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PDF CSV June 25, 2017 through June 25, 2019 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 PHP Field
TILETAMINE HYDROCHLORIDE Identification/B. Ultraviolet Absorption <197U> USP42–NF37 4347 1-Jun-2019 NA NA In Solution: Change
0.3 mg per mL.
to:
0.03 mg per mL.
0
TELMISARTAN TABLETS ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP42–NF37 4206 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]… Read More
0
SUMATRIPTAN SUCCINATE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP42–NF37 4145 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-(… Read More
0
SUMATRIPTAN ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP42–NF37 4139 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-(… Read More
0
SALMETEROL INHALATION POWDER IMPURITIES/Organic Impurities USP42–NF37 Online 1-Jun-2019 NA NA In Row 8 of Column 1 of Table 3: Change
Hyrdoxynaphthoic acid
to:
Hydroxynaphthoic acid
5
ROSUVASTATIN TABLETS PERFORMANCE TESTS/Dissolution <711>/Test 3 Revision Bulletin (Official April 01, 2019) Online 1-Jun-2019 NA NA In Medium: Change
(dissolve 63.0 of citric acid
to:
(dissolve 63.0 g of citric acid
0
PIPERAZINE PHOSPHATE Assay USP42–NF37 3549 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 · H3PO… Read More
0
PHENYLBUTAZONE INJECTION Assay USP42–NF37 3487 1-Jun-2019 NA NA Change
350(C/V)(RU/RS)
to:
714.3(C/V)(RU/RS)
0
MILRINONE ASSAY/Procedure USP42–NF37 2922 1-Jun-2019 NA NA In Buffer: Change
72.44 g of sodium tetraborate
to:
72.44 g of sodium tetraborate, anhydrous
0
LEVOCARNITINE IMPURITIES/Enantiomeric Purity USP42–NF37 2541 1-Jun-2019 NA NA In the second equation in Analysis: Change
Result = (RLPB)/(PAPB)
to:
Result = (RLPB)/(PA… Read More
0
GUANABENZ ACETATE IMPURITIES/Limit of 2,6-Dichlorobenzaldehyde/Chromatographic system USP42–NF37 2129 1-Jun-2019 NA NA In Column: Change
1.8-mm × 3-mm;
to:
1.8-m × 3-mm;
0
LIQUID GLUCOSE ASSAY/Reducing Sugars USP42–NF37 5741 1-Jun-2019 NA NA In the variable definition list in Analysis: Change
CU = concentration of dextrose equivalent
to:
CU = concentration of Liquid Glucose
0
EPRINOMECTIN IMPURITIES/Organic Impurities/Acceptance criteria USP42–NF37 1627 1-Jun-2019 NA NA In Total unknown impurities: Change
NMT 1.0
to:
NMT 1.0%
5
DULOXETINE DELAYED-RELEASE CAPSULES PERFORMANCE TESTS/Dissolution <711> USP42–NF37 1527 1-Jun-2019 NA NA In Test 3/Procedure: Change
1 N sodium hydroxide VS.
to:
0.1 N hydrochloric acid VS.
0
DULOXETINE DELAYED-RELEASE CAPSULES ASSAY/Procedure USP42–NF37 1527 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
0
DULOXETINE DELAYED-RELEASE CAPSULES IMPURITIES/Organic Impurities/Table 2 USP42–NF37 1527 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.
5
DRONEDARONE TABLETS PERFORMANCE TESTS/Dissolution <711> USP42–NF37 1519 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
0
DOXORUBICIN HYDROCHLORIDE ASSAY/Procedure USP42–NF37 1481 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)
0
DOXORUBICIN HYDROCHLORIDE IMPURITIES/Organic Impurities USP42–NF37 1481 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)
5
DIPHENHYDRAMINE HYDROCHLORIDE AND IBUPROFEN CAPSULES ASSAY/Procedure/Chromatographic system/Detectors USP42–NF37 1402 1-Jun-2019 NA NA Change
Identification test A: Diode array, UV 200–400 nm
to:
Identification B: Diode array, UV 200–400 nm
0
DIPHENHYDRAMINE HYDROCHLORIDE AND IBUPROFEN CAPSULES PERFORMANCE TESTS/Dissolution <711>/Analysis USP42–NF37 1402 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… Read More
5
DIDANOSINE IMPURITIES/Related Compounds USP42–NF37 1336 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
5
DACTINOMYCIN IDENTIFICATION/A. Ultraviolet Absorption <197U>/Acceptance criteria USP42–NF37 1203 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… Read More
0
CLOMIPHENE CITRATE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP42–NF37 1068 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
0
CETIRIZINE HYDROCHLORIDE ORALLY DISINTEGRATING TABLETS ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP42–NF37 897 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… Read More
0
CEFTIOFUR SODIUM IMPURITIES/High Molecular Weight Impurities USP42–NF37 859 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)
Read More
0
CEFTIOFUR HYDROCHLORIDE IMPURITIES/High Molecular Weight Impurities USP42–NF37 857 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)
Read More
0
BACILLUS COAGULANS CAPSULES ASSAY/Enumeration USP42–NF37 4749 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… Read More
0
BACILLUS COAGULANS ASSAY/Enumeration USP42–NF37 4746 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… Read More
0
BACILLUS COAGULANS ASSAY/Enumeration USP42–NF37 4746 1-Jun-2019 NA NA In Sample preparation and Analysis: Change
peptone water
to:
Peptone diluent
0
<561> ARTICLES OF BOTANICAL ORIGIN TEST FOR AFLATOXINS/Method I USP42–NF37 6701 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… Read More
0
REAGENTS AND REFERENCE TABLES SOLUTIONS/0.01 M Edetate Disodium VS USP42–NF37 6179 1-Jun-2019 NA NA In Standardization: Change
previously dried at 100°
to:
previously dried at 110°
0
REAGENTS AND REFERENCE TABLES SOLUTIONS/0.02 M Edetate Disodium VS USP42–NF37 6179 1-Jun-2019 NA NA In Standardization: Change
previously dried at 100°
to:
previously dried at 110°
0
<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 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… Read More
0
TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE TABLETS PERFORMANCE TESTS/Dissolution <711>/Test 1/Instrumental conditions USP42–NF37 4409 1-May-2019 NA NA In Cell: Change
5 cm
to:
5 mm
0
THALIDOMIDE Assay USP42–NF37 4281 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%.
0
SODIUM BICARBONATE COMPOUNDED INJECTION ASSAY/Procedure for Sodium Bicarbonate USP42–NF37 4023 1-May-2019 NA NA In Analysis: Change
Result = [(VSVB) x NA x F] x 100
to:
Result = [(VSVB) x NA x F x 100]/WRead More
0
PSEUDOEPHEDRINE HYDROCHLORIDE EXTENDED-RELEASE TABLETS PERFORMANCE TESTS/Dissolution <711> Revision Bulletin (Official March 01, 2019) Online 1-May-2019 NA NA In the Figure 1 caption: Change
(see Drug Release <724>, Figure 4c)
to:
(see Drug Release <724>, Figure 5c)
0
MORPHINE SULFATE EXTENDED-RELEASE CAPSULES IMPURITIES/Organic Impurities Revision Bulletin (Official November 01, 2018) Online 1-May-2019 NA NA In Row 4 of Column 1 of Table 5: Change
Morphine related compound Bb
to:
Morphine related compound B (anhydrous)b
5
MORPHINE SULFATE EXTENDED-RELEASE CAPSULES ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Revision Bulletin (Official November 01, 2018) Online 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… Read More
0
LEVALBUTEROL HYDROCHLORIDE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP42–NF37 2518 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).]… Read More
0
LEVALBUTEROL INHALATION SOLUTION IMPURITIES/Organic Impurities USP42–NF37 2520 1-May-2019 NA NA In Row 3 of Table 3: Change
Levalbuterol —  — —
to:
Levalbuterol 1.0 — —
0
LEVALBUTEROL INHALATION SOLUTION IMPURITIES/Limit of S-Albuterol USP42–NF37 Online 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 (… Read More
0
LEVALBUTEROL INHALATION SOLUTION ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP42–NF37 2520 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.
C13… Read More
0
INOSITOL IMPURITIES/Limit of Lead USP42–NF37 5776 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.
0
IMIPRAMINE PAMOATE CAPSULES ASSAY/Procedure USP42–NF37 Online 1-May-2019 NA NA In Solution A and Solution B and Diluent: Change
Chromatographic acetonitrile
to:
Acetonitrile
0
IMIPRAMINE PAMOATE CAPSULES IMPURITIES/Organic Impurities USP42–NF37 Online 1-May-2019 NA NA In Solution A: Change
Chromatographic acetonitrile
to:
Acetonitrile
AND
In Solution B: Change
chromatographic acetonitrile
to:
acetonitrile
5
HYPROMELLOSE PHTHALATE IMPURITIES/Chloride and Sulfate <221>, Chloride Harmonization (Official May 01, 2019) Online 1-May-2019 NA NA In Analysis: Change
Add 1 mL of silver nitrate TS to the Standard solution and then add a 50-mL portion of the Sample solution. Mix and allow to stand for 5 min protected from direct sunlight. Compare the turbidity of the… Read More
0
FELODIPINE EXTENDED-RELEASE TABLETS PERFORMANCE TESTS/Dissolution <711>/Test 2 USP42–NF37 1787 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… Read More
0
CLONIDINE TRANSDERMAL SYSTEM PERFORMANCE TESTS/Drug Release <724>/Test 1 USP42–NF37 1084 1-May-2019 NA NA Apparatus 7: Change
(see Figure 4a).
to:
(see Figure 5a).
0