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Divalproex Sodium (dye val' proe ex soe' dee um) (C16H31NaO4)n 310.41 Pentanoic acid, 2-propyl-, sodium salt (2:1); Sodium hydrogen bis(2-propylvalerate) oligomer DEFINITION Divalproex Sodium contains NLT 98.0% and NMT 102.0% of available valproic acid (C8H16O2). IDENTIFICATION • A. Infrared Absorption 197K • B. Identification Tests—General, Sodium 191: Ignite 100 mg. ASSAY • Procedure Solution A: 3.5 g of monobasic sodium phosphate monohydrate in 900 mL of water. Adjust with phosphoric acid to a pH of 3.5. Dilute with water to 1 L. Mobile phase: Acetonitrile and Solution A (1:1) Standard stock solution: 5.0 µg/mL of USP Valproic Acid RS in Mobile phase Standard solution: 0.5 mg/mL of USP Valproic Acid RS, from Standard stock solution in Mobile phase Impurity stock solution: 0.5 mg/mL of USP Valproic Acid Related Compound A RS in acetonitrile System suitability solution: 0.5 mg/mL of valproic acid, from Standard stock solution, and 5 µg/mL of valproic acid related compound A, from Impurity stock solution, in Mobile phase Sample solution: 0.5 mg/mL of Divalproex Sodium in Mobile phase Chromatographic system (See Chromatography 621, System Suitability.) Mode: LC Detector: UV 215 nm Column: 4.6-mm × 15-cm; 5-µm packing L7 Flow rate: 1 mL/min Injection size: 20 µL System suitability Sample: System suitability solution [Note—The relative retention times for valproic acid related compound A and valproic acid are 0.69 and 1.0, respectively. ] Suitability requirements Resolution: NLT 5.0 between valproic acid related compound A and valproic acid Tailing factor: NMT 1.5 for the valproic acid peak Relative standard deviation: NMT 2.0% Analysis Samples: Standard solution and Sample solution Calculate the percentage of C8H16O2) in the portion of Divalproex Sodium taken: Result = (rU/rS) × (CS/CU) × (Mr1/Mr2) × (1/F) × 100 rU = = peak area from the Sample solution rS = = peak area from the Standard solution CS = = concentration of USP Valproic Acid RS in the Standard solution (mg/mL) CU = = concentration of the Sample solution (mg/mL) Mr1 = = molecular weight for divalproex sodium repeating unit, 310.41 Mr2 = = molecular weight for valproic acid, 144.21 F = = number of moles of valproic acid/mole of divalproex sodium repeating unit, 2 Acceptance criteria: 98.0%–102.0% IMPURITIES Inorganic Impurities • Heavy Metals, Method II 231: NMT 20 ppm SPECIFIC TESTS • Water Determination, Method I 921: NMT 1.0%, determined on 3.0 g ADDITIONAL REQUIREMENTS • Packaging and Storage: Preserve in tight containers. Store at room temperature • USP Reference Standards 11 USP Divalproex Sodium RS USP Valproic Acid RS USP Valproic Acid Related Compound A RS Auxiliary Information— Please check for your question in the FAQs before contacting USP. Topic/Question Contact Expert Committee Monograph Ravi Ravichandran, Ph.D. Senior Scientist 1-301-816-8330 (MDPP05) Monograph Development-Psychiatrics and Psychoactives Reference Standards Lili Wang, Technical Services Scientist 1-301-816-8129 RSTech@usp.org USP33–NF28 Page 2830 Pharmacopeial Forum: Volume No. 32(6) Page 1675 Chromatographic Column— DIVALPROEX SODIUM Chromatographic columns text is not derived from, and not part of, USP 33 or NF 28. |
4樓2011-08-04 21:41:14
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