Monograph Title | Section | Source Publication | Page Number | Errata Post Date Sort ascending | Errata Official Date | Target Errata Print Publication | Target Online Fix Publication | Description |
---|---|---|---|---|---|---|---|---|
BENAZEPRIL HYDROCHLORIDE TABLETS | PERFORMANCE TESTS/Dissolution <711>/Test 1 | First Supplement to USP42–NF37 | 8644 | 26-Jul-2019 | 1-Aug-2019 | NA | NA | In the Standard solution: Change µg/mL to: µg/µL |
TIAGABINE HYDROCHLORIDE | ASSAY/Procedure | First Supplement to USP42–NF37 | 8823 | 26-Jul-2019 | 1-Aug-2019 | NA | NA | In Analysis: Change Result = (RU/RS) × (CS/CU) × ▲(Mr1/Mr2) ×▲ (USP 1-Aug-2019) 100 to: … Read More |
SODIUM BICARBONATE | IMPURITIES/Carbonate | USP42–NF37 | 4019 | 28-Jun-2019 | 1-Jul-2019 | NA | NA | In Analysis: Change and promptly add 10 g of sodium bicarbonate to: and promptly add 10 g of Sodium Bicarbonate |
SAW PALMETTO EXTRACT | COMPOSITION/Content of Long-Chain Alcohols and Sterols | USP42–NF37 | 5196 | 28-Jun-2019 | 1-Jul-2019 | NA | NA | In System suitability stock solution B: Change 2 mg/mL each of campesterol, stigmasterol, and USP β-Sitosterol RS and 0.37 mg/mL of stigmastanol to: 0.37 mg/mL of stigmastanol and 2 mg/mL each of campesterol, stigmasterol, and USP β-Sitosterol RS in… Read More |
ETIDRONATE DISODIUM | SPECIFIC TESTS/Water Determination <921> | USP42–NF37 | 1745 | 28-Jun-2019 | 1-Jul-2019 | NA | NA | In Sample solution: Change acetic acid to: glacial acetic acid |
CHOLINE BITARTRATE | IMPURITIES/Limit of Total Amines/System suitability | USP42–NF37 | 4839 | 28-Jun-2019 | 1-Jul-2019 | NA | NA | In Suitability requirements: Change μg/L. to: μg/mL. |
ACETAMINOPHEN ORAL SUSPENSION | ASSAY | Second Supplement to USP41–NF36 | Online | 28-Jun-2019 | 1-Jul-2019 | NA | NA | In the first Procedure: Change 90.0%–110.0%▲(Postponed on 1-Aug-2018) to: 90.0%–110.0%▲(RB 1-Aug-2018) |
VORICONAZOLE | IMPURITIES/Voriconazole Related Compounds C and D | USP42–NF37 | 4601 | 28-Jun-2019 | 1-Jul-2019 | NA | NA | In System suitability solution: Change 0.25 µg/mL of USP Voriconazole RS to: 0.25 µg/mL of USP Voriconazole RS in Mobile phase |
SAW PALMETTO CAPSULES | IDENTIFICATION/B. Presence of Sterols | USP42–NF37 | 5198 | 28-Jun-2019 | 1-Jul-2019 | NA | NA | In System suitability stock solution B: Change 2 mg/mL each of campesterol, stigmasterol, and USP β-Sitosterol RS, and 0.37 mg/mL of stigmastanol to: 0.37 mg/mL of stigmastanol and 2 mg/mL each of campesterol, stigmasterol, and USP β-Sitosterol RS in… Read More |
POLYVINYL ALCOHOL | IDENTIFICATION | USP42–NF37 | 3566 | 28-Jun-2019 | 1-Jul-2019 | NA | NA | In B: Change It meets the requirements in the test Viscosity—Capillary Methods <911>, Viscosity—Rotational Methods <912>, and Viscosity—Rolling Ball Method <913>. to: It meets the requirements in the… Read More |
CHOLINE CHLORIDE | IMPURITIES/Limit of Total Amines/System suitability | USP42–NF37 | 4841 | 28-Jun-2019 | 1-Jul-2019 | NA | NA | In Suitability requirements: Change μg/L. to: μg/mL. |
MORPHINE SULFATE EXTENDED-RELEASE CAPSULES | PERFORMANCE TESTS/Dissolution <711> | Revision Bulletin (Official November 01, 2018) | Online | 28-Jun-2019 | 1-Jul-2019 | NA | NA | In Test 1/Tolerances and Test 3/Tolerances: Change [(C17H19NO3)2 · H2SO4 · 5H2O)] to: [(C17H19NO3)2… Read More |
ZONISAMIDE | IMPURITIES/Organic Impurities | USP42–NF37 | 4675 | 28-Jun-2019 | 1-Jul-2019 | NA | NA | In Analysis: Change CU = concentration of zonisamide related compound A in the Sample solution (mg/mL) to: CU = concentration of zonisamide in the Sample solution (mg/mL) |
CHITOSAN | ASSAY/Degree of Deacetylation | USP42–NF37 | 5663 | 28-Jun-2019 | 1-Jul-2019 | NA | NA | In the Analysis: Change Result = {1 − [(7 × A2)/(3 × A1)] × 100 to: Result = {1 − [(7 × A2)/(3 × A1)]} × 100 |
GUANABENZ ACETATE | IMPURITIES/Limit of 2,6-Dichlorobenzaldehyde/Chromatographic system | USP42–NF37 | 2129 | 31-May-2019 | 1-Jun-2019 | NA | NA | In Column: Change 1.8-mm × 3-mm; to: 1.8-m × 3-mm; |
SUMATRIPTAN SUCCINATE | ADDITIONAL REQUIREMENTS/USP Reference Standards <11> | USP42–NF37 | 4145 | 31-May-2019 | 1-Jun-2019 | NA | NA | In USP Sumatriptan Succinate Related Impurities RS: Change Mixture of sumatriptan succinate, [3-[2-(methylamino) ethyl]-1H-indol-5-yl]-N-methylmethanesulfonamide maleate salt, sumatriptan succinate related compound C, [3-[2-(dimethylamino… Read More |
BACILLUS COAGULANS CAPSULES | ASSAY/Enumeration | USP42–NF37 | 4749 | 31-May-2019 | 1-Jun-2019 | NA | NA | In Peptone diluent: Change Dispense into sterile containers as needed for preparing samples. Trace mineral solution. Prepare a solution containing to: Dispense into sterile containers as needed for preparing samples. Trace mineral solution… Read More |
SALMETEROL INHALATION POWDER | IMPURITIES/Organic Impurities | USP42–NF37 | Online | 31-May-2019 | 1-Jun-2019 | NA | NA | In Row 8 of Column 1 of Table 3: Change Hyrdoxynaphthoic acid to: Hydroxynaphthoic acid |
CLOMIPHENE CITRATE | ADDITIONAL REQUIREMENTS/USP Reference Standards <11> | USP42–NF37 | 1068 | 31-May-2019 | 1-Jun-2019 | NA | NA | In USP Clomiphene Related Compound A RS: Change (E,Z)-2-[4-(1,2-Diphenylethyl)phenoxy]-N,N-diethylethanamine hydrochloride. to: (E,Z)-2-[4-(1,2-Diphenylvinyl)phenoxy]-N,N-diethylethanamine… Read More |
DOXORUBICIN HYDROCHLORIDE | ASSAY/Procedure | USP42–NF37 | 1481 | 31-May-2019 | 1-Jun-2019 | NA | NA | In the Analysis: Change P = potency of doxorubicin in USP Doxorubicin Hydrochloride RS (µg/mg) to: P = potency of doxorubicin hydrochloride in USP Doxorubicin Hydrochloride RS (µg/mg) |
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. |
PIPERAZINE PHOSPHATE | Assay | USP42–NF37 | 3549 | 31-May-2019 | 1-Jun-2019 | NA | NA | Change Each mL of 0.1 N perchloric acid is equivalent to 7.953 mg of C4H10N2 · 2HCl. to: Each mL of 0.1 N perchloric acid is equivalent to 9.207 mg of C4H10N2 · H3PO4… Read More |
BACILLUS COAGULANS | ASSAY/Enumeration | USP42–NF37 | 4746 | 31-May-2019 | 1-Jun-2019 | NA | NA | In Peptone diluent: Change Dispense into sterile containers as needed for preparing samples. Trace mineral solution. Prepare a solution containing to: Dispense into sterile containers as needed for preparing samples. Trace mineral solution… Read More |
REAGENTS AND REFERENCE TABLES | SOLUTIONS/0.02 M Edetate Disodium VS | USP42–NF37 | 6179 | 31-May-2019 | 1-Jun-2019 | NA | NA | In Standardization: Change previously dried at 100° to: previously dried at 110° |
CEFTIOFUR SODIUM | IMPURITIES/High Molecular Weight Impurities | USP42–NF37 | 859 | 31-May-2019 | 1-Jun-2019 | NA | NA | In Analysis: Change rC = peak response of ceftiofur from the Sample solution (mg/mL) rA = sum of the responses of all peaks that elute after ceftiofur from the Sample solution (mg/mL) to:… Read More |
DIPHENHYDRAMINE HYDROCHLORIDE AND IBUPROFEN CAPSULES | ASSAY/Procedure/Chromatographic system/Detectors | USP42–NF37 | 1402 | 31-May-2019 | 1-Jun-2019 | NA | NA | Change Identification test A: Diode array, UV 200–400 nm to: Identification B: Diode array, UV 200–400 nm |
DULOXETINE DELAYED-RELEASE CAPSULES | ASSAY/Procedure | USP42–NF37 | 1527 | 31-May-2019 | 1-Jun-2019 | NA | NA | In Buffer A: Change monobasic sodium phosphate to: monobasic potassium phosphate AND In Buffer B: Change monobasic sodium phosphate to: monobasic ammonium phosphate |
LEVOCARNITINE | IMPURITIES/Enantiomeric Purity | USP42–NF37 | 2541 | 31-May-2019 | 1-Jun-2019 | NA | NA | In the second equation in Analysis: Change Result = (RL − PB)/(PA − PB) to: Result = (RL − PB)/(PA… Read More |
TELMISARTAN TABLETS | ADDITIONAL REQUIREMENTS/USP Reference Standards <11> | USP42–NF37 | 4206 | 31-May-2019 | 1-Jun-2019 | NA | NA | In USP Telmisartan Related Compound A RS: Change 1,7’-Dimethyl-2’-propyl-1H,3’H-2,5’-bibenzo[d]imidazole. C19H20N4 304.39 to: 1,7’-Dimethyl-2’-propyl-1H,3’H-2,5’-bibenzo[d]imidazole… Read More |
LIQUID GLUCOSE | ASSAY/Reducing Sugars | USP42–NF37 | 5741 | 31-May-2019 | 1-Jun-2019 | NA | NA | In the variable definition list in Analysis: Change CU = concentration of dextrose equivalent to: CU = concentration of Liquid Glucose |
ROSUVASTATIN TABLETS | PERFORMANCE TESTS/Dissolution <711>/Test 3 | Revision Bulletin (Official April 01, 2019) | Online | 31-May-2019 | 1-Jun-2019 | NA | NA | In Medium: Change (dissolve 63.0 of citric acid to: (dissolve 63.0 g of citric acid |
DACTINOMYCIN | IDENTIFICATION/A. Ultraviolet Absorption <197U>/Acceptance criteria | USP42–NF37 | 1203 | 31-May-2019 | 1-Jun-2019 | NA | NA | In Absorptivity: Change The absorptivity of the Sample solution at 445 nm is NLT 95.0% and NMT 103.0% that of the Standard solution. to: The absorptivity, calculated on the dried basis, of the Sample solution at 445… Read More |
DOXORUBICIN HYDROCHLORIDE | IMPURITIES/Organic Impurities | USP42–NF37 | 1481 | 31-May-2019 | 1-Jun-2019 | NA | NA | In the fourth equation in Analysis: Change P = potency of doxorubicin in USP Doxorubicin Hydrochloride RS (µg/mg) to: P = potency of doxorubicin hydrochloride in USP Doxorubicin Hydrochloride RS (µg/mg) |
EPRINOMECTIN | IMPURITIES/Organic Impurities/Acceptance criteria | USP42–NF37 | 1627 | 31-May-2019 | 1-Jun-2019 | NA | NA | In Total unknown impurities: Change NMT 1.0 to: NMT 1.0% |
SUMATRIPTAN | ADDITIONAL REQUIREMENTS/USP Reference Standards <11> | USP42–NF37 | 4139 | 31-May-2019 | 1-Jun-2019 | NA | NA | In USP Sumatriptan Succinate Related Impurities RS: Change Mixture of sumatriptan succinate, [3-[2-(methylamino) ethyl]-1H-indol-5-yl]-N-methylmethanesulfonamide maleate salt, sumatriptan succinate related compound C, [3-[2-(dimethylamino… 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 |
<561> ARTICLES OF BOTANICAL ORIGIN | TEST FOR AFLATOXINS/Method I | USP42–NF37 | 6701 | 31-May-2019 | 1-Jun-2019 | NA | NA | In Aflatoxin standard solution: Change ε = molecular absorptivity to: ε = molar absorptivity AND in paragraph 2 of Aflatoxin standard solution: Change transfer an accurate volume of each aflatoxin standard stock solution to:… Read More |
CETIRIZINE HYDROCHLORIDE ORALLY DISINTEGRATING TABLETS | ADDITIONAL REQUIREMENTS/USP Reference Standards <11> | USP42–NF37 | 897 | 31-May-2019 | 1-Jun-2019 | NA | NA | In USP Cetirizine Related Compound A RS: Change 2-(2-{4-[(4-Chlorophenyl)phenylmethyl]piperazin-1-yl}ethoxy)acetic acid, ethyl ester dihydrochloride. C23H29ClN2O3 · 2HCl 489.86 to: (RS)-2-[2… Read More |
DIPHENHYDRAMINE HYDROCHLORIDE AND IBUPROFEN CAPSULES | PERFORMANCE TESTS/Dissolution <711>/Analysis | USP42–NF37 | 1402 | 31-May-2019 | 1-Jun-2019 | NA | NA | Change CS = concentration of USP Diphenhydramine Hydrochloride RS and USP Ibuprofen RS in the Standard solution (mg/mL) to: CS = concentration of USP Diphenhydramine Hydrochloride RS or USP Ibuprofen RS in… Read More |
DULOXETINE DELAYED-RELEASE CAPSULES | PERFORMANCE TESTS/Dissolution <711> | USP42–NF37 | 1527 | 31-May-2019 | 1-Jun-2019 | NA | NA | In Test 3/Procedure: Change 1 N sodium hydroxide VS. to: 0.1 N hydrochloric acid VS. |
MILRINONE | ASSAY/Procedure | USP42–NF37 | 2922 | 31-May-2019 | 1-Jun-2019 | NA | NA | In Buffer: Change 72.44 g of sodium tetraborate to: 72.44 g of sodium tetraborate, anhydrous |
TILETAMINE HYDROCHLORIDE | Identification/B. Ultraviolet Absorption <197U> | USP42–NF37 | 4347 | 31-May-2019 | 1-Jun-2019 | NA | NA | In Solution: Change 0.3 mg per mL. to: 0.03 mg per mL. |
REAGENTS AND REFERENCE TABLES | SOLUTIONS/0.01 M Edetate Disodium VS | USP42–NF37 | 6179 | 31-May-2019 | 1-Jun-2019 | NA | NA | In Standardization: Change previously dried at 100° to: previously dried at 110° |
CEFTIOFUR HYDROCHLORIDE | IMPURITIES/High Molecular Weight Impurities | USP42–NF37 | 857 | 31-May-2019 | 1-Jun-2019 | NA | NA | In Analysis: Change rC = peak response of ceftiofur from the Sample solution (mg/mL) rA = sum of the responses of all peaks that elute after ceftiofur from the Sample solution (mg/mL) to:… Read More |
PHENYLBUTAZONE INJECTION | Assay | USP42–NF37 | 3487 | 31-May-2019 | 1-Jun-2019 | NA | NA | Change 350(C/V)(RU/RS) to: 714.3(C/V)(RU/RS) |
DIDANOSINE | IMPURITIES/Related Compounds | USP42–NF37 | 1336 | 31-May-2019 | 1-Jun-2019 | NA | NA | In System suitability solution: Change 0.5 mg/mL of of didanosine from USP Didanosine System Suitability Mixture RS in Diluent to: 0.5 mg/mL of USP Didanosine System Suitability Mixture RS in Diluent |
DRONEDARONE TABLETS | PERFORMANCE TESTS/Dissolution <711> | USP42–NF37 | 1519 | 31-May-2019 | 1-Jun-2019 | NA | NA | In Tolerances/30 min: Change 20.0%–60.0% (Q) of the labeled amount of dronedarone free base to: 20.0%–60.0% of the labeled amount of dronedarone free base |
LEVALBUTEROL INHALATION SOLUTION | IMPURITIES/Limit of S-Albuterol | USP42–NF37 | Online | 26-Apr-2019 | 1-May-2019 | NA | NA | In Mobile phase: Change ▲Acetonitrile, methanol, and acetic acid (50:50). To each liter of the solution add 3 mL of acetic acid and 1 mL of triethylamine.▲ (USP 1-May-2019) to: Acetonitrile and methanol (50:50… Read More |
SODIUM BICARBONATE COMPOUNDED INJECTION | ASSAY/Procedure for Sodium Bicarbonate | USP42–NF37 | 4023 | 26-Apr-2019 | 1-May-2019 | NA | NA | In Analysis: Change Result = [(VS − VB) x NA x F] x 100 to: Result = [(VS − VB) x NA x F x 100]/W AND… Read More |
REAGENTS AND REFERENCE TABLES | REAGENT SPECIFICATIONS | USP42–NF37 | 6079 | 26-Apr-2019 | 1-May-2019 | NA | NA | In Beef Extract/Microbial Content: Change MT to: NMT |