Ergocalciferol Tablets
» Ergocalciferol Tablets contain not less than 100.0 percent and not more than 120.0 percent 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 40 USP Vitamin D Units = 1 µg.
A: Evaporate under a stream of nitrogen to dryness 1 mL of the filtrate obtained in Identification test B, and dissolve the residue in 50 mL of alcohol: the UV absorption 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 5 mg of ergocalciferol, with 10 mL of chloroform, and filter into a small flask: the filtrate so obtained responds to Identification test C under Ergocalciferol.
Disintegration 701: 30 minutes.
Uniformity of dosage units 905: meet the requirements.
Assay— Proceed with Tablets as directed for Chemical Method under Vitamin D Assay 581.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Curtis Phinney

(DSN05) Dietary Supplements - Non-Botanicals
Reference Standards Lili Wang, Technical Services Scientist
701 Margareth R.C. Marques, Ph.D.
Senior Scientist
(BPC05) Biopharmaceutics05
USP32–NF27 Page 2271