USPUSP-NF
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Oil- and Water-Soluble Vitamins Oral Solution

DEFINITION

Oil- and Water-Soluble Vitamins Oral Solution contains one or more of the following oil-soluble vitamins: Vitamin A, vitamin D as Ergocalciferol (vitamin D2) or Cholecalciferol (vitamin D3), and Vitamin E; one or more of the following water-soluble vitamins: Ascorbic Acid or its equivalent as Calcium Ascorbate or Sodium Ascorbate, Cyanocobalamin, Niacin or Niacinamide, Dexpanthenol or Panthenol, pantothenic acid (as Calcium Pantothenate or Racemic Calcium Pantothenate), Pyridoxine Hydrochloride, Riboflavin or Riboflavin-5′-Phosphate Sodium, and Thiamine Hydrochloride or Thiamine Mononitrate. It contains NLT 90.0% and NMT 250.0% 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) or alpha tocopheryl acetate (C31H52O3) or alpha tocopheryl acid succinate (C33H54O5), ascorbic acid (C6H8O6) or its salts as calcium ascorbate (C12H14CaO12·2H2O) or sodium ascorbate (C6H7NaO6), and thiamine (C12H17ClN4OS) as thiamine hydrochloride or thiamine mononitrate; NLT 90.0% and NMT 150.0% of the labeled amounts of calcium pantothenate (C18H32CaN2O10), dexpanthenol (C9H19NO4) or panthenol (C9H19NO4), niacin (C6H5NO2) or niacinamide (C6H6N2O), pyridoxine hydrochloride (C8H11NO3·HCl), and riboflavin (C17H20N4O6) or riboflavin-5′-phosphate sodium (C17H20N4NaO9P); and NLT 90.0% and NMT 450.0% of the labeled amount of cyanocobalamin (C63H88CoN14O14P).

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