Packaging and storage
Preserve in tight, light-resistant containers.
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.
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
Use low-actinic glassware throughout this procedure.]
Prepare a solution of ammonium hydroxide containing 60 µg per mL.
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.
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.
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%.
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 (C19
) 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,
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
: Lawrence Evans, III, Ph.D., Scientist
Expert Committee : (DSN05) Dietary Supplements - Non-Botanicals
USP29NF24 Page 2429
: Volume No. 30(2) Page 587
Phone Number : 1-301-816-8389