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CSV November 20, 2015 through November 20, 2017 See all Errata for USP–NF How to use
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Monograph Title Section Source Publication Page Number Errata Official Date Sort ascending Target Errata Print Publication Target Online Fix Publication Description
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
SODIUM LAURYL SULFATE IDENTIFICATION Second Supplement to USP40–NF35 8946 1-Dec-2017 USP42–NF37 Second Supplement to USP41–NF36 Line 1 of A.: Change
Infrared Absorption <197K> or <197A>
to:
⧫A. Infrared Absorption <197K> or <197A>⧫
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
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… 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:
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-… Read More
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)
HYDROXYZINE HYDROCHLORIDE ORAL SOLUTION ASSAY/Procedure First Supplement to USP40–NF35 8299 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 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)
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.
FLUVOXAMINE MALEATE ASSAY/Procedure Second Supplement to USP40–NF35 8797 1-Dec-2017 USP42–NF37 Second Supplement to USP41–NF36 Line 2of Solution A: Change
1 g/L
to:
1.1 g/L
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.
DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS ASSAY/Procedure Second Supplement to USP40–NF35 8752 1-Dec-2017 USP42–NF37 Second Supplement to USP41–NF36 Line 2of Mobile phase: Change
Adjust with phosphoric acid to a pH of 5.0.
to:
Adjust with diluted sodium hydroxide or phosphoric acid to a pH of 5.0.
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.
C15H… 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-… 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.
C15H… Read More
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
r Read More
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.
ALMOTRIPTAN TABLETS ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Second Supplement to USP40–NF35 8708 1-Dec-2017 USP42–NF37 Second Supplement to USP41–NF36 Line 4 of USP Almotriptan Related Compound B RS: Change
C15H22N3O2S
to:
C15H21N3O2S
AND
Line 2 of USP Almotriptan Related Compound D RS: Change
1-[({3-[2-(Dimethylamino)ethyl]indol… Read More
ALMOTRIPTAN MALATE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Interim Revision Announcement (Official May 01, 2017) ONLINE 1-Dec-2017 USP42–NF37 Second Supplement to USP41–NF36 Line 2 of USP Almotriptan Related Compound D RS: Change
1-[({3-[2-(Dimethylamino)ethyl]indol-5-yl}methyl)sulfonyl]pyrrolidine N-oxide.
C17H25N3O3S 351.46
to:
1-[({3-[2-(Dimethylamino)ethyl]indol-5-yl}methyl)sulfonyl]… Read More
<1790> VISUAL INSPECTION OF INJECTIONS 2. BACKGROUND/2.2 Patient Risk First Supplement to USP40–NF35 8099 1-Dec-2017 USP42–NF37 Second Supplement to USP41–NF36 Line 6 of paragraph 3: Change
109 particles/kg
to:
109 particles/kg
<1790> VISUAL INSPECTION OF INJECTIONS 4. INSPECTION LIFE-CYCLE/4.2 Prevention of Particulates First Supplement to USP40–NF35 8099 1-Dec-2017 USP42–NF37 Second Supplement to USP41–NF36 Line 5 of paragraph 1 of Robust Design During Development: Change
lamellae (46,47)
to:
lamellae as discussed in Evaluation of the Inner Surface Durability of Glass Containers <1660> and by the FDA (45)
AND
Line 2 of paragraph 4 of… Read More
<800> HAZARDOUS DRUGS—HANDLING IN HEALTHCARE SETTINGS 5. FACILITIES AND ENGINEERING CONTROLS/5.4 Containment Supplemental Engineering Controls First Supplement to USP40–NF35 ONLINE 1-Dec-2017 USP42–NF37 Second Supplement to USP41–NF36 Line 5 of paragraph 1: Change
containment reduction.
to:
contamination reduction.
<800> HAZARDOUS DRUGS—HANDLING IN HEALTHCARE SETTINGS 7. PERSONAL PROTECTIVE EQUIPMENT First Supplement to USP40–NF35 ONLINE 1-Dec-2017 USP42–NF37 Second Supplement to USP41–NF36 Line 2 of paragraph 2: Change
antineoplastic HDs.
to:
injectable antineoplastic HDs.
<191> IDENTIFICATION TESTS—GENERAL CHEMICAL IDENTIFICATION TESTS/Thiosulfate Second Supplement to USP40–NF35 ONLINE 1-Dec-2017 USP42–NF37 Second Supplement to USP41–NF36 Line 1 of A.: Change
yellow; with the addition of sulfur dioxide, filter paper moistened with mercurous nitrate TS blackens.
to:
yellow, and evolve sulfur dioxide, which blackens filter paper moistened with mercurous nitrate TS.
MONOBASIC POTASSIUM PHOSPHATE IMPURITIES/Arsenic, Method I <211> USP40–NF35 7847 1-Oct-2017 USP42–NF37 First Supplement to USP41–NF36 Line 1: Change
3 µg/g
to:
NMT 3 µg/g
POTASSIUM CITRATE EXTENDED-RELEASE TABLETS ASSAY/Procedure Revision Bulletin (Official April 01, 2017) ONLINE 1-Oct-2017 USP42–NF37 First Supplement to USP41–NF36 Line 1 of Chromatographic system/Column: Change
10-µm
to:
5-µm
AND
In the variable definition list in Analysis: Change
rU = citrate peak area from the Sample solution
rS = citrate… Read More
PEMETREXED FOR INJECTION ASSAY/Procedure/Analysis USP40–NF35 5590 1-Oct-2017 USP42–NF37 First Supplement to USP41–NF36 In the variable definition list: Change
Mr2 = molecular weight of pemetrexed disodium, 597.49
to:
Mr2 = molecular weight of pemetrexed disodium (anhydrous), 473.37
PEMETREXED DISODIUM IMPURITIES/Organic Impurities/Table 2 USP40–NF35 5588 1-Oct-2017 USP42–NF37 First Supplement to USP41–NF36 Footnote b: Change
{4-[2-(2-Amino-1-methyl-4-oxo-4,7-dihydro-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl}-4-L-glutamyl-L-glutamic acid.
to:
{4‐[2‐(2‐Amino‐4‐oxo‐4,7‐dihydro‐1H‐pyrrolo[2,3‐d]pyrimidin‐5‐yl)ethyl]benzoyl}‐4‐L‐glutamyl‐L‐glutamic acid.
MYCOPHENOLATE SODIUM ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP40–NF35 5256 1-Oct-2017 USP42–NF37 First Supplement to USP41–NF36 Line 2 of USP Mycophenolate Mofetil Related Compound B RS: Change
(RS)-7-Hydroxy-5-methoxy-4-methyl-6-[2-(5-methyl-2-oxo-tetrahydrofuran-5-yl)ethyl]-3H-isobenzofuranyl-1-one.
to:
(RS)-7-Hydroxy-5-methoxy-4-methyl-6-[2-(5-methyl-2-oxo-tetrahydrofuran-5-yl)ethyl]-… Read More
MYCOPHENOLATE SODIUM IMPURITIES/Organic Impurities USP40–NF35 5256 1-Oct-2017 USP42–NF37 First Supplement to USP41–NF36 Footnote a of Table 2: Change
(RS)-7-Hydroxy-5-methoxy-4-methyl-6-[2-(5-methyl-2-oxo-tetrahydrofuran-5-yl)ethyl]-3H-isobenzofuranyl-1-one.
to:
(RS)-7-Hydroxy-5-methoxy-4-methyl-6-[2-(5-methyl-2-oxo-tetrahydrofuran-5-yl)ethyl]-3H-isobenzofuran-1-… Read More
MYCOPHENOLATE MOFETIL FOR ORAL SUSPENSION ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP40–NF35 5251 1-Oct-2017 USP42–NF37 First Supplement to USP41–NF36 Line 2 of USP Mycophenolate Mofetil Related Compound B RS: Change
(RS)-7-Hydroxy-5-methoxy-4-methyl-6-[2-(5-methyl-2-oxo-tetrahydrofuran-5-yl)ethyl]-3H-isobenzofuranyl-1-one.
to:
(RS)-7-Hydroxy-5-methoxy-4-methyl-6-[2-(5-methyl-2-oxo-tetrahydrofuran-5-yl)ethyl… Read More
MYCOPHENOLATE MOFETIL FOR INJECTION ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP40–NF35 5250 1-Oct-2017 USP42–NF37 First Supplement to USP41–NF36 Line 2 of USP Mycophenolate Mofetil Related Compound B RS: Change
(RS)-7-Hydroxy-5-methoxy-4-methyl-6-[2-(5-methyl-2-oxo-tetrahydrofuran-5-yl)ethyl]-3H-isobenzofuranyl-1-one.
to:
(RS)-7-Hydroxy-5-methoxy-4-methyl-6-[2-(5-methyl-2-oxo-tetrahydrofuran-5-yl)ethyl… Read More
MEMANTINE HYDROCHLORIDE TABLETS PERFORMANCE TESTS/Dissolution <711>/Analysis USP40–NF35 5000 1-Oct-2017 USP42–NF37 First Supplement to USP41–NF36 In the variable definition list: Change
CS = concentration of USP Memantine Hydrochloride RS in the Standard solution (µg/mL)
to:
CS = concentration of USP Memantine Hydrochloride RS in the Standard stock solution (mg/… Read More
MEBENDAZOLE IMPURITIES/Organic Impurities/Table 2 USP40–NF35 4968 1-Oct-2017 USP42–NF37 First Supplement to USP41–NF36 Change footnotes
dEthyl 5-benzoyl-1-methylbenzimidazol-2-ylcarbamate.
eMethyl 5-(4-toluoyl)-1-methylbenzimidazol-2-ylcarbamate.
to:
dEthyl (5-benzoyl-1H-benzimidazol-2-yl)carbamate.
eMethyl 5-(4-toluoyl)-1H-… Read More
ISOSORBIDE DINITRATE EXTENDED-RELEASE TABLETS Dissolution <711>/Test 2 USP40–NF35 4710 1-Oct-2017 USP42–NF37 First Supplement to USP41–NF36 Line 1: Change
Buffer solution and Mobile phase—Prepare as directed in the Assay under Diluted Isosorbide Dinitrate.
to:
Buffer solution and Mobile phase—Prepare as directed in the Assay.
AND
Line 1 of Chromatographic… Read More
ISOSORBIDE DINITRATE EXTENDED-RELEASE TABLETS Assay USP40–NF35 4710 1-Oct-2017 USP42–NF37 First 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 solution—Dissolve 15.4 g of… Read More
ISOSORBIDE DINITRATE EXTENDED-RELEASE CAPSULES Assay USP40–NF35 4708 1-Oct-2017 USP42–NF37 First 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 solution—Dissolve 15.4 g of… Read More
GADOTERIDOL Chromatographic purity/Test 2 (Nongadolinium-Containing Impurities) USP40–NF35 4360 1-Oct-2017 USP42–NF37 First Supplement to USP41–NF36 Line 1 of pH 5.0 Buffer: Change
50 mM Ammonium
to:
50 mM Ammonium phosphate buffer
AND
Line 1 of pH 7.0 Buffer: Change
50 mM Ammonium
to:
50 mM Ammonium phosphate buffer
FLUVOXAMINE MALEATE IMPURITIES/Organic Impurities/Table 1 Second Supplement to USP40–NF35 8797 1-Oct-2017 USP42–NF37 First Supplement to USP41–NF36 Footnote b:Change
5-Methoxy-1-[4-(trifluoromethyl)phenyl]-1-pentanone (E)-O-[2-[(2-succinyl)amino]ethyl]oxime.
to:
(E)-5-Methoxy-1-[4-(trifluoromethyl)phenyl]-1-pentanone O-[2-[(2-succinyl)amino]ethyl]oxime.
AND
Footnotes c– g: Delete the space… Read More
FLUVOXAMINE MALEATE CHEMICAL INFORMATION Second Supplement to USP40–NF35 8797 1-Oct-2017 USP42–NF37 First Supplement to USP41–NF36 Line 4:Change
5-Methoxy-4’-(trifluoromethyl)valerophenone (E)-O-(2-aminoethyl)oxime, maleate (1:1)
to:
(E)-5-Methoxy-4’-(trifluoromethyl)valerophenone O-(2-aminoethyl)oxime, maleate (1:1)
FENOLDOPAM MESYLATE USP Reference standards <11> USP40–NF35 4159 1-Oct-2017 USP42–NF37 First Supplement to USP41–NF36 Line 2 of USP Fenoldopam Related Compound A RS: Change
1-Methyl-3-benzazepine-7,8-diol, 6-chloro-2,3,4,5-tetrahydro-1-(4-hydroxyphenyl)-, methanesulfonate (salt).
C17H18ClNO3 · CH4SO3 415.89
to:
6-Chloro-1-(4-… Read More
ENOXAPARIN SODIUM INJECTION SPECIFIC TESTS/Anti-Factor IIa Activity USP40–NF35 3982 1-Oct-2017 USP42–NF37 First Supplement to USP41–NF36 Delete
Standard solutions: Dilute USP Enoxaparin Sodium Solution for Bioassays RS with pH 7.4 buffer to obtain four dilutions having concentrations in the range between 0.015 and 0.075 IU of Anti-Factor IIa activity/mL.
ENALAPRIL MALEATE TABLETS PERFORMANCE TESTS/Dissolution <711>/Table 1 USP40–NF35 3971 1-Oct-2017 USP42–NF37 First Supplement to USP41–NF36 Row 3 of Column 3: Change
100
to:
200
EFAVIRENZ SPECIFIC TESTS/Enantiomeric Purity Second Supplement to USP40–NF35 ONLINE 1-Oct-2017 USP42–NF37 First Supplement to USP41–NF36 Line 1 of Mobile phase: Change
Hexane and ethanol (97:3)
to:
Hexane and absolute alcohol (97:3)
CANDESARTAN CILEXETIL TABLETS ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Second Supplement to USP40–NF35 8730 1-Oct-2017 USP42–NF37 First Supplement to USP41–NF36 Line 2 of USP Candesartan Cilexetil Related Compound D RS: Change
1-{[(Cyclohexyloxycarbonyloxy)carbonyl]oxy}ethyl 3-{[2’-(2-ethyl-2H-tetrazol-5-yl)biphenyl-4-yl]methyl}-2-oxo-2,3-dihydro-1H-benzimidazole-4-carboxylate.
to:
1-{[(Cyclohexyloxy)carbonyl]oxy}ethyl 3-({2… Read More
CALCIPOTRIENE OINTMENT IMPURITIES/Organic Impurities USP40–NF35 3114 1-Oct-2017 USP42–NF37 First Supplement to USP41–NF36 Footnote a of Table 1: Change
(5Z,7Z,22E,24R)-24-Cyclopropyl-9,10-secochola-5,7,10(19),22-tetraene-1α,3β,24-triol.
to:
(5Z,7Z,22E,24S)-24-Cyclopropyl-9,10-secochola-5,7,10(19),22-tetraene-1α,3β,24-triol.
POWDERED ASHWAGANDHA ROOT EXTRACT COMPOSITION/Content of Withanolides USP40–NF35 6804 1-Oct-2017 USP42–NF37 First Supplement to USP41–NF36 Add
Solution B: Acetonitrile, filtered and degassed
REAGENTS, INDICATORS AND SOLUTIONS SOLUTIONS/Volumetric Solutions/1 N Sulfuric Acid VS USP40–NF35 2434 1-Oct-2017 USP42–NF37 First Supplement to USP41–NF36 Line 3 of Standardization: Change
dried at 150°
to:
dried at 105°
REAGENTS REAGENT SPECIFICATIONS/Bromelain/Activity Determination USP40–NF35 2339 1-Oct-2017 USP42–NF37 First Supplement to USP41–NF36 Line 1 of Buffer solution: Change
Add 150 mg of sodium chloride
to:
Add 150 g of sodium chloride