Water-Soluble Vitamins with Minerals Oral Solution
»Water-Soluble Vitamins with Minerals Oral Solution contains one or more of the following water-soluble vitamins: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;and one or more minerals derived from substances generally recognized as safe,furnishing one or more of the following elements in ionizable form:iodine,iron,magnesium,manganese,and zinc.It contains not less than 90.0percent and not more than 450.0percent of the labeled amount of cyanocobalamin (C63H88CoN14O14P);not less than 90.0percent and not more than 250.0percent of the labeled amount of thiamine (C12H17ClN4OS)as thiamine hydrochloride or thiamine mononitrate;not less than 90.0percent and not more than 150.0percent 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 not less than 90.0percent and not more than 125.0percent of the labeled amounts of iodine (I),iron (Fe),magnesium (Mg),manganese (Mn),and zinc (Zn).
Packaging and storage— Preserve in tight,light-resistant containers,under an inert gas or with a minimum of headspace.
Labeling— The label states that the product is Water-Soluble Vitamins with Minerals Oral Solution.The label states the quantity of each vitamin and mineral present in terms of metric units in a given volume of the Oral Solution 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 products are labeled to contain panthenol,the label states the equivalent content of dexpanthenol.Where more than one Assaymethod is given for a particular vitamin or mineral,the labeling states with which Assaymethod the product complies only if Method 1is not used.
Microbial enumeration á2021ñ— The total aerobic microbial count does not exceed 3000cfu per mL,and the combined molds and yeasts count does not exceed 300cfu per mL.The Oral Solution also meets the requirements of the tests for absence of Salmonellaspecies,Escherichia coli,and Staphylococcus aureus.
Alcohol content,Method 1á611ñ(if present): between 90.0%and 120.0%of the labeled amount of C2H5OHis found.
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 cyanocobalamin— Proceed as directed in the Assay for cyanocobalamin,Method 2under Oil-and Water-Soluble Vitamins with Minerals Tablets,except to read Oral Solution in place of Tablets and to use the following Assay preparation.
Assay preparation— Transfer an accurately measured volume of Oral Solution,equivalent to about 1.0µg of cyanocobalamin,to an appropriate vessel containing,for each mLof Oral Solution taken,25mLof an aqueous extracting solution prepared just prior to use to contain,in each 100mL,1.29g of dibasic sodium phosphate,1.1g of anhydrous citric acid,and 1.0g of sodium metabisulfite.Autoclave the mixture at 121for 10minutes.Allow any undissolved particles to settle,and filter or centrifuge if necessary.Dilute an aliquot of the clear solution with water to obtain a final solution containing vitamin B12activity approximately equal to that of the Standard preparation.
Assay for calcium pantothenate,Method 1— Proceed as directed in the Assay for calcium pantothenate,Method 1under Oil-and Water-Soluble Vitamins with Minerals Oral Solution.
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,except to read Oral Solution in place of Tablets and to use the following Assay preparation.
Assay preparation— Transfer an accurately measured volume of Oral Solution,equivalent to about 50mg of calcium pantothenate,to a 1000-mLvolumetric flask containing 500mLof water.Add 10mLof 0.2Nacetic acid and 100mLof sodium acetate solution (1in 60),dilute with water to volume,and filter.Dilute an accurately measured volume of this solution quantitatively,and stepwise if necessary,with water to obtain a solution having about the same concentration as that of the Standard preparation.
Assay for dexpanthenol or panthenol,Method 1—
Dilute phosphoric acid,Mobile phase,and Chromatographic system— Proceed as directed in the Assay for calcium pantothenate,Method 1under Oil-and Water-Soluble Vitamins with Minerals Oral Solution.
Standard preparation,System suitability solution,Assay preparation,and Procedure— Proceed as directed in the Assay for dexpanthenol or panthenol,Method 1under Oil-and Water-Soluble Vitamins with Minerals Oral Solution.
Assay for dexpanthenol or panthenol,Method 2— Proceed as directed in the Assay for dexpanthenol or panthenolunder Water-Soluble Vitamins Capsules,except to read Oral Solution in place of Capsules and to use the following Assay preparation.
Assay preparation— Transfer an accurately measured volume of Oral Solution,equivalent to about 1.2mg of dexpanthenol or 2.4mg of panthenol,to a 100-mLvolumetric flask,dissolve in and dilute with water to volume,and mix.Dilute a portion of this solution quantitatively,and stepwise if necessary,with water to obtain a solution having a concentration of about 1.2µg of dexpanthenol (or 2.4µg of panthenol)per mL.
Assay for niacin or niacinamide— Proceed as directed in the Assay for niacin or niacinamideunder Oil-and Water-Soluble Vitamins with Minerals Oral Solution.
Assay for pyridoxine hydrochloride—
Diluting solution,Mobile phase,and Chromatographic system— Proceed as directed in the Assay for niacin or niacinamideunder Oil-and Water-Soluble Vitamins with Minerals Oral Solution.
Standard preparation,Assay preparation,and Procedure— Proceed as directed in the Assay for pyridoxine hydrochlorideunder Oil-and Water-Soluble Vitamins with Minerals Oral Solution.
Assay for riboflavin or riboflavin-5¢-phosphate sodium,Method 1— [NOTE—Riboflavin-5¢-phosphate sodium is quantitated against USP Riboflavin RSin this procedure.In the chromatogram of the Assay preparation,the riboflavin-5¢-phosphate peak is the only peak measured for calculation.]
Diluting solution,Mobile phase,and Chromatographic system— Proceed as directed in the Assay for niacin or niacinamideunder Oil-and Water-Soluble Vitamins with Minerals Oral Solution.
Standard preparation,Assay preparation,and Procedure— Proceed as directed in the Assay for riboflavin or riboflavin-5¢-phosphate sodium,Method 1under Oil-and Water-Soluble Vitamins with Minerals Oral Solution.
Assay for riboflavin or riboflavin-5¢-phosphate sodium,Method 2— Proceed as directed in the Assay for riboflavin or riboflavin-5¢-phosphate sodium,Method 2under Oil-and Water-Soluble Vitamins with Minerals Oral Solution.
Assay for thiamine—
Diluting solution,Mobile phase,and Chromatographic system— Proceed as directed in the Assay for niacin or niacinamideunder Oil-and Water-Soluble Vitamins with Minerals Oral Solution.
Standard preparation,Assay preparation,and Procedure— Proceed as directed in the Assay for thiamineunder Oil-and Water-Soluble Vitamins with Minerals Oral Solution.
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 yield solutions of suitable concentrations adaptable to the linear or working range of the instrument.
Assay for iodide,Method 1— Proceed as directed in the Assay for iodide,Method 1under Oil-and Water-Soluble Vitamins with Minerals Oral Solution.
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 Oral Solution.
Assay for magnesium— Proceed as directed in the Assay for magnesiumunder Oil-and Water-Soluble Vitamins with Minerals Oral Solution.
Assay for manganese— Proceed as directed in the Assay for manganeseunder Oil-and Water-Soluble Vitamins with Minerals Oral Solution.
Assay for zinc— Proceed as directed in the Assay for zincunder Oil-and Water-Soluble Vitamins with Minerals Oral Solution.
Auxiliary Information— Staff Liaison:Lawrence Evans,III,Ph.D.,Scientist
Expert Committee:(DSN)Dietary Supplements:Non-Botanicals
USP28–NF23Page 2181
Pharmacopeial Forum:Volume No.27(1)Page 2012
Phone Number:1-301-816-8389