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 Assay method is given for a particular vitamin or mineral, the labeling states with which Assay method the product complies only if Method 1 is not used.
Microbial enumeration 
2021
—
The total aerobic microbial count does not exceed 3000 cfu per mL, and the combined molds and yeasts count does not exceed 300 cfu per mL. The Oral Solution also meets the requirements of the tests for absence of
Salmonella species,
Escherichia coli, and
Staphylococcus aureus.
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 cyanocobalamin—
Proceed as directed in the
Assay for cyanocobalamin,
Method 2 under
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 1.0 µg of cyanocobalamin, to an appropriate vessel containing, for each mL of Oral Solution taken, 25 mL of an aqueous extracting solution prepared just prior to use to contain, in each 100 mL, 1.29 g of dibasic sodium phosphate, 1.1 g of anhydrous citric acid, and 1.0 g of sodium metabisulfite. Autoclave the mixture at 121
for 10 minutes. 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 B
12 activity approximately equal to that of the
Standard preparation.
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, 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 50 mg of calcium pantothenate, to a 1000-mL volumetric flask containing 500 mL of water. Add 10 mL of 0.2 N acetic acid and 100 mL of sodium acetate solution (1 in 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—
Assay for dexpanthenol or panthenol, Method 2—
Proceed as directed in the
Assay for dexpanthenol or panthenol under
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 1.2 mg of dexpanthenol or 2.4 mg of panthenol, to a 100-mL volumetric 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 1.2 µg of dexpanthenol (or 2.4 µg of panthenol) per mL.
Assay for pyridoxine hydrochloride—
Assay for riboflavin or riboflavin-5¢-phosphate sodium, Method 1—
[NOTE—Riboflavin-5
¢-phosphate sodium is quantitated against
USP Riboflavin RS in this procedure. In the chromatogram of the
Assay preparation, the riboflavin-5
¢-phosphate peak is the only peak measured for calculation.
]
Assay for thiamine—
Standard preparation, Assay preparation, and Procedure—
Proceed as directed in the
Assay for thiamine under
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 preparations and the Assay preparation may 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.
Auxiliary Information—
Staff Liaison :
Lawrence Evans, III, Ph.D., Scientist
Expert Committee : (DSN05) Dietary Supplements - Non-Botanicals
USP29–NF24 Page 2434
Pharmacopeial Forum : Volume No. 27(1) Page 2012
Phone Number : 1-301-816-8389
