Packaging and storage— Preserve in tight,light-resistant containers.

Labeling— Label the Capsules to indicate the form in which the vitamin is present,and to indicate the vitamin Aactivity in terms of the equivalent amount of retinol in mg.The vitamin Aactivity may be stated also in USP Units per Capsule,on the basis that 1USP Vitamin A Unit equals the biological activity of 0.3µg of the all-transisomer of retinol.

USP Reference standards á11ñ— USP Vitamin A RS.

Disintegration á701ñ: 45minutes,determined using 0.05Macetate buffer,prepared by mixing 2.99g of sodium acetate and 1.66mLof glacial acetic acid with water to obtain 1000mLof solution having a pHof 4.5±0.05,maintained at 37±2as the immersion fluid.

Uniformity of dosage units á905ñ: meet the requirements.

Other requirements— The contents of Capsules respond to the tests for Identificationfor vitamin Aand meet the requirements of the test for Absorbance ratiounder Vitamin A.

Assay— Using not less than 5Capsules,proceed as directed under Vitamin A Assay á571ñ.Calculate the content of retinol (C20H30O)in mg and in USP Vitamin A Units per Capsule.

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

USP28–NF23Page 2028

Phone Number:1-301-816-8389