Hydrocortisone Injectable Suspension
» Hydrocortisone Injectable Suspension is a sterile suspension of Hydrocortisone in Water for Injection. It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of hydrocortisone (C21H30O5).
Packaging and storage
Preserve in single-dose or in multiple-dose containers, preferably of Type I glass.
Bacterial endotoxins 85
It contains not more than 1.25 USP Endotoxin Units per mg of hydrocortisone.
pH 791:
between 5.0 and 7.0.
Other requirements
It meets the requirements under Injections 1.
Assay
Standard preparation
Prepare as directed for Standard Preparation under Assay for Steroids 351, using USP Hydrocortisone RS.
Assay preparation
Transfer to a separator an accurately weighed quantity of Injectable Suspension, equivalent to about 50 mg of hydrocortisone, using a total of 25 mL of water to effect the transfer. Extract with four 40-mL portions of chloroform, filtering each portion through chloroform-washed cotton into a 200-mL volumetric flask. Add chloroform to volume, and mix. Pipet 20 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, 100-mL conical flask, evaporate on a steam bath just to dryness, cool, and dissolve the residue in 50.0 mL of alcohol.
Procedure
Proceed as directed for Procedure under Assay for Steroids 351. Calculate the quantity, in mg, of C21H30O5 in the portion of Injectable Suspension taken by the formula:
5C(AU / AS).
Auxiliary Information
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USP32NF27 Page 2575
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