Riboflavin Tablets
»Riboflavin Tablets contain not less than 95.0percent and not more than 115.0percent of the labeled amount of C17H20N4O6.
Packaging and storage—
Preserve in tight,light-resistant containers.
Dissolution á711ñ—
Medium:
water;900mL.
Apparatus 2:
50rpm.
Time:
45minutes.
Procedure—
Determine the amount of C17H20N4O6dissolved,employing the procedure set forth in the Assay for niacin or niacinamide,pyridoxine hydrochloride,riboflavin,and thiamineunder Water-soluble Vitamins Tabletsusing filtered portions of the solution under test,suitably diluted with Dissolution Mediumif necessary,in comparison with a Standard solution having a known concentration of USP Riboflavin RSin the same medium.
Tolerances—
Not less than 75%(Q)of the labeled amount of C17H20N4O6is dissolved in 45minutes.
Uniformity of dosage units á905ñ:
meet the requirements.
Assay—
Weigh and finely powder not less than 20Tablets.Weigh accurately a portion of the powder,equivalent to about 20mg of riboflavin,transfer to a 250-mLflask,and add 150mLof 0.1Nhydrochloric acid.Shake vigorously,and wash down the sides of the flask with sufficient 0.1Nhydrochloric acid to ensure that the pHremains below 1.5during the subsequent period of heating.Heat the mixture on a steam bath,with frequent agitation,until the riboflavin has dissolved,or in an autoclave at 121
for 30minutes.Cool,adjust the mixture,with vigorous agitation,to a pHof 5to 6with 1Nsodium hydroxide,transfer to a 1000-mLvolumetric flask,dilute with water to volume,and mix.If the solution is not clear,filter through paper known not to adsorb riboflavin.Dilute an aliquot of the clear solution quantitatively and stepwise with water to make a final measured volume that contains approximately 0.1µg of riboflavin per mL.Using this as the Assay Preparation,proceed as directed under Riboflavin Assay á481ñ.Calculate the quantity,in mg,of C17H20N4O6in the portion of powdered Tablets taken by the formula:
for 30minutes.Cool,adjust the mixture,with vigorous agitation,to a pHof 5to 6with 1Nsodium hydroxide,transfer to a 1000-mLvolumetric flask,dilute with water to volume,and mix.If the solution is not clear,filter through paper known not to adsorb riboflavin.Dilute an aliquot of the clear solution quantitatively and stepwise with water to make a final measured volume that contains approximately 0.1µg of riboflavin per mL.Using this as the Assay Preparation,proceed as directed under Riboflavin Assay á481ñ.Calculate the quantity,in mg,of C17H20N4O6in the portion of powdered Tablets taken by the formula:
200,000C/W,
in which Cis the concentration,in mg per mL,of C17H20N4O6obtained for the Assay Preparation,and Wis the weight,in mg,of powdered Tablets.Calculate the quantity,in mg,of C17H20N4O6in each Tablet.
Auxiliary Information—
Staff Liaison:Lawrence Evans,III,Ph.D.,Scientist
Expert Committee:(DSN)Dietary Supplements:Non-Botanicals
USP28–NF23Page 1724
Phone Number:1-301-816-8389