Hydrocortisone Acetate Injectable Suspension
» Hydrocortisone Acetate Injectable Suspension is a sterile suspension of Hydrocortisone Acetate in a suitable aqueous medium. It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of total steroids, calculated as hydrocortisone acetate (C23H32O6). It may contain suitable buffers and suspending agents.
Packaging and storage— Preserve in single-dose or multiple-dose containers, preferably of Type I glass.
USP Reference standards 11
USP Hydrocortisone Acetate RS Click to View Structure
Identification— Extract a volume of Injectable Suspension, equivalent to about 50 mg of hydrocortisone acetate, with two 10-mL portions of peroxide-free ether, and discard the ether extracts. Filter with suction, wash with small portions of water, and dry at 105 for 1 hour: the hydrocortisone acetate so obtained responds to Identification test A under Hydrocortisone Acetate.
pH 791: between 5.0 and 7.0.
Other requirements— It meets the requirements under Injections 1.
Standard preparation— Prepare as directed for Standard Preparation under Assay for Steroids 351, using USP Hydrocortisone Acetate RS.
Assay preparation— Transfer to a separator an accurately measured volume of Injectable Suspension, equivalent to about 50 mg of hydrocortisone acetate, and dilute with water to about 15 mL. Extract with four 25-mL portions of chloroform, filtering each portion through chloroform-washed cotton into a 250-mL volumetric flask. Add chloroform to volume, and mix. Pipet 10 mL of this solution into a 100-mL volumetric flask, add chloroform to volume, and mix. Pipet 10 mL of the resulting solution into a glass-stoppered, 50-mL conical flask, evaporate the chloroform on a steam bath just to dryness, cool, and dissolve the residue in 20.0 mL of alcohol.
Procedure— Proceed as directed for Procedure under Assay for Steroids 351. Calculate the quantity, in mg, of hydrocortisone acetate (C23H32O6) in each mL of the Injectable Suspension taken by the formula:
5(C / V)(AU / AS)
in which V is the volume, in mL, of Injectable Suspension taken; and the other terms are as defined therein.
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Topic/Question Contact Expert Committee
Monograph Domenick Vicchio, Ph.D.
Senior Scientific Liaison
(SM42010) Monographs - Small Molecules 4
Reference Standards RS Technical Services
USP35–NF30 Page 3437