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 90.0percent and not more than 110.0percent 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 Iglass.
Identification— Extract a volume of Injectable Suspension,equivalent to about 50mg of hydrocortisone acetate,with two 10-mLportions of peroxide-free ether,and discard the ether extracts.Filter with suction,wash with small portions of water,and dry at 105for 1hour:the hydrocortisone acetate so obtained responds to Identificationtest Aunder Hydrocortisone Acetate.
pHá791ñ: between 5.0and 7.0.
Other requirements— It meets the requirements under Injections á1ñ.
Assay—
Standard preparation— Prepare as directed for Standard Preparationunder Assay for Steroids á351ñ,using USP Hydrocortisone Acetate RS.
Assay preparation— Transfer to a separator an accurately measured volume of Injectable Suspension,equivalent to about 50mg of hydrocortisone acetate,and dilute with water to about 15mL.Extract with four 25-mLportions of chloroform,filtering each portion through chloroform-washed cotton into a 250-mLvolumetric flask.Add chloroform to volume,and mix.Pipet 10mLof this solution into a 100-mLvolumetric flask,add chloroform to volume,and mix.Pipet 10mLof the resulting solution into a glass-stoppered,50-mLconical flask,evaporate the chloroform on a steam bath just to dryness,cool,and dissolve the residue in 20.0mLof alcohol.
Procedure— Proceed as directed for Procedureunder Assay for Steroids á351ñ.Calculate the quantity,in mg,of hydrocortisone acetate (C23H32O6)in each mLof the Injectable Suspension taken by the formula:
5(C/V)(AU/AS),
in which Vis the volume,in mL,of Injectable Suspension taken;and the other terms are as defined therein.
Auxiliary Information— Staff Liaison:Clydewyn M.Anthony,Ph.D.,Scientist
Expert Committee:(PA1)Pharmaceutical Analysis 1
USP28–NF23Page 964
Phone Number:1-301-816-8139
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