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
Assay method is given for a particular vitamin, 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 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.
]
Assay for ascorbic acid, Method 2—
Transfer an accurately measured volume of Oral Solution, equivalent to about 80 mg of ascorbic acid, to a conical flask. Add 50 mL of water, 100 mL of 0.1 N sulfuric acid VS, and 15.0 mL of 0.1 N iodine VS. Stir the contents for 30 seconds, add 5 mL of starch TS, and immediately titrate with 0.1 N sodium thiosulfate VS to the disappearance of the color. Each mL of 0.1 N iodine is equivalent to 8.806 mg of C6H8O6.
Assay for calcium ascorbate, Method 2—
Proceed as directed in the Assay for ascorbic acid, Method 2. Each mL of 0.1 N iodine is equivalent to 10.66 mg of C12H14CaO12·2H2O.
Assay for sodium ascorbate, Method 2—
Proceed as directed in the Assay for ascorbic acid, Method 2. Each mL of 0.1 N iodine is equivalent to 9.905 mg of C6H7NaO6.
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 equivalent 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 approximately 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.
]
