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
Sample
Transfer NLT 5 Capsules to a saponification flask, add 1020 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
Sample:
Transfer NLT 5 Capsules to a saponification flask, add 1020 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.
Auxiliary Information
Please check for your question in the FAQs before contacting USP.
USP35NF30 Page 4109
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