Errata - English

PDF CSV October 5, 2022 through October 5, 2024 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
SORBITAN MONOPALMITATE	IDENTIFICATION/A.	USP36–NF31	2213	27-Sep-2013	1-Oct-2013	USP38–NF33	First Supplement to USP37–NF32	Line 1 of Sample: Change 1 g of the residue obtained in the Assay for Fatty Acids to: Residue obtained in the Assay for Fatty Acids AND Line 2 of Acceptance criteria: Change 210–225 to: 210–225 on 1-g sample
BETHANECHOL CHLORIDE	IMPURITIES/Heavy Metals, Method 1 <231>	Second Supplement to USP36–NF31	6568	27-Sep-2013	1-Oct-2013	USP38–NF33	First Supplement to USP37–NF32	Line 1 of Test preparation: Change Bethacholine Chloride to: Bethanechol Chloride
STEARYL ALCOHOL	SPECIFIC TESTS/Fats and Fixed Oils, Hydroxyl Value <401>	USP36–NF31	2252	27-Sep-2013	1-Oct-2013	USP38–NF33	First Supplement to USP37–NF32	Line 14 of Analysis: Change [(V_S − V_B) × N × F]/W to: [(V_B − V_S) × N × M_r]/W AND Line 15 of Analysis: Change… Read More STEARYL ALCOHOL Line 14 of Analysis: Change [(V_S − V_B) × N × F]/W to: [(V_B − V_S) × N × M_r]/W AND Line 15 of Analysis: Change V_S = volume of 1 N sodium hydroxide consumed by the sample (mL) V_B = volume of 1 N sodium hydroxide consumed by the blank test (mL) to: V_B = volume of 1 N sodium hydroxide consumed by the blank test (mL) V_S = volume of 1 N sodium hydroxide consumed by the sample (mL) AND Line 21 of Analysis: Change F = molecular weight of potassium hydroxide, 56.11 to: M_r = molecular weight of potassium hydroxide, 56.11
ACETYLTRIBUTYL CITRATE	IDENTIFICATION/B.	USP36–NF31	1869	27-Sep-2013	1-Oct-2013	USP38–NF33	First Supplement to USP37–NF32	Line 2: Change USP Acetyltriethyl Citrate RS to: USP Acetyltributyl Citrate RS
CLAVULANATE POTASSIUM	IMPURITIES/Organic Impurities/Procedure 3: Limit of Aliphatic Amines	USP36–NF31	3022	27-Sep-2013	1-Oct-2013	USP38–NF33	First Supplement to USP37–NF32	In the definition list in Analysis: Change C_U = nominal concentration of Clavulanate Potassium in the Standard solution to: C_U = nominal concentration of Clavulanate Potassium in the Sample solution
CETOSTEARYL ALCOHOL	SPECIFIC TESTS/Fats and Fixed Oils, Hydroxyl Value <401>	USP36–NF31	1954	27-Sep-2013	1-Oct-2013	USP38–NF33	First Supplement to USP37–NF32	Line 1 of Mode in Titrimetric system: Change Direct titration to: Residual titration AND Line 16 of Analysis: Change Result = [(V_S − V_B) × F]/W to: Result = [(V_B… Read More CETOSTEARYL ALCOHOL Line 1 of Mode in Titrimetric system: Change Direct titration to: Residual titration AND Line 16 of Analysis: Change Result = [(V_S − V_B) × F]/W to: Result = [(V_B − V_S) × N × M_r]/W AND Line 17 of Analysis: Change V_S = Titrant volume consumed by the Sample (mL) V_B = Titrant volume consumed by the Blank (mL) F = calculation factor, 56.1 to: V_B = Titrant volume consumed by the Blank (mL) V_S = Titrant volume consumed by the Sample (mL) N = actual normality of 1 N sodium hydroxide (mEq/mL) M_r = molecular weight of potassium hydroxide, 56.11
MERCAPTOPURINE TABLETS	IMPURITIES/Organic Impurities/Procedure	USP36–NF31	4249	27-Sep-2013	1-Oct-2013	USP38–NF33	First Supplement to USP37–NF32	Line 6 of Sample stock solution: Change Dilute with water to volume. to: Dilute with Solution A to volume.
GLYCERYL MONOLINOLEATE	ASSAY/Procedure	USP36–NF31	2030	27-Sep-2013	1-Oct-2013	USP38–NF33	First Supplement to USP37–NF32	Line 13 of Chromatographic system: Change Column temperature: 40° to: Temperatures Detector: 40° Column: 40°
QUININE SULFATE	IMPURITIES/Dihydroquinine Sulfate	USP36–NF31	4995	27-Sep-2013	1-Oct-2013	USP38–NF33	First Supplement to USP37–NF32	Line 5 of Analysis: Change Result = (r_U/r_S) × 100 to: Result = r_U/(r_U + r_S) × 100
POLYISOBUTYLENE	IMPURITIES/Lead <251>	USP36–NF31	2149	27-Sep-2013	1-Oct-2013	USP38–NF33	First Supplement to USP37–NF32	Line 1 of Acceptance criteria: Change NMT 3 mg/g to: NMT 3 μg/g
TERAZOSIN CAPSULES	PERFORMANCE TESTS/Dissolution <711>/Test 1/Spectrometric conditions	USP36–NF31	5308	27-Sep-2013	1-Oct-2013	USP38–NF33	First Supplement to USP37–NF32	Line 1 of Analytical wavelength: Change UV 245 nm to: UV 246 nm AND Line 3 of Cell length: Change 0.2 cm for Capsules labeled to contain 10 mg to: 0.5 cm for Capsules labeled to contain 10 mg
SORBITAN MONOLAURATE	IDENTIFICATION/A.	USP36–NF31	2212	27-Sep-2013	1-Oct-2013	USP38–NF33	First Supplement to USP37–NF32	Line 1 of Sample: Change 1 g of the residue obtained in the Assay for Fatty Acids to: Residue obtained in the Assay for Fatty Acids AND Line 2 of Acceptance criteria: Change 260–280 to: 260–280 on 1-g sample
LOPINAVIR AND RITONAVIR TABLETS	PERFORMANCE TESTS/Dissolution <711>	First Supplement to USP36–NF31	6005	27-Sep-2013	1-Oct-2013	USP38–NF33	First Supplement to USP37–NF32	Line 1 of Tolerances: Change 80.0% to: 80%
SORBITAN TRIOLEATE	IDENTIFICATION/A.	USP36–NF31	2216	27-Sep-2013	1-Oct-2013	USP38–NF33	First Supplement to USP37–NF32	Line 1 of Sample: Change 1 g of the residue of oleic acid obtained in the Assay for Fatty Acids to: Residue obtained in the Assay for Fatty Acids AND Line 2 of Acceptance criteria: Change 192–204 to: 192–204 on 1-g sample
POLYMYXIN B SULFATE	IMPURITIES/Organic Impurities	Second Supplement to USP36–NF31	6686	27-Sep-2013	1-Oct-2013	USP38–NF33	First Supplement to USP37–NF32	Line 2: Change Buffer, Mobile phase, Diluent, Sensitivity solution, to: Buffer, Mobile phase, Diluent, Standard solution, Sensitivity solution, AND Line 1 of Samples in Analysis: Change Standard solution, Sample solution, and … Read More POLYMYXIN B SULFATE Line 2: Change Buffer, Mobile phase, Diluent, Sensitivity solution, to: Buffer, Mobile phase, Diluent, Standard solution, Sensitivity solution, AND Line 1 of Samples in Analysis: Change Standard solution, Sample solution, and Sensitivity solution to: Sample solution
<232> ELEMENTAL IMPURITIES—LIMITS	DRUG PRODUCTS/Options for Demonstrating Compliance	USP36–NF31	151	27-Sep-2013	1-Oct-2013	USP38–NF33	First Supplement to USP37–NF32	Line 17 of Summation Option: Change the manufacturer must validate to: the manufacturer must ensure
CAFFEINE CITRATE ORAL SOLUTION	Assay	USP36–NF31	2733	27-Sep-2013	1-Oct-2013	USP38–NF33	First Supplement to USP37–NF32	Line 3 of Chromatographic system: Change 150-cm column to: 15-cm column
BETADEX	IMPURITIES/Limit of Reducing Sugars	USP36–NF31	1905	27-Sep-2013	1-Oct-2013	USP38–NF33	First Supplement to USP37–NF32	Line 3 of Tartrate solution: Change 20 mg/mL of anhydrous sodium sulfate to: 200 mg/mL of anhydrous sodium sulfate
ETHIODIZED OIL INJECTION	Viscosity—Capillary Viscometer Methods <911> and Rotational Rheometer Methods <912>	USP36–NF31	3505	27-Sep-2013	1-Oct-2013	USP38–NF33	First Supplement to USP37–NF32	Line 1: Change and to: or
DIPHENHYDRAMINE HYDROCHLORIDE INJECTION	Assay	USP36–NF31	3276	26-Jul-2013	1-Aug-2013	USP38–NF33	First Supplement to USP37–NF32	Line 2: Change Mobile phase, Standard preparation, System suitability solution, and Chromatographic system—Prepare as directed in the Assay under Diphenhydramine Hydrochloride. to: Mobile phase—Prepare a solution of acetonitrile, water,… Read More DIPHENHYDRAMINE HYDROCHLORIDE INJECTION Line 2: Change Mobile phase, Standard preparation, System suitability solution, and Chromatographic system—Prepare as directed in the Assay under Diphenhydramine Hydrochloride. to: Mobile phase—Prepare a solution of acetonitrile, water, and triethylamine (50: 50: 0.5), adjust with glacial acetic acid to a pH of 6.5, filter, and degas. Make adjustments if necessary (see System Suitability under Chromatography <621>). Standard preparation—Dissolve an accurately weighed quantity of USP Diphenhydramine Hydrochloride RS in water to obtain a solution having a known concentration of about 0.5 mg per mL. AND After the Assay preparation subsection: Add System suitability solution—Dissolve about 5 mg of benzophenone in 5 mL of acetonitrile, dilute with water to 100 mL, and mix. Transfer 1.0 mL of this solution and 5 mg of diphenhydramine hydrochloride to a 10-mL volumetric flask, dilute with water to volume, and mix. Chromatographic system (see Chromatography <621>)—The liquid chromatograph is equipped with a 254-nm detector and a 4.6-mm × 25-cm column that contains packing L10. The flow rate is about 1 mL per minute. Chromatograph the System suitability solution, and record the peak responses as directed for Procedure; the resolution, R, between the benzophenone and diphenhydramine peaks is not less than 2.0. Chromatograph replicate injections of the Standard preparation, and record the peak responses as directed for Procedure; the relative standard deviation is not more than 2.0%, and the tailing factor for the diphenhydramine hydrochloride peak is not more than 2.0. AND Line 1 of Procedure: Change Proceed as directed for Procedure in the Assay under Diphenhydramine 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.
FEXOFENADINE HYDROCHLORIDE TABLETS	ASSAY/Procedure	USP36–NF31	3576	26-Jul-2013	1-Aug-2013	USP38–NF33	First Supplement to USP37–NF32	Line 6 of Sample stock solution: Change (equivalent to 80% of the total flask volume) to: (sufficient to fill the flask to 80% of its volume)
NIFEDIPINE EXTENDED-RELEASE TABLETS	PERFORMANCE TESTS/Dissolution <711>/Test 4/Instrumental conditions	USP36–NF31	4509	26-Jul-2013	1-Aug-2013	USP38–NF33	First Supplement to USP37–NF32	Line 1 of Cell: Change 0.5 cm to: 1 cm
GYMNEMA	IDENTIFICATION/B. Thin-Layer Chromatography/Chromatographic system	First Supplement to USP36–NF31	5880	26-Jul-2013	1-Aug-2013	USP38–NF33	First Supplement to USP37–NF32	Line 2 of Adsorbent: Change 5m to: 5 µm
POWDERED STINGING NETTLE EXTRACT	COMPOSITION/Content of Total Amino Acids	USP36–NF31	1608	26-Jul-2013	1-Aug-2013	USP38–NF33	First Supplement to USP37–NF32	Line 1 of Reagent solution: Change Solution containing 1.00 g of ninhydrin, 1.50 g of hydrindantin, to: Solution containing 1.00 g of ninhydrin, 150 mg of hydrindantin,
OXCARBAZEPINE	IMPURITIES/Organic Impurities, Procedure 1	First Supplement to USP36–NF31	6035	26-Jul-2013	1-Aug-2013	USP38–NF33	First Supplement to USP37–NF32	Row 4 of Column 1 of Table 1: Change Dibenzazepinone^b to: Oxcarbazepine related compound E AND Delete footnote b AND Reletter the following footnotes in both the table and footnote definitions: c to b d to c e to d
CALCIUM CARBONATE	IMPURITIES	USP36–NF31	2747	26-Jul-2013	1-Aug-2013	USP38–NF33	First Supplement to USP37–NF32	Line 1 of Acceptance criteria in Limit of Fluoride: Change 50 ppm to: NMT 50 ppm AND Line 1 of Acceptance criteria in Mercury, Method IIa <261>: Change 0.5 ppm to: NMT 0.5 ppm
CRYOPRESERVED HUMAN FIBROBLAST-DERIVED DERMAL SUBSTITUTE	Total collagen content	USP36–NF31	3155	26-Jul-2013	1-Aug-2013	USP38–NF33	First Supplement to USP37–NF32	Line 7 of Collagen calibration standards: Change by adding 25 mL, 50 mL, 100 mL, and 200 mL, to: by adding 25 μL, 50 μL, 100 μL, and 200 μL,
EDETATE DISODIUM	ASSAY/Procedure	USP36–NF31	3370	26-Jul-2013	1-Aug-2013	USP38–NF33	First Supplement to USP37–NF32	Line 16 of Analysis: Change Calculate the percentage of edetate disodium to: Calculate the weight of edetate disodium AND Line 19 of Analysis: Change Result = (V_T/V_U) × W × (M_r1/M_r2) ×… Read More EDETATE DISODIUM Line 16 of Analysis: Change Calculate the percentage of edetate disodium to: Calculate the weight of edetate disodium AND Line 19 of Analysis: Change Result = (V_T/V_U) × W × (M_r1/M_r2) × 100 to: Result = (V_T/V_U) × W × (M_r1/M_r2)
LEVOFLOXACIN	ADDITIONAL REQUIREMENTS/USP Reference Standards <11>	USP36–NF31	4099	26-Jul-2013	1-Aug-2013	USP38–NF33	First Supplement to USP37–NF32	Line 2 of USP Levofloxacin Related Compound A RS: Change (S)-9-Fluoro-3-methyl-10-(piperazin-1-yl)-7-oxo-2,3-dihydro-7H-pyrido[1,2,3-de][1,4-benzoxazine-6-carbocylic acid. to: (S)-9-Fluoro-3-methyl-10-(piperazin-1-yl)-7-oxo-2,3-dihydro-7H-pyrido[1,2,3-… Read More LEVOFLOXACIN Line 2 of USP Levofloxacin Related Compound A RS: Change (S)-9-Fluoro-3-methyl-10-(piperazin-1-yl)-7-oxo-2,3-dihydro-7H-pyrido[1,2,3-de][1,4-benzoxazine-6-carbocylic acid. to: (S)-9-Fluoro-3-methyl-10-(piperazin-1-yl)-7-oxo-2,3-dihydro-7H-pyrido[1,2,3-de][1,4]benzoxazine-6-carboxylic acid. AND Line 2 of USP Levofloxacin Related Compound B RS: Change (S)-9,10-Difluoro-3-methyl-7-oxo-2,3-dihydro-7H-pyrido[1,2,3-de][1,4-benzoxazine-6-carbocylic acid. to: (S)-9,10-Difluoro-3-methyl-7-oxo-2,3-dihydro-7H-pyrido[1,2,3-de][1,4]benzoxazine-6-carboxylic acid.
VENLAFAXINE HYDROCHLORIDE	ADDITIONAL REQUIREMENTS/USP Reference Standards <11>	USP36–NF31	5551	26-Jul-2013	1-Aug-2013	USP38–NF33	First Supplement to USP37–NF32	Line 2 of Venlafaxine Related Compound A RS: Change 1-(1-(4-methoxyphenyl)-2-(methylamino)ethyl)cyclohexanol. C₁₆H₂₅NO₂ 263.38 to: 1-(1-(4-Methoxyphenyl)-2-(methylamino)ethyl)cyclohexanol hydrochloride. C₁₆H₂₅NO_2… Read More VENLAFAXINE HYDROCHLORIDE Line 2 of Venlafaxine Related Compound A RS: Change 1-(1-(4-methoxyphenyl)-2-(methylamino)ethyl)cyclohexanol. C₁₆H₂₅NO₂ 263.38 to: 1-(1-(4-Methoxyphenyl)-2-(methylamino)ethyl)cyclohexanol hydrochloride. C₁₆H₂₅NO₂ · HCl 299.84
STINGING NETTLE	COMPOSITION/Content of Total Amino Acids	USP36–NF31	1604	26-Jul-2013	1-Aug-2013	USP38–NF33	First Supplement to USP37–NF32	Line 1 of Reagent solution: Change Solution containing 1.00 g of ninhydrin, 1.50 g of hydrindantin, to: Solution containing 1.00 g of ninhydrin, 150 mg of hydrindantin,
GENTAMICIN SULFATE	IMPURITIES/Limit of Methanol	First Supplement to USP36–NF31	5990	26-Jul-2013	1-Aug-2013	USP38–NF33	First Supplement to USP37–NF32	Line 11 of Analysis: Change Result = (R_U/R_S) × (C_S/C_U) × D × F × 100 to: Result = (R_U/R_S) × (C_S… Read More GENTAMICIN SULFATE Line 11 of Analysis: Change Result = (R_U/R_S) × (C_S/C_U) × D × F × 100 to: Result = (R_U/R_S) × (C_S/C_U) × D × F AND Line 18 of Analysis: Change C_S = percentage of methanol in the Standard solution (% v/v) to: C_S = percentage of methanol in the Standard solution AND Line 23 of Analysis: Change F = conversion factor, 0.001 g/mg to: F = conversion factor, 1000 mg/g
AMOXICILLIN	IMPURITIES/Organic Impurities/Procedure	USP36–NF31	2477	26-Jul-2013	1-Aug-2013	USP38–NF33	First Supplement to USP37–NF32	Line 2 of Acceptance criteria: Change [Note—The reporting limit is 0.03% of the amoxicillin peak from the Standard solution. ] to: [Note—The reporting limit is 0.03 times the amoxicillin peak from the Standard solution. ]
CLARITHROMYCIN EXTENDED-RELEASE TABLETS	PERFORMANCE TESTS/Dissolution <711>/Test 4	USP36–NF31	3019	26-Jul-2013	1-Aug-2013	USP38–NF33	First Supplement to USP37–NF32	Line 2 of Standard solution: Change and Medium (96:4). to: and Medium (4:96).
DIPHENHYDRAMINE HYDROCHLORIDE ORAL SOLUTION	Assay	USP36–NF31	3277	26-Jul-2013	1-Aug-2013	USP38–NF33	First Supplement to USP37–NF32	Line 2: Change Mobile phase, Standard preparation, System suitability solution, and Chromatographic system—Prepare as directed in the Assay under Diphenhydramine Hydrochloride. to: Mobile phase—Prepare a solution of acetonitrile, water,… Read More DIPHENHYDRAMINE HYDROCHLORIDE ORAL SOLUTION Line 2: Change Mobile phase, Standard preparation, System suitability solution, and Chromatographic system—Prepare as directed in the Assay under Diphenhydramine Hydrochloride. to: Mobile phase—Prepare a solution of acetonitrile, water, and triethylamine (50: 50: 0.5), adjust with glacial acetic acid to a pH of 6.5, filter, and degas. Make adjustments if necessary (see System Suitability under Chromatography <621>). Standard preparation—Dissolve an accurately weighed quantity of USP Diphenhydramine Hydrochloride RS in water to obtain a solution having a known concentration of about 0.5 mg per mL. AND After the Assay preparation subsection: Add System suitability solution—Dissolve about 5 mg of benzophenone in 5 mL of acetonitrile, dilute with water to 100 mL, and mix. Transfer 1.0 mL of this solution and 5 mg of diphenhydramine hydrochloride to a 10-mL volumetric flask, dilute with water to volume, and mix. Chromatographic system (see Chromatography <621>)—The liquid chromatograph is equipped with a 254-nm detector and a 4.6-mm × 25-cm column that contains packing L10. The flow rate is about 1 mL per minute. Chromatograph the System suitability solution, and record the peak responses as directed for Procedure; the resolution, R, between the benzophenone and diphenhydramine peaks is not less than 2.0. Chromatograph replicate injections of the Standard preparation, and record the peak responses as directed for Procedure; the relative standard deviation is not more than 2.0%, and the tailing factor for the diphenhydramine hydrochloride peak is not more than 2.0. AND Line 1 of Procedure: Change Proceed as directed for Procedure in the Assay under Diphenhydramine 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.
FLUPHENAZINE DECANOATE INJECTION	Assay	USP36–NF31	3639	26-Jul-2013	1-Aug-2013	USP38–NF33	First Supplement to USP37–NF32	Line 11 of Standard preparation: Delete (1:5) AND Line 8 of Assay preparation: Delete (1:5)
OLMESARTAN MEDOXOMIL	IMPURITIES/Organic Impurities/Impurity Table	USP36–NF31	4570	26-Jul-2013	1-Aug-2013	USP38–NF33	First Supplement to USP37–NF32	Footnote d: Change ((5-Methyl-2-oxo-1,3-dioxol-4-yl)methyl 4-(2-hydroxypropan-2-yl)-2-propyl-1-((2´-(1-trityl-1H-tetrazol-5-yl)biphenyl-4-yl)methyl)-1H-imidazole-5-carboxylate. to: (5-Methyl-2-oxo-1,3-dioxol-4-yl)methyl 4-(2-hydroxypropan-2-yl)-2-propyl-1-((2´-(2-trityl-1… Read More OLMESARTAN MEDOXOMIL Footnote d: Change ((5-Methyl-2-oxo-1,3-dioxol-4-yl)methyl 4-(2-hydroxypropan-2-yl)-2-propyl-1-((2´-(1-trityl-1H-tetrazol-5-yl)biphenyl-4-yl)methyl)-1H-imidazole-5-carboxylate. to: (5-Methyl-2-oxo-1,3-dioxol-4-yl)methyl 4-(2-hydroxypropan-2-yl)-2-propyl-1-((2´-(2-trityl-1H-tetrazol-5-yl)biphenyl-4-yl)methyl)-1H-imidazole-5-carboxylate.
POWDERED GYMNEMA	IDENTIFICATION/B. Thin-Layer Chromatography/Chromatographic system	First Supplement to USP36–NF31	5883	26-Jul-2013	1-Aug-2013	USP38–NF33	First Supplement to USP37–NF32	Line 2 of Adsorbent: Change 5m to: 5 µm
GLYCERYL DISTEARATE	ASSAY/Procedure/Chromatographic system	USP36–NF31	2029	26-Jul-2013	1-Aug-2013	USP38–NF33	First Supplement to USP37–NF32	Line 1 of Column temperature: Change Column temperature: 40° to: Temperatures Detector: 40° Column: 40°
OXCARBAZEPINE	IMPURITIES/Organic Impurities, Procedure 2	First Supplement to USP36–NF31	6035	26-Jul-2013	1-Aug-2013	USP38–NF33	First Supplement to USP37–NF32	Row 9 of Column 1 of Table 3: Change Oxcarbazepine related compound E^g to: Oxcarbazepine related compound E AND Delete footnote g
CEFDINIR CAPSULES	IMPURITIES/Organic Impurities/Table 2	USP36–NF31	2850	26-Jul-2013	1-Aug-2013	USP38–NF33	First Supplement to USP37–NF32	Row 16 of Column 1: Change Cefdinir impurity 2^e to: Cefdinir impurity 2^f AND Row 21 of Column 1: Change Cefdinir impurity 3^e to: Cefdinir impurity 3^f
DIPHENHYDRAMINE HYDROCHLORIDE CAPSULES	Assay	USP36–NF31	3276	26-Jul-2013	1-Aug-2013	USP38–NF33	First Supplement to USP37–NF32	Line 2: Change Mobile phase, Standard preparation, System suitability solution, and Chromatographic system—Prepare as directed in the Assay under Diphenhydramine Hydrochloride. to: Mobile phase—Prepare a solution of acetonitrile, water,… Read More DIPHENHYDRAMINE HYDROCHLORIDE CAPSULES Line 2: Change Mobile phase, Standard preparation, System suitability solution, and Chromatographic system—Prepare as directed in the Assay under Diphenhydramine Hydrochloride. to: Mobile phase—Prepare a solution of acetonitrile, water, and triethylamine (50: 50: 0.5), adjust with glacial acetic acid to a pH of 6.5, filter, and degas. Make adjustments if necessary (see System Suitability under Chromatography <621> ). Standard preparation—Dissolve an accurately weighed quantity of USP Diphenhydramine Hydrochloride RS in water to obtain a solution having a known concentration of about 0.5 mg per mL. AND After the Assay preparation subsection: Add System suitability solution—Dissolve about 5 mg of benzophenone in 5 mL of acetonitrile, dilute with water to 100 mL, and mix. Transfer 1.0 mL of this solution and 5 mg of diphenhydramine hydrochloride to a 10-mL volumetric flask, dilute with water to volume, and mix. Chromatographic system (see Chromatography <621>)—The liquid chromatograph is equipped with a 254-nm detector and a 4.6-mm × 25-cm column that contains packing L10. The flow rate is about 1 mL per minute. Chromatograph the System suitability solution, and record the peak responses as directed for Procedure; the resolution, R, between the benzophenone and diphenhydramine peaks is not less than 2.0. Chromatograph replicate injections of the Standard preparation, and record the peak responses as directed for Procedure; the relative standard deviation is not more than 2.0%, and the tailing factor for the diphenhydramine hydrochloride peak is not more than 2.0. AND Line 1 of Procedure: Change Proceed as directed for Procedure in the Assay under Diphenhydramine 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.
FELBAMATE TABLETS	IMPURITIES/Organic Impurities/System suitability/Suitability requirements	USP36–NF31	3537	26-Jul-2013	1-Aug-2013	USP38–NF33	First Supplement to USP37–NF32	Line 1 of Resolution: Change NMT 2 to: NLT 2
MOXIFLOXACIN OPHTHALMIC SOLUTION	Related compounds	USP36–NF31	4414	26-Jul-2013	1-Aug-2013	USP38–NF33	First Supplement to USP37–NF32	Row 1 of Column 3 of Table 2: Change Relative Retention Time vs. Moxifloxacin to: Relative Retention vs. Moxifloxacin AND Row 1 of Column 3 of Table 3: Change Relative Retention Time vs. Moxifloxacin to: Relative Retention vs. Moxifloxacin
VENLAFAXINE TABLETS	ADDITIONAL REQUIREMENTS/USP Reference Standards <11>	USP36–NF31	5554	26-Jul-2013	1-Aug-2013	USP38–NF33	First Supplement to USP37–NF32	Line 2 of Venlafaxine Related Compound A RS: Change 1-(1-(4-methoxyphenyl)-2-(methylamino)ethyl)cyclohexanol. C₁₆H₂₅NO₂ 263.38 to: 1-(1-(4-Methoxyphenyl)-2-(methylamino)ethyl)cyclohexanol hydrochloride. C₁₆H₂₅NO_2… Read More VENLAFAXINE TABLETS Line 2 of Venlafaxine Related Compound A RS: Change 1-(1-(4-methoxyphenyl)-2-(methylamino)ethyl)cyclohexanol. C₁₆H₂₅NO₂ 263.38 to: 1-(1-(4-Methoxyphenyl)-2-(methylamino)ethyl)cyclohexanol hydrochloride. C₁₆H₂₅NO₂ · HCl 299.84
POWDERED STINGING NETTLE	COMPOSITION/Content of Total Amino Acids	USP36–NF31	1606	26-Jul-2013	1-Aug-2013	USP38–NF33	First Supplement to USP37–NF32	Line 1 of Reagent solution: Change Solution containing 1.00 g of ninhydrin, 1.50 g of hydrindantin, to: Solution containing 1.00 g of ninhydrin, 150 mg of hydrindantin,
MEPROBAMATE TABLETS	ASSAY/Procedure	First Supplement to USP36–NF31	6015	26-Jul-2013	1-Aug-2013	USP38–NF33	First Supplement to USP37–NF32	Line 4 of Standard solution: Change Dissolve in 30% of the final flask volume, and dilute with water to volume. to: Dissolve in 30% of the final flask volume of acetonitrile, and dilute with water to volume.
BETAMETHASONE SODIUM PHOSPHATE	Identification/B. Thin-Layer Chromatographic Identification Test <201>	USP36–NF31	2645	26-Jul-2013	1-Aug-2013	USP38–NF33	First Supplement to USP37–NF32	Line 1 of Test solution: Change 1 mg per mL. to: 1 mg per mL in methanol.
DACARBAZINE FOR INJECTION	USP Reference standards <11>	USP36–NF31	3137	26-Jul-2013	1-Aug-2013	USP38–NF33	First Supplement to USP37–NF32	Line 3 of USP Dacarbazine Related Compound B RS: Change C₄H₃N₅O 137.10 to: C₄H₃N₅O · H₂O 155.12
EDETATE DISODIUM	ASSAY/Procedure	USP36–NF31	3370	26-Jul-2013	1-Aug-2013	USP38–NF33	First Supplement to USP37–NF32	Line 5: Delete Titrimetric system (See Titrimetry <541>.) Mode: Direct titration Titrant: 0.1 N sodium hydroxide VS Endpoint detection: Visual