Niacinamide Tablets DEFINITION Niacinamide Tablets contain NLT 90.0% and NMT 110.0% of the labeled amount of niacinamide (C6H6N2O). IDENTIFICATION • A. Infrared Absorption 197K Sample: Extract a quantity of powdered Tablets, equivalent to 500 mg of niacinamide, with two 10-mL portions of alcohol, evaporate the filtered alcohol extracts on a steam bath, and dry at 80 for 2 h. Acceptance criteria: Meet the requirements • B. Ultraviolet Absorption 197U Sample solution: 20 µg/mL of niacinamide in water from the Sample obtained in Identification test A Acceptance criteria: Meets the requirements in the chapter. The ratio A245/A262 is 0.630.67. ASSAY • Niacin or Niacinamide Assay, Chemical Method 441 Standard niacinamide preparation: Prepare as directed in the chapter. Assay preparation: Transfer an equivalent of 25 mg of niacinamide, from NLT 10 finely powdered Tablets, to a suitable flask. Add 50 mL of water and heat, if necessary, until no more dissolves. Cool, dilute with water to 10 µg/mL, mix, and filter. Analysis: Proceed as directed in the chapter for Procedure. Calculate the percentage of the labeled amount of niacinamide (C6H6N2O) in the portion of Tablets taken: Result = (AU/AS) × (CS/CU) × 100
Acceptance criteria: 90.0%110.0% PERFORMANCE TESTS • Dissolution, Procedure for a Pooled Sample 711 Medium: Water; 900 mL Apparatus 2: 50 rpm Time: 45 min Standard solution: Known concentration of USP Niacinamide RS in the Medium Sample solution: Filtered portion of the solution under test, suitably diluted with the Medium if necessary Mobile phase: A mixture of methanol, glacial acetic acid, and water (27:1:73) containing 140 mg of sodium 1-hexanesulfonate per 100 mL Chromatographic system Mode: LC Detector: UV 280 nm Column: 3.9-mm × 30-cm; packing L1 Flow rate: 1 mL/min Injection size: 10 µL System suitability Sample: Standard solution Suitability requirements Relative standard deviation: NMT 3.0% Analysis Samples: Standard solution and Sample solution Calculate the percentage of the labeled amount of niacinamide (C6H6N2O) dissolved: Result = (rU/rS) × (CS × D × V/L) × 100
Tolerances: NLT 75% (Q) of the labeled amount of niacinamide (C6H6N2O) is dissolved. • Uniformity of Dosage Units 905: Meet the requirements ADDITIONAL REQUIREMENTS • Packaging and Storage: Preserve in tight containers. Auxiliary Information Please check for your question in the FAQs before contacting USP.
USP35NF30 Page 4044 Pharmacopeial Forum: Volume No. 30(1) Page 139 |