Packaging and storage— Preserve in tight, light-resistant containers. Store in a dry place.

Labeling— Label the Capsules to indicate the content, in mg, of vitamin A in each capsule. The vitamin A content in each capsule may be expressed also in USP Vitamin A Units. Label the Capsules to show whether they contain ergocalciferol, cholecalciferol, or vitamin D from a natural source. Label the Capsules to indicate also the vitamin D content, in µg, in each capsule. The vitamin D content may be expressed also in USP Vitamin D Units in each capsule.

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

Residual solvents 467: meet the requirements.

Assay for vitamin A— Transfer to a saponification flask not less than 5 Capsules, add 10 to 20 mL of water, and heat for about 10 minutes. Crush any remaining solids with the blunt end of a glass rod, and proceed as directed in the second paragraph for Procedure in the Vitamin A Assay 571, beginning with “Reflux in an all-glass apparatus.”

Assay for vitamin D— Transfer to a saponification flask not less than 5 Capsules, add 10 to 20 mL of water, and heat for about 10 minutes. Crush any remaining solids with the blunt end of a glass rod, and proceed as directed for Chemical Method under Vitamin D Assay 581. The Test Preparation used in the chromatographic procedures shall contain not more than the equivalent of 7.5 mg of vitamin A or less than 125 µg of vitamin D. If the ratio of vitamin A to vitamin D in the Test Preparation 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