA | NA | Delete (This monograph is postponed indefinitely.) |
SALIX SPECIES BARK POWDER | ADDITIONAL REQUIREMENTS | USP42–NF37 | 5189 | 25-Jan-2019 | 1-Feb-2019 | NA | NA | In Labeling: Change The label states the Latin binomial(s) of one or several Salix species included in the article. to: The label states the Latin binomial(s) of one or several Salix species included in the article. Dosage forms… Read More |
SALMETEROL INHALATION POWDER | ASSAY/Procedure/Analysis | First Supplement to USP41–NF36 | Online | 25-Jan-2019 | 1-Feb-2019 | NA | NA | In the definition list: Change Mr1 = molecular weight of salmeterol free base, 415.75 to: Mr1 = molecular weight of salmeterol free base, 415.57 |
SALIX SPECIES BARK DRY EXTRACT | ADDITIONAL REQUIREMENTS | USP42–NF37 | 5187 | 25-Jan-2019 | 1-Feb-2019 | NA | NA | In Labeling: Change It meets the labeling requirements of Botanical Extracts <565>. to: It meets the labeling requirements of Botanical Extracts <565>. Dosage forms prepared with this article should bear the following… Read More |
BENZETHONIUM CHLORIDE | IMPURITIES/Organic Impurities/Acceptance criteria | First Supplement to USP41–NF36 | 8297 | 25-Jan-2019 | 1-Feb-2019 | NA | NA | In Total impurities: Change 1.0% to: NMT 1.0% |
SALIX SPECIES BARK | ADDITIONAL REQUIREMENTS | USP42–NF37 | 5185 | 25-Jan-2019 | 1-Feb-2019 | NA | NA | In Labeling: Change The label states the Latin binomial(s) of one or several Salix species included in the article. to: The label states the Latin binomial(s) of one or several Salix species included in the article. Dosage forms… Read More |
SALMETEROL INHALATION POWDER | PERFORMANCE TESTS | First Supplement to USP41–NF36 | Online | 25-Jan-2019 | 1-Feb-2019 | NA | NA | In the definition list in Particle Size Distribution by Cascade Impaction/Analysis: Change Mr1 = molecular weight of salmeterol free base, 415.75 to: Mr1 = molecular weight of salmeterol… Read More |
SALIX SPECIES BARK POWDER | INTRODUCTION | USP42–NF37 | 5189 | 25-Jan-2019 | 1-Feb-2019 | NA | NA | Delete (This monograph is postponed indefinitely.) |
PANTOPRAZOLE SODIUM | IMPURITIES/Organic Impurities/Test 2/Chromatographic system | First Supplement to USP41–NF36 | 8392 | 28-Dec-2018 | 1-Jan-2019 | NA | NA | In Column: Change 4.6-mm x 12.5-cm; 5-μm packing L1 to: 4-mm x 12.5-cm; 5-μm packing L1 |
METACRESOL | IDENTIFICATION/B. | USP41–NF36 | 2605 | 28-Dec-2018 | 1-Jan-2019 | NA | NA | Change The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay. to: The retention time of the metacresol peak of the Sample solution corresponds to… Read More |
VITAMIN A | ADDITIONAL REQUIREMENTS | USP41–NF36 | 4327 | 28-Dec-2018 | 1-Jan-2019 | NA | NA | Change Delete the following ▲•USP Reference Standards <11> USP Retinyl Acetate RS USP Retinyl Palmitate RS ▲(CN 1-May-2018) to: •USP Reference Standards <11> USP Retinyl Acetate RS … Read More |
ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES | PERFORMANCE TESTS/Dissolution <11>/Test 3/Buffer stage | Revision Bulletin (Official March 01, 2018) | Online | 28-Dec-2018 | 1-Jan-2019 | NA | NA | In the Standard solution: Change 0.25 M sodium hydroxide, to: 0.25 N sodium hydroxide, AND In the Sample solution: Change 0.25sodium hydroxide, to: 0.25 N sodium hydroxide, |
TELMISARTAN AND HYDROCHLOROTHIAZIDE TABLETS | PERFORMANCE TESTS/Dissolution <711>/Test 1/Chromatographic system | Revision Bulletin (Official February 01, 2018) | Online | 28-Dec-2018 | 1-Jan-2019 | NA | NA | In Flow rate: Change The flow rate goes back to 0.6 mL to: The flow rate goes back to 0.6 mL/min |
OLEYL OLEATE | CHEMICAL INFORMATION | USP41–NF36 | 5471 | 28-Dec-2018 | 1-Jan-2019 | NA | NA | Change 532.92 to: 532.94 |
HOMATROPINE HYDROBROMIDE | Limit of tropine | USP41–NF36 | 2038 | 28-Dec-2018 | 1-Jan-2019 | NA | NA | In Tropine reference solution: Change 0.4 mg per mL. to: 0.4 mg per mL in Diluent. |
TRIAZOLAM TABLETS | Uniformity of dosage units <905> | USP41–NF36 | 4202 | 28-Dec-2018 | 1-Jan-2019 | NA | NA | In Mobile phase and Chromatographic system: Change Proceed as directed in the Assay under Triazolam. to: Proceed as directed in the Assay. AND In Procedure: Change Proceed as directed for Procedure… Read More |
OXYBUTYNIN CHLORIDE EXTENDED-RELEASE TABLETS | IMPURITIES/Organic Impurities | Revision Bulletin (Official April 01, 2018) | Online | 30-Nov-2018 | 1-Dec-2018 | USP43–NF38 | USP42–NF37 | This erratum applies to the Revision Bulletin posted on www.uspnf.com only. In the variable definition list in Analysis: Change CU = nominal concentration of the Sample solution (mg… Read More |
CUPRIC CHLORIDE | ASSAY/Procedure | USP41–NF36 | 1109 | 30-Nov-2018 | 1-Dec-2018 | USP43–NF38 | USP42–NF37 | Line 1 of Analysis: Change To the Sample solution to: To 50 mL of the Sample solution |
AZEOTROPIC ISOPROPYL ALCOHOL | ADDITIONAL REQUIREMENTS/USP Reference Standards <11> | USP41–NF36 | 2257 | 30-Nov-2018 | 1-Dec-2018 | USP43–NF38 | USP42–NF37 | Line 1 of USP 2-Propanol System Suitability RS: Change It contains 0.1% of each of the following: ethyl ether, acetone, isopropyl alcohol, diisopropyl ether, 1-propanol, and 2-butanol. to: It is a mixture of the following: ethyl ether (0.1%), acetone (0.1… Read More |
AMLODIPINE AND ATORVASTATIN TABLETS | PERFORMANCE TESTS/Dissolution <711> | First Supplement to USP41–NF36 | 8270 | 30-Nov-2018 | 1-Dec-2018 | USP43–NF38 | USP42–NF37 | In the second Calculate statement in Analysis: Change (C33H34FN2O5) to: (C33H35FN2O5) AND In Tolerances: Change (C33H… Read More |
LIDOCAINE | ASSAY/Procedure | First Supplement to USP41–NF36 | Online | 30-Nov-2018 | 1-Dec-2018 | USP43–NF38 | USP42–NF37 | This erratum applies to the new USP-NF ONLINE platform only. Line 2 of Standard solution: Change 1 N sodium hydroxide, to: 1 N hydrochloric acid, AND Line 2 of Sample solution: Change 1 N sodium hydroxide, to: 1 N… Read More |