Ascorbic Acid Oral Solution DEFINITION Ascorbic Acid Oral Solution is a solution of Ascorbic Acid in a hydroxylic organic solvent or an aqueous mixture thereof. It contains NLT 90.0% and NMT 110.0% of the labeled amount of ascorbic acid (C6H8O6). IDENTIFICATION • A. Sample solution: A volume of Oral Solution equivalent to 40 mg of ascorbic acid Analysis: To the Sample solution add 4 mL of 0.1 N hydrochloric acid, then 4 drops of methylene blue TS, and warm to 40. Acceptance criteria: The deep blue color becomes appreciably lighter or is completely discharged within 3 min. • B. Sample solution: A volume of Oral Solution equivalent to 20 mg of ascorbic acid Analysis: To the Sample solution add 15 mL of trichloroacetic acid solution (1 in 20). Add 200 mg of activated charcoal, shake the mixture vigorously for 1 min, and pass through a small fluted filter, returning the filtrate, if necessary, until clear. To 5 mL of the filtrate add 1 drop of pyrrole, agitate gently until dissolved, then heat in a bath at 50. Acceptance criteria: A blue color develops. ASSAY • Procedure Sample solution: Transfer a volume of Oral Solution equivalent to 50 mg of ascorbic acid, previously diluted with water if necessary, to a 100-mL volumetric flask. Add 20 mL of metaphosphoricacetic acid TS, dilute with water to volume, and mix. Blank: A mixture of 5.5 mL of metaphosphoricacetic acid TS and 15 mL of water Titrimetric system (See Titrimetry 541.) Mode: Direct titration Titrant: Standard dichlorophenolindophenol VS Analysis: Transfer a volume of the Sample solution, equivalent to 2 mg of ascorbic acid, into a 50-mL conical flask. Add 5 mL of metaphosphoricacetic acid TS, and titrate with Titrant until a rose-pink color persists for at least 5 s. Correct for the volume of the Titrant consumed by the Blank. Calculate the percentage of ascorbic acid (C6H8O6) in the portion of Oral Solution taken: Result = {[(VS VB) × F]/W} × 100
Acceptance criteria: 90.0%110.0% OTHER COMPONENTS • Alcohol Determination, Method I 611 (if present): 90.0%110.0% of the labeled content of alcohol (C2H5OH) ADDITIONAL REQUIREMENTS • Packaging and Storage: Preserve in tight, light-resistant containers. • Labeling: Label Oral Solution that contains alcohol to state the alcohol content. Auxiliary Information Please check for your question in the FAQs before contacting USP.
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