Oleovitamin A and D
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Tóm tắt nội dung
This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition
Issued and maintained by the United States Pharmacopeial Convention (USP)
1 DEFINITION
Oleovitamin A and D is a solution of vitamin A and vitamin D in sh 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.
2 ASSAY
A. Vitamin A Assay 〈571〉
Analysis: The acceptance criteria may be met by following any one of the specified procedures described in the Chemical Methods or Chromatographic Methods in the chapter. The method and procedure used should be stated in the labeling.
Acceptance criteria: NLT 90.0% of the labeled amount
B. Vitamin D Assay 〈581〉
Analysis: The acceptance criteria may be met by following any one of the specified procedures described in the Chromatographic Methods in the chapter. The procedure used should be stated in the labeling.
Acceptance criteria: NLT 90.0% of the labeled amount
3 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/g. The vitamin A content may also be expressed in USP Vitamin A Units/g. Label it to show whether it contains ergocalciferol, cholecalciferol, or vitamin D from a natural source. Label it to indicate the vitamin D content, in µg, of ergocalciferol or cholecalciferol/g. Its vitamin D content may be expressed also in USP Vitamin D Units/g.
