Niacinamide (nye'' a sin' a mide). DEFINITION Niacinamide contains NLT 98.5% and NMT 101.5% of niacinamide (C6H6N2O), calculated on the dried basis. IDENTIFICATION • B. Ultraviolet Absorption 197U Sample solution: 20 µg/mL in water Acceptance criteria: It meets the requirements in the chapter, and the A245/A262 ratio is 0.630.67. ASSAY • Procedure Mobile phase: Methanol and 0.005 M sodium 1-heptanesulfonate (30:70) Standard solution: Transfer 50 mg of USP Niacinamide RS to a 100-mL volumetric flask. Add 3 mL of water to dissolve, and dilute with Mobile phase to volume. Dilute with Mobile phase to 0.04 mg/mL. Niacin standard solution Prepare as directed in the Standard solution, using USP Niacin RS instead of USP Niacinamide RS. Sample solution: Prepare as directed in the Standard solution, using Niacinamide instead of USP Niacinamide RS. System suitability solution: Mix equal volumes of the Standard solution and Niacin standard solution. Chromatographic system Mode: LC Detector: UV 254 nm Column: 3.9-mm × 30-cm; packing L1 Flow rate: 2 mL/min Injection size: 20 µL System suitability Samples: Standard solution and System suitability solution Suitability requirements Resolution: NLT 3.0 between niacin and niacinamide, System suitability solution Relative standard deviation: NMT 2.0%, Standard solution Analysis Samples: Standard solution and Sample solution Calculate the percentage of niacinamide (C6H6N2O) in the portion of Niacinamide taken: Result = (rU/rS) × (CS/CU) × 100
Acceptance criteria: 98.5%101.5% on the dried basis IMPURITIES • Residue on Ignition 281: NMT 0.1% • Heavy Metals, Method II 231: NMT 30 ppm • Readily Carbonizable Substances 271 Sample solution: Dissolve 200 mg of Niacinamide in 5 mL of sulfuric acid. Acceptance criteria: The Sample solution has no more color than Matching Fluid A. SPECIFIC TESTS • Melting Range or Temperature 741: 128131 • Loss on Drying 731: Dry a sample over silica gel for 4 h: it loses NMT 0.5% of its weight. ADDITIONAL REQUIREMENTS • Packaging and Storage: Preserve in tight containers. Auxiliary Information Please check for your question in the FAQs before contacting USP.
USP35NF30 Page 4043 Pharmacopeial Forum: Volume No. 34(5) Page 1176Chromatographic Column Chromatographic columns text is not derived from, and not part of, USP 35 or NF 30. |