Monograph Title | Section | Source Publication | Page Number | Errata Post Date Sort ascending | Errata Official Date | Target Errata Print Publication | Target Online Fix Publication | Description |
---|---|---|---|---|---|---|---|---|
ROPIVACAINE HYDROCHLORIDE INJECTION | USP Reference standards <11> | USP43–NF38 | 3945 | 29-May-2020 | 1-Jun-2020 | NA | NA | In USP Ropivacaine Related Compound A RS: Change 2,6-Dimethylaniline hydrochloride. C8H12ClN 157.64 [CAS-21436-98-6]. to: 2,6-Dimethylaniline hydrochloride. C8H11N · HCl 157.64 AND In USP… Read More |
DOXYCYCLINE CAPSULES | PERFORMANCE TESTS | USP43–NF38 | 1519 | 29-May-2020 | 1-Jun-2020 | NA | NA | In Dissolution <711>: Change Test 2 to: Test 2: If the product complies with this test, the labeling indicates that it meets USP Dissolution Test 2. |
DOLASETRON MESYLATE | ASSAY/Procedure | USP43–NF38 | 1483 | 29-May-2020 | 1-Jun-2020 | NA | NA | Change Mobile phase: Acetonitrile, water, and 1 M ammonium formate (450:440:110), adding 0.19 mL of triethylamine to the acetonitrile portion to: Solution A: Add 0.19 mL of triethylamine to each 450 mL of acetonitrile. Mobile phase… Read More |
INDOMETHACIN SUPPOSITORIES | ASSAY/Procedure | Revision Bulletin (Official December 01, 2019) | Online | 29-May-2020 | 1-Jun-2020 | NA | NA | In Chromatographic system/Detector: Change PDA (scan 200–600). to: PDA (scan 200–600 nm). |
CARISOPRODOL | IMPURITIES/Organic Impurities | USP43–NF38 | 776 | 24-Apr-2020 | 1-May-2020 | NA | NA | In Table 2: Change Carisoprdol related compound Aa to: Carisoprodol related compound Aa |
OIL- AND WATER-SOLUBLE VITAMINS TABLETS | STRENGTH | USP43–NF38 | 5419 | 24-Apr-2020 | 1-May-2020 | NA | NA | In the variable definition for F in Vitamin E, Method 2/Analysis: Change 1/2 for products labeled to contain all-rac vitamin E sources) to: 1/2 (for products labeled to contain all-rac vitamin E sources) AND In Biotin,… Read More |
DIHYDROERGOTAMINE MESYLATE | Assay | USP43–NF38 | 1388 | 24-Apr-2020 | 1-May-2020 | NA | NA | Change Diluent 1—Prepare a solution of 0.1 mL of phosphoric acid in 1000 mL of water. Diluent 2—Prepare a mixture of Diluent 1 and acetonitrile (60:40). to: Diluent 1—Prepare a solution of 0.1 mL of phosphoric acid in 1000 mL… Read More |
GLYCERYL MONO AND DICAPRYLATE | IDENTIFICATION/A. Fatty Acid Composition | USP43–NF38 | 5794 | 24-Apr-2020 | 1-May-2020 | NA | NA | In Standard solution 3: Change USP Methyl Caproate RS, USP Methyl Caprylate RS, USP Methyl Caprate RS, USP Methyl Laurate RS, and USP Methyl Laurate RS. to: USP Methyl Caproate RS, USP Methyl Caprylate RS, USP Methyl Caprate RS, USP Methyl Laurate RS… Read More |
LEVONORDEFRIN | Identification/B: | USP43–NF38 | 2611 | 24-Apr-2020 | 1-May-2020 | NA | NA | Change Ultraviolet Absorption <197U>— to: Spectroscopic Identification Tests <197>, Ultraviolet-Visible Spectroscopy: 197U |
0.002 M EDETATE DISODIUM VS | REAGENTS AND REFERENCE TABLES/Solutions | USP43–NF38 | 6240 | 24-Apr-2020 | 1-May-2020 | NA | NA | Change 0.0744 g to: 0.744 g |
PANTOPRAZOLE SODIUM | ADDITIONAL REQUIREMENTS/USP Reference Standards <11> | USP43–NF38 | 3388 | 24-Apr-2020 | 1-May-2020 | NA | NA | In USP Pantoprazole Related Compound E RS: Change C34H28F4N6O8S2 764.74 to: C32H28F4N6O8S2 764.72 |
OXYBUTYNIN CHLORIDE EXTENDED-RELEASE TABLETS | PERFORMANCE TESTS/Dissolution <711>/Test 2 | Revision Bulletin (Official October 01, 2019) | Online | 24-Apr-2020 | 1-May-2020 | NA | NA | In Buffer stage medium: Change Simulated gastric fluid, to: Simulated intestinal fluid, |
RALTEGRAVIR TABLETS | ASSAY/Procedure | USP43–NF38 | 3834 | 24-Apr-2020 | 1-May-2020 | NA | NA | In Analysis: Change Mr1 = molecular weight of raltegravir, 444.44 to: Mr1 = molecular weight of raltegravir, 444.42 |
RALTEGRAVIR CHEWABLE TABLETS | IMPURITIES/Organic Impurities | USP43–NF38 | 3835 | 24-Apr-2020 | 1-May-2020 | NA | NA | In Analysis: Change Mr1 = molecular weight of raltegravir, 444.44 to: Mr1 = molecular weight of raltegravir, 444.42 |
CETIRIZINE HYDROCHLORIDE ORALLY DISINTEGRATING TABLETS | ADDITIONAL REQUIREMENTS/USP Reference Standards <11> | USP43–NF38 | 915 | 24-Apr-2020 | 1-May-2020 | NA | NA | In USP Cetirizine Related Compound A RS: Change 506.98 to: 506.97 |
OIL-SOLUBLE VITAMINS TABLETS | STRENGTH | USP43–NF38 | 5356 | 24-Apr-2020 | 1-May-2020 | NA | NA | In Vitamin E, Method 3/Analysis: Change alpha -ocopheryl acetate to: alpha-tocopheryl acetate |
DEMECLOCYCLINE HYDROCHLORIDE | SPECIFIC TESTS/Loss on Drying | USP43–NF38 | 1248 | 24-Apr-2020 | 1-May-2020 | NA | NA | In Analysis: Change Dry the Sample at 60° for 3 h. to: Dry the Sample in a capillary-stoppered bottle in vacuum at 60° for 3 h. |
WATER-SOLUBLE VITAMINS WITH MINERALS TABLETS | STRENGTH | USP43–NF38 | 5552 | 24-Apr-2020 | 1-May-2020 | NA | NA | In the Calculate statement in Niacin or Niacinamide, Pyridoxine Hydrochloride, Riboflavin, and Thiamine, Method 1/Analysis: Delete , calcium pantothenate (C18H32CaN2O10), and folic acid (C19… Read More |
EPINEPHRINE | ADDITIONAL REQUIREMENTS | USP43–NF38 | Online | 24-Apr-2020 | 1-May-2020 | NA | NA | This erratum applies to the USP-NF ONLINE platform only. In USP Reference Standards <11>: Add USP Racepinephrine Hydrochloride RS |
SODIUM METABISULFITE | IMPURITIES/Limit of Chloride | USP43–NF38 | 6020 | 24-Apr-2020 | 1-May-2020 | NA | NA | In Analysis: Change (see Nephelometry, Turbidimetry, and Visual Comparison <855>). to: (see Visual Comparison <630>). |
MEXILETINE HYDROCHLORIDE | CHEMICAL INFORMATION | USP43–NF38 | 2943 | 24-Apr-2020 | 1-May-2020 | NA | NA | Change [5370-01-04]. to: [5370-01-4]. |
<856> NEAR-INFRARED SPECTROSCOPY | 4. VALIDATION AND VERIFICATION | USP43–NF38 | 7161 | 24-Apr-2020 | 1-May-2020 | NA | NA | In 4.1 Validation/4.1.1 Accuracy/Validation criteria/Criteria 1: Change Suitable agreement between SEP to: Suitable agreement between the standard error of prediction (SEP) |
PROPRANOLOL HYDROCHLORIDE | IMPURITIES/Organic Impurities | USP43–NF38 | 3746 | 24-Apr-2020 | 1-May-2020 | NA | NA | In System suitability/Suitability requirements/Relative standard deviation: Change NMT 5.0, to: NMT 5.0%, |
RALTEGRAVIR CHEWABLE TABLETS | ASSAY/Procedure | USP43–NF38 | 3835 | 24-Apr-2020 | 1-May-2020 | NA | NA | In Analysis: Change Mr1 = molecular weight of raltegravir, 444.44 to: Mr1 = molecular weight of raltegravir, 444.42 |
VITAMIN E | ASSAY/Alpha Tocopheryl Acid Succinate | USP43–NF38 | 4637 | 24-Apr-2020 | 1-May-2020 | NA | NA | In Sample solution: Change tocoopheryl to: tocopheryl |
REPOSITORY CORTICOTROPIN INJECTION | ADDITIONAL REQUIREMENTS | USP43–NF38 | 1174 | 24-Apr-2020 | 1-May-2020 | NA | NA | In USP Reference Standards <11>: Add USP Ascorbic Acid RS |
OIL- AND WATER-SOLUBLE VITAMINS WITH MINERALS TABLETS | STRENGTH | USP43–NF38 | 5476 | 24-Apr-2020 | 1-May-2020 | NA | NA | In the Calculate statement in Niacin or Niacinamide, Pyridoxine Hydrochloride, Riboflavin, and Thiamine, Method 1/Analysis: Delete , calcium pantothenate (C18H32CaN2O10), and folic acid (C19… Read More |
EPINEPHRINE | IMPURITIES/Organic Impurities | USP43–NF38 | 1645 | 24-Apr-2020 | 1-May-2020 | NA | NA | In the third calculation in the Analysis: Change CU = concentration of Epinephrine in the Sample solution (mg/mL) to: CU = concentration of Epinephrine in the Sample solution (µg/mL) |
HEXYLENE GLYCOL | IMPURITIES/Organic Impurities | USP43–NF38 | 5814 | 24-Apr-2020 | 1-May-2020 | NA | NA | In Any other individual impurity/Relative Response Factor in Table 2: Change – to: 1.0 |
LOPERAMIDE HYDROCHLORIDE | IMPURITIES/Organic Impurities | USP43–NF38 | 2658 | 24-Apr-2020 | 1-May-2020 | NA | NA | In System suitability/Suitability requirements/Peak-to-valley ratio: Change NLT 1.5 for loperamide related compounds G and H; NLT 1.5 for loperamide related compounds E and A, System suitability solution to: NLT 1.5 for… Read More |
0.02 M EDETATE DISODIUM VS | REAGENTS AND REFERENCE TABLES/Solutions | USP43–NF38 | 6240 | 24-Apr-2020 | 1-May-2020 | NA | NA | Change 0.7444 g to: 7.444 g |
POLYVINYL ALCOHOL | IDENTIFICATION/A. | USP43–NF38 | 3593 | 24-Apr-2020 | 1-May-2020 | NA | NA | Change Infrared Absorption <197K> to: Spectroscopic Identification Tests <197>, Infrared Spectroscopy: 197K |
RALTEGRAVIR TABLETS | PERFORMANCE TESTS/Dissolution <711> | USP43–NF38 | 3834 | 24-Apr-2020 | 1-May-2020 | NA | NA | In Analysis: Change Mr1 = molecular weight of raltegravir, 444.44 to: Mr1 = molecular weight of raltegravir, 444.42 |
SACCHARIN SODIUM | SPECIFIC TESTS/Readily Carbonizable Substances Test <271> | USP43–NF38 | 3965 | 24-Apr-2020 | 1-May-2020 | NA | NA | In Matching fluid A: Change ferric chloride TS, to: ferric chloride CS, |
BUDESONIDE | IMPURITIES/Organic Impurities | USP43–NF38 | 604 | 24-Apr-2020 | 1-May-2020 | NA | NA | In footnote k in Table 2: Change 16α,17-[Butylidenebis(oxy)]-11β,21-dihydroxypregna-1,4-diene-3,20-dione-21-acetate. to: 16α,17-[Butylidenebis(oxy)]-11β-hydroxypregna-1,4-diene-3,20-dione-21-yl acetate. |
OIL-SOLUBLE VITAMINS TABLETS | ADDITIONAL REQUIREMENTS/Labeling | USP43–NF38 | 5356 | 24-Apr-2020 | 1-May-2020 | NA | NA | In footnote 1: Change -alpha-tocopheryl to: all-rac-alpha-tocopheryl AND Change USP Vitamin E unit to: USP Vitamin E Unit AND Change 2R-alphatocopherol to: 2R-alpha-tocopherol |
DEXAMETHASONE ACETATE | Chromatographic purity | USP43–NF38 | 1290 | 24-Apr-2020 | 1-May-2020 | NA | NA | Change Format buffer to: Formate buffer |
CAPRYLIC ACID | ASSAY/Procedure/Chromatographic system | USP43–NF38 | 5664 | 24-Apr-2020 | 1-May-2020 | NA | NA | In Column: Change 30-cm to: 30-m |
LEUCOVORIN CALCIUM FOR INJECTION | ASSAY/Procedure/Chromatographic system | USP43–NF38 | 2569 | 24-Apr-2020 | 1-May-2020 | NA | NA | Delete Run time: 2 times the retention time of the leucovorin peak |
SUCROSE PALMITATE | IMPURITIES/Inorganic Impurities | USP43–NF38 | 6078 | 24-Apr-2020 | 1-May-2020 | NA | NA | In Fats and Fixed Oils, Acid Value <401>: Change NMT 6.0%, to: NMT 6.0, |
NIACIN | IDENTIFICATION/B. | USP43–NF38 | 3138 | 24-Apr-2020 | 1-May-2020 | NA | NA | Change Ultraviolet Absorption <197U> to: Spectroscopic Identification Tests <197>, Ultraviolet-Visible Spectroscopy: 197U |
<1125> NUCLEIC ACID-BASED TECHNIQUES -- GENERAL | APPENDICES | USP43–NF38 | 7865 | 24-Apr-2020 | 1-May-2020 | NA | NA | In Appendix 2: Delete the Row for dNTP dinucleotide triphosphate |
RALTEGRAVIR TABLETS | DEFINITION | USP43–NF38 | 3834 | 24-Apr-2020 | 1-May-2020 | NA | NA | Change (C20H20FN6O5) to: (C20H21FN6O5) |
RALTEGRAVIR CHEWABLE TABLETS | PERFORMANCE TESTS/Dissolution <711> | USP43–NF38 | 3835 | 24-Apr-2020 | 1-May-2020 | NA | NA | In Analysis: Change Mr1 = molecular weight of raltegravir, 444.44 to: Mr1 = molecular weight of raltegravir, 444.42 |
ALOSETRON HYDROCHLORIDE | IMPURITIES/Organic Impurities | USP43–NF38 | 141 | 24-Apr-2020 | 1-May-2020 | NA | NA | In System suitability/Suitability requirements/Resolution: Change NLT 7 to: NLT 3 |
CALCIUM AND VITAMIN D WITH MINERALS TABLETS | STRENGTH | USP43–NF38 | 4845 | 24-Apr-2020 | 1-May-2020 | NA | NA | In Calcium, Copper, Magnesium, Manganese, and Zinc, Method 2/Acceptance criteria: Change NLT 90.0%–125.0% to: 90.0%–125.0% |
DAPSONE TABLETS | IDENTIFICATION/B. | USP43–NF38 | 1241 | 24-Apr-2020 | 1-May-2020 | NA | NA | Change Ultraviolet Absorption <197U> to: Spectroscopic Identification Tests <197>, Ultraviolet-Visible Spectroscopy: 197U |
WATER-SOLUBLE VITAMINS TABLETS | STRENGTH | USP43–NF38 | 5512 | 24-Apr-2020 | 1-May-2020 | NA | NA | In Biotin, Method 3/Solid-phase extraction: Change anion-xchange to: anion-exchange AND In the Calculate statement in Niacin or Niacinamide, Pyridoxine Hydrochloride, Riboflavin, and Thiamine, Method 1/Analysis: Delete ,… Read More |
EPINEPHRINE | IMPURITIES/Enantiomeric Purity | USP43–NF38 | Online | 24-Apr-2020 | 1-May-2020 | NA | NA | This erratum applies to the USP-NF ONLINE platform only. In System suitability solution: Change 0.03 mg/mL of in Mobile phase to: 0.03 mg/mL of USP Racepinephrine Hydrochloride RS in Mobile phase |
POLYOXYL 35 CASTOR OIL | IDENTIFICATION/C. Identity by Fatty Acid Composition | USP43–NF38 | 5956 | 24-Apr-2020 | 1-May-2020 | NA | NA | In System suitability/Suitability requirements/Relative standard deviation: Change linoeate to: linoleate |