Monograph Title | Section | Source Publication | Page Number | Errata Post Date | Errata Official Date | Target Errata Print Publication | Target Online Fix Publication Sort descending | Description |
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<1046> CELL-BASED ADVANCED THERAPIES AND TISSUE-BASED PRODUCTS | REGULATIONS AND STANDARDS | USP43–NF38 | 7400 | 30-Oct-2020 | 1-Nov-2020 | NA | NA | In Table 5/Row 8 of Column 2: Change 221 CFR 1271 to: 21 CFR 1271 |
ORBIFLOXACIN | Related compounds | USP43–NF38 | 3275 | 20-Nov-2020 | 1-Dec-2020 | NA | NA | In Procedure: Change 20,000(CS)(ri/rS)(1/F) in which CS is the concentration, in mg per mL, of orbifloxacin in the Standard solution; ri is… Read More |
HYDROXYZINE PAMOATE | IMPURITIES/Organic Impurities | USP43–NF38 | 2269 | 28-May-2021 | 1-Jun-2021 | NA | NA | In System suitability/Suitability requirements/Resolution: Change 4-chlorobenophenone to: 4-chlorobenzophenone |
TIAGABINE HYDROCHLORIDE | ADDITIONAL REQUIREMENTS/USP Reference Standards <11> | USPNF 2021 ISSUE 1 | Online | 29-Oct-2021 | 1-Nov-2021 | NA | NA | In USP Tiagabine Hydrochloride RS: Delete [NOTE—Available in monohydrate form.] |
DACARBAZINE FOR INJECTION | IMPURITIES | USPNF Online | Online | 29-Apr-2022 | 1-May-2022 | NA | NA | Delete Limit of 2-Azahypoxanthine test |
SODIUM PICOSULFATE | IMPURITIES/Organic Impurities | USPNF Online | Online | 30-Sep-2022 | 1-Oct-2022 | NA | NA | In Buffer: Change cetylrimethylammonium bromide, to: cetyltrimethylammonium bromide, |
MIRTAZAPINE TABLETS | IMPURITIES/Organic Impurities | USPNF Online | Online | 24-Feb-2023 | 1-Mar-2023 | NA | NA | In System suitability/Suitability requirements/Resolution: Change 10-ketomirtazpine to: 10-ketomirtazapine AND In Table 1: Change 1-Ketomirtazpinec to: 1-Ketomirtazapinec |
IODIXANOL INJECTION | IMPURITIES | USPNF Online | Online | 23-Feb-2024 | 1-Mar-2024 | NA | NA | In Organic Impurities, Procedure 2/footnote 4: Change 5-[[3-[[3-[[[3-[[3-[[3,5-Bis-[[[2,3-dihydroxypropyl]amino]carbonyl]-2,4,6-triiodophenyl](acetylimino)]-2-hydroxypropyl](acetylimino)]-5-[[[2,3-dihydroxypropyl]amino]carbonyl]-2,4,6-triiodophenyl]carbonyl]amino]-2-hy… Read More |
SALIX SPECIES BARK POWDER | INTRODUCTION | USP42–NF37 | 5189 | 25-Jan-2019 | 1-Feb-2019 | NA | NA | Delete (This monograph is postponed indefinitely.) |
DULOXETINE DELAYED-RELEASE CAPSULES | IMPURITIES/Organic Impurities/Table 2 | USP42–NF37 | 1527 | 31-May-2019 | 1-Jun-2019 | NA | NA | In footnote a: Change This is a process impurity that is included in Table 1 for identification purposes only. to: This is a process impurity that is included for identification purposes only. |
BENDAMUSTINE HYDROCHLORIDE FOR INJECTION | IMPURITIES/Organic Impurities | USP42–NF37 | 487 | 27-Sep-2019 | 1-Oct-2019 | NA | NA | In Table 2: Change Bendamustine related compound B to: Bendamustine related compound Ba AND Change Bendamustine related compound Ca to: Bendamustine related compound Cb AND Change … Read More |
PROPOFOL | IMPURITIES/Organic Impurities, Procedure 2 | USP43–NF38 | 3739 | 24-Apr-2020 | 1-May-2020 | NA | NA | In Table 3: Delete Propofol related compound Bb 0.8 1.0 0.05 AND Change Propofol related compound Ac to: Propofol related compound Ab AND Change b2,6-Diisopropylbenzoquinone. … Read More |
METOPROLOL SUCCINATE EXTENDED-RELEASE TABLETS | ADDITIONAL REQUIREMENTS | USP43–NF38 | 2918 | 31-Jul-2020 | 1-Aug-2020 | NA | NA | In Labeling: Change as metoprolol succinate [(C15H25NO3)2 · C4H6O6]. to: as metoprolol tartrate [(C15H25NO3)2 · C4… Read More |
PACLITAXEL INJECTION | TITLE | USPNF 2021 ISSUE 1 | Online | 26-Feb-2021 | 1-May-2021 | NA | NA | Change Paclit 1axel Injection to: Paclitaxel Injection |
GEMCITABINE FOR INJECTION | IMPURITIES/Organic Impurities | USP43–NF38 | 2094 | 30-Jul-2021 | 1-Aug-2021 | NA | NA | In Table 2: Change Cytosinea to: Cytosine AND Delete footnote a AND Update footnote order |
ONDANSETRON HYDROCHLORIDE | USP Reference standards <11> | USPNF Online | Online | 28-Jan-2022 | 1-Feb-2022 | NA | NA | In USP Ondansetron Related Compound A RS: Change 3-[(Dimethylamino)methyl]-1,2,3,9-tetrahydro-9-methyl-4H-carbazol-4-one hydrochloride. to: 3-[(Dimethylamino)methyl]-9-methyl-1,2,3,9-tetrahydro-4H-carbazol-4-one hydrochloride. AND… Read More |
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE TABLETS | ASSAY/Procedure | USPNF Online | Online | 24-Jun-2022 | 1-Jul-2022 | NA | NA | In Buffer: Change Adjust with phosphoric acid to a pH of 6.4 ± 0.01. to: Adjust with phosphoric acid to a pH of 6.4 ± 0.1. |
MOMETASONE FUROATE TOPICAL SOLUTION | IDENTIFICATION | USPNF Online | Online | 18-Nov-2022 | 1-Dec-2022 | NA | NA | In test A: Change The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, both relative to the internal standard, as obtained in the Assay. to: The retention time of the major… Read More |
VIGABATRIN TABLETS | IMPURITIES/Organic Impurities | USPNF Online | Online | 28-Apr-2023 | 1-May-2023 | NA | NA | In Analysis: Change CS = concentration of USP Vigabatrin Related Compound A in the Standard solution to: CS = concentration of USP Vigabatrin Related Compound A RS in the Standard solution |
AMOXICILLIN FOR INJECTABLE SUSPENSION | Identification | USPNF Online | Online | 27-Oct-2023 | 1-Nov-2023 | NA | NA | Change Prepare a test solution containing the equivalent of 4 mg of amoxicillin per mL by adding 0.1 N hydrochloric acid to Amoxicillin for Injectable Suspension. Allow the solution to stand for 5 minutes before use: the solution responds to the Identification… Read More |
IMIPRAMINE PAMOATE CAPSULES | IMPURITIES/Organic Impurities | USP42–NF37 | Online | 26-Apr-2019 | 1-May-2019 | NA | NA | In Solution A: Change Chromatographic acetonitrile to: Acetonitrile AND In Solution B: Change chromatographic acetonitrile to: acetonitrile |
ALPROSTADIL | ASSAY/Procedure | USP42–NF37 | 151 | 26-Jul-2019 | 1-Aug-2019 | NA | NA | In System suitability stock solution: Change Standard solution to: Standard stock solution |
<857> ULTRAVIOLET-VISIBLE SPECTROSCOPY | QUALIFICATION OF UV-VIS SPECTROMETERS | Second Supplement to USP42–NF37 | 9570 | 27-Dec-2019 | 1-Jan-2020 | NA | NA | In all instances in Table 4: Change < to: ≤ AND In Control of Photometric Response/Acidic Nicotinic Acid Solutions in 0.1 N Hydrochloric Acid/paragraph 1: Change Using nicotinic acid solutions, the absorbance accuracy… 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. |
INOSITOL | IMPURITIES/Limit of Lead | USP42–NF37 | 5776 | 26-Apr-2019 | 1-May-2019 | NA | NA | In Standard lead solution: Delete A comparison solution prepared on the basis of 100 µL of the Standard lead solution per g of substance being tested contains the equivalent of 1 part of lead per million parts of substance being tested. |
LAMOTRIGINE TABLETS FOR ORAL SUSPENSION | PERFORMANCE TESTS/Dissolution <711>/Chromatographic procedure 1 | First Supplement to USP42–NF37 | 8720 | 26-Jul-2019 | 1-Aug-2019 | NA | NA | In Buffer: Change glacial acetic acid acid to: glacial acetic acid |
ITRACONAZOLE CAPSULES | PERFORMANCE TESTS/Dissolution <711>/Test 1 | Revision Bulletin (Official August 01, 2019) | Online | 27-Mar-2020 | 1-Apr-2020 | NA | NA | In System suitability/Suitability requirements/Relative standard deviation: Change NMT 2.0% for 5 replicate injections to: NMT 2.0% for 5 replicates |
ROPIVACAINE HYDROCHLORIDE | ADDITIONAL REQUIREMENTS | USP43–NF38 | 3943 | 29-May-2020 | 1-Jun-2020 | NA | NA | In USP Reference Standards <11>/USP Ropivacaine Related Compound A RS: Change 2,6-Dimethylaniline hydrochloride. C8H12ClN 157.64 [CAS-21436-98-6]. to: 2,6-Dimethylaniline hydrochloride. C8H11… Read More |
OXYGEN | IMPURITIES | USP43–NF38 | 3347 | 30-Oct-2020 | 1-Nov-2020 | NA | NA | Change Impurities Testing in Medical Gases Assay 〈413〉 to: Impurities Testing in Medical Gases 〈413〉 |
ATORVASTATIN CALCIUM TABLETS | ADDITIONAL REQUIREMENTS/USP Reference Standards <11> | USP43–NF38 | 418 | 20-Nov-2020 | 1-Dec-2020 | NA | NA | In USP Atorvastatin Related Compound H RS: Change 540.62 to: 540.64 |
MINOXIDIL TABLETS | IMPURITIES/Organic Impurities | USPNF 2021 ISSUE 1 | Online | 28-May-2021 | 1-Jun-2021 | NA | NA | In Analysis: Change Result = (rU/rS) × (CU/CS) × 100 to: Result = (rU/rS) × (CS/CU) × 100 |
ISOPROTERENOL HYDROCHLORIDE INJECTION | Color and clarity | USPNF 2021 ISSUE 1 | Online | 19-Nov-2021 | 1-Dec-2021 | NA | NA | Change Using the Injection as the Test solution, proceed as directed for Color and clarity under Isoproterenol Inhalation Solution. to: Standard solution—Transfer 2.0 mL of 0.100 N iodine VS to a 500-mL volumetric flask,… Read More |
DIMENHYDRINATE TABLETS | OTHER COMPONENTS/8-Chlorotheophylline | USPNF Online | Online | 27-May-2022 | 1-Jun-2022 | NA | NA | In Analysis: Change CU = nominal concentration of dimenhydrinate in the Sample solution (mg/mL) to: CU = determined concentration of dimenhydrinate in the Sample solution, as obtained in the Assay… Read More |
TETRACYCLINE HYDROCHLORIDE | ADDITIONAL REQUIREMENTS/Labeling | USPNF Online | Online | 28-Oct-2022 | 1-Nov-2022 | NA | NA | Change Where tetracycline hydrochloride must be sterile or subjected to further processing during the preparation of injectable dosage forms to ensure acceptable levels of bacterial endotoxins, it is so labeled. to: Where Tetracycline Hydrochloride must be… Read More |
PRAZOSIN HYDROCHLORIDE CAPSULES | ASSAY/Procedure | USPNF Online | Online | 31-Mar-2023 | 1-Apr-2023 | NA | NA | In Analysis: Change CS = concentration of USP Prazosin Hydrochloride RS in the Standard solution (µg/mL) CU = nominal concentration of prazosin in the Sample solution (µg/mL) Mr1… Read More |
CRANBERRY FRUIT DRY JUICE | COMPOSITION | USPNF Online | Online | 25-Aug-2023 | 1-Sep-2023 | NA | NA | In Content of Proanthocyanidins/Standard stock solution: Change USP Procyanidin A2 RS to: USP Procyanidin A2 RS AND In Content of Proanthocyanidins/Analysis: Change Use the absorbance recorded for Standard… Read More |
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 |
BACILLUS COAGULANS | ASSAY/Enumeration | USP42–NF37 | 4746 | 31-May-2019 | 1-Jun-2019 | NA | NA | In Sample preparation and Analysis: Change peptone water to: Peptone diluent |
GADOTERIDOL | Limit of gadoteridol related compound A | USP42–NF37 | 2020 | 25-Oct-2019 | 1-Nov-2019 | NA | NA | In Chromatographic system: Change packing L21 to: packing L47 |
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 |
SODIUM IODIDE I 123 CAPSULES | Other requirements | USP43–NF38 | 2365 | 28-Aug-2020 | 1-Sep-2020 | NA | NA | Change Other requirements A solution or suspension prepared by homogenizing 1 or more Capsules in water to yield a concentration of not less than 1 MBq (25 µCi) per mL meets the requirements of the Assay for radioactivity under Sodium… Read More |
TRIHEXYPHENIDYL HYDROCHLORIDE TABLETS | IMPURITIES/Organic Impurities | USP43–NF38 | 4519 | 26-Mar-2021 | 1-Apr-2021 | NA | NA | In Sample solution: Change Nominally 1 mg/mL of trihexyphenidyl hydrochloride in Diluent prepared as follows. to: Nominally 1 mg/mL of trihexyphenidyl hydrochloride prepared as follows. |
CETIRIZINE HYDROCHLORIDE | IMPURITIES/Residue on Ignition 〈281〉 | USPNF 2021 ISSUE 1 | Online | 27-Aug-2021 | 1-Sep-2021 | NA | NA | Delete Sample: 1 g |
FULVESTRANT | CHEMICAL INFORMATION | USPNF Online | Online | 28-Jan-2022 | 1-Feb-2022 | NA | NA | Change 606.77 to: 606.78 |
BACLOFEN INJECTION | SPECIFIC TESTS | USPNF Online | Online | 29-Jul-2022 | 1-Aug-2022 | NA | NA | Change • Osmolality and Osmolarity 〈785〉, Osmolality: 270–320 mOsm/kg to: • Osmolality and Osmolarity 〈785〉 Osmolality: 270–320 mOsm/kg |
MESO-ZEAXANTHIN | CHEMICAL INFORMATION | USPNF Online | Online | 27-Jan-2023 | 1-Jun-2023 | NA | NA | Change (3R,3′S-meso)-Zeaxanthin to: (3R,3′S)-Zeaxanthin |
DIGOXIN TABLETS | ASSAY/Procedure | USPNF Online | Online | 30-Jun-2023 | 1-Jul-2023 | NA | NA | In Chromatographic system: Change Column: 4.2-mm × 25-cm; 5-μm packing L1 to: Column: 4.6-mm × 25-cm; 5-µm packing L1 |
DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE CAPSULES | ADDITIONAL REQUIREMENTS | USPNF Online | Online | 17-Nov-2023 | 1-Dec-2023 | NA | NA | In USP Reference Standards 〈11〉/USP Dihydrodutasteride RS: Change N-[2,5-Bis(trifluoromethyl)phenyl]-3-oxo-4-aza-5α-androst-1-ene-17β-carboxamide. to: N-[2,5-Bis(trifluoromethyl)phenyl]-3-oxo-4-aza-5α-androstane-17β-carboxamide. |
<3> TOPICAL AND TRANSDERMAL DRUG PRODUCTS—PRODUCT QUALITY TESTS | SPECIFIC TESTS FOR TDS | USPNF Online | Online | 28-Jul-2023 | 1-Dec-2023 | NA | NA | In Release Liner Peel Test: Change The product fails the test if the mean peel force is outside the acceptable range determined during product development. to: The product fails the test if the overall mean peel force is outside the acceptable range… Read More |
ACARBOSE | IMPURITIES | USPNF Online | Online | 29-Dec-2023 | 1-Jan-2024 | NA | NA | In Chromatographic Purity/Analysis: Change Result = (rU/rA) × (1/F) × 100 to: Result = (rU/rA) × (1/F) |