Oleovitamin A and D Capsules
DEFINITION
Oleovitamin A and D Capsules contain NLT 90.0% of the labeled amounts of vitamins A and D. The oil in Oleovitamin A and D Capsules 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.
ASSAY
• Vitamin A Assay 
571
571 Sample Transfer NLT 5 Capsules to a saponification flask, add 10–20 mL of water, and heat for 10 min. Crush any remaining solids with the blunt end of a glass rod.
Analysis: Proceed as directed in Chemical Method for Procedure, in the second paragraph, beginning with “Reflux in an all-borosilicate glass apparatus”.
Acceptance criteria: NLT 90.0% of the labeled amount
• Vitamin D Assay 581
581 Sample: Transfer NLT 5 Capsules to a saponification flask, add 10–20 mL of water, and heat for 10 min. Crush any remaining solids with the blunt end of a glass rod.
Analysis: Proceed as directed in Chemical Method. The Sample Preparation shall contain NMT the equivalent of 7.5 mg of vitamin A or NLT 125 µg of vitamin D.
Proceed as directed in Biological Method if the ratio of vitamin A to vitamin D exceeds 300:1.
Acceptance criteria: NLT 90.0% of the labeled amount
ADDITIONAL REQUIREMENTS
• 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.
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Auxiliary Information— Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Natalia Davydova Scientific Liaison 1-301-816-8328 | (DS2010) Monographs - Dietary Supplements |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP35–NF30 Page 4109