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 95.0percent and not more than 110.0percent of the labeled amount of folic acid (C19H19N7O6).
Packaging and storage— Preserve in single-dose or multiple-dose containers,preferably of Type Iglass,protected from light.
Identification— To a volume of the Injection equivalent to about 100mg of folic acid add water to make about 25mL.Adjust with hydrochloric acid to a pHof 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 80for 1hour:the UVabsorption spectrum of a 1in 100,000solution of the folic acid so obtained in sodium hydroxide solution (1in 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/A365is between 2.80and 3.00.
Bacterial endotoxins á85ñ— It contains not more than 357.1USP Endotoxin Units per mg of folic acid.
pHá791ñ: between 8.0and 11.0.
Other requirements— It meets the requirements under Injections á1ñ.
Assay—
Mobile phase,System suitability solution,Standard preparation,and Chromatographic system— Proceed as directed in the Assayunder Folic Acid Tablets.
Assay preparation— Dilute an accurately measured volume of Injection,quantitatively and stepwise,with an aqueous solvent containing 2mLof ammonium hydroxide and 1g of sodium perchlorate per 100mL,to obtain a solution having a concentration close to that of the Standard preparationand between 0.20and 0.80mg per mL.
Procedure— Proceed as directed in the Assayunder Folic Acid Tablets,and calculate the quantity,in mg,of folic acid (C19H19N7O6)in each mLof the Injection.
Auxiliary Information— Staff Liaison:Lawrence Evans,III,Ph.D.,Scientist
Expert Committee:(DSN)Dietary Supplements:Non-Botanicals
USP28–NF23Page 870
Phone Number:1-301-816-8389