Ascorbic Acid Oral Solution
»Ascorbic Acid Oral Solution is a solution of Ascorbic Acid in a hydroxylic organic solvent or an aqueous mixture thereof.It contains not less than 90.0percent and not more than 110.0percent of the labeled amount of C6H8O6.
Packaging and storage—
Preserve in tight,light-resistant containers.
Labeling—
Label Oral Solution that contains alcohol to state the alcohol content.
Identification—
A:
To a volume of Oral Solution equivalent to 40mg of ascorbic acid add 4mLof 0.1Nhydrochloric acid,then add 4drops of methylene blue TS,and warm to 40
:the deep blue color becomes appreciably lighter or is completely discharged within 3minutes.
:the deep blue color becomes appreciably lighter or is completely discharged within 3minutes.
B:
To a volume of Oral Solution equivalent to 20mg of ascorbic acid add 15mLof trichloroacetic acid solution (1in 20),then add about 200mg of activated charcoal,shake the mixture vigorously for 1minute,and filter through a small fluted filter,returning the filtrate,if necessary,until clear.To 5mLof the filtrate add 1drop of pyrrole,agitate gently until dissolved,then heat in a bath at 50:a blue color develops.
:a blue color develops.
Assay—
Transfer to a 100-mLvolumetric flask an accurately measured volume of Oral Solution,equivalent to about 50mg of ascorbic acid,previously diluted with water if necessary.Add 20mLof metaphosphoric-acetic acids TS,dilute with water to volume,and mix.Accurately measure a volume of the dilution,equivalent to about 2mg of ascorbic acid,into a 50-mLconical flask,add 5mLof metaphosphoric-acetic acids TS,and titrate with standard dichlorophenol-indophenol solution until a rose-pink color persists for at least 5seconds.Correct for the volume of the dichlorophenol-indophenol solution consumed by a mixture of 5.5mLof metaphosphoric-acetic acids TSand 15mLof water.
From the ascorbic acid equivalent of the standard dichlorophenol-indophenol solution,calculate the ascorbic acid content in each mLof the Oral Solution.
Auxiliary Information—
Staff Liaison:Lawrence Evans,III,Ph.D.,Scientist
Expert Committee:(DSN)Dietary Supplements:Non-Botanicals
USP28–NF23Page 178
Phone Number:1-301-816-8389