Riboflavin Tablets DEFINITION Riboflavin Tablets contains NLT 95.0% and NMT 115.0% of the labeled amount of riboflavin (C17H20N4O6). ASSAY • Riboflavin Assay 481 Assay preparation: Transfer a portion of the powder from NLT 20 finely powdered Tablets, equivalent to 20 mg of riboflavin, to a 250-mL flask, and add 150 mL of 0.1 N hydrochloric acid. Shake vigorously, and wash down the sides of the flask with sufficient 0.1 N hydrochloric acid to ensure that the pH remains below 1.5 during the subsequent period of heating. Heat the mixture on a steam bath, with frequent agitation, until the riboflavin has dissolved, or in an autoclave at 121 for 30 min. Cool, and with vigorous agitation, adjust the mixture with 1 N sodium hydroxide to a pH of 56. Transfer to a 1000-mL volumetric flask, and dilute with water to volume. If the solution is not clear, filter through paper known not to adsorb riboflavin. Dilute an aliquot of the clear solution with water to a final volume that contains 0.1 µg/mL of riboflavin. Analysis: Proceed as directed in the chapter. Calculate the percentage of the labeled amount of riboflavin (C17H20N4O6) in the portion of Tablets taken: Result = (IU/IS) × (CS/CU) × 100
Acceptance criteria: 95.0%115.0% PERFORMANCE TESTS • Dissolution 711 Medium: Water; 900 mL Apparatus 2: 50 rpm Time: 45 min Standard solution: Known concentration of USP Riboflavin RS in 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 1.40 mg/mL of sodium 1-hexanesulfonate 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 riboflavin (C17H20N4O6) dissolved: Result = (rU/rS) × (CS × D × V/L) × 100
Tolerances: NLT 75% (Q) of the labeled amount of riboflavin (C17H20N4O6) is dissolved. • Uniformity of Dosage Units 905: Meet the requirements ADDITIONAL REQUIREMENTS • Packaging and Storage: Preserve in tight, light-resistant containers. Auxiliary Information Please check for your question in the FAQs before contacting USP.
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