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Oil-Soluble Vitamins Tablets
» Oil-Soluble Vitamins Tablets contain two or more of the following oil-soluble vitamins: Vitamin A, Vitamin D as Ergocalciferol (Vitamin D2) or Cholecalciferol (Vitamin D3), Vitamin E, Phytonadione (Vitamin K1), and Beta Carotene. Tablets contain not less than 90.0 percent and not more than 165.0 percent of the labeled amounts of vitamin A (C20H30O) as retinol or esters of retinol in the form of retinyl acetate (C22H32O2) or retinyl palmitate (C36H46O2); vitamin D as cholecalciferol (C27H44O) or ergocalciferol (C28H44O); vitamin E as alpha tocopherol (C29H50O2), alpha tocopheryl acetate (C31H52O3), or alpha tocopheryl acid succinate (C33H54O5); phytonadione (C31H46O2); and beta carotene (C40H56).
Oil-Soluble Vitamins Tablets contain no other vitamins or any minerals. They may contain other labeled added substances that are generally recognized as safe, in amounts that are unobjectionable.
Packaging and storage— Preserve in tight, light-resistant containers.
Labeling* — Label the Tablets to state that the product is Oil-Soluble Vitamins Tablets. The label also states the quantity of each vitamin per dosage unit and where necessary the chemical form in which it is present. Where the product contains vitamin E, the label indicates whether it is the d- or dl- form. Where more than one Assay method is given for a particular vitamin, the labeling states the Assay method used only if Method 1 is not used.
Microbial enumeration 2021— The total aerobic microbial count does not exceed 3000 cfu per g, and the combined molds and yeasts count does not exceed 300 cfu per g. Tablets also meet the requirements of the tests for absence of Salmonella species, Escherichia coli, and Staphylococcus aureus.
Disintegration and dissolution 2040: meet the requirements for Disintegration only. Do not perform the test for Dissolution.
Weight variation 2091: meet the requirements.
Residual solvents 467: meet the requirements.
(Official January 1, 2007)
NOTE— In the following Assays, where more than one Assay method is given for an individual ingredient, the requirements may be met by following any one of the specified methods, the method used being stated in the labeling only if Method 1 is not used.
Assay for vitamin A, Method 1— Proceed as directed in the Assay for vitamin A, Method 1 under Oil- and Water-Soluble Vitamins with Minerals Tablets.
Assay for vitamin A, Method 2— Proceed as directed in the Assay for vitamin A, Method 2 under Oil- and Water-Soluble Vitamins with Minerals Tablets.
Assay for vitamin A, Method 3— Proceed as directed in the Assay for vitamin A, Method 3 under Oil- and Water-Soluble Vitamins with Minerals Tablets.
Assay for cholecalciferol or ergocalciferol (vitamin D), Method 1— Proceed as directed in the Assay for cholecalciferol or ergocalciferol (vitamin D), Method 1 under Oil- and Water-Soluble Vitamins with Minerals Tablets.
Assay for cholecalciferol or ergocalciferol (vitamin D), Method 2— Proceed as directed in the Assay for cholecalciferol or ergocalciferol (vitamin D), Method 2 under Oil- and Water-Soluble Vitamins with Minerals Tablets.
Assay for cholecalciferol or ergocalciferol (vitamin D), Method 3— Proceed as directed in the Assay for cholecalciferol or ergocalciferol (vitamin D), Method 3 under Oil- and Water-Soluble Vitamins with Minerals Tablets.
Assay for vitamin E, Method 1— Proceed as directed in the Assay for vitamin E, Method 1 under Oil- and Water-Soluble Vitamins with Minerals Tablets.
Assay for vitamin E, Method 2— Proceed as directed in the Assay for vitamin E, Method 2 under Oil- and Water-Soluble Vitamins with Minerals Tablets.
Assay for vitamin E, Method 3— Proceed as directed in the Assay for vitamin E, Method 3 under Oil- and Water-Soluble Vitamins with Minerals Tablets.
Assay for phytonadione, Method 1— Proceed as directed in the Assay for phytonadione, Method 1 under Oil- and Water-Soluble Vitamins with Minerals Tablets.
Assay for phytonadione, Method 2— Proceed as directed in the Assay for phytonadione, Method 2 under Oil- and Water-Soluble Vitamins with Minerals Tablets.
Assay for beta carotene— Proceed as directed in the Assay for beta carotene under Oil- and Water-Soluble Vitamins with Minerals Tablets.
*  For information on USP Units of activity for vitamins and labeling in terms of units, see the footnote to the Labeling section under Oil- and Water-Soluble Vitamins with Minerals Tablets.
Auxiliary Information— Staff Liaison : Lawrence Evans, III, Ph.D., Scientist
Expert Committee : (DSN05) Dietary Supplements - Non-Botanicals
USP29–NF24 Page 2389
Pharmacopeial Forum : Volume No. 28(5) Page 1547
Phone Number : 1-301-816-8389