Oleovitamin A and D
(oh'' lee oh vye' ta min).
DEFINITION
Oleovitamin A and D is a solution of vitamin A and vitamin D in fish liver oil or in an edible vegetable oil. The vitamin D is present as ergocalciferol or cholecalciferol obtained by the activation of ergosterol or 7-dehydrocholesterol, or from natural sources. Oleovitamin A and D contains NLT 90.0% of the labeled amounts of vitamins A and D.
ASSAY
•  Vitamin A
Analysis: Proceed as directed in Vitamin A Assay 571.
Acceptance criteria: NLT 90.0% of the labeled amount
•  Vitamin D
Analysis: Weigh a quantity of Oleovitamin A and D expected to contain the equivalent of 125–250 µg of vitamin D, but NMT 7.5 mg of vitamin A, and proceed as directed for Chemical Method in Vitamin D Assay 581. If the assay specimen contains less than the equivalent of 2.5 µg/g of vitamin D, or if the ratio of vitamin A to vitamin D exceeds 300:1, proceed as directed for Biological Method in Vitamin D Assay 581.
Acceptance criteria: NLT 90.0% of the labeled amount
ADDITIONAL REQUIREMENTS
•  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 terms of retinol 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, of ergocalciferol or cholecalciferol per g. Its vitamin D content may be expressed also in USP Vitamin D Units per g.
•  USP Reference Standards 11
USP Cholecalciferol RS Click to View Structure
USP Ergocalciferol RS Click to View Structure
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USP35–NF30 Page 4109
Chromatographic Column— 
Chromatographic columns text is not derived from, and not part of, USP 35 or NF 30.