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 D as 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 90.0 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 (C36H60O2), vitamin D as ergocalciferol (C28H44O) or cholecalciferol (C27H44O); vitamin E as alpha tocopherol (C29H50O2), alpha tocopheryl acetate (C31H52O3), or alpha tocopheryl acid succinate (C33H54O5); phytonadione (C31H46O2); and beta carotene (C40H56); and not less than 90.0 percent and not more than 150.0 percent of the labeled amounts of ascorbic acid (C6H8O6) or its salts, as calcium ascorbate (C12H14CaO12·2H2O) or sodium ascorbate (C6H7NaO6); biotin (C10H16N2O3S); cyanocobalamin (C63H88CoN14 O14P); folic acid (C19H19N7O6); niacin (C6H5NO2) or niacinamide (C6H6N2O); calcium pantothenate (C18H32 CaN2O10); 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 Assay method is given for a particular vitamin, the labeling states with which Assay method the product complies only if Method 1 is not used.
USP Reference standards
![]() ![]() 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
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Disintegration and dissolution
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Weight variation
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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.
Assay for ascorbic acid, Method 1
Proceed as directed in the Assay for ascorbic acid, Method 1 under Oil- and Water-Soluble Vitamins with Minerals Tablets.
Assay for ascorbic acid, Method 2
Proceed as directed in the Assay for Ascorbic Acid under Automated Methods of Analysis
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Assay for calcium ascorbate, Method 1
Proceed as directed in the Assay for ascorbic acid, Method 1 under Oil- and Water-Soluble Vitamins with Minerals Tablets.
Assay for calcium ascorbate, Method 2
Proceed as directed in the Assay for Ascorbic Acid under Automated Methods of Analysis
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Assay for sodium ascorbate, Method 1
Proceed as directed in the Assay for ascorbic acid, Method 1 under Oil- and Water-Soluble Vitamins with Minerals Tablets.
Assay for sodium ascorbate, Method 2
Proceed as directed in the Assay for Ascorbic Acid under Automated Methods of Analysis
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Assay for biotin, Method 1
Proceed as directed in the Assay for biotin, Method 1 under Oil- and Water-Soluble Vitamins with Minerals Tablets.
Assay for biotin, Method 2
Proceed as directed in the Assay for biotin, Method 2 under Oil- and Water-Soluble Vitamins with Minerals Tablets.
Assay for biotin, Method 3
Proceed as directed in the Assay for biotin, Method 3 under Oil- and Water-Soluble Vitamins with Minerals Tablets.
Assay for cyanocobalamin, Method 1
Proceed as directed in the Assay for cyanocobalamin, Method 1 under Oil- and Water-Soluble Vitamins with Minerals Tablets.
Assay for cyanocobalamin, Method 2
Proceed as directed in the Assay for cyanocobalamin, Method 2 under Oil- and Water-Soluble Vitamins with Minerals Tablets.
Assay for folic acid, Method 1
Proceed as directed in the Assay for folic acid, Method 1 under Oil- and Water-Soluble Vitamins with Minerals Tablets.
Assay for folic acid, Method 2
Proceed as directed in the Assay for folic acid, Method 2 under Water-Soluble Vitamins Tablets.
Assay for calcium pantothenate, Method 1
Proceed as directed in the Assay for calcium pantothenate, Method 1 under Oil- and Water-Soluble Vitamins with Minerals Tablets.
Assay for calcium pantothenate, Method 2
Proceed as directed in the Assay for calcium pantothenate, Method 2 under Oil- and Water-Soluble Vitamins with Minerals Tablets.
Assay for calcium pantothenate, Method 3
Proceed as directed in the Assay for calcium pantothenate, Method 3 under 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 1 under Oil- and Water-Soluble Vitamins with Minerals Tablets.
Assay for niacin, Method 2
Proceed as directed in the Assay for niacin, Method 2 under Oil- and Water-Soluble Vitamins with Minerals Tablets.
Assay for niacinamide, Method 2
Proceed as directed in the Assay for niacinamide, Method 2 under Oil- and Water-Soluble Vitamins with Minerals Tablets.
Assay for pyridoxine hydrochloride, Method 2
Proceed as directed in the Assay for pyridoxine hydrochloride, Method 2 under Oil- and Water-Soluble Vitamins with Minerals Tablets.
Assay for riboflavin, Method 2
Proceed as directed in the Assay for riboflavin, Method 2 under Oil- and Water-Soluble Vitamins with Minerals Tablets.
Assay for thiamine, Method 2
Proceed as directed in the Assay for thiamine, Method 2 under 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 3 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
Please check for your question in the FAQs before contacting USP.
Chromatographic Column
USP32NF27 Page 1092
Pharmacopeial Forum: Volume No. 30(2) Page 585
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.
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