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.
USP35NF30 Page 2243
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