Monograph Title | Section | Source Publication | Page Number | Errata Post Date Sort ascending | Errata Official Date | Target Errata Print Publication | Target Online Fix Publication | Description |
---|---|---|---|---|---|---|---|---|
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 |
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 |
<855> NEPHELOMETRY AND TURBIDIMETRY | 5. FORMAZIN TURBIDITY STANDARDS | USP42–NF37 | 7059 | 26-Apr-2019 | 1-May-2019 | NA | NA | In paragraph 1: Change IUPAC Compendium of Chemical Technology, to: IUPAC Compendium of Chemical Terminology, |
FELODIPINE EXTENDED-RELEASE TABLETS | PERFORMANCE TESTS/Dissolution <711>/Test 2 | USP42–NF37 | 1787 | 26-Apr-2019 | 1-May-2019 | NA | NA | In the second variable definition list in Analysis: Change VS = volume of the Sample solution withdrawn at each time point, i to: VS = volume of the Sample solution withdrawn at… Read More |
LEVALBUTEROL INHALATION SOLUTION | IMPURITIES/Organic Impurities | USP42–NF37 | 2520 | 26-Apr-2019 | 1-May-2019 | NA | NA | In Row 3 of Table 3: Change Levalbuterol — — — to: Levalbuterol 1.0 — — |
THALIDOMIDE | Assay | USP42–NF37 | 4281 | 26-Apr-2019 | 1-May-2019 | NA | NA | In Chromatographic system: Change and the relative standard deviation for replicate injections is not more than 1.0%. to: and the relative standard deviation for the response ratio of thalidomide to phenacetin is not more than 1.0%. |
REAGENTS AND REFERENCE TABLES | REAGENT SPECIFICATIONS | USP42–NF37 | 6104 | 26-Apr-2019 | 1-May-2019 | NA | NA | In Ferric Nitrate: Change [10421-48-4]. to: [7782-61-8]. |
PSEUDOEPHEDRINE HYDROCHLORIDE EXTENDED-RELEASE TABLETS | PERFORMANCE TESTS/Dissolution <711> | Revision Bulletin (Official March 01, 2019) | Online | 26-Apr-2019 | 1-May-2019 | NA | NA | In the Figure 1 caption: Change (see Drug Release <724>, Figure 4c) to: (see Drug Release <724>, Figure 5c) |
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE TABLETS | PERFORMANCE TESTS/Dissolution <711> | First Supplement to USP42–NF37 | Online | 26-Apr-2019 | 1-May-2019 | NA | NA | In Row 2 of Column 3 of Table 4: Change 0.014▲/0.028▲2S (USP41) to: 0.014 AND In Row 3 of Column 3 of Table 4: Change 0.014 to: 0.014/0.028 AND In Chromatographic… Read More |
LEVALBUTEROL HYDROCHLORIDE | ADDITIONAL REQUIREMENTS/USP Reference Standards <11> | USP42–NF37 | 2518 | 26-Apr-2019 | 1-May-2019 | NA | NA | In USP Levalbuterol Related Compound D RS: Change 5-{2-[(1,1-Dimethylethyl)amino]-1-hydroxyethyl}-2-hydroxy-benzaldehyde. C13H19NO3 237.29 ▲[NOTE—This may be available as the sulfate salt (2:1).]▲ (USP… Read More |
MORPHINE SULFATE EXTENDED-RELEASE CAPSULES | ADDITIONAL REQUIREMENTS/USP Reference Standards <11> | Revision Bulletin (Official November 01, 2018) | Online | 26-Apr-2019 | 1-May-2019 | NA | NA | In USP Morphine Related Compound B RS: Change 2,2'-Bimorphine. C34H36N2O6 568.66 to: 2,2'-Bimorphine trihydrate. C34H36N2O6 ∙ 3H2O 622.72 |
INOSITOL | IMPURITIES/Limit of Lead | USP42–NF37 | 5776 | 26-Apr-2019 | 1-May-2019 | NA | NA | In Standard lead solution: Delete A comparison solution prepared on the basis of 100 µL of the Standard lead solution per g of substance being tested contains the equivalent of 1 part of lead per million parts of substance being tested. |
<1160> PHARMACEUTICAL CALCULATIONS IN PHARMACY PRACTICE | 10. ALLIGATION ALTERNATE AND ALGEBRA METHODS FOR COMBINING MULTIPLE STRENGTHS OF THE SAME ACTIVE PHARMACEUTICAL INGREDIENT | USP42–NF37 | 7831 | 26-Apr-2019 | 1-May-2019 | NA | NA | In 10.2 Algebra Method/10.2.1 Calculating by using the algebra method/Examples—Algebra method: In example 2, in equations 1, 2, 3, and 4 in all instances: Change Cs to: Qs AND In example… Read More |
ATORVASTATIN CALCIUM | ADDITIONAL REQUIREMENTS/USP Reference Standards <11> | USP42–NF37 | 410 | 26-Apr-2019 | 1-May-2019 | NA | NA | In USP Atorvastatin Related Compound A RS: Change Desfluoro impurity, or (3R,5R)-7-[3-(phenylcarbamoyl)-2-isopropyl-4,5-diphenyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic acid, calcium salt. to: Calcium (3R,5R)-7-[2-… Read More |
IMIPRAMINE PAMOATE CAPSULES | ASSAY/Procedure | USP42–NF37 | Online | 26-Apr-2019 | 1-May-2019 | NA | NA | In Solution A and Solution B and Diluent: Change Chromatographic acetonitrile to: Acetonitrile |
LEVALBUTEROL INHALATION SOLUTION | ADDITIONAL REQUIREMENTS/USP Reference Standards <11> | USP42–NF37 | 2520 | 26-Apr-2019 | 1-May-2019 | NA | NA | In USP Levalbuterol Related Compound D RS: Change 5-[2-{(1,1-Dimethylethyl)amino}-1-hydroxyethyl]-2-hydroxy-benzaldehyde; Also known as 5-[2-{(1,1-Dimethylethyl)amino}methyl]-4-hydroxy-3-(methoxymethyl)-benzenemethanol. C13H… Read More |
TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE TABLETS | PERFORMANCE TESTS/Dissolution <711>/Test 1/Instrumental conditions | USP42–NF37 | 4409 | 26-Apr-2019 | 1-May-2019 | NA | NA | In Cell: Change 5 cm to: 5 mm |
<855> NEPHELOMETRY AND TURBIDIMETRY | 4. INSTRUMENTATION | USP42–NF37 | 7059 | 26-Apr-2019 | 1-May-2019 | NA | NA | In paragraph 2: Change silicone diodes to: silicon diodes |
CLONIDINE TRANSDERMAL SYSTEM | PERFORMANCE TESTS/Drug Release <724>/Test 1 | USP42–NF37 | 1084 | 26-Apr-2019 | 1-May-2019 | NA | NA | Apparatus 7: Change (see Figure 4a). to: (see Figure 5a). |
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 |
<1160> PHARMACEUTICAL CALCULATIONS IN PHARMACY PRACTICE | 19. MEAN KINETIC TEMPERATURE/19.2 MKT Equation | USP42–NF37 | 7831 | 26-Apr-2019 | 1-May-2019 | NA | NA | In the variable definition list: Change Tn = value for the total number of storage temperatures recorded during the observation period temperature recorded during the nth time period, e.g., nth week to: Tn… Read More |
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE TABLETS | ASSAY/Procedure/Chromatographic system | First Supplement to USP42–NF37 | Online | 26-Apr-2019 | 1-May-2019 | NA | NA | In Column: Change 4.6-mm × 15-cm; 5-µm packing L7. [Note—Conditioning of the Column with Solution A and Solution B ▲(90:10)▲ (ERR 1-Mar-2019) for about 30 min is recommended prior to use.] to: 4.6-mm × 15-cm… Read More |
IMIPRAMINE PAMOATE CAPSULES | IMPURITIES/Organic Impurities | USP42–NF37 | Online | 26-Apr-2019 | 1-May-2019 | NA | NA | In Solution A: Change Chromatographic acetonitrile to: Acetonitrile AND In Solution B: Change chromatographic acetonitrile to: acetonitrile |