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 Assay method is given for a particular vitamin, the labeling states which Assay method is used only if Method 1 is not used.
Microbial enumeration 
2021
—
The total aerobic microbial count does not exceed 3000 cfu per g, and the combined molds and yeasts count does not exceed 300 cfu per g. Tablets also meet 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 folic acid, Method 2—
[NOTE—Use low-actinic glassware throughout this procedure.
]
Diluting solution—
Prepare a solution of ammonium hydroxide containing 60 µg per mL.
Mobile phase—
Transfer 0.4 mL of triethylamine, 15.0 mL of glacial acetic acid, and 350 mL of methanol to a 2000-mL volumetric flask, dilute with 0.008 M sodium 1-hexanesulfonate to volume, and mix. Filter, and degas. Make adjustments if necessary (see
System Suitability under
Chromatography 621).
Standard stock solution—
Dissolve an accurately weighed quantity of
USP Folic Acid RS in
Diluting solution to obtain a solution having a known concentration of about 60 µg per mL. Prepare this solution fresh daily.
Standard preparation—
Transfer 5.0 mL of
Standard stock solution to a stoppered 125-mL flask. Add 10.0 mL of a mixture of methanol and glacial acetic acid (9:1) and 30.0 mL of a mixture of methanol and ethylene glycol (1:1). Insert the stopper, shake for 15 minutes in a water bath maintained at 60
, and cool. Filter, discarding the first few mL of the filtrate.
Assay preparation—
Weigh and finely powder a counted number of Tablets. Transfer an accurately weighed portion of the powder, equivalent to about 0.3 mg of folic acid, to a stoppered 125-mL flask. Proceed as directed for Standard preparation beginning with “Add 10.0 mL”.
Chromatographic system (see Chromatography 621)—
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 2.0 mL per 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 5 µL) of the
Standard preparation and the
Assay preparation into the chromatograph, record the chromatograms, and measure the areas of the major peaks. Calculate the quantity, in mg, of folic acid (C
19H
19N
7O
6) in the portion of Tablets taken by the formula:
40C(rU / rS),
in which
C is the concentration, in mg per mL, of
USP Folic Acid RS in the
Standard preparation; and
rU and rS are the peak responses of folic acid obtained from the
Assay preparation and the
Standard preparation, respectively.
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 1 under
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 3 under
Oil- and Water-Soluble Vitamins with Minerals Tablets.
Auxiliary Information—
Staff Liaison :
Lawrence Evans, III, Ph.D., Scientist
Expert Committee : (DSN05) Dietary Supplements - Non-Botanicals
USP29–NF24 Page 2429
Pharmacopeial Forum : Volume No. 30(2) Page 587
Phone Number : 1-301-816-8389
