Monograph Title | Section | Source Publication | Page Number | Errata Post Date Sort ascending | Errata Official Date | Target Errata Print Publication | Target Online Fix Publication | Description |
---|---|---|---|---|---|---|---|---|
DEXAMETHASONE SODIUM PHOSPHATE INJECTION | ASSAY/Procedure | Interim Revision Announcement (Official May 01, 2015) | Online | 29-Jan-2016 | 1-Feb-2016 | USP40–NF35 | Second Supplement to USP39–NF34 | Line 9 of Analysis: Change CS = concentration of USP Dexamethasone Sodium Phosphate RS in the Standard solution (µg/mL) to: CS = concentration of USP Dexamethasone Sodium Phosphate RS in the Standard solution (mg/mL) |
GALANTAMINE HYDROBROMIDE | IMPURITIES/Organic Impurities | USP38–NF33 | 3646 | 29-Jan-2016 | 1-Feb-2016 | USP40–NF35 | Second Supplement to USP39–NF34 | Line 8 of Analysis: Change Result = (rU/rS) × (CS/CU) × (1/F) × (100/100 − L) to: Result = (rU/rS) × (C… Read More |
GLUCOSAMINE SULFATE POTASSIUM CHLORIDE | CHEMICAL INFORMATION | USP38–NF33 | 6074 | 29-Jan-2016 | 1-Feb-2016 | USP40–NF35 | Second Supplement to USP39–NF34 | Line 5: Change [38899-05-7]. to: [1296149-08-0]. |
ALTEPLASE FOR INJECTION | ASSAY/Biological Potency | USP39–NF34 | 2401 | 29-Jan-2016 | 1-Feb-2016 | USP40–NF35 | Second Supplement to USP39–NF34 | Line 1 of Human thrombin solution: Change 33 Units in terms of the U.S. Standard Thrombin/mL in Buffer to: 33 U.S. Units in terms of the U.S. Standard Thrombin/mL in Buffer AND Line 5 of Analysis: Change Standard solution and Sample solution… Read More |
RISPERIDONE TABLETS | Assay | USP38–NF33 | 5195 | 29-Jan-2016 | 1-Feb-2016 | USP40–NF35 | Second Supplement to USP39–NF34 | Line 4 of Procedure: Change Calculate the quantity, in mg, of risperidone to: Calculate the percentage of the labeled amount of risperidone |
IMIQUIMOD CREAM | SPECIFIC TESTS/pH <791> | First Supplement to USP38–NF33 | 7409 | 29-Jan-2016 | 1-Feb-2016 | USP40–NF35 | Second Supplement to USP39–NF34 | Line 1 of Sample: Change Nominally 50 mg/mL of imiquimod from Cream in water. to: Nominally 2.5 mg/mL of imiquimod from Cream in water. |
DEXAMETHASONE SODIUM PHOSPHATE OPHTHALMIC SOLUTION | ASSAY/Procedure | Interim Revision Announcement (Official May 01, 2015) | Online | 29-Jan-2016 | 1-Feb-2016 | USP40–NF35 | Second Supplement to USP39–NF34 | Line 9 of Analysis: Change CS = concentration of USP Dexamethasone Sodium Phosphate RS in the Standard solution (µg/mL) to: CS = concentration of USP Dexamethasone Sodium Phosphate RS in the Standard solution (mg/mL) |
GALANTAMINE TABLETS | PERFORMANCE TESTS/Dissolution | USP38–NF33 | 3649 | 29-Jan-2016 | 1-Feb-2016 | USP40–NF35 | Second Supplement to USP39–NF34 | Line 6 of Analysis in Test 1: Change Result = (AU/AS) × (CS/L) × (Mr1/Mr2) × 100 to: Result = (AU/AS… Read More |
GLUCOSAMINE SULFATE SODIUM CHLORIDE | CHEMICAL INFORMATION | USP38–NF33 | 6075 | 29-Jan-2016 | 1-Feb-2016 | USP40–NF35 | Second Supplement to USP39–NF34 | Line 5: Change [38899-05-7]. to: [1296149-13-7]. |
ROPINIROLE TABLETS | IMPURITIES/Organic Impurities | USP39–NF34 | 5756 | 29-Jan-2016 | 1-Feb-2016 | USP40–NF35 | Second Supplement to USP39–NF34 | Footnote b of Table 2: Change 4-[2-(Dipropylnitroryl)ethyl]-1,3-dihydrox-2H-indol-2-one. to: N-[2-(2-Oxoindolin-4-yl)ethyl]-N-propylpropan-1-amine oxide. |
DEXTROAMPHETAMINE SULFATE | ASSAY/Procedure | USP38–NF33 | 3060 | 29-Jan-2016 | 1-Feb-2016 | USP40–NF35 | Second Supplement to USP39–NF34 | Line 1 of System suitability solution: Change 0.02 µg/mL each of USP Dextroamphetamine Related Compound A RS and USP Dextroamphetamine Related Compound B RS in Standard solution to: Transfer about 40 mL of the Standard solution to a 50-mL volumetric flask. Using a… Read More |
TAMSULOSIN HYDROCHLORIDE CAPSULES | ASSAY/Procedure 8 | USP38–NF33 | 5442 | 29-Jan-2016 | 1-Feb-2016 | USP40–NF35 | Second Supplement to USP39–NF34 | Line 1 of Standard solution: Change Prepare a solution containing 1.0 mg/mL of USP Tamsulosin Hydrochloride RS in methanol. to: Prepare a solution containing 0.1 mg/mL of USP Tamsulosin Hydrochloride RS in methanol. AND Line 6 of Sample solution: Change Add 30 mL of… Read More |
ALTEPLASE | ASSAY/Biological Potency | USP39–NF34 | 2398 | 29-Jan-2016 | 1-Feb-2016 | USP40–NF35 | Second Supplement to USP39–NF34 | Line 1 of Human thrombin solution: Change 33 Units in terms of the U.S. Standard Thrombin/mL in Buffer to: 33 U.S. Units in terms of the U.S. Standard Thrombin/mL in Buffer AND Line 5 of Analysis: Change Standard solution and Sample solution… Read More |
NIFEDIPINE EXTENDED-RELEASE TABLETS | PERFORMANCE TESTS/Dissolution <711>/Test 9 | Revision Bulletin (Official December 01, 2015) | Online | 29-Jan-2016 | 1-Feb-2016 | USP40–NF35 | Second Supplement to USP39–NF34 | Line 4 of Medium: Change 6 g/L to: 10 g/L |
<852> ATOMIC ABSORPTION SPECTROSCOPY | VALIDATION AND VERIFICATION/Precision/Intermediate Precision | USP38–NF33 | 649 | 20-Nov-2015 | 1-Dec-2015 | USP40–NF35 | Second Supplement to USP39–NF34 | Line 3: Change As a minimum, the analytical procedure should be assessed by performing the repeatability test in any of the conditions previously mentioned (totaling 12 measurements). to: As a minimum, the analytical procedure should be assessed by performing the repeatability test in… Read More |
OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION | IMPURITIES/Limit of Late Eluting Impurities | USP38–NF33 | 4625 | 20-Nov-2015 | 1-Dec-2015 | USP40–NF35 | Second Supplement to USP39–NF34 | Add [Note–Protect solutions from light.] |
MILK THISTLE | COMPOSITION/Content of Silymarin | Second Supplement to USP38–NF33 | 7878 | 20-Nov-2015 | 1-Dec-2015 | USP40–NF35 | Second Supplement to USP39–NF34 | Line 3 of Sample stock solution: Change Transfer the thimble to a continuous-extraction apparatus fitted with a 250-mL round-bottom flask containing 150 mL of hexane, and heat the flask on a heating mantle for 4 h. After the extraction, detach the round-bottom flask from the extraction… Read More |
LOPINAVIR AND RITONAVIR ORAL SOLUTION | IMPURITIES/Organic Impurities | Second Supplement to USP38–NF33 | 8139 | 20-Nov-2015 | 1-Dec-2015 | USP40–NF35 | Second Supplement to USP39–NF34 | Row 17 of Column 3 of Table 2: Change 0.2 to: 0.2p AND Add footnote pDisregard any peak less than 0.01%. |
ISOSORBIDE MONONITRATE TABLETS | USP Reference standards <11> | USP38–NF33 | 3974 | 20-Nov-2015 | 1-Dec-2015 | USP40–NF35 | Second Supplement to USP39–NF34 | Line 2 of USP Diluted Isosorbide Mononitrate Related Compound A RS: Change 1,4:3,5-Dianhydro-D-glucitol 2-nitrate. to: 1,4:3,6-Dianhydro-D-glucitol 2-nitrate. |
METAXALONE TABLETS | PERFORMANCE TESTS/Dissolution <711> | First Supplement to USP38–NF33 | 7432 | 20-Nov-2015 | 1-Dec-2015 | USP40–NF35 | Second Supplement to USP39–NF34 | Line 2 of Buffer, Mobile phase, Chromatographic system, and System suitability: Change Proceed as directed in the Assay. to: Proceed as directed in the Assay, except use 270 nm for analysis. AND Line 10 of Analysis: Change V = volume of… Read More |
CORTICOTROPIN FOR INJECTION | ASSAY/Procedure | Second Supplement to USP38–NF33 | 8061 | 20-Nov-2015 | 1-Dec-2015 | USP40–NF35 | Second Supplement to USP39–NF34 | Line 7 of Replication: Change (see <111>, Confidence Intervals for Individual Assays). to: (see <111>, The Confidence Interval and Limits of Potency). |
<659> PACKAGING AND STORAGE REQUIREMENTS | GENERAL DEFINITIONS | USP38–NF33 | 447 | 20-Nov-2015 | 1-Dec-2015 | USP40–NF35 | Second Supplement to USP39–NF34 | Line 1 of Single-Dose (see also Injections <1>, Containers for Injections): Change A single-unit package for an article intended for parenteral administration. Examples of single-dose containers include prefilled syringes, cartridges, fusion-sealed containers, and closure-… Read More |
CYCLOBENZAPRINE HYDROCHLORIDE TABLETS | IMPURITIES/Organic Impurities/Analysis | USP38–NF33 | 2972 | 20-Nov-2015 | 1-Dec-2015 | USP40–NF35 | Second Supplement to USP39–NF34 | Line 3: Change Calculate the percentage of any individual unspecified degradation product to: Calculate the percentage of any individual degradation product AND Line 6: Change rU = peak response of any individual unspecified degradation product from the… Read More |
LIGHT MINERAL OIL | SPECIFIC TESTS/Readily Carbonizable Substances Test <271> | USP38–NF33 | 6763 | 20-Nov-2015 | 1-Dec-2015 | USP40–NF35 | Second Supplement to USP39–NF34 | Line 1 of Acceptance criteria: Change The Sample may turn hazy, but it remains colorless, or shows a slight pink or yellow color, and the Sample does not become darker than the Standard solution. to: The oil portion of the Sample may turn hazy, but it… Read More |
POWDERED MILK THISTLE | COMPOSITION/Content of Silymarin | Second Supplement to USP38–NF33 | 7880 | 20-Nov-2015 | 1-Dec-2015 | USP40–NF35 | Second Supplement to USP39–NF34 | Line 3 of Sample stock solution: Change Transfer the thimble to a continuous-extraction apparatus fitted with a 250-mL round-bottom flask containing 150 mL of hexane, and heat the flask on a heating mantle for 4 h. After the extraction, detach the round-bottom flask from the extraction… Read More |
MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLETS | IMPURITIES/Organic Impurities | Second Supplement to USP38–NF33 | 8158 | 20-Nov-2015 | 1-Dec-2015 | USP40–NF35 | Second Supplement to USP39–NF34 | Row 6 of Column 2 of Table 5: Change 0.62 to: 0.82 |
<601> INHALATION AND NASAL DRUG PRODUCTS—AEROSOLS, SPRAYS, AND POWDERS—PERFORMANCE QUALITY TESTS | C. AERODYNAMIC SIZE DISTRIBUTION—INHALATION AEROSOLS, SPRAYS, AND POWDERS | USP38–NF33 | 388 | 20-Nov-2015 | 1-Dec-2015 | USP40–NF35 | Second Supplement to USP39–NF34 | Line 13 of paragraph 2 of C.3 Apparatus 2 for Inhalation Powders—Marple Miller Impactor/C.3.1 Design—Apparatus 2: Change Adjust the timer controlling the operation of the two-way solenoid valve so that it opens this valve for a duration of T seconds as determined during… Read More |
OLMESARTAN MEDOXOMIL | IMPURITIES/Organic Impurities | USP38–NF33 | 4622 | 20-Nov-2015 | 1-Dec-2015 | USP40–NF35 | Second Supplement to USP39–NF34 | Footnote d of Impurity Table: Change (5-Methyl-2-oxo-1,3-dioxol-4-yl)methyl 4-(2-hydroxypropan-2-yl)-2-propyl-1-((2′-(2-trityl-1H-tetrazol-5-yl)biphenyl-4-yl)methyl)-1H-imidazole-5-carboxylate. to: (5-Methyl-2-oxo-1,3-dioxol-4-yl)methyl 4-(2-hydroxypropan-2-yl)-2-… Read More |
DESCRIPTION AND SOLUBILITY | SUNFLOWER OIL | Second Supplement to USP38–NF33 | 7761 | 20-Nov-2015 | 1-Dec-2015 | USP40–NF35 | Second Supplement to USP39–NF34 | Line 5: Change NF category: Coating agent; emollient; solvent; tablet and/or capsule diluent; vehicle (oleaginous). to: NF category: Coating agent; emollient; solvent; diluent; vehicle (oleaginous). |
REPOSITORY CORTICOTROPIN INJECTION | ASSAY/Procedure | Second Supplement to USP38–NF33 | 8063 | 20-Nov-2015 | 1-Dec-2015 | USP40–NF35 | Second Supplement to USP39–NF34 | Line 7 of Replication: Change (see <111>, Confidence Intervals for Individual Assays). to: (see <111>, The Confidence Interval and Limits of Potency). |
DILUTED ISOSORBIDE MONONITRATE | USP Reference standards <11> | USP38–NF33 | 3973 | 20-Nov-2015 | 1-Dec-2015 | USP40–NF35 | Second Supplement to USP39–NF34 | Line 2 of USP Diluted Isosorbide Mononitrate Related Compound A RS: Change 1,4:3,5-Dianhydro-D-glucitol 2-nitrate. to: 1,4:3,6-Dianhydro-D-glucitol 2-nitrate. |
CEFDINIR FOR ORAL SUSPENSION | PERFORMANCE TESTS/Dissolution <711> | First Supplement to USP38–NF33 | 7357 | 20-Nov-2015 | 1-Dec-2015 | USP40–NF35 | Second Supplement to USP39–NF34 | Line 5 of Analysis: Change Result = (AU/AS) × CS × d × V × D × (1/L) × 100 to: Result = (AU/AS) × CS × (… Read More |
CORTICOTROPIN INJECTION | ASSAY/Procedure | Second Supplement to USP38–NF33 | 8059 | 20-Nov-2015 | 1-Dec-2015 | USP40–NF35 | Second Supplement to USP39–NF34 | Line 7 of Replication: Change (see <111>, Confidence Intervals for Individual Assays). to: (see <111>, The Confidence Interval and Limits of Potency). |
MANNITOL INJECTION | Specific rotation <781> | Second Supplement to USP38–NF33 | Online | 20-Nov-2015 | 1-Dec-2015 | USP40–NF35 | Second Supplement to USP39–NF34 | Line 1: Change Transfer an accurately measured volume of Injection, equivalent to about 1 g of mannitol as determined by the Assay, to a 100-mL volumetric flask:it meets the requirements of the test for Specific rotation under Mannitol. to: +137° to +145°.Transfer… Read More |
RIVASTIGMINE | IMPURITIES/Organic Impurities | USP38–NF33 | 5212 | 25-Sep-2015 | 1-Oct-2015 | USP40–NF35 | First Supplement to USP39–NF34 | Row 3 of Column 1 of Table 1: Change Nor impurity (rivastigmine related compound B) to: Nor impuritya AND Add footnote a: a(S)‐3‐[1‐(Dimethylamino)ethyl]phenyl dimethylcarbamate (racemic mixture is rivastigmine related compound B). |
ROPIVACAINE HYDROCHLORIDE INJECTION | USP Reference standards <11> | USP38–NF33 | 5227 | 25-Sep-2015 | 1-Oct-2015 | USP40–NF35 | First Supplement to USP39–NF34 | Line 2 of USP Ropivacaine Related Compound B RS: Change (R)-ropivacaine hydrochloride monohydrate; (R)-(−)-1-propylpiperidine-2-carboxylic acid (2,6-dimethylphenyl)-amide hydrochloride monohydrate. to: (R)-Ropivacaine hydrochloride monohydrate; (R)-(+)-1-… Read More |
CALCIUM LACTATE TABLETS | ASSAY/Procedure | USP38–NF33 | 2553 | 25-Sep-2015 | 1-Oct-2015 | USP40–NF35 | First Supplement to USP39–NF34 | Line 3 of Analysis: Change While stirring, add 30 mL of Titrant from a 50-mL buret. to: While stirring, add 15 mL of Titrant from a 50-mL buret. |
IPRATROPIUM BROMIDE | ASSAY/Procedure | USP38–NF33 | 3932 | 25-Sep-2015 | 1-Oct-2015 | USP40–NF35 | First Supplement to USP39–NF34 | Line 4 of Analysis: Change (C20H30BrNO3 · H2O) to: (C20H30BrNO3) |
RIBAVIRIN TABLETS | IMPURITIES/Organic Impurities, Procedure 1 | USP38–NF33 | 5162 | 25-Sep-2015 | 1-Oct-2015 | USP40–NF35 | First Supplement to USP39–NF34 | Footnote e of Table 2: Change 1-β-D-Ribofuranosyl-1H-1,2,4-triazole-3-carboxamide. to: 1-β-D-Ribofuranosyl-1H-1,2,4-triazole-5-carboxamide. |
RIVASTIGMINE TARTRATE CAPSULES | ADDITIONAL REQUIREMENTS/USP Reference Standards <11> | USP38–NF33 | 5215 | 25-Sep-2015 | 1-Oct-2015 | USP40–NF35 | First Supplement to USP39–NF34 | Line 2 of USP Rivastigmine Related Compound B RS: Change N,N-Dimethylcarbamic acid-3-[1-(dimethylamino)ethyl]phenyl ester. to: (RS)‐3‐[1‐(Dimethylamino)ethyl]phenyl dimethylcarbamate. |
CHLORPHENIRAMINE MALEATE | SPECIFIC TESTS/Optical Rotation, Specific Rotation <781> | Second Supplement to USP38–NF33 | Online | 25-Sep-2015 | 1-Oct-2015 | USP40–NF35 | First Supplement to USP39–NF34 | Line 1: Delete Specific Rotation |
<1024> BOVINE SERUM | APPENDIX 1 | USP38–NF33 | 719 | 25-Sep-2015 | 1-Oct-2015 | USP40–NF35 | First Supplement to USP39–NF34 | Line 2 of bullet 1 of International Regulations and Guidance Documents in second paragraph: Change http://www.emea.europa.eu/pdfs/human/bwp/026895en.pdf to: … Read More |
HYDROXYZINE PAMOATE ORAL SUSPENSION | ADDITIONAL REQUIREMENTS/USP Reference Standards <11> | USP38–NF33 | 3817 | 25-Sep-2015 | 1-Oct-2015 | USP40–NF35 | First Supplement to USP39–NF34 | Delete USP Hydroxyzine Hydrochloride RS |
NOREPINEPHRINE BITARTRATE | CHEMICAL INFORMATION | USP38–NF33 | 4582 | 25-Sep-2015 | 1-Oct-2015 | USP40–NF35 | First Supplement to USP39–NF34 | Line 6: Change [69815-49-2]. to: [108341-18-0]. |
RIVASTIGMINE TARTRATE | ADDITIONAL REQUIREMENTS/USP Reference Standards <11> | USP38–NF33 | 5213 | 25-Sep-2015 | 1-Oct-2015 | USP40–NF35 | First Supplement to USP39–NF34 | Line 2 of USP Rivastigmine Related Compound B RS: Change N,N-Dimethylcarbamic acid-3-[1-(dimethylamino)ethyl]phenyl ester. to: (RS)‐3‐[1‐(Dimethylamino)ethyl]phenyl dimethylcarbamate. |
VALGANCICLOVIR HYDROCHLORIDE | Assay | USP38–NF33 | 5729 | 25-Sep-2015 | 1-Oct-2015 | USP40–NF35 | First Supplement to USP39–NF34 | Line 4 of Procedure: Change Calculate the percentage, on the anhydrous and solvent-free basis, of C14H22N6O5 · HCl to: Calculate the percentage of valganciclovir hydrochloride (C14H22N6O5 · HCl… Read More |
<4> MUCOSAL DRUG PRODUCTS—PRODUCT QUALITY TESTS | PRODUCT QUALITY TESTS FOR MUCOSAL DRUG PRODUCTS/General Necessary Tests/Impurities | USP38–NF33 | 76 | 25-Sep-2015 | 1-Oct-2015 | USP40–NF35 | First Supplement to USP39–NF34 | Line 1 of footnote 2: Change http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q3B_R2/Step4/Q3B_R2_Guideline.pdf. to: … Read More |
CHLOROXYLENOL | IMPURITIES/Limit of Tetrachloroethylene | USP38–NF33 | 2774 | 25-Sep-2015 | 1-Oct-2015 | USP40–NF35 | First Supplement to USP39–NF34 | Row 3 of Column 1 of Table 2: Change 210 to: 70 Row 3 of Column 2 of Table 2: Change 0 to: 35 |
METHOHEXITAL | CHEMICAL INFORMATION | USP38–NF33 | 4316 | 25-Sep-2015 | 1-Oct-2015 | USP40–NF35 | First Supplement to USP39–NF34 | Line 5: Change [18652-93-2] to: [151-83-7] |
RIVASTIGMINE | ADDITIONAL REQUIREMENTS/USP Reference Standards <11> | USP38–NF33 | 5212 | 25-Sep-2015 | 1-Oct-2015 | USP40–NF35 | First Supplement to USP39–NF34 | Line 2 of USP Rivastigmine Related Compound B RS: Change Nor impurity; (S)-3-[1-(Dimethylamino)ethyl]phenyl dimethylcarbamate. to: Nor impurity (racemic mixture); (RS)‐3‐[1‐(Dimethylamino)ethyl]phenyl dimethylcarbamate. |