Monograph Title | Section | Source Publication | Page Number | Errata Post Date Sort ascending | Errata Official Date | Target Errata Print Publication | Target Online Fix Publication | Description |
---|---|---|---|---|---|---|---|---|
FLUDARABINE PHOSPHATE | IMPURITIES/Limit of Sodium | USP37–NF32 | 3003 | 21-Nov-2014 | 1-Dec-2014 | USP39–NF34 | Second Supplement to USP38–NF33 | Line 1 of Standard solution: Change 1 µg/mL of sodium chloride in water to: 1 µg/mL of sodium in water |
MINOCYCLINE FOR INJECTION | IMPURITIES | USP37–NF32 | 3843 | 21-Nov-2014 | 1-Dec-2014 | USP39–NF34 | Second Supplement to USP38–NF33 | Line 6 of Limit of Epiminocycline: Change [Note—The relative retention times for epiminocycline and minocycline are 0.86 and 1.0, respectively.] to: [Note—The relative retention times for epiminocycline and minocycline are 0.7 and 1.0, respectively.] |
SULFAMETHOXAZOLE AND TRIMETHOPRIM INJECTION | ASSAY/Procedure | USP37–NF32 | 4784 | 21-Nov-2014 | 1-Dec-2014 | USP39–NF34 | Second Supplement to USP38–NF33 | Line 3 of Standard solution: Change in Mobile phase from Sample stock solution to: in Mobile phase from Standard stock solution |
SAW PALMETTO EXTRACT | COMPOSITION/Content of Long-Chain Alcohols and Sterols | USP37–NF32 | 5545 | 21-Nov-2014 | 1-Dec-2014 | USP39–NF34 | Second Supplement to USP38–NF33 | Line 3 of Acceptance criteria:Add The lipophilic Extract contains 0.15%–0.35% of long-chain alcohols, and the hydroalcoholic Extract contains 0.01%–0.15% of long-chain alcohols on the anhydrous basis. |
ERYTHROMYCIN DELAYED-RELEASE TABLETS | PERFORMANCE TESTS/Dissolution <711>/Test 1/Buffer stage | First Supplement to USP37–NF32 | 6633 | 21-Nov-2014 | 1-Dec-2014 | USP39–NF34 | Second Supplement to USP38–NF33 | Line 1 of Standard solution: Change 0.28 mg/mL of USP Erythromycin RS in Medium to: Dissolve USP Erythromycin RS in Medium to obtain a concentration similar to that of the Sample solution. AND Line 1 of Sample solution: Change Pass portions of… Read More |
POLYSORBATE 80 | SPECIFIC TESTS/Fats and Fixed Oils, Acid Value <401> | Second Supplement to USP37–NF32 | 7089 | 21-Nov-2014 | 1-Dec-2014 | USP39–NF34 | Second Supplement to USP38–NF33 | Line 1 of Analysis: Change with 0.1 N potassium hydroxide or 0.1 N sodium hydroxide to: with 0.1 N potassium hydroxide VS or 0.1 N sodium hydroxide VS |
ESCITALOPRAM ORAL SOLUTION | IMPURITIES/Organic Impurities | USP37–NF32 | 2580 | 26-Sep-2014 | 1-Oct-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Row 6 of Column 1 of Table 3: Change Desfluorocitalopramf to: Desfluorocitalopramf,c |
KETOPROFEN EXTENDED-RELEASE CAPSULES | PERFORMANCE TESTS/Uniformity of Dosage Units <905>/System suitability/Suitability requirements | USP37–NF32 | 3469 | 26-Sep-2014 | 1-Oct-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Line 1 of Tailing factor: Change NLT 1.5 to: NMT 1.5 |
STERILE WATER FOR INHALATION | CHEMICAL INFORMATION | USP37–NF32 | 5174 | 26-Sep-2014 | 1-Oct-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Add the chemical formula and molecular weight: H2O 18.02 |
STERILE WATER FOR IRRIGATION | ADDITIONAL REQUIREMENTS/USP Reference Standards <11> | USP37–NF32 | 5175 | 26-Sep-2014 | 1-Oct-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Add: USP 1,4-Benzoquinone RS AND USP Sucrose RS |
ETHYLCELLULOSE DISPERSION TYPE B | ASSAY/Procedure | USP37–NF32 | 5981 | 26-Sep-2014 | 1-Oct-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Line 3 of Analysis: Change Calculate the percentage of ethylcellulose in the portion of Ethylcellulose Dispersion Type B taken: to: Calculate the percentage of the labeled amount of ethylcellulose in the portion of Ethylcellulose Dispersion Type B taken: |
CALCIUM GLUCONATE INJECTION | Identification | USP37–NF32 | 2089 | 26-Sep-2014 | 1-Oct-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Line 1 of Identification test A: Change A volume of Injection diluted, if necessary, with water to obtain a test solution of calcium gluconate (1 in 100) responds to Identification test B under Calcium Gluconate. to: Dissolve a quantity of it in water to… Read More |
IRINOTECAN HYDROCHLORIDE INJECTION | IMPURITIES/Organic Impurities | USP37–NF32 | 3403 | 26-Sep-2014 | 1-Oct-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Row 3 of Column 1 of Table 2: Change Camptothecinb to: Camptothecinb,d AND Row 5 of Column 1: Change 7-Ethylcamptothecinc to: 7-Ethylcamptothecinc,d AND Add a footnote: dThese process impuritiesare… Read More |
WATER FOR HEMODIALYSIS | CHEMICAL INFORMATION | USP37–NF32 | 5173 | 26-Sep-2014 | 1-Oct-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Add the chemical formula and molecular weight: H2O 18.02 |
STERILE WATER FOR INJECTION | ADDITIONAL REQUIREMENTS/USP Reference Standards <11> | USP37–NF32 | 5175 | 26-Sep-2014 | 1-Oct-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Add: USP 1,4-Benzoquinone RS AND USP Sucrose RS |
CELLACEFATE | ASSAY/Content of Acetyl | USP37–NF32 | 5919 | 26-Sep-2014 | 1-Oct-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Line 12 of Analysis: Result = {[(P − 0.5182 × B)/(100 − B)] − (0.5772 × C)} × 100 to: Result = 100 × [P − (0.5182 × B)]/(100 − B) − (0.5772 × C) |
DACARBAZINE FOR INJECTION | IMPURITIES/Limit of 2-Azahypoxanthine | Second Supplement to USP37–NF32 | Online | 26-Sep-2014 | 1-Oct-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Line 2 of Analysis: Change 2-azahypoxanthine monohydrate to: 2-azahypoxanthine |
DIDANOSINE DELAYED-RELEASE CAPSULES | PERFORMANCE TESTS/Dissolution <711>/Analysis | USP37–NF32 | 2603 | 26-Sep-2014 | 1-Oct-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Line 11 of the variable definition list: Change CS = concentration of didanosine in the Standard solution (mg/mL) to: CS = concentration of USP Didanosine Related Compound A RS in the Standard solution for the Acid stage or… Read More |
OXYBUTYNIN CHLORIDE | SPECIFIC TESTS/Loss on Drying <731> | USP37–NF32 | 4129 | 26-Sep-2014 | 1-Oct-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Line 1 of Acceptance criteria: Change NMT 3.0% to: NMT 3% |
STERILE WATER FOR INHALATION | ADDITIONAL REQUIREMENTS/USP Reference Standards <11> | USP37–NF32 | 5174 | 26-Sep-2014 | 1-Oct-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Add: USP 1,4-Benzoquinone RS AND USP Sucrose RS |
PURE STEAM | CHEMICAL INFORMATION | USP37–NF32 | 5176 | 26-Sep-2014 | 1-Oct-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Add the chemical formula and molecular weight: H2O 18.02 |
CHLORPHENIRAMINE MALEATE | IMPURITIES/Organic Impurities | First Supplement to USP37–NF32 | 6617 | 26-Sep-2014 | 1-Oct-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Line 1 of Standard solution: Change 1.1 μg/mL of USP Chlorpheniramine Maleate RS in Diluent, to: 1.4 μg/mL of USP Chlorpheniramine Maleate RS in Diluent, |
DACARBAZINE | USP Reference standards <11> | USP37–NF32 | 2504 | 26-Sep-2014 | 1-Oct-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Line 3 of USP Dacarbazine Related Compound B RS: Change C4H3N5O 137.10 to: C4H3N5O · H2O 155.12 |
KETOPROFEN EXTENDED-RELEASE CAPSULES | ASSAY/Procedure/System suitability/Suitability requirements | USP37–NF32 | 3469 | 26-Sep-2014 | 1-Oct-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Line 1 of Tailing factor: Change NLT 1.5 to: NMT 1.5 |
WATER FOR INJECTION | CHEMICAL INFORMATION | USP37–NF32 | 5173 | 26-Sep-2014 | 1-Oct-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Add the chemical formula and molecular weight: H2O 18.02 |
STERILE WATER FOR IRRIGATION | CHEMICAL INFORMATION | USP37–NF32 | 5175 | 26-Sep-2014 | 1-Oct-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Add the chemical formula and molecular weight: H2O 18.02 |
POWDERED CELLULOSE | IDENTIFICATION/B. Procedure | USP37–NF32 | 5923 | 26-Sep-2014 | 1-Oct-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Fourth equation in Analysis: Change Result = 95 × [η]c/WS × [(100 − %LOD)/100] to: Result = [95 × [η]c]/{WS × [(100 − %LOD)/100]} |
BETAMETHASONE SODIUM PHOSPHATE | IMPURITIES/Limit of Free Betamethasone | USP37–NF32 | 1965 | 26-Sep-2014 | 1-Oct-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Line 1 of Sample stock solution: Change 1.0 mg/mL of Betamethasone Sodium Phosphate in water to: 1.0 mg/mL of Betamethasone Sodium Phosphate in water, prepared as follows. Dissolve 25.0 mg of Betamethasone Sodium Phosphate in water to make 25.0 mL. |
DROSPIRENONE AND ETHINYL ESTRADIOL TABLETS | IMPURITIES/Organic Impurities/Chromatographic system | USP37–NF32 | 2739 | 26-Sep-2014 | 1-Oct-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Line 2 of Detector 2: Change Monitor the signal at 344 nm between 37 and 42 min. to: Monitor the signal at 344 nm for ethinyl estradiol related compound B (typically between 37 and 42 min). |
PSEUDOEPHEDRINE HYDROCHLORIDE | ASSAY/Procedure | USP37–NF32 | 4481 | 26-Sep-2014 | 1-Oct-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Line 2 of System suitability solution: Change 0.02 mg/mL of USP Ephedrine Sulfate RS to: 0.002 mg/mL of USP Ephedrine Sulfate RS |
STERILE WATER FOR INJECTION | CHEMICAL INFORMATION | USP37–NF32 | 5175 | 26-Sep-2014 | 1-Oct-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Add the chemical formula and molecular weight: H2O 18.02 |
STERILE PURIFIED WATER | ADDITIONAL REQUIREMENTS | USP37–NF32 | 5176 | 26-Sep-2014 | 1-Oct-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Add a section: USP Reference Standards <11> USP 1,4-Benzoquinone RS USP Sucrose RS |
DEXCHLORPHENIRAMINE MALEATE | IMPURITIES/Organic Impurities | First Supplement to USP37–NF32 | 6626 | 26-Sep-2014 | 1-Oct-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Line 1 of Standard solution: 2.2 μg/mL of USP Dexchlorpheniramine Maleate RS in Diluent, to: 2.8 μg/mL of USP Dexchlorpheniramine Maleate RS in Diluent, |
AMIFOSTINE | ASSAY/Procedure/System suitability/Suitability requirements | USP37–NF32 | 1717 | 25-Jul-2014 | 1-Aug-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Line 1 of Column efficiency: Change NLT 100 to: NLT 1000 |
TIZANIDINE TABLETS | ASSAY/Procedure/System suitability | Second Supplement to USP37–NF32 | Online | 25-Jul-2014 | 1-Aug-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Change Sample: Standard solution to: Samples: System suitability solution and Standard solution AND Change Resolution: NLT 4.0 between tizanidine and tizanidine related compound C; NLT 4.0 between tizanidine and tizanidine related compound… Read More |
CEFUROXIME FOR INJECTION | Constituted solution | USP37–NF32 | 2246 | 25-Jul-2014 | 1-Aug-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Line 3: Change meets the requirements for Constituted Solutions under Labeling under Injections <1>. to: meets the requirements for Constituted Solutions under Injections <1>. |
DULOXETINE DELAYED-RELEASE CAPSULES | IDENTIFICATION | USP37–NF32 | 2743 | 25-Jul-2014 | 1-Aug-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Change A. Infrared Absorption <197S> to: A. Infrared Absorption <197F> |
LEVODOPA | IMPURITIES | USP37–NF32 | 3533 | 25-Jul-2014 | 1-Aug-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Row 6 of Column 1 of Table 1: Change 1-Veratrylglycine to: L-Veratrylglycinea AND Add a footnote: a3-(3,4-Dimethoxyphenyl)-L-alanine. |
VINBLASTINE SULFATE | IDENTIFICATION/B. | USP37–NF32 | 5150 | 25-Jul-2014 | 1-Aug-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Line 1 of Sample: Change 100 mg/mL in water to: 10 mg/mL in water |
CEFADROXIL | ASSAY/Procedure | First Supplement to USP37–NF32 | 6602 | 25-Jul-2014 | 1-Aug-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Line 3 of Sample solution: Change USP Cefadroxil RS to: Cefadroxil |
<1788> METHODS FOR THE DETERMINATION OF PARTICULATE MATTER IN INJECTIONS AND OPHTHALMIC SOLUTIONS | LIGHT OBSCURATION PARTICLE COUNT TEST/Instrument Standardization Tests/Particle Counting Accuracy—System Suitability | USP37–NF32 | 1301 | 25-Jul-2014 | 1-Aug-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Line 26 of Method 1—MWHC Instruments: Change PB is the average particle count obtained from the suspension; to: PS is the average particle count obtained from the suspension; |
TERBINAFINE HYDROCHLORIDE | ADDITIONAL REQUIREMENTS/USP Reference Standards <11> | First Supplement to USP37–NF32 | 6704 | 25-Jul-2014 | 1-Aug-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Line 2 of USP Terbinafine Related Compound A RS: Change N-Methyl-C-(naphthalen-1-yl)methanamine. to: N-Methyl-C-(naphthalen-1-yl)methanamine hydrochloride. AND Line 2 of USP Terbinafine Related Compound B RS: Change (2Z)-N,6,6-Trimethyl-… Read More |
CEFTIZOXIME FOR INJECTION | Constituted solution | USP37–NF32 | 2240 | 25-Jul-2014 | 1-Aug-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Line 1: Change At the time of use, it meets the requirements for Constituted Solutions under Labeling under Injections <1>. to: At the time of use, it meets the requirements for Constituted Solutions under Injections <1>. |
DOXAPRAM HYDROCHLORIDE INJECTION | ASSAY/Procedure | USP37–NF32 | 2708 | 25-Jul-2014 | 1-Aug-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Line 7 of Analysis: Change RU = peak response ratio of the doxapram to the internal standard from the Sample solution RS = peak response ratio of the doxapram to the internal standard from the Sample solution to: RU… Read More |
LEFLUNOMIDE | IMPURITIES/Organic Impurities/Procedure 2 | USP37–NF32 | 3502 | 25-Jul-2014 | 1-Aug-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Line 3 of Analysis: Change [Note—Disregard any peak with an area less than the leflunomide peak from the System suitability solution. to: [Note—Disregard any peak with an area less than the leflunomide peak from the Sensitivity solution. |
NALTREXONE HYDROCHLORIDE | Assay | USP37–NF32 | 3922 | 25-Jul-2014 | 1-Aug-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Line 7 of Procedure: Change (377.86/341.41)10C(rU/rS) in which 377.86 and 341.41 are the molecular weights of naltrexone hydrochloride and naltrexone to: (377.86/341.40)10C(rU/r… Read More |
<551> VITAMIN E ASSAY | ASSAY/Procedure 4/Chromatographic system | First Supplement to USP37–NF32 | 6338 | 25-Jul-2014 | 1-Aug-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Line 1 of Flow rate: Change 1.5 mL/min to: 1 mL/min |
GENERAL NOTICES TO USP-NF | 6. TESTING PRACTICES AND PROCEDURES/6.50. Preparation of Solutions | First Supplement to USP37–NF32 | 6291 | 25-Jul-2014 | 1-Aug-2014 | USP38–NF33 | USP38–NF33 | Line 6 of 6.50.20. Solutions: Change An expression such as “(1 in 10)” means that 1 part by volume of a liquid shall be diluted with a sufficient quantity of the diluent or solvent to make the volume of the finished solution 10 parts by volume. An expression such as “(20:5:2… Read More |
SUFENTANIL CITRATE | ASSAY/Procedure/System suitability/Suitability requirements | First Supplement to USP37–NF32 | 6701 | 25-Jul-2014 | 1-Aug-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Line 1 of Relative standard deviation: Change NMT 0.7% to: NMT 0.73% |
BUMETANIDE | IMPURITIES | USP37–NF32 | 2024 | 25-Jul-2014 | 1-Aug-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Row 4 of Column 1 of Table 1: Change Paroxetine butyl 3-(butylamino)-4-phenoxy-5-sulfamoylbenzoate to: Butyl 3-(butylamino)-4-phenoxy-5-sulfamoylbenzoate |