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Monograph Title Section Source Publication Page Number Errata Official Date Target Errata Print Publication Target Online Fix Publication Description
AMLODIPINE AND ATORVASTATIN TABLETS IMPURITIES/Organic Impurities Related to Atorvastatin First Supplement to USP41–NF36 8270 1-Mar-2018 USP42–NF37 Second Supplement to USP41–NF36 In the variable definition list in Analysis: Change
Mr2 = molecular weight of atorvastatin calcium, 1209.39
to:
Mr2 = molecular weight of atorvastatin calcium, 1155.34
<1103> IMMUNOLOGICAL TEST METHODS—ENZYME-LINKED IMMUNOSORBENT ASSAY (ELISA) PROCEDURES/Solid Phase USP40–NF35 1344 1-Feb-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 7 of Coating the Solid Phase—Immobilization of Capture Reagent: Change
1–10 µg/well
to:
1–10 µg/mL
BRETYLIUM TOSYLATE IN DEXTROSE INJECTION Identification USP40–NF35 3049 1-Feb-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 1 of B: Change
It responds to the Identification test under Dextrose.
to:
Add a few drops of a solution (1 in 20) to 5 mL of hot alkaline cupric tartrate TS. A copious red precipitate of cuprous oxide is formed.
POWDERED DIGITALIS IDENTIFICATION/B. Thin-Layer Chromatographic Identification Test USP40–NF35 3762 1-Feb-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 3 of Standard solution A: Change
lead acetate,
to:
lead acetate TS,
AND
Line 11 of Analysis: Change
Locate the two prominent bands from Standard solution A corresponding in RF value to the two bands from Standard… Read More
DOBUTAMINE IN DEXTROSE INJECTION Identification USP40–NF35 3843 1-Feb-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 1 of B: Change
It meets the requirements for the Identification test under Dextrose.
to:
Add a few drops of a solution (1 in 20) to 5 mL of hot alkaline cupric tartrate TS. A copious red precipitate of cuprous oxide is formed.
DOPAMINE HYDROCHLORIDE AND DEXTROSE INJECTION Identification USP40–NF35 3866 1-Feb-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 1 of A: Change
It responds to the Identification test under Dextrose.
to:
Add a few drops of a solution (1 in 20) to 5 mL of hot alkaline cupric tartrate TS. A copious red precipitate of cuprous oxide is formed.
ESZOPICLONE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP40–NF35 4090 1-Feb-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 2 of USP Eszopiclone Related Compound A RS: Change
6-(5-Chloropyridin-2-yl)-7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b]pyrazin-5-yl 4-methylpiperazine-1-carboxylate 4-oxide.
C17H17ClN6O4 404.81
to:
[Note—This… Read More
LIDOCAINE HYDROCHLORIDE AND DEXTROSE INJECTION Identification USP40–NF35 4852 1-Feb-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 1 of B: Change
It responds to the Identification test under Dextrose.
to:
Add a few drops of a solution (1 in 20) to 5 mL of hot alkaline cupric tartrate TS. A copious red precipitate of cuprous oxide is formed.
NEVIRAPINE TABLETS IMPURITIES/Organic Impurities USP40–NF35 5333 1-Feb-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 1 of Standard solution: Change
0.125 μg/mL of USP Nevirapine Anhydrous RS from Standard stock solution A in Diluent
to:
0.125 μg/mL of USP Nevirapine Anhydrous RS in Diluent
TIMOLOL MALEATE TABLETS ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP40–NF35 6481 1-Feb-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 3 of USP Timolol Related Compound D RS: Change
C6H9N7O4S
to:
C6H9N3O2S
ECHINACEA ANGUSTIFOLIA IDENTIFICATION USP40–NF35 6923 1-Feb-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 5 of A. Thin-Layer Chromatography/Presence of echinacoside and dicaffeoylquinic acid/System suitability: Change
Standard solution B shows two major blue bands at about the middle of the chromatogram due to caftaric acid (lower RF)… Read More
POWDERED ECHINACEA ANGUSTIFOLIA IDENTIFICATION USP40–NF35 6926 1-Feb-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 5 of A. Thin-Layer Chromatography/Presence of echinacoside and dicaffeoylquinic acid/System suitability: Change
Standard solution B shows two major blue bands at about the middle of the chromatogram due to caftaric acid (lower RF)… Read More
POWDERED ECHINACEA ANGUSTIFOLIA EXTRACT IDENTIFICATION USP40–NF35 6928 1-Feb-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 5 of A. Thin-Layer Chromatography/Presence of echinacoside and dicaffeoylquinic acid/System suitability: Change
Standard solution B shows two major blue bands at about the middle of the chromatogram due to caftaric acid (lower RF)… Read More
ECHINACEA PALLIDA IDENTIFICATION USP40–NF35 6931 1-Feb-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 5 of A. Thin-Layer Chromatography/Presence of echinacoside and absence of dicaffeoylquinic acid/System suitability: Change
Standard solution B shows two major blue bands at about the middle of the chromatogram due to caftaric acid (lower RF… Read More
POWDERED ECHINACEA PALLIDA IDENTIFICATION USP40–NF35 6933 1-Feb-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 5 of A. Thin-Layer Chromatography/Presence of echinacoside and absence of dicaffeoylquinic acid/System suitability: Change
Standard solution B shows two major blue bands at about the middle of the chromatogram due to caftaric acid (lower RF… Read More
POWDERED ECHINACEA PALLIDA EXTRACT IDENTIFICATION USP40–NF35 6935 1-Feb-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 5 of A. Thin-Layer Chromatography/Presence of echinacoside and absence of dicaffeoylquinic acid/System suitability: Change
Standard solution B shows two major blue bands at about the middle of the chromatogram due to caftaric acid (lower RF… Read More
ECHINACEA PURPUREA AERIAL PARTS IDENTIFICATION USP40–NF35 6937 1-Feb-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 3 of A. Thin-Layer Chromatography/Presence of chicoric acid and absence of echinacoside/System suitability: Change
Standard solution B shows two major blue bands at about the middle of the chromatogram due to caftaric acid (lower RF… Read More
ECHINACEA PURPUREA ROOT IDENTIFICATION USP40–NF35 6940 1-Feb-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 3 of A. Thin-Layer Chromatography/Presence of chicoric acid and absence of echinacoside/System suitability: Change
Standard solution B shows two major blue bands at about the middle of the chromatogram due to caftaric acid (lower RF… Read More
POWDERED ECHINACEA PURPUREA IDENTIFICATION USP40–NF35 6942 1-Feb-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 3 of A. Thin-Layer Chromatography/Presence of chicoric acid and absence of echinacoside/System suitability: Change
Standard solution B shows two major blue bands at about the middle of the chromatogram due to caftaric acid (lower RF… Read More
POWDERED ECHINACEA PURPUREA EXTRACT IDENTIFICATION USP40–NF35 6944 1-Feb-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 3 of A. Thin-Layer Chromatography/Presence of chicoric acid and absence of echinacoside/System suitability: Change
Standard solution B shows two major blue bands at about the middle of the chromatogram due to caftaric acid (lower RF Read More
PHENYTOIN ORAL SUSPENSION PERFORMANCE TESTS/Dissolution <711> USP41–NF36 3286 1-Feb-2018 USP42–NF37 Second Supplement to USP41–NF36 In the Analysis: Change
CS = concentration of USP Phenytoin RS in the Standard solution
to:
CS = concentration of USP Phenytoin RS in the Standard solution (mg/mL)
ECHINACEA SPECIES DRY EXTRACT CAPSULES IDENTIFICATION USP41–NF36 4590 1-Feb-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 4 of A. HPTLC for Articles of Botanical Origin <203>/For Capsules containing Echinacea angustifolia Dry Extract/System suitability: Change
Standard solution B shows two major blue bands at about the middle section due to caftaric acid (… Read More
ECHINACEA SPECIES DRY EXTRACT TABLETS IDENTIFICATION USP41–NF36 4592 1-Feb-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 4 of A. HPTLC for Articles of Botanical Origin <203>/For Tablets containing Echinacea angustifolia Dry Extract/System suitability: Change
Standard solution B shows two major blue bands at about the middle section due to caftaric acid (… Read More
ECHINACEA SPECIES POWDER CAPSULES IDENTIFICATION USP41–NF36 4595 1-Feb-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 4 of A. HPTLC for Articles of Botanical Origin <203>/For Capsules containing Echinacea angustifolia powder prepared from dried rhizome and roots/System suitability: Change
Standard solution B shows two major blue bands at about the middle… Read More
ESZOPICLONE TABLETS ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Revision Bulletin (Official August 01, 2017) Online 1-Feb-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 2 of USP Eszopiclone Related Compound A RS: Change
6-(5-Chloropyridin-2-yl)-7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b]pyrazin-5-yl 4-methylpiperazine-1-carboxylate 4-oxide.
C17H17ClN6O4 404.81
to:
[Note—This… Read More
QUETIAPINE EXTENDED-RELEASE TABLETS IMPURITIES/Organic Impurities Revision Bulletin (Official November 01, 2017) Online 1-Feb-2018 USP42–NF37 Second Supplement to USP41–NF36 Footnote a of Table 5: Change
total impurities.
to:
total degradation products.
AND
Footnote b: Change
total impurities.
to:
total degradation products.
NIACIN EXTENDED-RELEASE TABLETS ASSAY/Procedure Revision Bulletin (Official January 01, 2018) Online 1-Feb-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 3 of System suitability: Change
Table 4
to:
Table 13
TIMOLOL MALEATE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> First Supplement to USP40–NF35 8416 1-Feb-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 2 of USP Timolol Related Compound A RS: Change
(R)-1-(tert-Butylamino)-3-(4-morpholino-1,2,5-thiadiazol-3-yloxy)propan-2-ol.
C13H24N4O3S 316.42
to:
(R)-1-(tert-Butylamino)-3-(4-morpholino-1,2,… Read More
REAGENTS, INDICATORS AND SOLUTIONS Solutions/Test Solutions/3. Solutions Prepared Fresh USP40–NF35 2419 1-Jan-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 2 of 0.06 M Phosphoric Acid TS: Change
volumetric flask
to:
1000-mL volumetric flask
VALERIAN IDENTIFICATION/C. Thin-Layer Chromatography USP40–NF35 7238 1-Jan-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 2 of Chromatographic system/Developing solvent system:Change
acetic acid
to:
glacial acetic acid
AND
Line 2 ofChromatographic system/Derivatization reagent B: Change
aceticacid
to:
glacial acetic acid
POWDERED VALERIAN IDENTIFICATION/C. Thin-Layer Chromatography USP40–NF35 7240 1-Jan-2018 USP42–NF37 Second Supplement to USP41–NF36
Line 2 of Chromatographic system/Developing solvent system:Change
acetic acid
to:
glacial acetic acid
AND
Line 2 ofChromatographic system/Derivatization reagent B: Change
aceticacid
to:
glacial acetic acid
POWDERED VALERIAN EXTRACT IDENTIFICATION/A. Thin-Layer Chromatography USP40–NF35 7241 1-Jan-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 2 of Chromatographic system/Developing solvent system:Change
acetic acid
to:
glacial acetic acid
AND
Line 2 ofChromatographic system/Derivatization reagent B: Change
aceticacid
to:
glacial acetic acid
VALERIAN TINCTURE IDENTIFICATION/A. Thin-Layer Chromatography USP40–NF35 7243 1-Jan-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 2 of Chromatographic system/Developing solvent system:Change
acetic acid
to:
glacial acetic acid
AND
Line 2 ofChromatographic system/Derivatization reagent B: Change
aceticacid
to:
glacial acetic acid
VALERIAN TABLETS IDENTIFICATION/A. Thin-Layer Chromatography USP40–NF35 7244 1-Jan-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 2 of Chromatographic system/Developing solvent system:Change
acetic acid
to:
glacial acetic acid
AND
Line 2 ofChromatographic system/Derivatization reagent B: Change
aceticacid
to:
glacial acetic acid
CLINDAMYCIN PHOSPHATE IMPURITIES/Organic Impurities/Table 2 Revision Bulletin (Official May 01, 2017) Online 1-Jan-2018 USP42–NF37 Second Supplement to USP41–NF36 Footnote e and f: Change
e Methyl 7-chloro-6,7,8-trideoxy-6-[(2S,4R)-1-methyl-4-ethylpyrrolidine-2-carboxamido]-1-thio-L-threo-α-D-galacto-octopyranoside 3-phosphate.
f Methyl 7-chloro-6,7,8-trideoxy-6-[(2S,4R)-1-methyl-4-… Read More
OLMESARTAN MEDOXOMIL TABLETS ASSAY/Chromatographic system Revision Bulletin (Official August 01, 2017) Online 1-Jan-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 1 of Detector: Change
Identification B
to:
Identification A
CHLOROQUINE PHOSPHATE IMPURITIES/Organic Impurities USP40–NF35 3377 1-Dec-2017 USP42–NF37 Second Supplement to USP41–NF36 Line 3 of Analysis: Change
Calculate the percentage of each specified impurity
to:
Calculate the percentage of each specified impurity, other than chloroquine related compound G,
AND
In Analysis/second equation/variable definition list: Change
rU… Read More
CHLORPHENIRAMINE MALEATE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP40–NF35 3385 1-Dec-2017 USP42–NF37 Second Supplement to USP41–NF36 Line 2 of USP Chlorpheniramine Related Compound C RS: Change
3-(4-Chlorophenyl-N-methyl-3-(pyridin-2-yl)propan-1-amine.
C15H17CIN2 260.76
to:
3-(4-Chlorophenyl)-N-methyl-3-(pyridin-2-yl)propan-1-amine maleate.
C15H17… Read More
CILOSTAZOL USP Reference standards <11> USP40–NF35 3418 1-Dec-2017 USP42–NF37 Second Supplement to USP41–NF36 Line 2 of USP Cilostazol Related Compound C RS: Change
1-(4-(5-Cyclohexyl-1H-tetrazol-1-yl)butyl)-6-(4-(1-cyclohexyl-1H-tetrazol-5-yl)butoxy)-3,4-dihydroquinolin-2(1H)-one.
C31H43N9O3 589.73
to:
1-(4-(1-Cyclohexyl-1… Read More
DEXCHLORPHENIRAMINE MALEATE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP40–NF35 3685 1-Dec-2017 USP42–NF37 Second Supplement to USP41–NF36 Line 2 of USP Chlorpheniramine Related Compound C RS: Change
3-(4-Chlorophenyl-N-methyl-3-(pyridin-2-yl)propan-1-amine.
C15H17CIN2 260.76
to:
3-(4-Chlorophenyl)-N-methyl-3-(pyridin-2-yl)propan-1-amine maleate.
C15H17… Read More
DONEPEZIL HYDROCHLORIDE IMPURITIES/Organic Impurities, Procedure 2 USP40–NF35 3859 1-Dec-2017 USP42–NF37 Second Supplement to USP41–NF36 Footnote b of Table 3: Change
(E)-4-[(5,6-Dimethoxy-1-oxo-1H-inden-2-yl)methyl]pyridine 1-oxide.
to:
(E)-4-[(5,6-Dimethoxy-1-oxo-1,3-dihydro-2H-inden-2-ylidene)methyl]pyridine 1-oxide.
GLUTARAL CONCENTRATE ASSAY/Procedure USP40–NF35 4414 1-Dec-2017 USP42–NF37 Second Supplement to USP41–NF36 Line 7 of Analysis: Change
Add a weighed quantity of Concentrate containing 1.2 g of glutaral by means of a suitable weighing pipet.
to:
Add 1.2 g of Glutaral Concentrate.
HYDROXYZINE HYDROCHLORIDE ASSAY/Procedure USP40–NF35 4539 1-Dec-2017 USP42–NF37 Second Supplement to USP41–NF36 Line 2 of Solution B: Change
(0.5: 99.5)
to:
(0.05: 99.95)
HYDROXYZINE HYDROCHLORIDE TABLETS ASSAY/Procedure USP40–NF35 4542 1-Dec-2017 USP42–NF37 Second Supplement to USP41–NF36 Line 2of Solution B: Change
(0.5: 99.5)
to:
(0.05: 99.95)
IRINOTECAN HYDROCHLORIDE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP40–NF35 4676 1-Dec-2017 USP42–NF37 Second Supplement to USP41–NF36 Line 2 of USP Irinotecan Related Compound C RS: Change
(S)-9-[(1,4′-Bipiperidine)-1′-carbonyloxy]-4-methyl-11-ethyl-3,4,12,14-tetrahydro-4-hydroxy-3,14-dioxo-1H-pyrano[3′,4′:6,7]indolizino[1,2-b]quinoline hydrochloride.
to:
11-Ethyl-4-hydroxy-4-methyl-3,14-dioxo-3,4,… Read More
MYCOPHENOLIC ACID DELAYED-RELEASE TABLETS PERFORMANCE TESTS/Dissolution <711> USP40–NF35 5257 1-Dec-2017 USP42–NF37 Second Supplement to USP41–NF36 In Acid stage/Analysis/variable definition list: Change
V = volume of Medium, 750 mL
to:
V = volume of Acid stage medium, 750 mL
AND
In Buffer stage/Analysis/variable definition list: Change
V = volume of Medium… Read More
MYCOPHENOLIC ACID DELAYED-RELEASE TABLETS IMPURITIES/Organic Impurities USP40–NF35 5257 1-Dec-2017 USP42–NF37 Second Supplement to USP41–NF36 Change
Mobile phase, Standard solution, Sample solution, and Chromatographic system:
to:
Mobile phase, Diluent, Standard solution, Sample solution, and Chromatographic system:
PILOCARPINE HYDROCHLORIDE OPHTHALMIC SOLUTION ASSAY/Procedure USP40–NF35 5706 1-Dec-2017 USP42–NF37 Second Supplement to USP41–NF36 Line 2 of Standard solution: Change
water
to:
methanol
VERAPAMIL HYDROCHLORIDE EXTENDED-RELEASE TABLETS PERFORMANCE TESTS/Dissolution <711> USP40–NF35 6680 1-Dec-2017 USP42–NF37 Second Supplement to USP41–NF36 Row 5 of column 2 of Table 9: Change
4
to:
5
CALCIUM STEARATE IDENTIFICATION USP40–NF35 7557 1-Dec-2017 USP42–NF37 Second Supplement to USP41–NF36 Line 3 of B.: Change
obtained in the Assay.
to:
obtained in the Assay for Content of Stearic Acid and Palmitic Acid.