Folic Acid Injection
» Folic Acid Injection is a sterile solution of Folic Acid in Water for Injection prepared with the aid of Sodium Hydroxide or Sodium Carbonate. It contains not less than 95.0 percent and not more than 110.0 percent of the labeled amount of folic acid (C19H19N7O6).
Packaging and storage Preserve in single-dose or multiple-dose containers, preferably of Type I glass, protected from light.
USP Reference standards 11
USP Endotoxin RS
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.
Bacterial endotoxins 85 It contains not more than 357.1 USP Endotoxin Units per mg of folic acid.
pH 791: between 8.0 and 11.0.
Other requirements It meets the requirements under Injections 1.
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 (C19H19N7O6) in each mL of the Injection.
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USP35NF30 Page 3276