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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 90.0 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 (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 90.0 percent and not more than 125.0 percent 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 90.0 percent and not more than 125.0 percent 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 Assay method is given for a particular vitamin, the labeling states which Assay method is used only if Method 1 is not used.
Microbial enumeration 2021— The total aerobic microbial count does not exceed 3000 cfu per g, and the combined molds and yeasts count does not exceed 300 cfu per g. Tablets also meet the requirements of the tests for absence of Salmonella species, Escherichia coli, and Staphylococcus aureus.
Disintegration and dissolution 2040: meet the requirements for Dissolution.
Weight variation 2091: meet the requirements.
Residual solvents 467: meet the requirements.
(Official January 1, 2007)
NOTE— In the following Assays, where more than one Assay method 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 1 is not used.
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 16.
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 16.
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 16.
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 Oil- and Water-Soluble Vitamins with Minerals 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.
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 preparations and the Assay preparation may 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 calcium under Oil- and Water-Soluble Vitamins with Minerals Tablets, except to use 15 mL, in place of 60 mL, of hydrochloric acid when preparing the Assay preparation.
Assay for chromium— Proceed as directed in the Assay for chromium under Oil- and Water-Soluble Vitamins with Minerals Tablets, except to use 15 mL, in place of 60 mL, of hydrochloric acid when preparing the Assay preparation.
Assay for copper— Proceed as directed in the Assay for copper under Oil- and Water-Soluble Vitamins with Minerals Tablets, except to use 15 mL, in place of 60 mL, of hydrochloric acid when preparing the Assay preparation.
Assay for fluoride, Method 1— Proceed as directed in the Assay for fluoride, Method 1 under Oil- and Water-Soluble Vitamins with Minerals Tablets.
Assay for fluoride, Method 2— Proceed as directed in the Assay for fluoride, Method 2 under Oil- and Water-Soluble Vitamins with Minerals Tablets.
Assay for iodide, Method 1— Proceed as directed in the Assay for iodide, Method 1 under Oil- and Water-Soluble Vitamins with Minerals Tablets.
Assay for iodide, Method 2— Proceed as directed in the Assay for Iodide under Automated Methods of Analysis 16.
Assay for iron— Proceed as directed in the Assay for iron under Oil- and Water-Soluble Vitamins with Minerals Tablets, except to use 15 mL, in place of 60 mL, of hydrochloric acid when preparing the Assay preparation.
Assay for magnesium— Proceed as directed in the Assay for magnesium under Oil- and Water-Soluble Vitamins with Minerals Tablets, except to use 15 mL, in place of 60 mL, of hydrochloric acid when preparing the Assay preparation.
Assay for manganese— Proceed as directed in the Assay for manganese under Oil- and Water-Soluble Vitamins with Minerals Tablets, except to use 15 mL, in place of 60 mL, of hydrochloric acid when preparing the Assay preparation.
Assay for molybdenum, Method 1— Proceed as directed in the Assay for molybdenum, Method 1 under Oil- and Water-Soluble Vitamins with Minerals Tablets.
Assay for molybdenum, Method 2— Proceed as directed in the Assay for molybdenum, Method 2 under Oil- and Water-Soluble Vitamins with Minerals Tablets.
Assay for phosphorus— Proceed as directed in the Assay for phosphorus under Oil- and Water-Soluble Vitamins with Minerals Tablets.
Assay for potassium— Proceed as directed in the Assay for potassium under Oil- and Water-Soluble Vitamins with Minerals Tablets, except to use 15 mL, in place of 60 mL, of hydrochloric acid when preparing the Assay preparation.
Assay for selenium, Method 1— Proceed as directed in the Assay for selenium, Method 1 under Oil- and Water-Soluble Vitamins with Minerals Tablets.
Assay for selenium, Method 2— Proceed as directed in the Assay for selenium, Method 2 under Oil- and Water-Soluble Vitamins with Minerals Tablets.
Assay for zinc— Proceed as directed in the Assay for zinc under Oil- and Water-Soluble Vitamins with Minerals Tablets, except to use 15 mL, in place of 60 mL, of hydrochloric acid when preparing the Assay preparation.
Auxiliary Information— Staff Liaison : Lawrence Evans, III, Ph.D., Scientist
Expert Committee : (DSN05) Dietary Supplements - Non-Botanicals
USP29–NF24 Page 2435
Pharmacopeial Forum : Volume No. 30(2) Page 587
Phone Number : 1-301-816-8389