Niacinamide Tablets
»Niacinamide Tablets contain not less than 90.0percent and not more than 110.0percent of the labeled amount of C6H6N2O.
Packaging and storage—
Preserve in tight containers.
Identification—
A:
Extract a quantity of powdered Tablets,equivalent to about 500mg of niacinamide,with two 10-mLportions of alcohol,evaporate the filtered alcohol extracts on a steam bath,and dry at 80
for 2hours:the IRabsorption spectrum of a potassium bromide dispersion of the residue so obtained exhibits maxima only at the same wavelengths as that of a similar preparation of USP Niacinamide RS.
for 2hours:the IRabsorption spectrum of a potassium bromide dispersion of the residue so obtained exhibits maxima only at the same wavelengths as that of a similar preparation of USP Niacinamide RS.
B:
From the niacinamide obtained in Identificationtest A,prepare a solution (1in 50,000),and determine the absorbance of this solution in a 1-cm cell at 245nm and at 262nm,with a suitable spectrophotometer,using water as the blank:the ratio A245/A262is between 0.63and 0.67.
Dissolution,Procedure for a Pooled Sample á711ñ—
Medium:
water;900mL.
Apparatus 2:
50rpm.
Time:
45minutes.
Procedure—
Determine the amount of C6H6N2Odissolved,employing the procedure set forth in the Assay for niacin or niacinamide,pyridoxine hydrochloride,riboflavin,and thiamineunder Water-soluble Vitamins Tablets,using filtered portions of the solution under test,suitably diluted with Dissolution Medium,if necessary,in comparison with a Standard solution having a known concentration of USP Niacinamide RSin the same medium.
Tolerances—
Not less than 75%(Q)of the labeled amount of C6H6N2Ois dissolved in 45minutes.
Uniformity of dosage units á905ñ:
meet the requirements.
Assay—
Proceed with Tablets as directed for Chemical Methodunder Niacin or Niacinamide Assay á441ñ,using Standard Niacinamide Preparationas the Standard Preparationin the Assay Procedure:and the following as the Assay Preparation.Weigh and finely powder not less than 10Tablets.Weigh accurately a quantity of the powder,equivalent to about 25mg of niacinamide,and transfer with the aid of about 50mLof water to a 250-mLvolumetric flask.Heat,if necessary,until no more dissolves,cool,dilute with water to volume,and mix.Pipet 10mLof the solution into a 100-mLvolumetric flask,dilute with water to volume,and mix.Calculate the quantity,in mg,of C6H6N2Oin the portion of Tablets taken by the formula:
25(AU/AS).
Auxiliary Information—
Staff Liaison:Lawrence Evans,III,Ph.D.,Scientist
Expert Committee:(DSN)Dietary Supplements:Non-Botanicals
USP28–NF23Page 1370
Pharmacopeial Forum:Volume No.30(1)Page 139
Phone Number:1-301-816-8389