| Monograph Title | Section | Source Publication | Page Number | Errata Post Date Sort ascending | Errata Official Date | Target Errata Print Publication | Target Online Fix Publication | Description |
|---|---|---|---|---|---|---|---|---|
| NAPHAZOLINE HYDROCHLORIDE | IMPURITIES/Organic Impurities | First Supplement to USP39–NF34 | 8105 | 18-Nov-2016 | 1-Dec-2016 | USP41–NF36 | Second Supplement to USP40–NF35 | Line 16 of Analysis: Change Calculate the percentage of any individual unspecified impurity to: Calculate the percentage of any other individual impurity AND Line 20 of Analysis: Change rU = peak response of any individual unspecified… Read More |
| CIPROFLOXACIN | ADDITIONAL REQUIREMENTS/USP Reference Standards <11> | Second Supplement to USP39–NF34 | 8597 | 18-Nov-2016 | 1-Dec-2016 | USP41–NF36 | Second Supplement to USP40–NF35 | Line 2 of USP Ciprofloxacin Ethylenediamine Analog RS: Change 7-(2-Aminoethylamino)-1-cyclopropyl-6-fluoro-4-oxo-1,4-dihydroquinoline-3-carboxylic acid. C15H16FN3O3 305.30 to: 1-Cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-[(2-aminoethyl)… Read More |
| CIPROFLOXACIN HYDROCHLORIDE | ADDITIONAL REQUIREMENTS/USP Reference Standards <11> | Second Supplement to USP39–NF35 | 8600 | 18-Nov-2016 | 1-Dec-2016 | USP41–NF36 | Second Supplement to USP40–NF35 | Line 2 of USP Ciprofloxacin Ethylenediamine Analog RS: Change 7-(2-Aminoethylamino)-1-cyclopropyl-6-fluoro-4-oxo-1,4-dihydroquinoline-3-carboxylic acid. C15H16FN3O3 305.30 to: 1-Cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-[(2-aminoethyl)… Read More |
| DEXTROSE | IDENTIFICATION/C. Water Determination <921> | Second Supplement to USP39–NF34 | 8612 | 18-Nov-2016 | 1-Dec-2016 | USP41–NF36 | Second Supplement to USP40–NF35 | Line 1: Change Water Determination <921> to: Water Determination <921>, Method I |
| OMEGA-3-ACID ETHYL ESTERS CAPSULES | ASSAY/Content of EPAee, DHAee, and Total Omega-3-Acid Ethyl Esters | Second Supplement to USP39–NF34 | 8755 | 18-Nov-2016 | 1-Dec-2016 | USP41–NF36 | Second Supplement to USP40–NF35 | Line 21 of Analysis: Change CU = nominal concentration of the total omega-3-acid ethyl esters in the Sample solution (g/mL) to: CU = Capsule fill content of the Sample solution (g/mL) |
| OMEGA-3-ACID ETHYL ESTERS CAPSULES | SPECIFIC TESTS/Concentration of Omega-3-Acid Ethyl Esters | Second Supplement to USP39–NF34 | 8755 | 18-Nov-2016 | 1-Dec-2016 | USP41–NF36 | Second Supplement to USP40–NF35 | Line 21: Change CU = nominal concentration of the total omega-3-acid ethyl esters in the Sample solution (g/mL) to: CU = Capsule fill content of the Sample solution (g/mL) |
| POVIDONE | IMPURITIES/Formic Acid | Second Supplement to USP39–NF34 | 8778 | 18-Nov-2016 | 1-Dec-2016 | USP41–NF36 | Second Supplement to USP40–NF35 | Line 3 of Sample solution: Change column of about 80 mm to: column of about 8 mm |
| ROPINIROLE EXTENDED-RELEASE TABLETS | PERFORMANCE TESTS/Dissolution <711>/Test 1 | Second Supplement to USP39–NF34 | 8814 | 18-Nov-2016 | 1-Dec-2016 | USP41–NF36 | Second Supplement to USP40–NF35 | Line 2 of Buffer 1: Adjust with Solution A to a pH of 4.0. to: Adjust with Solution A to a pH of 4.0. Dilute with water to 1 L. |
| <661.1> PLASTIC MATERIALS OF CONSTRUCTION | TEST METHODS | USP40–NF35 | 542 | 18-Nov-2016 | 1-Dec-2016 | USP41–NF36 | Second Supplement to USP40–NF35 | Line 1 of Physicochemical Tests/Acidity or Alkalinity/BRP indicator solution: Change 1.0 mg/mL of bromophenol blue, to: 1.0 mg/mL of bromothymol blue, AND Line 3 of Plastic Additives/Polyethylene, Cyclic Olefins, and Polypropylene/Phenolic… Read More |
| DUTASTERIDE | IMPURITIES/Organic Impurities, Procedure 2/Table 4 | USP40–NF35 | 3924 | 18-Nov-2016 | 1-Dec-2016 | USP41–NF36 | Second Supplement to USP40–NF35 | Footnote a: Change (5α,17β)-N-[2,5-Bis(trifluoromethyl)phenyl]-3-oxo-4-azaandrost-17 carboxamide. to: (5α,17β)-N-[2,5-Bis(trifluoromethyl)phenyl]-3-oxo-4-azaandrostane-17-carboxamide. |
| <1010> ANALYTICAL DATA—INTERPRETATION AND TREATMENT | APPENDIX C: EXAMPLES OF OUTLIER TESTS FOR ANALYTICAL DATA/Hampel's Rule | USP39–NF34 | 767 | 30-Sep-2016 | 1-Oct-2016 | USP41–NF36 | First Supplement to USP40–NF35 | Row 13 of Column 4 of Table 5. Test Results of Re-Applied Hampel's Rule: Change 0.14 to: 0.15 |
| CALCIUM GLUCONATE | CHEMICAL INFORMATION | USP39–NF34 | 2877 | 30-Sep-2016 | 1-Oct-2016 | USP41–NF36 | First Supplement to USP40–NF35 | Line 5: Change [18016-24-5]. to: [66905-23-5]. |
| CALCIUM GLUCONATE INJECTION | DEFINITION | USP39–NF34 | 2879 | 30-Sep-2016 | 1-Oct-2016 | USP41–NF36 | First Supplement to USP40–NF35 | Line 8: Change It may contain sodium hydroxide added for adjustment of the pH. to: It may contain sodium hydroxide or hydrochloric acid added for adjustment of the pH. |
| FLUORESCEIN SODIUM | ASSAY/Procedure | USP39–NF34 | 3960 | 30-Sep-2016 | 1-Oct-2016 | USP41–NF36 | First Supplement to USP40–NF35 | Line 3 of Standard stock solution: Change 1.0 mg/mL of fluorescein sodium in Diluent is prepared as follows. to: 1.0 mg/mL of fluorescein sodium is prepared as follows. |
| NORFLOXACIN | SPECIFIC TESTS/Loss on Drying <731> | USP39–NF34 | 5101 | 30-Sep-2016 | 1-Oct-2016 | USP41–NF36 | First Supplement to USP40–NF35 | Line 1 of Analysis: Change Dry at 100° to constant weight. to: Dry under vacuum at a pressure not exceeding 5 mm of mercury at 100° to constant weight. |
| PARICALCITOL INJECTION | IMPURITIES/Organic Impurities/Chromatographic system/Columns | USP39–NF34 | 5279 | 30-Sep-2016 | 1-Oct-2016 | USP41–NF36 | First Supplement to USP40–NF35 | Line 1 of Guard: Change 4.6-mm × 7.5-mm; packing L1 to: 4.6-mm × 7.5-mm or 4.6-mm × 10-mm; packing L1 |
| PHENYTOIN SODIUM | IDENTIFICATION/B. Identification Tests—General, Sodium <191> | USP39–NF34 | 5388 | 30-Sep-2016 | 1-Oct-2016 | USP41–NF36 | First Supplement to USP40–NF35 | Line 2: Change tetramethylammonium hydroxide solution, to: tetramethylammonium hydroxide TS, |
| POTASSIUM CITRATE EXTENDED-RELEASE TABLETS | OTHER COMPONENTS/Content of Potassium | USP39–NF34 | 5465 | 30-Sep-2016 | 1-Oct-2016 | USP41–NF36 | First Supplement to USP40–NF35 | Line 10 of Analysis: Change Result = (C/CU) × [Mr/(3 × Ar)] × 100 to: Result = C × 100/CU AND Line 13 of Analysis: Change CU =… Read More |
| PROPOFOL | ADDITIONAL REQUIREMENTS/USP Reference Standards <11> | USP39–NF34 | 5573 | 30-Sep-2016 | 1-Oct-2016 | USP41–NF36 | First Supplement to USP40–NF35 | Line 2 of USP Propofol Related Compound B RS: Change 2,6-Diisopropylbenzoquinone. to: 2,6-Diisopropyl-1,4-benzoquinone. |
| PROPOFOL INJECTABLE EMULSION | ADDITIONAL REQUIREMENTS/USP Reference Standards <11> | USP39–NF34 | 5575 | 30-Sep-2016 | 1-Oct-2016 | USP41–NF36 | First Supplement to USP40–NF35 | Line 2 of USP Propofol Related Compound B RS: Change 2,6-Diisopropylbenzoquinone. to: 2,6-Diisopropyl-1,4-benzoquinone. |
| TRAVOPROST OPHTHALMIC SOLUTION | ADDITIONAL REQUIREMENTS/USP Reference Standards <11> | USP39–NF34 | 6226 | 30-Sep-2016 | 1-Oct-2016 | USP41–NF36 | First Supplement to USP40–NF35 | Line 2 of USP Travoprost Related Compound A RS: Change (5Z,13E)-(9S,11R,15R)-9,11,15-Trihydroxy-16-(m-trifluoromethylphenoxy)-17,18,19,20-tetranor-5,13-prostadienoic acid. to: (5Z,13E)-(9S,11R,15R)-9,11,15-… Read More |
| VITAMIN A ORAL LIQUID PREPARATION | ASSAY/Vitamin A | USP39–NF34 | 6374 | 30-Sep-2016 | 1-Oct-2016 | USP41–NF36 | First Supplement to USP40–NF35 | Line 7 of Analysis: Change Result = (rU/rS) × (C/W) × (V/D) × U × (100/L) to: Result = (rU/rS) × (C/W) × D × U… Read More |
| ST. JOHN'S WORT | SPECIFIC TESTS | USP39–NF34 | 6817 | 30-Sep-2016 | 1-Oct-2016 | USP41–NF36 | First Supplement to USP40–NF35 | Insert missing test: Articles of Botanical Origin <561>, Methods of Analysis, Total Ash: NMT 5.0% |
| <800> HAZARDOUS DRUGS—HANDLING IN HEALTHCARE SETTINGS | REFERENCES | First Supplement to USP39–NF34 | 7721 | 30-Sep-2016 | 1-Oct-2016 | USP41–NF36 | First Supplement to USP40–NF35 | Line 2 of first reference: Delete http://www.acoem.org/Reproductive_Developmental_Hazard_Management.aspx. AND Line 2 of second reference: Delete … Read More |
| <800> HAZARDOUS DRUGS—HANDLING IN HEALTHCARE SETTINGS | APPENDICES/Appendix 3: Types of Biological Safety Cabinets/Class II | First Supplement to USP39–NF34 | 7721 | 30-Sep-2016 | 1-Oct-2016 | USP41–NF36 | First Supplement to USP40–NF35 | Line 5 of Type A1 (formerly, Type A): Change radionucleotides to: radionuclides AND Line 5 of Type A2 (formerly, Type B3): Change radionucleotides to: radionuclides AND Line 5 of Type B1: Change radionucleotides to: radionuclides … Read More |
| DANTROLENE SODIUM | IDENTIFICATION/D. | First Supplement to USP39–NF34 | 8035 | 30-Sep-2016 | 1-Oct-2016 | USP41–NF36 | First Supplement to USP40–NF35 | Line 2 of Solution A: Change tetramethylammonium hydroxide solution to: tetramethylammonium hydroxide TS |
| OXYMETAZOLINE HYDROCHLORIDE | ADDITIONAL REQUIREMENTS/USP Reference Standards <11> | First Supplement to USP39–NF34 | 8116 | 30-Sep-2016 | 1-Oct-2016 | USP41–NF36 | First Supplement to USP40–NF35 | USP Oxymetazoline Related Compound A RS: Change N-(2-Aminoethyl)-2-[4-(tert-butyl)-3-hydroxy-2,6-dimethylphenyl]acetamide. C16H26N2O2 278.39 to: N-(2-Aminoethyl)-2-[4-(tert-butyl)-3-hydroxy-2,6-dimethylphenyl]… Read More |
| OXYMETAZOLINE HYDROCHLORIDE | IMPURITIES/Organic Impurities/Table 2 | First Supplement to USP39–NF34 | 8116 | 30-Sep-2016 | 1-Oct-2016 | USP41–NF36 | First Supplement to USP40–NF35 | Row 2 of Column 1: Change Oxymetazoline related compound A to: Oxymetazoline related compound Aa AND Add footnote a: N-(2-Aminoethyl)-2-[4-(tert-butyl)-3-hydroxy-2,6-dimethylphenyl]acetamide. |
| PERINDOPRIL ERBUMINE | CHEMICAL INFORMATION | First Supplement to USP39–NF34 | 8127 | 30-Sep-2016 | 1-Oct-2016 | USP41–NF36 | First Supplement to USP40–NF35 | Line 9: Delete (2S,3aS,7aS)-1-{(S)-2-[(R)-1-Ethoxy-1-oxopentan-2-ylamino]propanoyl}octahydro-1H-indole-2-carboxylic acid |
| PERINDOPRIL ERBUMINE | ADDITIONAL REQUIREMENTS/USP Reference Standards <11> | First Supplement to USP39–NF34 | 8127 | 30-Sep-2016 | 1-Oct-2016 | USP41–NF36 | First Supplement to USP40–NF35 | Line 2 of USP Perindopril Related Compound A RS: Change (2S,3aS,7aS)-Octahydro-1H-indole-2-carboxylic acid hydrochloride. C17H28N2O5 · HCl 205.68 to: (2S,3aS,7aS)-Octahydro-1H-… Read More |
| PERINDOPRIL ERBUMINE | IMPURITIES/Organic Impurities/Table 2 | First Supplement to USP39–NF34 | 8127 | 30-Sep-2016 | 1-Oct-2016 | USP41–NF36 | First Supplement to USP40–NF35 | Line 2 of footnote g: Change ocatahydro to: octahydro |
| DESLORATADINE | ADDITIONAL REQUIREMENTS/USP Reference Standards <11> | Second Supplement to USP39–NF34 | 8607 | 30-Sep-2016 | 1-Oct-2016 | USP41–NF36 | First Supplement to USP40–NF35 | Line 2 of USP Desloratadine Related Compound B RS: Change 8-Chloro-11-(1,2,3,6-tetrahydropyridin-4-yl)-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridine. C19H19ClN2 310.82 to: 8-Chloro-11-(1,2,3,6-tetrahydropyridin-4-yl)-6,11-dihydro-5… Read More |
| <1663> EXTRACTABLES ASSOCIATED WITH PHARMACEUTICAL PACKAGING SYSTEMS | REFERENCES | USP39–NF34 | 1835 | 29-Jul-2016 | 1-Aug-2016 | USP41–NF36 | First Supplement to USP40–NF35 | Delete references 5, 7, 9, and 12. |
| <1664> ASSESSMENT OF DRUG PRODUCT LEACHABLES ASSOCIATED WITH PHARMACEUTICAL PACKAGING/DELIVERY SYSTEMS | REFERENCES | USP39–NF34 | 1850 | 29-Jul-2016 | 1-Aug-2016 | USP41–NF36 | First Supplement to USP40–NF35 | Delete reference 8. |
| <1664.1> ORALLY INHALED AND NASAL DRUG PRODUCTS | REFERENCES | USP39–NF34 | 1862 | 29-Jul-2016 | 1-Aug-2016 | USP41–NF36 | First Supplement to USP40–NF35 | Delete reference 3. |
| FELBAMATE ORAL SUSPENSION | PERFORMANCE TESTS/Dissolution <711> | USP39–NF34 | 3855 | 29-Jul-2016 | 1-Aug-2016 | USP41–NF36 | First Supplement to USP40–NF35 | Line 4 of System suitability: Change [Note—The relative retention times for methylparaben and felbamate are about 0.5 and 1.0, respectively.] to: [Note—The relative retention times for felbamate and methylparaben are about 1.0 and 1.5, respectively.] |
| FEXOFENADINE HYDROCHLORIDE | CHEMICAL INFORMATION | USP39–NF34 | 3895 | 29-Jul-2016 | 1-Aug-2016 | USP41–NF36 | First Supplement to USP40–NF35 | Line 7: Change [138452-21-8]. to: [153439-40-8]. |
| FLUORESCEIN SODIUM | IMPURITIES/Organic Impurities | USP39–NF34 | 3960 | 29-Jul-2016 | 1-Aug-2016 | USP41–NF36 | First Supplement to USP40–NF35 | Row 7 of column 1 of Table 2: Change Total impurities to: Total unspecified impurities |
| GRANISETRON HYDROCHLORIDE | USP Reference standards <11> | USP39–NF34 | 4151 | 29-Jul-2016 | 1-Aug-2016 | USP41–NF36 | First Supplement to USP40–NF35 | Line 2 of USP Granisetron Related Compound B RS: Change (N-[(1R,3r,5)-9-Methyl-9-azabicyclo[3.3.1]non-3-yl]-1H-indazole-3-carboxamide). to: (N-[(1R,3r,5S)-9-Methyl-9-azabicyclo[3.3.1]non-3-yl]-1H-indazole-3-carboxamide). AND… Read More |
| GRANISETRON HYDROCHLORIDE INJECTION | USP Reference standards <11> | USP39–NF34 | 4153 | 29-Jul-2016 | 1-Aug-2016 | USP41–NF36 | First Supplement to USP40–NF35 | Line 2 of USP Granisetron Related Compound B RS: Change (N-[(1R,3r,5)-9-Methyl-9-azabicyclo[3.3.1]non-3-yl]-1H-indazole-3-carboxamide). to: N-[(1R,3r,5S)-9-Methyl-9-azabicyclo[3.3.1]non-3-yl]-1H-indazole-3-carboxamide. |
| GRANISETRON HYDROCHLORIDE TABLETS | USP Reference standards <11> | USP39–NF34 | 4155 | 29-Jul-2016 | 1-Aug-2016 | USP41–NF36 | First Supplement to USP40–NF35 | Line 2 of USP Granisetron Related Compound B RS: Change (N-[(1R,3r,5)-9-Methyl-9-azabicyclo[3.3.1]non-3-yl]-1H-indazole-3-carboxamide). to: N-[(1R,3r,5S)-9-Methyl-9-azabicyclo[3.3.1]non-3-yl]-1H-indazole-3-carboxamide. |
| HALCINONIDE CREAM | IMPURITIES/Organic Impurities/Chromatographic system | USP39–NF34 | 4176 | 29-Jul-2016 | 1-Aug-2016 | USP41–NF36 | First Supplement to USP40–NF35 | Line 1 of Column: Change 1.8-µm packing L1 to: 1.7-µm packing L1 |
| HALOPERIDOL DECANOATE | IMPURITIES/Organic Impurities/Table 2 | USP39–NF34 | 4184 | 29-Jul-2016 | 1-Aug-2016 | USP41–NF36 | First Supplement to USP40–NF35 | Footnote k: Change 4-(4′-Chlorobiphenyl-4-yl)-1-[4-(4-fluorophenyl)-4-oxobutyl]piperidin-4-yl decanoate. to: 4-(3′-Chlorobiphenyl-4-yl)-1-[4-(4-fluorophenyl)-4-oxobutyl]piperidin-4-yl decanoate. AND Footnote l: Change 4-(3′-Chlorobiphenyl-4-yl)-1-[4-(4-fluorophenyl)-4-oxobutyl]… Read More |
| KETOROLAC TROMETHAMINE INJECTION | ADDITIONAL REQUIREMENTS/USP Reference Standards <11> | USP39–NF34 | 4468 | 29-Jul-2016 | 1-Aug-2016 | USP41–NF36 | First Supplement to USP40–NF35 | Line 4 of USP Ketorolac Related Compound A RS: Change 358.15 to: 358.39 AND Line 3 of USP Ketorolac Related Compound B RS: Change 227.09 to: 227.26 AND Line 3 of USP Ketorolac Related Compound C RS: Change 225.09 to: 225.24 AND Line 3 of USP Ketorolac… Read More |
| LOVASTATIN | USP Reference standards <11> | USP39–NF34 | 4631 | 29-Jul-2016 | 1-Aug-2016 | USP41–NF36 | First Supplement to USP40–NF35 | Line 2 of USP Lovastatin Related Compound A RS: Change [Dihydro-lovastatin][butanoic acid, 2-methyl-, 1,2,3,4,4a,7,8,8a-octahydro-3,7-dimethyl-8-[2(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α(R*),3α,7β,8β(2S*,4S*),-8αβ]]]-.… Read More |
| NAPROXEN TABLETS | ASSAY/Procedure/System suitability/Suitability requirements | USP39–NF34 | 4993 | 29-Jul-2016 | 1-Aug-2016 | USP41–NF36 | First Supplement to USP40–NF35 | Line 1 of Tailing factor: Change NLT 2.0 to: NMT 2.0 |
| NAPROXEN TABLETS | IMPURITIES/Organic Impurities | USP39–NF34 | 4993 | 29-Jul-2016 | 1-Aug-2016 | USP41–NF36 | First Supplement to USP40–NF35 | Line 6 of Analysis: Change Result = (rU/rS) × (CU/CS) × 100 to: Result = (rU/rS) × (CS/CU… Read More |
| RIZATRIPTAN BENZOATE TABLETS | PERFORMANCE TESTS/Dissolution <711>/Chromatographic procedure | USP39–NF34 | 5750 | 29-Jul-2016 | 1-Aug-2016 | USP41–NF36 | First Supplement to USP40–NF35 | Add Buffer: 1.36 g/L of monobasic potassium phosphate. Adjust the pH of the solution with phosphoric acid to 2.5. |
| SIMETHICONE | ASSAY/Procedure/Analysis | USP39–NF34 | 5843 | 29-Jul-2016 | 1-Aug-2016 | USP41–NF36 | First Supplement to USP40–NF35 | Line 1 of Samples: Change Standard stock solution, Standard solution, Sample stock solution, and Sample solution to: Standard solution and Sample solution |
| SIMVASTATIN TABLETS | IMPURITIES/Organic Impurities/Analysis | USP39–NF34 | 5848 | 29-Jul-2016 | 1-Aug-2016 | USP41–NF36 | First Supplement to USP40–NF35 | Line 5: Change Result = (rU/rS) × (CS/CU) × (Mr1/Mr2) × 100 to: Result = (rU/rS) × (C… Read More |