Ergocalciferol Tablets
»Ergocalciferol Tablets contain not less than 100.0percent and not more than 120.0percent of the labeled amount of C28H44O.
Packaging and storage— Preserve in tight,light-resistant containers.
Labeling— Label the Tablets to indicate the content of ergocalciferol in mg.The activity may be expressed also in terms of USP Units,on the basis that 40USP Vitamin D Units =1µg.
Identification—
A: Evaporate under a stream of nitrogen to dryness 1mLof the filtrate obtained in Identificationtest B,and dissolve the residue in 50mLof alcohol:the UVabsorption spectrum of the solution exhibits maxima and minima at the same wavelengths as that of a similar preparation of USP Ergocalciferol RS,concomitantly measured.
B: Triturate a quantity of powdered Tablets,equivalent to about 5mg of ergocalciferol,with 10mLof chloroform,and filter into a small flask:the filtrate so obtained responds to Identificationtest Cunder Ergocalciferol.
Uniformity of dosage units á905ñ: meet the requirements.
Assay— Proceed with Tablets as directed for Chemical Methodunder Vitamin D Assay á581ñ.
Auxiliary Information— Staff Liaison:Lawrence Evans,III,Ph.D.,Scientist
Expert Committee:(DSN)Dietary Supplements:Non-Botanicals
USP28–NF23Page 748
Phone Number:1-301-816-8389