Packaging and storage— Preserve in tight containers, protected from light and air, preferably under an atmosphere of an inert gas. Store in a dry place.

Labeling— Label it to indicate the content of vitamin A in mg per g. The vitamin A content may also be expressed in USP Vitamin A Units per g. Label it to show whether it contains ergocalciferol, cholecalciferol, or vitamin D from a natural source. Label it to indicate also the vitamin D content in µg per g. Its vitamin D content may be expressed also in USP Vitamin D Units per g.

USP Reference standards 11— USP Ergocalciferol RS or USP Cholecalciferol RS.

Organic volatile impurities, Method V 467: meets the requirements.

Residual solvents 467: meets the requirements.

Assay for vitamin A— Proceed as directed under Vitamin A Assay 571.

Assay for vitamin D— Accurately measure a portion of Oleovitamin A and D expected to contain about the equivalent of 125 to 250 µg of vitamin D, but not more than 7.5 mg of vitamin A, and proceed as directed for Chemical Method under Vitamin D Assay 581. If the assay specimen contains less than the equivalent of 2.5 µg of vitamin D per g, or if the ratio of vitamin A to vitamin D exceeds 300 to 1, proceed as directed for Biological Method under Vitamin D Assay 581.

Expert Committee : (DSN05) Dietary Supplements - Non-Botanicals

USP29–NF24 Page 1577

Phone Number : 1-301-816-8389