Folic Acid Tablets DEFINITION Folic Acid Tablets contain NLT 90.0% and NMT 115.0% of the labeled amount of folic acid (C19H19N7O6). IDENTIFICATION • A. Ultraviolet Absorption Sample solution: Digest the quantity of powdered Tablets, equivalent to 100 mg of folic acid, with 100 mL of 0.1 N sodium hydroxide, and filter. Adjust with hydrochloric acid to a pH of 3.0. Cool to 5, filter, and wash the precipitate of folic acid with cold water until the last washing shows an absence of chloride. Then wash with acetone, and dry at 80 for 1 h. Dissolve the residue in 0.1 N sodium hydroxide to obtain a 10-µg/mL solution. Acceptance criteria: The UV absorption spectrum of the Sample solution exhibits maxima and minima at the same wavelengths as that of a similar solution of USP Folic Acid RS, concomitantly measured. The absorbance ratio A256/A365 is 2.803.00. ASSAY • Procedure Mobile phase: Transfer 35.1 g of sodium perchlorate and 1.40 g of monobasic potassium phosphate to a 1-L volumetric flask. Add 7.0 mL of 1 N potassium hydroxide and 40 mL of methanol, dilute with water to volume, and mix. Adjust with 1 N potassium hydroxide or phosphoric acid to a pH of 7.2. Diluent: Aqueous solution containing 2 mL of ammonium hydroxide and 1 g of sodium perchlorate per 100 mL System suitability solution: 0.2 mg/mL each of USP Folic Acid RS and USP Folic Acid Related Compound A RS in Diluent. [NoteBefore use, pass through a filter of 1-µm or finer pore size. ] Standard solution: 0.20 mg/mL of USP Folic Acid RS, corrected for water content in Diluent Sample solution: Equivalent to 0.2 mg/mL of folic acid, from NLT 20 powdered Tablets in Diluent; shake gently to aid dissolution, and filter, discarding the first portion. Chromatographic system Mode: LC Detector: UV 254 nm Column: 4.6-mm × 25-cm; packing L1 Flow rate: 1 mL/min Injection size: 25 µL System suitability Samples: System suitability solution and Standard solution Suitability requirements Resolution: NLT 3.6 between folic acid related compound A (calcium formyltetrahydrofolate) and folic acid, System suitability solution Relative standard deviation: NMT 2.0%, Standard solution Analysis Samples: Standard solution and Sample solution Calculate the percentage of the labeled amount of folic acid (C19H19N7O6) in the portion of Tablets taken: Result = (rU/rS) × (CS/CU) × 100
Acceptance criteria: 90.0%115.0% PERFORMANCE TESTS • Dissolution 711 Medium: Water; 500 mL Apparatus 2: 50 rpm Time: 45 min Standard solution: Solution having a known concentration of USP Folic Acid RS, corrected for water content, in Medium Sample solution: Filtered portion of the solution under test, suitably diluted with the Medium if necessary Analysis Samples: Standard solution and Sample solution Proceed as directed in the Assay, making any necessary modifications. Calculate the percentage of the labeled amount of folic acid (C19H19N7O6) dissolved: Result = (rU/rS) × (CS × D × V/L) × 100
Tolerances: NLT 75% (Q) of the labeled amount of folic acid (C19H19N7O6) is dissolved. • Uniformity of Dosage Units 905: Meet the requirements ADDITIONAL REQUIREMENTS • Packaging and Storage: Preserve in well-closed containers. Auxiliary Information Please check for your question in the FAQs before contacting USP.
USP35NF30 Page 3276 Pharmacopeial Forum: Volume No. 29(2) Page 409Chromatographic Column Chromatographic columns text is not derived from, and not part of, USP 35 or NF 30. |