Oil-and Water-Soluble Vitamins Oral Solution
»Oil-and Water-Soluble Vitamins Oral Solution contains one or more of the following oil-soluble vitamins:Vitamin A,Vitamin Das Ergocalciferol (Vitamin D2)or Cholecalciferol (Vitamin D3),and Vitamin E;and 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 not less than 90.0percent and not more than 250.0percent 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 Das cholecalciferol (C27H44O)or ergocalciferol (C28H44O),vitamin Eas 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;not less than 90.0percent and not more than 150.0percent of the labeled amounts of niacin (C6H5NO2)or niacinamide (C6H6N2O),dexpanthenol (C9H19NO4)or panthenol (C9H19NO4),calcium pantothenate (C18H32CaN2O10),pyridoxine hydrochloride (C8H11NO3·HCl),and riboflavin (C17H20N4O6)or riboflavin-5¢-phosphate sodium (C17H20N4NaO9P);and not less than 90.0percent and not more than 450.0percent of the labeled amount of cyanocobalamin (C63H88CoN14O14P).
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 Oil-and Water-Soluble Vitamins Oral Solution.The label states the quantity of each vitamin present in a given volume of Oral Solution and,where necessary,the chemical form in which a vitamin is present.Where the product contains vitamin E,the label indicates whether it is the d-or dl-form.Where the product is labeled to contain panthenol,the label states the equivalent content of dexpanthenol.Where more than one Assaymethod is given for a particular vitamin,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 Iá611ñ(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 vitamin A— Proceed as directed in the Assay for vitamin Aunder Oil-and Water-Soluble Vitamins with Minerals Oral Solution.
Assay for cholecalciferol or ergocalciferol (vitamin D)— [NOTE—Where vitamin D(ergocalciferol or cholecalciferol)is specified in the following procedure,use the chemical form present in the formulation and the relevant USP Reference Standard.Use low-actinic glassware throughout this procedure.]
Diluting solution and Mobile phase— Prepare as directed in the Assay for vitamin Aunder Oil-and Water-Soluble Vitamins with Minerals Oral Solution.
Standard preparation,Assay preparation,Chromatographic system,and Procedure— Proceed as directed in the Assay for cholecalciferol or ergocalciferol(vitamin D)under Oil-and Water-Soluble Vitamins with Minerals Oral Solution.
Assay for vitamin E— Proceed as directed in the Assay for vitamin Eunder Oil-and Water-Soluble Vitamins with Minerals Oral Solution.
Assay for ascorbic acid,Method 1— Proceed as directed in the Assay for Ascorbic Acidunder Automated Methods of Analysis á16ñ.
Assay for ascorbic acid,Method 2— Transfer an accurately measured volume of Oral Solution,equivalent to about 80mg of ascorbic acid,to a conical flask.Add 50mLof water,100mLof 0.1Nsulfuric acid VS,and 15.0mLof 0.1Niodine VS.Stir the contents for 30seconds,add 5mLof starch TS,and immediately titrate with 0.1Nsodium thiosulfate VSto the disappearance of the color.Each mLof 0.1Niodine is equivalent to 8.806mg of C6H8O6.
Assay for calcium ascorbate,Method 1— Proceed as directed in the Assay for Ascorbic Acidunder Automated Methods of Analysis á16ñ.
Assay for calcium ascorbate,Method 2— Proceed as directed in the Assay for ascorbic acid,Method 2.Each mLof 0.1Niodine is equivalent to 10.66mg of C12H14CaO12·2H2O.
Assay for sodium ascorbate,Method 1— Proceed as directed in the Assay for Ascorbic Acidunder Automated Methods of Analysis á16ñ.
Assay for sodium ascorbate,Method 2— Proceed as directed in the Assay for ascorbic acid,Method 2.Each mLof 0.1Niodine is equivalent to 9.905mg of C6H7NaO6.
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 equivalent 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 approximately 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.
*  For information on USP Units of activity for vitamins and labeling in terms of units,see the footnote to the Labelingsection under Oil-and Water-Soluble Vitamins with Minerals Tablets.
Auxiliary Information— Staff Liaison:Lawrence Evans,III,Ph.D.,Scientist
Expert Committee:(DSN)Dietary Supplements:Non-Botanicals
USP28–NF23Page 2142
Pharmacopeial Forum:Volume No.27(1)Page 1935
Phone Number:1-301-816-8389