Calcium Pantothenate Tablets DEFINITION Calcium Pantothenate Tablets contain NLT 95.0% and NMT 115.0% of the labeled amount of the dextrorotatory isomer of calcium pantothenate (C18H32CaN2O10). IDENTIFICATION • A. Identification TestsGeneral, Calcium 191 Sample solution: Digest a quantity of powdered Tablets, equivalent to 150 mg of calcium pantothenate, with 15 mL of 1 N sodium hydroxide, and filter. Acceptance criteria: Meet the requirements • B. Sample solution: 5 mL of the filtrate obtained in Identification test A Analysis: Add 5 mL of 1 N hydrochloric acid and 2 drops of ferric chloride TS to the Sample solution. Acceptance criteria: A strong yellow color is produced. ASSAY • Calcium Pantothenate Assay 91 Assay preparation: Weigh and finely powder NLT 20 Tablets. Weigh a portion of the powder, equivalent to 25 mg of calcium pantothenate, and transfer, with the aid of about 50 mL of water, to a 1000-mL volumetric flask. Add 2 mL of 1 N acetic acid and 100 mL of sodium acetate solution (1 in 60), then dilute with water to volume. Make further accurate dilutions, with water, to a concentration between 0.01 and 0.04 µg/mL of calcium pantothenate. Acceptance criteria: 95.0%115.0% OTHER COMPONENTS • Content of Calcium Sample: A portion of the powder from NLT 20 finely powdered Tablets, equivalent to 500 mg of calcium pantothenate Blank: Proceed as directed in the Analysis, without the Sample. Titrimetric system (See Titrimetry 541.) Mode: Direct titration Titrant: 0.05 M edetate disodium VS Indicator: Hydroxy naphthol blue, 300 mg Endpoint detection: Visual Analysis: Transfer the Sample to a a suitable crucible. Ignite, gently at first, until free from carbon. Cool the crucible. Add 10 mL of water, and dissolve the residue by adding sufficient 3 N hydrochloric acid, dropwise, to achieve complete solution. Transfer the solution to a suitable container, and dilute with water to 150 mL. Add 15 mL of 1 N sodium hydroxide, then add the Indicator. Titrate with Titrant to a distinct blue endpoint. Perform a Blank determination. Calculate the percentage of calcium in the content of calcium pantothenate, as determined by the Assay, in the portion of Tablets taken: Result = {[(VS VB) × M × F]/W} × 100
Acceptance criteria: 7.9%9.7% of the weight of calcium pantothenate (C18H32CaN2O10) in the Tablets, as determined by the Assay PERFORMANCE TESTS • Dissolution, Procedure for a Pooled Sample 711 Medium: Water; 900 mL Apparatus 2: 50 rpm Time: 45 min Mobile phase: Phosphoric acid and water (1:1000) Standard solution: A known concentration of USP Calcium Pantothenate RS in Medium Sample solution: A filtered portion of the solution under test, suitably diluted with Medium if necessary, having a concentration of C18H32CaN2O10 similar to that of the Standard solution Chromatographic system Mode: LC Detector: UV 210 nm Column: 3.9-mm × 15-cm; packing L1 Flow rate: 1.5 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 calcium pantothenate (C18H32CaN2O10) dissolved: Result = (rU/rS) × (CS × D × V/L) × 100
Tolerances: NLT 75% (Q) of the labeled amount of calcium pantothenate (C18H32CaN2O10) is dissolved. • Uniformity of Dosage Units 905: Meet the requirements ADDITIONAL REQUIREMENTS • Packaging and Storage: Preserve in tight containers. • Labeling: Label the Tablets to indicate the content of dextrorotatory calcium pantothenate. Auxiliary Information Please check for your question in the FAQs before contacting USP.
USP35NF30 Page 2461 Pharmacopeial Forum: Volume No. 30(1) Page 81 |