Oil-and Water-Soluble Vitamins Tablets
»Oil-and Water-Soluble Vitamins Tablets contain one 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,and one or more of the following water-soluble vitamins:Ascorbic Acid or its equivalent as Calcium Ascorbate or Sodium Ascorbate,Biotin,Cyanocobalamin,Folic Acid,Niacin or Niacinamide,Pantothenic Acid (as Calcium Pantothenate or Racemic Calcium Pantothenate),Pyridoxine Hydrochloride,Riboflavin,and Thiamine Hydrochloride or Thiamine Mononitrate.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 (C36H60O2),vitamin Das ergocalciferol (C28H44O)or cholecalciferol (C27H44O);vitamin Eas alpha tocopherol (C29H50O2),alpha tocopheryl acetate (C31H52O3),or alpha tocopheryl acid succinate (C33H54O5);phytonadione (C31H46O2);and beta carotene (C40H56);and not less than 90.0percent and not more than 150.0percent of the labeled amounts of ascorbic acid (C6H8O6)or its salts,as calcium ascorbate (C12H14CaO12·2H2O)or sodium ascorbate (C6H7NaO6);biotin (C10H16N2O3S);cyanocobalamin (C63H88CoN14O14P);folic acid (C19H19N7O6);niacin (C6H5NO2)or niacinamide (C6H6N2O);calcium pantothenate (C18H32CaN2O10);pyridoxine hydrochloride (C8H11NO3·HCl);riboflavin (C17H20N4O6);and thiamine (C12H17ClN4OS)as thiamine hydrochloride or thiamine mononitrate.
They do not contain 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*
The label states that the product is Oil-and Water-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 with which Assaymethod the product complies only if Method 1is not used.
USP Reference standards á11ñ
USP Alpha Tocopherol RS.USP Alpha Tocopheryl Acetate RS.USP Alpha Tocopheryl Acid Succinate RS.USP Biotin RS.USP Calcium Pantothenate RS.USP Cholecalciferol RS.USP Cyanocobalamin RS.USP Ergocalciferol RS.USP Folic Acid RS.USP Niacin RS.USP Niacinamide RS.USP Phytonadione RS.USP Pyridoxine Hydrochloride RS.USP Riboflavin RS.USP Thiamine Hydrochloride RS.USP Vitamin A RS.
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 Dissolution.
Weight variation á2091ñ:
meet the requirements.
NOTEWhere more than one Assay methodis 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 theAssay for phytonadione,Method 1underOil-and Water-Soluble Vitamins with Minerals Tablets.
Assay for phytonadione,Method 2
Proceed as directed in theAssay for phytonadione,Method 2underOil-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.
Assay for ascorbic acid,Method 1
Proceed as directed in the Assay for ascorbic acid,Method 1under Oil-and Water-Soluble Vitamins with Minerals Tablets.
Assay for ascorbic acid,Method 2
Proceed as directed in the Assay for Ascorbic Acidunder Automated Methods of Analysis á16ñ.
Assay for calcium ascorbate,Method 1
Proceed as directed in the Assay for ascorbic acid,Method 1under Oil-and Water-Soluble Vitamins with Minerals Tablets.
Assay for calcium ascorbate,Method 2
Proceed as directed in the Assay for Ascorbic Acidunder Automated Methods of Analysis á16ñ.
Assay for sodium ascorbate,Method 1
Proceed as directed in the Assay for ascorbic acid,Method 1under Oil-and Water-Soluble Vitamins with Minerals Tablets.
Assay for sodium ascorbate,Method 2
Proceed as directed in the Assay for Ascorbic Acidunder Automated Methods of Analysis á16ñ.
Assay for biotin,Method 1
Proceed as directed in the Assay for biotin,Method 1under Oil-and Water-Soluble Vitamins with Minerals Tablets.
Assay for biotin,Method 2
Proceed as directed in the Assay for biotin,Method 2under Oil-and Water-Soluble Vitamins with Minerals Tablets.
Add the following:
Assay for biotin,Method 3
Proceed as directed in the Assay for biotin,Method 3under Oil-and Water-Soluble Vitamins with Minerals Tablets.USP28
Assay for cyanocobalamin,Method 1
Proceed as directed in the Assay for cyanocobalamin,Method 1under Oil-and Water-Soluble Vitamins with Minerals Tablets.
Assay for cyanocobalamin,Method 2
Proceed as directed in the Assay for cyanocobalamin,Method 2under Oil-and Water-Soluble Vitamins with Minerals Tablets.
Assay for folic acid,Method 1
Proceed as directed in the Assay for folic acid,Method 1under Oil-and Water-Soluble Vitamins with Minerals Tablets.
Assay for folic acid,Method 2
Proceed as directed in the Assay for folic acid,Method 2under Water-Soluble Vitamins Tablets.
Assay for calcium pantothenate,Method 1
Proceed as directed in the Assay for calcium pantothenate,Method 1under Oil-and Water-Soluble Vitamins with Minerals Tablets.
Assay for calcium pantothenate,Method 2
Proceed as directed in the Assay for calcium pantothenate,Method 2under Oil-and Water-Soluble Vitamins with Minerals Tablets.
Assay for calcium pantothenate,Method 3
Proceed as directed in the Assay for calcium pantothenate,Method 3under Oil-and Water-Soluble Vitamins with Minerals Tablets.
Assay for niacin or niacinamide,pyridoxine hydrochloride,riboflavin,and thiamine,Method 1
Proceed as directed in the Assay for niacin or niacinamide,pyridoxine hydrochloride,riboflavin,and thiamine,Method 1under Oil-and Water-Soluble Vitamins with Minerals Tablets.
Assay for niacin,Method 2
Proceed as directed in the Assay for niacin,Method 2under Oil-and Water-Soluble Vitamins with Minerals Tablets.
Assay for niacinamide,Method 2
Proceed as directed in the Assay for niacinamide,Method 2under Oil-and Water-Soluble Vitamins with Minerals Tablets.
Assay for pyridoxine hydrochloride,Method 2
Proceed as directed in the Assay for pyridoxine hydrochloride,Method 2under Oil-and Water-Soluble Vitamins with Minerals Tablets.
Assay for riboflavin,Method 2
Proceed as directed in the Assay for riboflavin,Method 2under Oil-and Water-Soluble Vitamins with Minerals Tablets.
Assay for thiamine,Method 2
Proceed as directed in the Assay for thiamine,Method 2under Oil-and Water-Soluble Vitamins with Minerals Tablets.
Assay for niacin or niacinamide,pyridoxine hydrochloride,riboflavin,and thiamine,Method 3
Proceed as directed in the Assay for niacin or niacinamide,pyridoxine hydrochloride,riboflavin,and thiamine,Method 3under 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
USP28NF23Page 2143
Pharmacopeial Forum:Volume No.30(2)Page 585
Phone Number:1-301-816-8389
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