Water-Soluble Vitamins Tablets
»Water-Soluble Vitamins Tablets contain two or more of the following water-soluble vitamins:Ascorbic Acid or its equivalent as Sodium Ascorbate or Calcium 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.Tablets contain not less than 90.0percent and not more than 150.0percent of the labeled amounts of ascorbic acid (C6H8O6)or its equivalent as sodium ascorbate or calcium ascorbate,biotin (C10H16N2O3S),cyanocobalamin (C63H88CoN14O14P),folic acid (C19H19N7O6),niacin (C6H5NO2)or niacinamide (C6H6N2O),calcium pantothenate (C18H32CaN2O10),pyridoxine hydrochloride (C8H11NO3·HCl),riboflavin (C17H20N4O6),and thiamine (C12H17ClN4OS)as thiamine hydrochloride or thiamine mononitrate.
They do not contain any form of Beta Carotene or Vitamin A,D,E,or K.They do not contain any minerals for which nutritional value is claimed.They may contain other labeled added substances 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 Tablets.The label also states the quantity of each vitamin in terms of metric units per dosage unit,and where necessary,the salt form in which it is present.Where more than one Assaymethod is given for a particular vitamin,the labeling states which Assaymethod is used only if Method 1is not used.
Microbial enumeration 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— [NOTE—Use low-actinic glassware throughout this procedure.]
Diluting solution— Prepare a solution of ammonium hydroxide containing 60µg per mL.
Mobile phase— Transfer 0.4mLof triethylamine,15.0mLof glacial acetic acid,and 350mLof methanol to a 2000-mLvolumetric flask,dilute with 0.008Msodium 1-hexanesulfonate to volume,and mix.Filter,and degas.Make adjustments if necessary (see System Suitabilityunder Chromatography á621ñ).
Standard stock solution— Dissolve an accurately weighed quantity of USP Folic Acid RSin Diluting solutionto obtain a solution having a known concentration of about 60µg per mL.Prepare this solution fresh daily.
Standard preparation— Transfer 5.0mLof Standard stock solutionto a stoppered 125-mLflask.Add 10.0mLof a mixture of methanol and glacial acetic acid (9:1)and 30.0mLof a mixture of methanol and ethylene glycol (1:1).Insert the stopper,shake for 15minutes in a water bath maintained at 60,and cool.Filter,discarding the first few mLof the filtrate.
Assay preparation— Weigh and finely powder a counted number of Tablets.Transfer an accurately weighed portion of the powder,equivalent to about 0.3mg of folic acid,to a stoppered 125-mLflask.Proceed as directed for Standard preparationbeginning with “Add 10.0mL”.
Chromatographic system (see Chromatography á621ñ)— The liquid chromatograph is equipped with a 270-nm detector and a 4.6-mm ×25-cm column that contains packing L7.The column temperature is maintained at 50,and the flow rate is about 2.0mLper minute.Chromatograph the Standard preparation,and record the peak responses as directed for Procedure:the relative standard deviation for replicate injections is not more than 2.0%.
Procedure— Separately inject equal volumes (about 5µL)of the Standard preparationand the Assay preparationinto the chromatograph,record the chromatograms,and measure the areas of the major peaks.Calculate the quantity,in mg,of folic acid (C19H19N7O6)in the portion of Tablets taken by the formula:
40C(rU/rS),
in which Cis the concentration,in mg per mL,of USP Folic Acid RSin the Standard preparation;and rUand rSare the peak responses of folic acid obtained from the Assay preparationand the Standard preparation,respectively.
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.
Auxiliary Information— Staff Liaison:Lawrence Evans,III,Ph.D.,Scientist
Expert Committee:(DSN)Dietary Supplements:Non-Botanicals
USP28–NF23Page 2176
Pharmacopeial Forum:Volume No.30(2)Page 587
Phone Number:1-301-816-8389