Water-Soluble Vitamins with Minerals Tablets »Water-Soluble Vitamins with Minerals Tablets contain 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;and one or more minerals derived from substances generally recognized as safe,furnishing one or more of the following elements in ionizable form:calcium,chromium,copper,fluorine,iodine,iron,magnesium,manganese,molybdenum,phosphorus,potassium,selenium,and zinc.Tablets contain 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),calcium pantothenate (C18H32CaN2O10),niacin (C6H5NO2)or niacinamide (C6H6N2O),pyridoxine hydrochloride (C8H11NO3·HCl),riboflavin (C17H20N4O6),and thiamine (C12H17ClN4OS)as thiamine hydrochloride or thiamine mononitrate;not less than 90.0percent and not more than 125.0percent of the labeled amounts of calcium (Ca),copper (Cu),iron (Fe),magnesium (Mg),manganese (Mn),phosphorus (P),potassium (K),and zinc (Zn);and not less than 90.0percent and not more than 125.0percent of the labeled amounts of chromium (Cr),fluorine (F),iodine (I),molybdenum (Mo),and selenium (Se). They do not contain any form of Beta Carotene or Vitamin A,D,E,or K.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 Water-Soluble Vitamins with Minerals Tablets.The label also states the quantity of each vitamin and mineral in terms of metric units per dosage unit and where necessary the chemical form in which a vitamin is present,and also states the salt form of the mineral used as the source of each element.Where more than one Assaymethod is given for a particular vitamin,the labeling states which Assaymethod is used only if Method 1is not used. USP Reference standards á11ñ USP Biotin RS.USP Calcium Pantothenate RS.USP Cyanocobalamin RS.USP Folic Acid RS.USP Niacin RS.USP Niacinamide RS.USP Pyridoxine Hydrochloride RS.USP Riboflavin RS.USP Sodium Fluoride RS.USP Thiamine Hydrochloride RS. Microbial limits 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. 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 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 Oil-and Water-Soluble Vitamins with Minerals 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. NOTE—Commercially available atomic absorption standard solutions for the minerals,where applicable,may be used where preparation of a standard stock solution is described in the following Assays.Use deionized water where water is specified.Where atomic absorption spectrophotometry is specified in the Assay,the Standard preparationsand the Assay preparationmay be diluted quantitatively with the solvent specified,if necessary,to obtain solutions of suitable concentrations adaptable to the linear or working range of the instrument. Assay for calcium— Proceed as directed in the Assay for calciumunder Oil-and Water-Soluble Vitamins with Minerals Tablets,except to use 15mL,in place of 60mL,of hydrochloric acid when preparing the Assay preparation. Assay for chromium— Proceed as directed in the Assay for chromiumunder Oil-and Water-Soluble Vitamins with Minerals Tablets,except to use 15mL,in place of 60mL,of hydrochloric acid when preparing the Assay preparation. Assay for copper— Proceed as directed in the Assay for copperunder Oil-and Water-Soluble Vitamins with Minerals Tablets,except to use 15mL,in place of 60mL,of hydrochloric acid when preparing the Assay preparation. Assay for fluoride,Method 1— Proceed as directed in the Assay for fluoride,Method 1under Oil-and Water-Soluble Vitamins with Minerals Tablets. Assay for fluoride,Method 2— Proceed as directed in the Assay for fluoride,Method 2under Oil-and Water-Soluble Vitamins with Minerals Tablets. Assay for iodide,Method 1— Proceed as directed in the Assay for iodide,Method 1under Oil-and Water-Soluble Vitamins with Minerals Tablets. Assay for iodide,Method 2— Proceed as directed in the Assay for Iodideunder Automated Methods of Analysis á16ñ. Assay for iron— Proceed as directed in the Assay for ironunder Oil-and Water-Soluble Vitamins with Minerals Tablets,except to use 15mL,in place of 60mL,of hydrochloric acid when preparing the Assay preparation. Assay for magnesium— Proceed as directed in the Assay for magnesiumunder Oil-and Water-Soluble Vitamins with Minerals Tablets,except to use 15mL,in place of 60mL,of hydrochloric acid when preparing the Assay preparation. Assay for manganese— Proceed as directed in the Assay for manganeseunder Oil-and Water-Soluble Vitamins with Minerals Tablets,except to use 15mL,in place of 60mL,of hydrochloric acid when preparing the Assay preparation. Assay for molybdenum,Method 1— Proceed as directed in the Assay for molybdenum,Method 1under Oil-and Water-Soluble Vitamins with Minerals Tablets. Assay for molybdenum,Method 2— Proceed as directed in the Assay for molybdenum,Method 2under Oil-and Water-Soluble Vitamins with Minerals Tablets. Assay for phosphorus— Proceed as directed in the Assay for phosphorusunder Oil-and Water-Soluble Vitamins with Minerals Tablets. Assay for potassium— Proceed as directed in the Assay for potassiumunder Oil-and Water-Soluble Vitamins with Minerals Tablets,except to use 15mL,in place of 60mL,of hydrochloric acid when preparing the Assay preparation. Assay for selenium,Method 1— Proceed as directed in the Assay for selenium,Method 1under Oil-and Water-Soluble Vitamins with Minerals Tablets. Assay for selenium,Method 2— Proceed as directed in the Assay for selenium,Method 2under Oil-and Water-Soluble Vitamins with Minerals Tablets. Assay for zinc— Proceed as directed in the Assay for zincunder Oil-and Water-Soluble Vitamins with Minerals Tablets,except to use 15mL,in place of 60mL,of hydrochloric acid when preparing the Assay preparation. Auxiliary Information— Staff Liaison:Lawrence Evans,III,Ph.D.,Scientist Expert Committee:(DSN)Dietary Supplements:Non-Botanicals USP28–NF23Page 2182 Pharmacopeial Forum:Volume No.30(2)Page 587 Phone Number:1-301-816-8389