Packaging and storage
Preserve in single-dose or multiple-dose containers, preferably of Type I glass, protected from light.
Identification
To a volume of the Injection equivalent to about 100 mg of folic acid add water to make about 25 mL. Adjust with hydrochloric acid to a pH of 3.0, cool to 5
, then filter, and wash the precipitate of folic acid with cold water until the last washing shows an absence of chloride. Then wash with acetone, and dry at 80
for 1 hour: the UV absorption spectrum of a 1 in 100,000 solution of the folic acid so obtained in sodium hydroxide solution (1 in 250) exhibits maxima and minima at the same wavelengths as that of a similar solution of
USP Folic Acid RS, concomitantly measured. The ratio
A256 /
A365 is between 2.80 and 3.00.
Other requirements
It meets the requirements under
Injections 1.
Assay
Mobile phase, System suitability solution, Standard preparation, and Chromatographic system
Proceed as directed in the
Assay under
Folic Acid Tablets.
Assay preparation
Dilute an accurately measured volume of Injection, quantitatively and stepwise, with an aqueous solvent containing 2 mL of ammonium hydroxide and 1 g of sodium perchlorate per 100 mL, to obtain a solution having a concentration close to that of the Standard preparation and between 0.20 and 0.80 mg per mL.
Procedure
Proceed as directed in the
Assay under
Folic Acid Tablets, and calculate the quantity, in mg, of folic acid (C
19H
19N
7O
6) in each mL of the Injection.