Hydrocortisone Injectable Suspension
»Hydrocortisone Injectable Suspension is a sterile suspension of Hydrocortisone in Water for Injection.It contains not less than 90.0percent and not more than 110.0percent of the labeled amount of hydrocortisone (C21H30O5).
Packaging and storage— Preserve in single-dose or in multiple-dose containers,preferably of Type Iglass.
Identification— It responds to the Identificationtest under Hydrocortisone Lotion.
Bacterial endotoxins á85ñ— It contains not more than 1.25USP Endotoxin Units per mg of hydrocortisone.
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 RS.
Assay preparation— Transfer to a separator an accurately weighed quantity of Injectable Suspension,equivalent to about 50mg of hydrocortisone,using a total of 25mLof water to effect the transfer.Extract with four 40-mLportions of chloroform,filtering each portion through chloroform-washed cotton into a 200-mLvolumetric flask.Add chloroform to volume,and mix.Pipet 20mLof this solution into a 100-mLvolumetric flask,add chloroform to volume,and mix.Pipet 10mLof the resulting solution into a glass-stoppered,100-mLconical flask,evaporate on a steam bath just to dryness,cool,and dissolve the residue in 50.0mLof alcohol.
Procedure— Proceed as directed for Procedureunder Assay for Steroids á351ñ.Calculate the quantity,in mg,of C21H30O5in the portion of Injectable Suspension taken by the formula:
5C(AU/AS).
Auxiliary Information— Staff Liaison:Clydewyn M.Anthony,Ph.D.,Scientist
Expert Committee:(PA1)Pharmaceutical Analysis 1
USP28–NF23Page 960
Phone Number:1-301-816-8139
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