Oil-Soluble Vitamins Tablets
»Oil-Soluble Vitamins Tablets contain two or more of the following oil-soluble vitamins:Vitamin A,Vitamin Das Ergocalciferol (Vitamin D2)or Cholecalciferol (Vitamin D3),Vitamin E,Phytonadione (Vitamin K1),and Beta Carotene.Tablets contain not less than 90.0percent and not more than 165.0percent 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 Das cholecalciferol (C27H44O)or ergocalciferol (C28H44O);vitamin Eas 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 Assaymethod is given for a particular vitamin,the labeling states the Assaymethod used only if Method 1is not used.
Microbial enumeration á2021ñ— The total aerobic microbial count does not exceed 3000cfu per g,and the combined molds and yeasts count does not exceed 300cfu per g.Tablets also meet the requirements of the tests for absence of Salmonellaspecies,Escherichia coli,and Staphylococcus aureus.
Disintegration and dissolution á2040ñ: meet the requirements for Disintegrationonly.Do not perform the test for Dissolution.
Weight variation á2091ñ: meet the requirements.
NOTE—In the following Assays,where more than one Assaymethod 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 1is not used.
Assay for vitamin A,Method 1— Proceed as directed in the Assay for vitamin A,Method 1under Oil-and Water-Soluble Vitamins with Minerals Tablets.
Assay for vitamin A,Method 2— Proceed as directed in the Assay for vitamin A,Method 2under Oil-and Water-Soluble Vitamins with Minerals Tablets.
Assay for vitamin A,Method 3— Proceed as directed in the Assay for vitamin A,Method 3under 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 1under 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 2under 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 3under Oil-and Water-Soluble Vitamins with Minerals Tablets.
Assay for vitamin E,Method 1— Proceed as directed in the Assay for vitamin E,Method 1under Oil-and Water-Soluble Vitamins with Minerals Tablets.
Assay for vitamin E,Method 2— Proceed as directed in the Assay for vitamin E,Method 2under Oil-and Water-Soluble Vitamins with Minerals Tablets.
Assay for vitamin E,Method 3— Proceed as directed in the Assay for vitamin E,Method 3under Oil-and Water-Soluble Vitamins with Minerals Tablets.
Assay for phytonadione,Method 1— Proceed as directed in the Assay for phytonadione,Method 1under Oil-and Water-Soluble Vitamins with Minerals Tablets.
Assay for phytonadione,Method 2— Proceed as directed in the Assay for phytonadione,Method 2under Oil-and Water-Soluble Vitamins with Minerals Tablets.
Assay for beta carotene— Proceed as directed in the Assay for beta caroteneunder 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 Labelingsection under Oil-and Water-Soluble Vitamins with Minerals Tablets.
Auxiliary Information— Staff Liaison:Lawrence Evans,III,Ph.D.,Scientist
Expert Committee:(DSN)Dietary Supplements:Non-Botanicals
USP28–NF23Page 2138
Pharmacopeial Forum:Volume No.28(5)Page 1547
Phone Number:1-301-816-8389