Errata - English

PDF CSV February 21, 2023 through February 22, 2025 All Errata for USP–NF How to use

Monograph Title	Section	Source Publication	Page Number	Errata Post Date Sort ascending	Errata Official Date	Target Errata Print Publication	Target Online Fix Publication	Description
<1207> STERILE PRODUCT PACKAGING−INTEGRITY EVALUATION	5. PRODUCT–PACKAGE QUALITY REQUIREMENTS AND THE MAXIMUM ALLOWABLE LEAKAGE LIMIT/5.1 Sterility and Product Formulation Content must be Preserved; Gas Headspace Content Preservation is not Required	First Supplement to USP39–NF34	7764	18-Nov-2016	1-Dec-2016	USP41–NF36	Second Supplement to USP40–NF35	Line 3 of paragraph 5: Change ultra-cold storage (<80°) to: ultra-cold storage (≤−80°)
CIPROFLOXACIN HYDROCHLORIDE	ADDITIONAL REQUIREMENTS/USP Reference Standards <11>	Second Supplement to USP39–NF35	8600	18-Nov-2016	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 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)amino]-3-quinolinecarboxylic acid hydrochloride. C₁₅H₁₆FN₃O₃ · HCl 341.77
ROPINIROLE EXTENDED-RELEASE TABLETS	PERFORMANCE TESTS/Dissolution <711>/Test 1	Second Supplement to USP39–NF34	8814	18-Nov-2016	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.
<670> AUXILIARY PACKAGING COMPONENTS	DESICCANTS/Silica Gel/Inorganic Impurities	USP39–NF34	510	18-Nov-2016	1-Dec-2016	USP41–NF36	Second Supplement to USP40–NF35	Line 1 of Soluble ionizable salts: Change (as NaSO₃): to: (as Na₂SO₄):
DIGOXIN INJECTION	IDENTIFICATION/B.	USP39–NF34	3493	18-Nov-2016	1-Dec-2016	USP41–NF36	Second Supplement to USP40–NF35	Line 1 of Procedure: Change Proceed as directed for Procedure in the test for Related glycosides under Digoxin, except to omit the use of the Gitoxin standard solution. to: Apply 10 µL of the Test solution and 10 µL of the Standard solution… Read More DIGOXIN INJECTION Line 1 of Procedure: Change Proceed as directed for Procedure in the test for Related glycosides under Digoxin, except to omit the use of the Gitoxin standard solution. to: Apply 10 µL of the Test solution and 10 µL of the Standard solution on a line parallel to and about 2.5 cm from the bottom edge of a reversed-phase thin-layer chromatographic plate coated with a 0.25-mm layer of chromatographic silica gel mixture to which is permanently bonded octadecylsilane (C18). Allow the spots to dry, and place the plates in a developing chamber containing a mixture of methanol and water (7:3). Develop the chromatogram until the solvent front has moved about 15 cm above the line of application. Remove the plate, and allow the solvent to evaporate. Spray the plate with Chloramine T–trichloroacetic acid reagent, freshly mixed, and heat in an oven at 110° for 10 minutes.
POWDERED CHASTE TREE EXTRACT	CONTAMINANTS	USP39–NF34	6553	18-Nov-2016	1-Dec-2016	USP41–NF36	Second Supplement to USP40–NF35	Change Microbial Enumeration Tests <2021>: The total bacterial count does not exceed 10⁴ cfu/g. The total combined molds and yeasts count does not exceed 1000 cfu/g. It meets the requirements of the tests for absence of Salmonella species and Escherichia coli… Read More POWDERED CHASTE TREE EXTRACT Change Microbial Enumeration Tests <2021>: The total bacterial count does not exceed 10⁴ cfu/g. The total combined molds and yeasts count does not exceed 1000 cfu/g. It meets the requirements of the tests for absence of Salmonella species and Escherichia coli. to: Microbial Enumeration Tests <2021>: The total bacterial count does not exceed 10⁴ cfu/g. The total combined molds and yeasts count does not exceed 10³ cfu/g. Absence of Specified Microorganisms <2022>: Meets the requirements of the tests for absence of Salmonella species and Escherichia coli
NAPHAZOLINE HYDROCHLORIDE	IMPURITIES/Organic Impurities	First Supplement to USP39–NF34	8105	18-Nov-2016	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 r_U = peak response of any individual unspecified… Read More NAPHAZOLINE HYDROCHLORIDE 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 r_U = peak response of any individual unspecified impurity to: r_U = peak response of any other individual impurity
OMEGA-3-ACID ETHYL ESTERS CAPSULES	SPECIFIC TESTS/Concentration of Omega-3-Acid Ethyl Esters	Second Supplement to USP39–NF34	8755	18-Nov-2016	1-Dec-2016	USP41–NF36	Second Supplement to USP40–NF35	Line 21: Change C_U = nominal concentration of the total omega-3-acid ethyl esters in the Sample solution (g/mL) to: C_U = Capsule fill content of the Sample solution (g/mL)
CYCLOBENZAPRINE HYDROCHLORIDE	ADDITIONAL REQUIREMENTS/USP Reference Standards <11>	USP39–NF34	3333	18-Nov-2016	1-Dec-2016	USP41–NF36	Second Supplement to USP40–NF35	Line 2 of USP Cyclobenzaprine Related Compound B RS: Change 3-(5H-Dibenzo[a,d]cyclohepten-5-ylidene)-N-methyl-1-propanamine. C₁₉H₁₉N 261.36 to: 3-(5H-Dibenzo[a,d]cyclohepten-5-ylidene)-N-methyl-1-propanamine… Read More CYCLOBENZAPRINE HYDROCHLORIDE Line 2 of USP Cyclobenzaprine Related Compound B RS: Change 3-(5H-Dibenzo[a,d]cyclohepten-5-ylidene)-N-methyl-1-propanamine. C₁₉H₁₉N 261.36 to: 3-(5H-Dibenzo[a,d]cyclohepten-5-ylidene)-N-methyl-1-propanamine hydrochloride. C₁₉H₁₉N · HCl 297.82
RIBOFLAVIN 5′-PHOSPHATE SODIUM	ASSAY/Procedure	USP39–NF34	5698	18-Nov-2016	1-Dec-2016	USP41–NF36	Second Supplement to USP40–NF35	Line 2 of Instrumental conditions: Change Nephelometry, Turbidimetry, and Visual Comparison <855> to: Fluorescence Spectroscopy <853>
NORFLOXACIN	SPECIFIC TESTS/Loss on Drying <731>	USP39–NF34	5101	30-Sep-2016	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.
PROPOFOL INJECTABLE EMULSION	ADDITIONAL REQUIREMENTS/USP Reference Standards <11>	USP39–NF34	5575	30-Sep-2016	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.
<800> HAZARDOUS DRUGS—HANDLING IN HEALTHCARE SETTINGS	APPENDICES/Appendix 3: Types of Biological Safety Cabinets/Class II	First Supplement to USP39–NF34	7721	30-Sep-2016	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 <800> HAZARDOUS DRUGS—HANDLING IN HEALTHCARE SETTINGS 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 AND Line 5 of Type B2 (total exhaust): Change radionucleotides to: radionuclides
PERINDOPRIL ERBUMINE	ADDITIONAL REQUIREMENTS/USP Reference Standards <11>	First Supplement to USP39–NF34	8127	30-Sep-2016	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 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-indole-2-carboxylic acid. C₉H₁₅NO₂ 169.22
CALCIUM GLUCONATE INJECTION	DEFINITION	USP39–NF34	2879	30-Sep-2016	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.
POTASSIUM CITRATE EXTENDED-RELEASE TABLETS	OTHER COMPONENTS/Content of Potassium	USP39–NF34	5465	30-Sep-2016	1-Oct-2016	USP41–NF36	First Supplement to USP40–NF35	Line 10 of Analysis: Change Result = (C/C_U) × [M_r/(3 × A_r)] × 100 to: Result = C × 100/C_U AND Line 13 of Analysis: Change C_U =… Read More POTASSIUM CITRATE EXTENDED-RELEASE TABLETS Line 10 of Analysis: Change Result = (C/C_U) × [M_r/(3 × A_r)] × 100 to: Result = C × 100/C_U AND Line 13 of Analysis: Change C_U = nominal concentration, based on the Assay value, of potassium citrate monohydrate in the Sample solution (µg/mL) M_r = molecular weight of potassium citrate monohydrate, 324.41 A_r = atomic weight of potassium, 39.10 to: C_U = concentration of potassium citrate anhydrous (C₆H₅K₃O₇) in the Sample solution calculated from the Assay value of potassium citrate monohydrate (C₆H₅K₃O₇ · H₂O) (µg/mL)
ST. JOHN'S WORT	SPECIFIC TESTS	USP39–NF34	6817	30-Sep-2016	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%
OXYMETAZOLINE HYDROCHLORIDE	IMPURITIES/Organic Impurities/Table 2	First Supplement to USP39–NF34	8116	30-Sep-2016	1-Oct-2016	USP41–NF36	First Supplement to USP40–NF35	Row 2 of Column 1: Change Oxymetazoline related compound A to: Oxymetazoline related compound A^a AND Add footnote a: N-(2-Aminoethyl)-2-[4-(tert-butyl)-3-hydroxy-2,6-dimethylphenyl]acetamide.
<1010> ANALYTICAL DATA—INTERPRETATION AND TREATMENT	APPENDIX C: EXAMPLES OF OUTLIER TESTS FOR ANALYTICAL DATA/Hampel's Rule	USP39–NF34	767	30-Sep-2016	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
PARICALCITOL INJECTION	IMPURITIES/Organic Impurities/Chromatographic system/Columns	USP39–NF34	5279	30-Sep-2016	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
TRAVOPROST OPHTHALMIC SOLUTION	ADDITIONAL REQUIREMENTS/USP Reference Standards <11>	USP39–NF34	6226	30-Sep-2016	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 TRAVOPROST OPHTHALMIC SOLUTION 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-Trihydroxy-16-(m-trifluoromethylphenoxy)-17,18,19,20-tetranor-5,13-prostadienoic acid or (Z)-7-((1R,2R,3R,5S)-3,5-Dihydroxy-2-{(R,E)-3-hydroxy-4-[3-(trifluoromethyl)phenoxy]but-1-enyl}cyclopentyl)hept-5-enoic acid.
DANTROLENE SODIUM	IDENTIFICATION/D.	First Supplement to USP39–NF34	8035	30-Sep-2016	1-Oct-2016	USP41–NF36	First Supplement to USP40–NF35	Line 2 of Solution A: Change tetramethylammonium hydroxide solution to: tetramethylammonium hydroxide TS
PERINDOPRIL ERBUMINE	IMPURITIES/Organic Impurities/Table 2	First Supplement to USP39–NF34	8127	30-Sep-2016	1-Oct-2016	USP41–NF36	First Supplement to USP40–NF35	Line 2 of footnote g: Change ocatahydro to: octahydro
FLUORESCEIN SODIUM	ASSAY/Procedure	USP39–NF34	3960	30-Sep-2016	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.
PROPOFOL	ADDITIONAL REQUIREMENTS/USP Reference Standards <11>	USP39–NF34	5573	30-Sep-2016	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.
<800> HAZARDOUS DRUGS—HANDLING IN HEALTHCARE SETTINGS	REFERENCES	First Supplement to USP39–NF34	7721	30-Sep-2016	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 Line 2 of first reference: Delete http://www.acoem.org/Reproductive_Developmental_Hazard_Management.aspx. AND Line 2 of second reference: Delete http://www.asco.org/advocacy/worker-safety-when-handling-hazardous-drugs-focus-statement-oncology-societies.
PERINDOPRIL ERBUMINE	CHEMICAL INFORMATION	First Supplement to USP39–NF34	8127	30-Sep-2016	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
CALCIUM GLUCONATE	CHEMICAL INFORMATION	USP39–NF34	2877	30-Sep-2016	1-Oct-2016	USP41–NF36	First Supplement to USP40–NF35	Line 5: Change [18016-24-5]. to: [66905-23-5].
PHENYTOIN SODIUM	IDENTIFICATION/B. Identification Tests—General, Sodium <191>	USP39–NF34	5388	30-Sep-2016	1-Oct-2016	USP41–NF36	First Supplement to USP40–NF35	Line 2: Change tetramethylammonium hydroxide solution, to: tetramethylammonium hydroxide TS,
VITAMIN A ORAL LIQUID PREPARATION	ASSAY/Vitamin A	USP39–NF34	6374	30-Sep-2016	1-Oct-2016	USP41–NF36	First Supplement to USP40–NF35	Line 7 of Analysis: Change Result = (r_U/r_S) × (C/W) × (V/D) × U × (100/L) to: Result = (r_U/r_S) × (C/W) × D × U… Read More VITAMIN A ORAL LIQUID PREPARATION Line 7 of Analysis: Change Result = (r_U/r_S) × (C/W) × (V/D) × U × (100/L) to: Result = (r_U/r_S) × (C/W) × D × U × (100/L) AND Line 16 of the Analysis: Delete V = volume of the Sample solution (mL)
OXYMETAZOLINE HYDROCHLORIDE	ADDITIONAL REQUIREMENTS/USP Reference Standards <11>	First Supplement to USP39–NF34	8116	30-Sep-2016	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 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]acetamide hydrochloride. C₁₆H₂₆N₂O₂ · HCl 314.85
DESLORATADINE	ADDITIONAL REQUIREMENTS/USP Reference Standards <11>	Second Supplement to USP39–NF34	8607	30-Sep-2016	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 DESLORATADINE 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-5H-benzo[5,6]cyclohepta[1,2-b]pyridine hydrochloride. C₁₉H₂₀Cl₂N₂ 347.28
<1663> EXTRACTABLES ASSOCIATED WITH PHARMACEUTICAL PACKAGING SYSTEMS	REFERENCES	USP39–NF34	1835	29-Jul-2016	1-Aug-2016	USP41–NF36	First Supplement to USP40–NF35	Delete references 5, 7, 9, and 12.
FLUORESCEIN SODIUM	IMPURITIES/Organic Impurities	USP39–NF34	3960	29-Jul-2016	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
HALOPERIDOL DECANOATE	IMPURITIES/Organic Impurities/Table 2	USP39–NF34	4184	29-Jul-2016	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 HALOPERIDOL DECANOATE 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]piperidin-4-yl decanoate. to: 4-(4′-Chlorobiphenyl-4-yl)-1-[4-(4-fluorophenyl)-4-oxobutyl]piperidin-4-yl decanoate.
RIZATRIPTAN BENZOATE TABLETS	PERFORMANCE TESTS/Dissolution <711>/Chromatographic procedure	USP39–NF34	5750	29-Jul-2016	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.
TRIHEXYPHENIDYL HYDROCHLORIDE ORAL SOLUTION	Assay	USP39–NF34	6266	29-Jul-2016	1-Aug-2016	USP41–NF36	First Supplement to USP40–NF35	Line 1 of Mobile phase and Chromatographic system: Change Prepare as directed in the Assay under TrihexyphenidylHydrochloride. to: Mobile phase—Prepare a mixture of acetonitrile, water, and triethylamine (920:80:0.2), adjust with phosphoric acid to a pH… Read More TRIHEXYPHENIDYL HYDROCHLORIDE ORAL SOLUTION Line 1 of Mobile phase and Chromatographic system: Change Prepare as directed in the Assay under TrihexyphenidylHydrochloride. to: Mobile phase—Prepare a mixture of acetonitrile, water, and triethylamine (920:80:0.2), adjust with phosphoric acid to a pH of 4.0, mix, filter, and degas. Make adjustments if necessary (see System Suitability under Chromatography <621>). Chromatographic system (see Chromatography <621>)—The liquid chromatograph is equipped with a 210-nm detector and a 4.6-mm × 8-cm column that contains 3-µm packing L1. The flow rate is about 2 mL per minute. Chromatograph the Standard preparation, and record the peak responses as directed for Procedure: the column efficiency determined from the analyte peak is not less than 1300 theoretical plates, the tailing factor for the analyte peak is not more than 3.0, and the relative standard deviation for replicate injections is not more than 1.0%. AND Line 1 of Procedure: Change Proceed as directed for Procedure in the Assay under Trihexyphenidyl Hydrochloride. to: Separately inject equal volumes (about 10 µL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks. AND Line 7 of Procedure: Change and the other terms are as defined therein. to: C is the concentration, in mg per mL, of USP Trihexyphenidyl Hydrochloride RS in the Standard preparation, r_U and r_S are the trihexyphenidyl peak responses obtained from the Assay preparation and the Standard preparation, respectively.
SULINDAC TABLETS	IMPURITIES/Organic Impurities	First Supplement to USP39–NF34	8160	29-Jul-2016	1-Aug-2016	USP41–NF36	First Supplement to USP40–NF35	Line 1 of System suitability/Relative standard deviation: Change NMT 2.0% for any peak to: NMT 2.0% for sulindac, sulindac related compound B, and sulindac related compound C AND Line 3 of Analysis: Change Calculate the percentage of the labeled amount of… Read More SULINDAC TABLETS Line 1 of System suitability/Relative standard deviation: Change NMT 2.0% for any peak to: NMT 2.0% for sulindac, sulindac related compound B, and sulindac related compound C AND Line 3 of Analysis: Change Calculate the percentage of the labeled amount of sulindac related compound A, sulindac related compound B, or sulindac related compound C in the portion of Tablets taken: to: Calculate the percentage of sulindac related compound B or sulindac related compound C in the portion of Tablets taken: AND Line 8 of Analysis: Change r_U = peak response of sulindac related compound A, sulindac related compound B, or sulindac related compound C from the Sample solution to: r_U = peak response of sulindac related compound B or sulindac related compound C from the Sample solution AND Line 12 of Analysis: Change r_S = peak response of sulindac related compound A, sulindac related compound B, or sulindac related compound C from the Standard solution to: r_S = peak response of sulindac related compound B or sulindac related compound C from the Standard solution
FELBAMATE ORAL SUSPENSION	PERFORMANCE TESTS/Dissolution <711>	USP39–NF34	3855	29-Jul-2016	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.]
GRANISETRON HYDROCHLORIDE TABLETS	USP Reference standards <11>	USP39–NF34	4155	29-Jul-2016	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.
NAPROXEN TABLETS	ASSAY/Procedure/System suitability/Suitability requirements	USP39–NF34	4993	29-Jul-2016	1-Aug-2016	USP41–NF36	First Supplement to USP40–NF35	Line 1 of Tailing factor: Change NLT 2.0 to: NMT 2.0
SODIUM NITROPRUSSIDE	Identification	USP39–NF34	5880	29-Jul-2016	1-Aug-2016	USP41–NF36	First Supplement to USP40–NF35	Line 1 of Identification C: Change A solution (1 in 4) responds to the flame test for Sodium <191>. to: A solution (1 in 4) imparts an intense yellow color to a nonluminous flame.
BISOCTRIZOLE	IMPURITIES/Organic Impurities	First Supplement to USP39–NF34	8008	29-Jul-2016	1-Aug-2016	USP41–NF36	First Supplement to USP40–NF35	Footnote b of Table 2: Change Phenol, 2,2-methylenebis[6-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)]. to: Phenol, 2,2′-methylenebis[6-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)].
<1664> ASSESSMENT OF DRUG PRODUCT LEACHABLES ASSOCIATED WITH PHARMACEUTICAL PACKAGING/DELIVERY SYSTEMS	REFERENCES	USP39–NF34	1850	29-Jul-2016	1-Aug-2016	USP41–NF36	First Supplement to USP40–NF35	Delete reference 8.
GRANISETRON HYDROCHLORIDE	USP Reference standards <11>	USP39–NF34	4151	29-Jul-2016	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 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 Line 2 of USP Granisetron Related Compound E RS: Change ((1R,3rS,5S)-9-Methyl-9-azabicyclo[3.3.1]nonan-3-amine, acetate salt). to: ((1R,3r,5S)-9-Methyl-9-azabicyclo[3.3.1]nonan-3-amine, acetate salt).
KETOROLAC TROMETHAMINE INJECTION	ADDITIONAL REQUIREMENTS/USP Reference Standards <11>	USP39–NF34	4468	29-Jul-2016	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 KETOROLAC TROMETHAMINE INJECTION 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 Related Compound D: Change 211.1 to: 211.3
SIMETHICONE	ASSAY/Procedure/Analysis	USP39–NF34	5843	29-Jul-2016	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
BANABA LEAF DRY EXTRACT	IDENTIFICATION	USP39–NF34	6494	29-Jul-2016	1-Aug-2016	USP41–NF36	First Supplement to USP40–NF35	Delete Identification A. AND Line 1 of Identification B: Change B. to: A. AND Line 1 of Identification C: Change C. to: B.
OMEGA-3-ACID ETHYL ESTERS CAPSULES	ASSAY/Content of EPAee, DHAee, and Total Omega-3-Acid Ethyl Esters/Analysis	Second Supplement to USP39–NF34	8755	29-Jul-2016	1-Aug-2016	USP41–NF36	First Supplement to USP40–NF35	Line 16 of the third equation: Change L = label claim of total omega-3-acids ethyl esters (g/Capsule) to: L = label claim of total omega-3-acids ethyl esters (mg/Capsule)
FEXOFENADINE HYDROCHLORIDE	CHEMICAL INFORMATION	USP39–NF34	3895	29-Jul-2016	1-Aug-2016	USP41–NF36	First Supplement to USP40–NF35	Line 7: Change [138452-21-8]. to: [153439-40-8].