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 Ain each capsule.The vitamin Acontent in each capsule may be expressed also in USP Vitamin A Units.Label the Capsules to show whether they contain ergocalciferol,cholecalciferol,or vitamin Dfrom a natural source.Label the Capsules to indicate also the vitamin Dcontent,in µg,in each capsule.The vitamin Dcontent may be expressed also in USP Vitamin D Units in each capsule.

USP Reference standards á11ñ— USP Ergocalciferol RSor USP Cholecalciferol RS.

Assay for vitamin A— Transfer to a saponification flask not less than 5Capsules,add 10to 20mLof water,and heat for about 10minutes.Crush any remaining solids with the blunt end of a glass rod,and proceed as directed in the second paragraph for Procedurein the Vitamin A Assay á571ñ,beginning with “Reflux in an all-glassapparatus.”

Assay for vitamin D— Transfer to a saponification flask not less than 5Capsules,add 10to 20mLof water,and heat for about 10minutes.Crush any remaining solids with the blunt end of a glass rod,and proceed as directed for Chemical Methodunder Vitamin D Assay á581ñ.The Test Preparationused in the chromatographic procedures shall contain not more than the equivalent of 7.5mg of vitamin Aor less than 125µg of vitamin D.If the ratio of vitamin Ato vitamin Din the Test Preparationexceeds 300to 1,proceed as directed for Biological Methodunder Vitamin D Assay á581ñ.

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

USP28–NF23Page 1415

Phone Number:1-301-816-8389