Sodium Ascorbate (soe' dee um a skor' bate). DEFINITION Sodium Ascorbate contains NLT 99.0% and NMT 101.0% of sodium ascorbate (C6H7NaO6), calculated on the dried basis. IDENTIFICATION • A. Infrared Absorption 197M Sample: Use undried Sodium Ascorbate. Acceptance criteria: Meets the requirements • B. Reducing capacity Sample solution: 20 mg/mL Analysis: Add 1 mL of 0.1 N hydrochloric acid to 4 mL of the Sample solution, and add alkaline cupric tartrate TS. Acceptance criteria: The solution reduces alkaline cupric tartrate TS slowly at room temperature, but more readily upon heating. • C. Identification TestsGeneral, Sodium 191: A 20-mg/mL solution meets the requirements. ASSAY • Procedure Sample: 400 mg of Sodium Ascorbate Blank: 100 mL of carbon dioxide-free water and 25 mL of 2 N sulfuric acid Titrimetric system (See Titrimetry 541.) Mode: Direct titration Titrant: 0.1 N iodine VS Endpoint detection: Visual Analysis: Dissolve the Sample in a mixture of 100 mL of carbon dioxide-free water and 25 mL of 2 N sulfuric acid. Titrate immediately with the Titrant, and add 3 mL of starch TS as the endpoint is approached. Perform the Blank determination. Calculate the percentage of sodium ascorbate (C6H7NaO6) in the portion of Sodium Ascorbate taken: Result = {[(VS VB) × N × F]/W} × 100
Acceptance criteria: 99.0%101.0% on the dried basis IMPURITIES • Heavy Metals, Method II 231: NMT 20 ppm SPECIFIC TESTS • Optical Rotation, Specific Rotation 781S Sample solution: 100 mg/mL in carbon dioxide-free water. Use the solution immediately after preparation. Acceptance criteria: +103 to +108 • Loss on Drying 731: Dry a sample in a suitable vacuum drying tube, using phosphorus pentoxide as the desiccant, at 60 for 4 h: it loses NMT 0.25% of its weight. ADDITIONAL REQUIREMENTS • Packaging and Storage: Preserve in tight, light-resistant containers. Auxiliary Information Please check for your question in the FAQs before contacting USP.
USP35NF30 Page 4646 Chromatographic Column Chromatographic columns text is not derived from, and not part of, USP 35 or NF 30. |