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Monograph Title Section Source Publication Page Number Errata Official Date Target Errata Print Publication Target Online Fix Publication Description
NAPHAZOLINE HYDROCHLORIDE IMPURITIES/Organic Impurities First Supplement to USP39–NF34 8105 1-Dec-2016 USP41–NF36 Second Supplement to USP40–NF35 Line 16 of Analysis: Change
Calculate the percentage of any individual unspecified impurity
to:
Calculate the percentage of any other individual impurity
AND
Line 20 of Analysis: Change
rU = peak response of any individual unspecified… Read More
CIPROFLOXACIN ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Second Supplement to USP39–NF34 8597 1-Dec-2016 USP41–NF36 Second Supplement to USP40–NF35 Line 2 of USP Ciprofloxacin Ethylenediamine Analog RS: Change
7-(2-Aminoethylamino)-1-cyclopropyl-6-fluoro-4-oxo-1,4-dihydroquinoline-3-carboxylic acid.
C15H16FN3O3 305.30
to:
1-Cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-[(2-aminoethyl)… Read More
CIPROFLOXACIN HYDROCHLORIDE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Second Supplement to USP39–NF35 8600 1-Dec-2016 USP41–NF36 Second Supplement to USP40–NF35 Line 2 of USP Ciprofloxacin Ethylenediamine Analog RS: Change
7-(2-Aminoethylamino)-1-cyclopropyl-6-fluoro-4-oxo-1,4-dihydroquinoline-3-carboxylic acid.
C15H16FN3O3 305.30
to:
1-Cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-[(2-aminoethyl)… Read More
DEXTROSE IDENTIFICATION/C. Water Determination <921> Second Supplement to USP39–NF34 8612 1-Dec-2016 USP41–NF36 Second Supplement to USP40–NF35 Line 1: Change
Water Determination <921>
to:
Water Determination <921>, Method I
OMEGA-3-ACID ETHYL ESTERS CAPSULES ASSAY/Content of EPAee, DHAee, and Total Omega-3-Acid Ethyl Esters Second Supplement to USP39–NF34 8755 1-Dec-2016 USP41–NF36 Second Supplement to USP40–NF35 Line 21 of Analysis: Change
CU = nominal concentration of the total omega-3-acid ethyl esters in the Sample solution (g/mL)
to:
CU = Capsule fill content of the Sample solution (g/mL)
OMEGA-3-ACID ETHYL ESTERS CAPSULES SPECIFIC TESTS/Concentration of Omega-3-Acid Ethyl Esters Second Supplement to USP39–NF34 8755 1-Dec-2016 USP41–NF36 Second Supplement to USP40–NF35 Line 21: Change
CU = nominal concentration of the total omega-3-acid ethyl esters in the Sample solution (g/mL)
to:
CU = Capsule fill content of the Sample solution (g/mL)
POVIDONE IMPURITIES/Formic Acid Second Supplement to USP39–NF34 8778 1-Dec-2016 USP41–NF36 Second Supplement to USP40–NF35 Line 3 of Sample solution: Change
column of about 80 mm
to:
column of about 8 mm
ROPINIROLE EXTENDED-RELEASE TABLETS PERFORMANCE TESTS/Dissolution <711>/Test 1 Second Supplement to USP39–NF34 8814 1-Dec-2016 USP41–NF36 Second Supplement to USP40–NF35 Line 2 of Buffer 1: Adjust with Solution A to a pH of 4.0.
to:
Adjust with Solution A to a pH of 4.0. Dilute with water to 1 L.
<661.1> PLASTIC MATERIALS OF CONSTRUCTION TEST METHODS USP40–NF35 542 1-Dec-2016 USP41–NF36 Second Supplement to USP40–NF35 Line 1 of Physicochemical Tests/Acidity or Alkalinity/BRP indicator solution: Change
1.0 mg/mL of bromophenol blue,
to:
1.0 mg/mL of bromothymol blue,
AND
Line 3 of Plastic Additives/Polyethylene, Cyclic Olefins, and Polypropylene/Phenolic… Read More
DUTASTERIDE IMPURITIES/Organic Impurities, Procedure 2/Table 4 USP40–NF35 3924 1-Dec-2016 USP41–NF36 Second Supplement to USP40–NF35 Footnote a: Change
(5α,17β)-N-[2,5-Bis(trifluoromethyl)phenyl]-3-oxo-4-azaandrost-17 carboxamide.
to:
(5α,17β)-N-[2,5-Bis(trifluoromethyl)phenyl]-3-oxo-4-azaandrostane-17-carboxamide.
<1010> ANALYTICAL DATA—INTERPRETATION AND TREATMENT APPENDIX C: EXAMPLES OF OUTLIER TESTS FOR ANALYTICAL DATA/Hampel's Rule USP39–NF34 767 1-Oct-2016 USP41–NF36 First Supplement to USP40–NF35 Row 13 of Column 4 of Table 5. Test Results of Re-Applied Hampel's Rule: Change
0.14
to:
0.15
CALCIUM GLUCONATE CHEMICAL INFORMATION USP39–NF34 2877 1-Oct-2016 USP41–NF36 First Supplement to USP40–NF35 Line 5: Change
[18016-24-5].
to:
[66905-23-5].
CALCIUM GLUCONATE INJECTION DEFINITION USP39–NF34 2879 1-Oct-2016 USP41–NF36 First Supplement to USP40–NF35 Line 8: Change
It may contain sodium hydroxide added for adjustment of the pH.
to:
It may contain sodium hydroxide or hydrochloric acid added for adjustment of the pH.
FLUORESCEIN SODIUM ASSAY/Procedure USP39–NF34 3960 1-Oct-2016 USP41–NF36 First Supplement to USP40–NF35 Line 3 of Standard stock solution: Change
1.0 mg/mL of fluorescein sodium in Diluent is prepared as follows.
to:
1.0 mg/mL of fluorescein sodium is prepared as follows.
NORFLOXACIN SPECIFIC TESTS/Loss on Drying <731> USP39–NF34 5101 1-Oct-2016 USP41–NF36 First Supplement to USP40–NF35 Line 1 of Analysis: Change
Dry at 100° to constant weight.
to:
Dry under vacuum at a pressure not exceeding 5 mm of mercury at 100° to constant weight.
PARICALCITOL INJECTION IMPURITIES/Organic Impurities/Chromatographic system/Columns USP39–NF34 5279 1-Oct-2016 USP41–NF36 First Supplement to USP40–NF35 Line 1 of Guard: Change
4.6-mm × 7.5-mm; packing L1
to:
4.6-mm × 7.5-mm or 4.6-mm × 10-mm; packing L1
PHENYTOIN SODIUM IDENTIFICATION/B. Identification Tests—General, Sodium <191> USP39–NF34 5388 1-Oct-2016 USP41–NF36 First Supplement to USP40–NF35 Line 2: Change
tetramethylammonium hydroxide solution,
to:
tetramethylammonium hydroxide TS,
POTASSIUM CITRATE EXTENDED-RELEASE TABLETS OTHER COMPONENTS/Content of Potassium USP39–NF34 5465 1-Oct-2016 USP41–NF36 First Supplement to USP40–NF35 Line 10 of Analysis: Change
Result = (C/CU) × [Mr/(3 × Ar)] × 100
to:
Result = C × 100/CU
AND
Line 13 of Analysis: Change
CU =… Read More
PROPOFOL ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP39–NF34 5573 1-Oct-2016 USP41–NF36 First Supplement to USP40–NF35 Line 2 of USP Propofol Related Compound B RS: Change
2,6-Diisopropylbenzoquinone.
to:
2,6-Diisopropyl-1,4-benzoquinone.
PROPOFOL INJECTABLE EMULSION ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP39–NF34 5575 1-Oct-2016 USP41–NF36 First Supplement to USP40–NF35 Line 2 of USP Propofol Related Compound B RS: Change
2,6-Diisopropylbenzoquinone.
to:
2,6-Diisopropyl-1,4-benzoquinone.
TRAVOPROST OPHTHALMIC SOLUTION ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP39–NF34 6226 1-Oct-2016 USP41–NF36 First Supplement to USP40–NF35 Line 2 of USP Travoprost Related Compound A RS: Change
(5Z,13E)-(9S,11R,15R)-9,11,15-Trihydroxy-16-(m-trifluoromethylphenoxy)-17,18,19,20-tetranor-5,13-prostadienoic acid.
to:
(5Z,13E)-(9S,11R,15R)-9,11,15-… Read More
VITAMIN A ORAL LIQUID PREPARATION ASSAY/Vitamin A USP39–NF34 6374 1-Oct-2016 USP41–NF36 First Supplement to USP40–NF35 Line 7 of Analysis: Change
Result = (rU/rS) × (C/W) × (V/D) × U × (100/L)
to:
Result = (rU/rS) × (C/W) × D × U… Read More
ST. JOHN'S WORT SPECIFIC TESTS USP39–NF34 6817 1-Oct-2016 USP41–NF36 First Supplement to USP40–NF35 Insert missing test:
Articles of Botanical Origin <561>, Methods of Analysis, Total Ash: NMT 5.0%
<800> HAZARDOUS DRUGS—HANDLING IN HEALTHCARE SETTINGS REFERENCES First Supplement to USP39–NF34 7721 1-Oct-2016 USP41–NF36 First Supplement to USP40–NF35 Line 2 of first reference: Delete
http://www.acoem.org/Reproductive_Developmental_Hazard_Management.aspx.
AND
Line 2 of second reference: Delete
Read More
<800> HAZARDOUS DRUGS—HANDLING IN HEALTHCARE SETTINGS APPENDICES/Appendix 3: Types of Biological Safety Cabinets/Class II First Supplement to USP39–NF34 7721 1-Oct-2016 USP41–NF36 First Supplement to USP40–NF35 Line 5 of Type A1 (formerly, Type A): Change
radionucleotides
to:
radionuclides
AND
Line 5 of Type A2 (formerly, Type B3): Change
radionucleotides
to:
radionuclides
AND
Line 5 of Type B1: Change
radionucleotides
to:
radionuclides
Read More
DANTROLENE SODIUM IDENTIFICATION/D. First Supplement to USP39–NF34 8035 1-Oct-2016 USP41–NF36 First Supplement to USP40–NF35 Line 2 of Solution A: Change
tetramethylammonium hydroxide solution
to:
tetramethylammonium hydroxide TS
OXYMETAZOLINE HYDROCHLORIDE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> First Supplement to USP39–NF34 8116 1-Oct-2016 USP41–NF36 First Supplement to USP40–NF35 USP Oxymetazoline Related Compound A RS: Change
N-(2-Aminoethyl)-2-[4-(tert-butyl)-3-hydroxy-2,6-dimethylphenyl]acetamide.
C16H26N2O2 278.39
to:
N-(2-Aminoethyl)-2-[4-(tert-butyl)-3-hydroxy-2,6-dimethylphenyl]… Read More
OXYMETAZOLINE HYDROCHLORIDE IMPURITIES/Organic Impurities/Table 2 First Supplement to USP39–NF34 8116 1-Oct-2016 USP41–NF36 First Supplement to USP40–NF35 Row 2 of Column 1: Change
Oxymetazoline related compound A
to:
Oxymetazoline related compound Aa
AND
Add footnote a:
N-(2-Aminoethyl)-2-[4-(tert-butyl)-3-hydroxy-2,6-dimethylphenyl]acetamide.
PERINDOPRIL ERBUMINE CHEMICAL INFORMATION First Supplement to USP39–NF34 8127 1-Oct-2016 USP41–NF36 First Supplement to USP40–NF35 Line 9: Delete
(2S,3aS,7aS)-1-{(S)-2-[(R)-1-Ethoxy-1-oxopentan-2-ylamino]propanoyl}octahydro-1H-indole-2-carboxylic acid
PERINDOPRIL ERBUMINE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> First Supplement to USP39–NF34 8127 1-Oct-2016 USP41–NF36 First Supplement to USP40–NF35 Line 2 of USP Perindopril Related Compound A RS: Change
(2S,3aS,7aS)-Octahydro-1H-indole-2-carboxylic acid hydrochloride.
C17H28N2O5 · HCl 205.68
to:
(2S,3aS,7aS)-Octahydro-1H-… Read More
PERINDOPRIL ERBUMINE IMPURITIES/Organic Impurities/Table 2 First Supplement to USP39–NF34 8127 1-Oct-2016 USP41–NF36 First Supplement to USP40–NF35 Line 2 of footnote g: Change
ocatahydro
to:
octahydro
DESLORATADINE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Second Supplement to USP39–NF34 8607 1-Oct-2016 USP41–NF36 First Supplement to USP40–NF35 Line 2 of USP Desloratadine Related Compound B RS: Change
8-Chloro-11-(1,2,3,6-tetrahydropyridin-4-yl)-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridine.
C19H19ClN2 310.82
to:
8-Chloro-11-(1,2,3,6-tetrahydropyridin-4-yl)-6,11-dihydro-5… Read More
<1663> EXTRACTABLES ASSOCIATED WITH PHARMACEUTICAL PACKAGING SYSTEMS REFERENCES USP39–NF34 1835 1-Aug-2016 USP41–NF36 First Supplement to USP40–NF35 Delete references 5, 7, 9, and 12.
<1664> ASSESSMENT OF DRUG PRODUCT LEACHABLES ASSOCIATED WITH PHARMACEUTICAL PACKAGING/DELIVERY SYSTEMS REFERENCES USP39–NF34 1850 1-Aug-2016 USP41–NF36 First Supplement to USP40–NF35 Delete reference 8.
<1664.1> ORALLY INHALED AND NASAL DRUG PRODUCTS REFERENCES USP39–NF34 1862 1-Aug-2016 USP41–NF36 First Supplement to USP40–NF35 Delete reference 3.
FELBAMATE ORAL SUSPENSION PERFORMANCE TESTS/Dissolution <711> USP39–NF34 3855 1-Aug-2016 USP41–NF36 First Supplement to USP40–NF35 Line 4 of System suitability: Change
[Note—The relative retention times for methylparaben and felbamate are about 0.5 and 1.0, respectively.]
to:
[Note—The relative retention times for felbamate and methylparaben are about 1.0 and 1.5, respectively.]
FEXOFENADINE HYDROCHLORIDE CHEMICAL INFORMATION USP39–NF34 3895 1-Aug-2016 USP41–NF36 First Supplement to USP40–NF35 Line 7: Change
[138452-21-8].
to:
[153439-40-8].
FLUORESCEIN SODIUM IMPURITIES/Organic Impurities USP39–NF34 3960 1-Aug-2016 USP41–NF36 First Supplement to USP40–NF35 Row 7 of column 1 of Table 2: Change
Total impurities
to:
Total unspecified impurities
GRANISETRON HYDROCHLORIDE USP Reference standards <11> USP39–NF34 4151 1-Aug-2016 USP41–NF36 First Supplement to USP40–NF35 Line 2 of USP Granisetron Related Compound B RS: Change
(N-[(1R,3r,5)-9-Methyl-9-azabicyclo[3.3.1]non-3-yl]-1H-indazole-3-carboxamide).
to:
(N-[(1R,3r,5S)-9-Methyl-9-azabicyclo[3.3.1]non-3-yl]-1H-indazole-3-carboxamide).
AND… Read More
GRANISETRON HYDROCHLORIDE INJECTION USP Reference standards <11> USP39–NF34 4153 1-Aug-2016 USP41–NF36 First Supplement to USP40–NF35 Line 2 of USP Granisetron Related Compound B RS: Change
(N-[(1R,3r,5)-9-Methyl-9-azabicyclo[3.3.1]non-3-yl]-1H-indazole-3-carboxamide).
to:
N-[(1R,3r,5S)-9-Methyl-9-azabicyclo[3.3.1]non-3-yl]-1H-indazole-3-carboxamide.
GRANISETRON HYDROCHLORIDE TABLETS USP Reference standards <11> USP39–NF34 4155 1-Aug-2016 USP41–NF36 First Supplement to USP40–NF35 Line 2 of USP Granisetron Related Compound B RS: Change
(N-[(1R,3r,5)-9-Methyl-9-azabicyclo[3.3.1]non-3-yl]-1H-indazole-3-carboxamide).
to:
N-[(1R,3r,5S)-9-Methyl-9-azabicyclo[3.3.1]non-3-yl]-1H-indazole-3-carboxamide.
HALCINONIDE CREAM IMPURITIES/Organic Impurities/Chromatographic system USP39–NF34 4176 1-Aug-2016 USP41–NF36 First Supplement to USP40–NF35 Line 1 of Column: Change
1.8-µm packing L1
to:
1.7-µm packing L1
HALOPERIDOL DECANOATE IMPURITIES/Organic Impurities/Table 2 USP39–NF34 4184 1-Aug-2016 USP41–NF36 First Supplement to USP40–NF35 Footnote k: Change
4-(4′-Chlorobiphenyl-4-yl)-1-[4-(4-fluorophenyl)-4-oxobutyl]piperidin-4-yl decanoate.
to:
4-(3′-Chlorobiphenyl-4-yl)-1-[4-(4-fluorophenyl)-4-oxobutyl]piperidin-4-yl decanoate.
AND
Footnote l: Change
4-(3′-Chlorobiphenyl-4-yl)-1-[4-(4-fluorophenyl)-4-oxobutyl]… Read More
KETOROLAC TROMETHAMINE INJECTION ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP39–NF34 4468 1-Aug-2016 USP41–NF36 First Supplement to USP40–NF35 Line 4 of USP Ketorolac Related Compound A RS: Change
358.15
to:
358.39
AND
Line 3 of USP Ketorolac Related Compound B RS: Change
227.09
to:
227.26
AND
Line 3 of USP Ketorolac Related Compound C RS: Change
225.09
to:
225.24
AND
Line 3 of USP Ketorolac… Read More
LOVASTATIN USP Reference standards <11> USP39–NF34 4631 1-Aug-2016 USP41–NF36 First Supplement to USP40–NF35 Line 2 of USP Lovastatin Related Compound A RS: Change
[Dihydro-lovastatin][butanoic acid, 2-methyl-, 1,2,3,4,4a,7,8,8a-octahydro-3,7-dimethyl-8-[2(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α(R*),3α,7β,8β(2S*,4S*),-8αβ]]]-.… Read More
NAPROXEN TABLETS ASSAY/Procedure/System suitability/Suitability requirements USP39–NF34 4993 1-Aug-2016 USP41–NF36 First Supplement to USP40–NF35 Line 1 of Tailing factor: Change
NLT 2.0
to:
NMT 2.0
NAPROXEN TABLETS IMPURITIES/Organic Impurities USP39–NF34 4993 1-Aug-2016 USP41–NF36 First Supplement to USP40–NF35 Line 6 of Analysis: Change
Result = (rU/rS) × (CU/CS) × 100
to:
Result = (rU/rS) × (CS/CU… Read More
RIZATRIPTAN BENZOATE TABLETS PERFORMANCE TESTS/Dissolution <711>/Chromatographic procedure USP39–NF34 5750 1-Aug-2016 USP41–NF36 First Supplement to USP40–NF35 Add
Buffer: 1.36 g/L of monobasic potassium phosphate. Adjust the pH of the solution with phosphoric acid to 2.5.
SIMETHICONE ASSAY/Procedure/Analysis USP39–NF34 5843 1-Aug-2016 USP41–NF36 First Supplement to USP40–NF35 Line 1 of Samples: Change
Standard stock solution, Standard solution, Sample stock solution, and Sample solution
to:
Standard solution and Sample solution
SIMVASTATIN TABLETS IMPURITIES/Organic Impurities/Analysis USP39–NF34 5848 1-Aug-2016 USP41–NF36 First Supplement to USP40–NF35 Line 5: Change
Result = (rU/rS) × (CS/CU) × (Mr1/Mr2) × 100
to:
Result = (rU/rS) × (C… Read More