Monograph Title | Section | Source Publication | Page Number | Errata Post Date Sort ascending | Errata Official Date | Target Errata Print Publication | Target Online Fix Publication | Description |
---|---|---|---|---|---|---|---|---|
AMINOBENZOATE POTASSIUM | IMPURITIES/Limit of Aniline and p-Toluidine | USP41–NF36 | 209 | 31-Aug-2018 | 1-Sep-2018 | USP43–NF38 | Second Supplement to USP41–NF36 | Line 3 of System suitability: Change [Note—The relative retention times of aniline and p-toluidine are about 4.1 and 5.1 min, respectively.] to: [Note—The relative retention times of aniline and p-toluidine are 0.8 and 1.0, respectively… Read More |
FISH OIL CONTAINING OMEGA-3 ACIDS DELAYED-RELEASE CAPSULES | DEFINITION | USP41–NF36 | 4622 | 31-Aug-2018 | 1-Sep-2018 | USP43–NF38 | Second Supplement to USP41–NF36 | Line 7: Change Scombroidae, to: Scombridae, |
MILRINONE LACTATE INJECTION | IMPURITIES/Organic Impurities | USP41–NF36 | 2748 | 31-Aug-2018 | 1-Sep-2018 | USP43–NF38 | Second Supplement to USP41–NF36 | Equation in Analysis: Change Result = (rU/rS) × (CS/CU) × (Mr1/Mr2) × 100 to: Result = (rU… Read More |
HYDROCHLOROTHIAZIDE CAPSULES | PERFORMANCE TESTS/Dissolution/Test 2 | USP41–NF36 | 2049 | 31-Aug-2018 | 1-Sep-2018 | USP43–NF38 | Second Supplement to USP41–NF36 | Line 1 of Empty capsules solution: Change Place 10 Capsules into to: Place 10 empty capsules into |
<1663> ASSESSMENT OF EXTRACTABLES ASSOCIATED WITH PHARMACEUTICAL PACKAGING/DELIVERY SYSTEMS | REFERENCES | USP41–NF36 | 7910 | 27-Jul-2018 | 1-Aug-2018 | USP43–NF38 | Second Supplement to USP41–NF36 | Line 2 of reference 7: Delete http://webstore.ansi.org/RecordDetail.aspx?sku=ASTM%20F1980-07(2011)&source=msn&adgroup=astm. Accessed 19 March 2013. |
FISH OIL CONTAINING OMEGA-3 ACIDS | DEFINITION | USP41–NF36 | 4617 | 27-Jul-2018 | 1-Aug-2018 | USP43–NF38 | Second Supplement to USP41–NF36 | Line 5: Change Scombroidae, to: Scombridae, |
SODIUM FLUORIDE AND ACIDULATED PHOSPHATE TOPICAL SOLUTION | ASSAY | First Supplement to USP41–NF36 | 8423 | 27-Jul-2018 | 1-Aug-2018 | USP43–NF38 | Second Supplement to USP41–NF36 | Line 1 of Sample solution: Change 1.1 µg/mL of sodium fluoride to: 0.5 µg/mL of fluoride ion AND In the variable definition list in Analysis: Change CU = nominal concentration of sodium fluoride in the Sample… Read More |
REAGENTS | CHROMATOGRAPHIC COLUMNS/Packings | USP41–NF36 | 5776 | 27-Jul-2018 | 1-Aug-2018 | USP43–NF38 | Second Supplement to USP41–NF36 | Line 2 of L73: Delete [Note—Available as Jordi-Gel DBV from www.jordiflp.com.] |
DEXAMETHASONE SODIUM PHOSPHATE INJECTION | ADDITIONAL REQUIREMENTS/USP Reference Standards <11> | USP41–NF36 | 1204 | 27-Jul-2018 | 1-Aug-2018 | USP43–NF38 | Second Supplement to USP41–NF36 | Delete USP Endotoxin RS |
RACEPINEPHRINE INHALATION SOLUTION | ADDITIONAL REQUIREMENTS | USP41–NF36 | 3564 | 27-Jul-2018 | 1-Aug-2018 | USP43–NF38 | Second Supplement to USP41–NF36 | Add USP Reference Standards <11> USP Epinephrine Bitartrate RS |
MICONAZOLE NITRATE | IMPURITIES/Organic Impurities | First Supplement to USP41–NF36 | Online | 27-Jul-2018 | 1-Aug-2018 | USP43–NF38 | Second Supplement to USP41–NF36 | (Note: This errata applies to the new USP-NF ONLINE platform only.) Line 1 of Standard solution: Change 1.2 µg/mL each of USP Miconazole Nitrate RS, USP Econazole Nitrate RS, USP Doxazosin Related Compound C RSUSP Doxazosin Related Compound C RS… Read More |
<123> GLUCAGON BIOIDENTITY TESTS | PROCEDURE/B. In Vitro Cell-Based Bioidentity Test | First Supplement to USP41–NF36 | 8627 | 27-Jul-2018 | 1-Aug-2018 | USP43–NF38 | Second Supplement to USP41–NF36 | Line 1 of Medium B: Change Kreb's salt solution containing 0.3% (v/v) human serum albumen to: Krebs' salt solution containing 0.3% (v/v) human serum albumin AND Line 1 of Medium C: change Kreb's salt solution containing 0.3% (v/v)… Read More |
FOLIC ACID INJECTION | USP Reference standards <11> | USP41–NF36 | 1866 | 27-Jul-2018 | 1-Aug-2018 | USP43–NF38 | Second Supplement to USP41–NF36 | Delete USP Endotoxin RS |
ZIPRASIDONE HYDROCHLORIDE | IMPURITIES/Organic Impurities | Second Supplement to USP41–NF36 | 8992 | 27-Jul-2018 | 1-Aug-2018 | USP43–NF38 | Second Supplement to USP41–NF36 | In the second variable definition in Analysis: Change rU = peak response of chloroindolinone or ziprasidone related compound F from the Sample solution to: rU = peak response of chloroindolinone,… Read More |
<661.1> PLASTIC MATERIALS OF CONSTRUCTION | TEST METHODS | USP41–NF36 | 6403 | 27-Jul-2018 | 1-Aug-2018 | USP43–NF38 | Second Supplement to USP41–NF36 | Line 1 of Plastic Additives/Reference solutions/Reference solution I: Change 0.24 mg/mL of USP Plastic Additive 4 RS prepared in the Solvent mixture to: 0.24 mg/mL of USP Plastic Additive 4 RS prepared in methylene… Read More |
DIVALPROEX SODIUM DELAYED-RELEASE CAPSULES | PERFORMANCE TESTS/Dissolution <711>/Test 2 | USP41–NF36 | 1354 | 27-Jul-2018 | 1-Aug-2018 | USP43–NF38 | Second Supplement to USP41–NF36 | Line 1 of Tolerances: Change NMT 20% (Q) of the labeled amount of to: NMT 20% of the labeled amount of |
RACEPINEPHRINE HYDROCHLORIDE | USP Reference standards <11> | USP41–NF36 | 3565 | 27-Jul-2018 | 1-Aug-2018 | USP43–NF38 | Second Supplement to USP41–NF36 | Add USP Epinephrine Bitartrate RS |
MICONAZOLE NITRATE | ADDITIONAL REQUIREMENTS | First Supplement to USP41–NF36 | Online | 27-Jul-2018 | 1-Aug-2018 | USP43–NF38 | Second Supplement to USP41–NF36 | (Note: This errata applies to the new USP-NF ONLINE platform only.) Line 4 of USP Reference Standards <11>: Change USP Doxazosin Related Compound C RS to: USP Miconazole Related Compound C RS AND Line 7 of USP Reference… Read More |
REAGENTS | REAGENTS, INDICATORS, AND SOLUTIONS/Reagent Specifications | USP41–NF36 | 5737 | 27-Jul-2018 | 1-Aug-2018 | USP43–NF38 | Second Supplement to USP41–NF36 | Line 4 of N-(2-Tetrahydrofuroyl)piperazine: Change EMS-DOTTIKON, www.ems-dottikon.ch. to: Oakwood Chemical, www.oakwoodchemical.com. |
BUPROPION HYDROCHLORIDE | IDENTIFICATION/C. Identification Tests—General <191>, Chloride | USP41–NF36 | 573 | 27-Jul-2018 | 1-Aug-2018 | USP43–NF38 | Second Supplement to USP41–NF36 | Line 1 of Acceptance criteria: Change Meets the requirements of test to: Meets the requirements of test A |
RACEPINEPHRINE | USP Reference standards <11> | USP41–NF36 | 3564 | 27-Jul-2018 | 1-Aug-2018 | USP43–NF38 | Second Supplement to USP41–NF36 | Add USP Epinephrine Bitartrate RS |
MICONAZOLE NITRATE | ASSAY/Procedure | First Supplement to USP41–NF36 | Online | 27-Jul-2018 | 1-Aug-2018 | USP43–NF38 | Second Supplement to USP41–NF36 | (Note: This errata applies to the new USP-NF ONLINE platform only.) Line 1 of System suitability solution: Change 0.1 mg/mL of USP Miconazole Nitrate RS and 6 µg/mL of USP Econazole Nitrate RS in Diluent. to: 0.1 mg/mL of USP… Read More |
POLYDEXTROSE | ASSAY/Procedure | First Supplement to USP41–NF36 | 8491 | 29-Jun-2018 | 1-Jul-2018 | USP42–NF37 | Second Supplement to USP41–NF36 | Line 1 of Sample solution: Change Polydextrose, calculated on the anhydrous and ash-free basis, in Mobile phase to: Polydextrose in Mobile phase AND Line 1 of Acceptance criteria: Change NLT 90.0% to: NLT 90.0… Read More |
HYDROGENATED POLYDEXTROSE | ASSAY/Procedure | USP41–NF36 | 5495 | 29-Jun-2018 | 1-Jul-2018 | USP42–NF37 | Second Supplement to USP41–NF36 | Change Standard solution: 4.0 mg/mL of USP Polydextrose RS, calculated on the anhydrous and ash-free basis, in Mobile phase Sample solution: 4.0 mg/mL of Hydrogenated Polydextrose, calculated on the anhydrous and ash-free basis, in … Read More |
<198> NUCLEAR MAGNETIC RESONANCE SPECTROSCOPY IDENTITY TESTING OF BACTERIAL POLYSACCHARIDES USED IN VACCINE MANUFACTURE | 2. PROCEDURE | First Supplement to USP41–NF36 | 8633 | 29-Jun-2018 | 1-Jul-2018 | USP42–NF37 | Second Supplement to USP41–NF36 | Line 3 of 2.1 Equipment Requirements/Processing Parameters: Change adsorption to: absorption |
CALCIUM CITRATE MALATE | IMPURITIES/Limit of Fluoride | First Supplement to USP41–NF36 | 8299 | 29-Jun-2018 | 1-Jul-2018 | USP42–NF37 | Second Supplement to USP41–NF36 | Line 1 of Standard solution: Change Transfer 1.0 mL of Standard stock solution to: Transfer 2.0 mL of Standard stock solution |
CHORIONIC GONADOTROPIN FOR INJECTION | ADDITIONAL REQUIREMENTS | USP41–NF36 | 1982 | 29-Jun-2018 | 1-Jul-2018 | USP42–NF37 | Second Supplement to USP41–NF36 | Line 2 of USP Reference Standards <11>: Delete USP Endotoxin RS |
ESZOPICLONE | ADDITIONAL REQUIREMENTS/USP Reference Standards | Second Supplement to USP41–NF36 | Online | 25-May-2018 | 1-Jun-2018 | USP42–NF37 | Second Supplement to USP41–NF36 | Line 2 of USP Eszopiclone Related Compound A RS: [Note—This material may be available in the free base or salt form.] 6-(5-Chloropyridin-2-yl)-7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b]pyrazin-5-yl 4-methylpiperazine-1-carboxylate 4-oxide… Read More |
FLUMAZENIL | IMPURITIES/Limit of Flumazenil Related Compound C | USP41–NF36 | 1775 | 25-May-2018 | 1-Jun-2018 | USP42–NF37 | Second Supplement to USP41–NF36 | Line 2 of Standard solution B: Change 0.12 μg/mL to: 0.12 μL/mL |
SODIUM METABISULFITE | ASSAY/Procedure/Analysis | USP41–NF36 | 5573 | 25-May-2018 | 1-Jun-2018 | USP42–NF37 | Second Supplement to USP41–NF36 | In the Calculate statement: Change sodium metabisulfite (Na2S2O5) to: sulfur dioxide (SO2) |
<210> MONOSACCHARIDE ANALYSIS | PROCEDURES/Procedure 3: Enzymatic Hydrolysis and Analysis by RP-HPLC of DMB-labeled Sialic Acids | First Supplement to USP41–NF36 | Online | 25-May-2018 | 1-Jun-2018 | USP42–NF37 | Second Supplement to USP41–NF36 | Line 6 of Analysis: Change Convert the protein concentration from mg/mL to (1 μM = 1 nmol/mL). to: Convert the protein concentration from mg/mL to μM (1 μM = 1 nmol/mL). |
CARBIDOPA AND LEVODOPA TABLETS | ASSAY/Procedure/Chromatographic system | USP41–NF36 | 693 | 25-May-2018 | 1-Jun-2018 | USP42–NF37 | Second Supplement to USP41–NF36 | Line 1 of Detector: Change Identification B, to: Identification A, |
ERYTHRITOL | IMPURITIES/Related Compounds/Analysis | USP41–NF36 | 5335 | 25-May-2018 | 1-Jun-2018 | USP42–NF37 | Second Supplement to USP41–NF36 | Line 2: Change Samples: Standard solution and Sample solution to: Samples: Standard solution A and Sample solution AND In the variable definition list: Change rS =… Read More |
<1661> EVALUATION OF PLASTIC PACKAGING SYSTEMS AND THEIR MATERIALS OF CONSTRUCTION WITH RESPECT TO THEIR USER SAFETY IMPACT | APPLICABILITY AND APPLICATION OF <661.1> | USP41–NF36 | 7902 | 25-May-2018 | 1-Jun-2018 | USP42–NF37 | Second Supplement to USP41–NF36 | Line 3 of Application/4.: Change proscribed to: prescribed AND Line 3 of Description of Polymers Contained in <661.1>/Polyethylenes: Change Low-density polypropylene (LDPE) to: Low-density polyethylene (… Read More |
ESZOPICLONE TABLETS | ADDITIONAL REQUIREMENTS/USP Reference Standards | Second Supplement to USP41–NF36 | Online | 25-May-2018 | 1-Jun-2018 | USP42–NF37 | Second Supplement to USP41–NF36 | Line 2 of USP Eszopiclone Related Compound A RS: [Note—This material may be available in the free base or salt form.] 6-(5-Chloropyridin-2-yl)-7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b]pyrazin-5-yl 4-methylpiperazine-1-carboxylate 4-oxide… Read More |
LAMIVUDINE ORAL SOLUTION | ASSAY/Procedure/Chromatographic system | USP41–NF36 | 2328 | 25-May-2018 | 1-Jun-2018 | USP42–NF37 | Second Supplement to USP41–NF36 | Line 1 of Flow rate: Change 1 mL/mL to: 1 mL/min |
COMPRESSIBLE SUGAR | IMPURITIES/Limit of Calcium | USP41–NF36 | 5631 | 25-May-2018 | 1-Jun-2018 | USP42–NF37 | Second Supplement to USP41–NF36 | Line 1: Delete Proceed as directed in Identification Tests—General <191>, Calcium. |
ZIPRASIDONE HYDROCHLORIDE | IMPURITIES/Organic Impurities/Analysis | Second Supplement to USP41–NF36 | 8993 | 25-May-2018 | 1-Jun-2018 | USP42–NF37 | Second Supplement to USP41–NF36 | In the second Calculate statement: Change chloroindolinone and ziprasidone related compound F to: chloroindolinone, ziprasidone related compound F, and any individual unspecified impurity AND In the second variable definition list: Change F… Read More |
DOXEPIN HYDROCHLORIDE | ADDITIONAL REQUIREMENTS/USP Reference Standards <11> | USP41–NF36 | 1404 | 25-May-2018 | 1-Jun-2018 | USP42–NF37 | Second Supplement to USP41–NF36 | Line 2 of USP Doxepin Related Compound C RS: Change (E,Z)-3-(Dibenzo[b,e]oxepin-11(6H-ylidene)-N-methyl-propoan-1-amine. to: (E,Z)-3-(Dibenzo[b,e]oxepin-11(6H)-ylidene)-N-methylpropan-1-… Read More |
ETHYLENE GLYCOL AND VINYL ALCOHOL GRAFT COPOLYMER | IMPURITIES/Procedure 2: Vinyl Acetate | USP41–NF36 | 5346 | 25-May-2018 | 1-Jun-2018 | USP42–NF37 | Second Supplement to USP41–NF36 | Line 6 of Sample solution: Change Pass through a 0.2-mm membrane filter. to: Pass through a 0.2-μm membrane filter. |
MICONAZOLE NITRATE TOPICAL POWDER | ADDITIONAL REQUIREMENTS/USP Reference Standards <11> | First Supplement to USP41–NF36 | 8355 | 25-May-2018 | 1-Jun-2018 | USP42–NF37 | Second Supplement to USP41–NF36 | Line 2 of USP Miconazole Related Compound C RS: Change 2-[(2,4-Dichlorobenzyl)oxy]-2-(2,4-dichlorophenyl)ethan-1-amine. C15H13Cl4NO 365.08 to: 2-[(2,4-Dichlorobenzyl)oxy]-2-(2,4-dichlorophenyl)ethan-1-amine… Read More |
CHOLESTEROL | IMPURITIES/Limit of Related Sterols and Other Organic Impurities/Analysis | USP41–NF36 | 5296 | 25-May-2018 | 1-Jun-2018 | USP42–NF37 | Second Supplement to USP41–NF36 | In the second variable definition list: Change CS2 = concentration of USP Cholesterol RS in the Standard solution (mg/mL) to: CS2 = concentration of USP Cholesterol RS in the System suitability… Read More |
<1601> PRODUCTS FOR NEBULIZATION—CHARACTERIZATION TESTS | AERODYNAMIC ASSESSMENT OF NEBULIZED AEROSOLS | USP41–NF36 | 7874 | 25-May-2018 | 1-Jun-2018 | USP42–NF37 | Second Supplement to USP41–NF36 | Line 1 of paragraph 3: Change general information chapter Aerosols, Nasal Sprays, Metered-Dose Inhalers, and Dry Powder Inhalers <601>), to: general chapter Inhalation and Nasal Drug Products: Aerosols, Sprays, and Powders—… Read More |
<724> DRUG RELEASE | GENERAL DRUG RELEASE STANDARDS | USP41–NF36 | 6471 | 27-Apr-2018 | 1-May-2018 | USP42–NF37 | Second Supplement to USP41–NF36 | Figure 5: Change O to: Ø |
ISOSORBIDE DINITRATE CHEWABLE TABLETS | Identification | USP41–NF36 | 2270 | 27-Apr-2018 | 1-May-2018 | USP42–NF37 | Second Supplement to USP41–NF36 | Line 1: Change Chewable Tablets respond to the Identification test under Isosorbide Dinitrate Tablets. to: Transfer a suitable quantity of finely powdered Tablets to a glass-stoppered centrifuge tube. Add 10 mL of sodium hydroxide solution (1… Read More |
ETHYL ACETATE | IMPURITIES/Chromatographic Purity | USP41–NF36 | 5336 | 27-Apr-2018 | 1-May-2018 | USP42–NF37 | Second Supplement to USP41–NF36 | Line 3 of Acceptance criteria: Change Ethyl isobutyl ether: to: 1-Ethoxy-2-methylpropane: |
<1210> STATISTICAL TOOLS FOR PROCEDURE VALIDATION | 3. ACCURACY AND PRECISION | USP41–NF36 | 7622 | 27-Apr-2018 | 1-May-2018 | USP42–NF37 | Second Supplement to USP41–NF36 | Line 4 of paragraph 3 of 3.2 Combined Validation of Accuracy and Precision: Change validate evaluate to: validate AND Variable definition in paragraph 6 of 3.2 Combined Validation of Accuracy and Precision:… Read More |
ARGATROBAN | ADDITIONAL REQUIREMENTS/USP Reference Standards <11> | USP41–NF36 | 346 | 27-Apr-2018 | 1-May-2018 | USP42–NF37 | Second Supplement to USP41–NF36 | Line 2 of USP Argatroban Related Compound B RS: Change Ethyl (2R,4R)-1-[N8-nitro-L-arginyl]-4-methylpiperidine-2-carboxylate hydrochloride. C15H28N6O5 ∙ HCl 408.88 to: … Read More |
DIDANOSINE FOR ORAL SOLUTION | ASSAY/Procedure/Chromatographic system | USP41–NF36 | 1275 | 27-Apr-2018 | 1-May-2018 | USP42–NF37 | Second Supplement to USP41–NF36 | Line 1 of Guard column: Change 20-cm; to: 20-mm; |
ISOSORBIDE DINITRATE SUBLINGUAL TABLETS | Assay | USP41–NF36 | 2272 | 27-Apr-2018 | 1-May-2018 | USP42–NF37 | Second Supplement to USP41–NF36 | Change Buffer solution, Mobile phase, Internal standard solution, Standard preparation, and Chromatographic system—Prepare as directed in the Assay under Diluted Isosorbide Dinitrate. to: Buffer… Read More |