U.S. PHARMACOPEIA

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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.
Identification— It responds to the Identification test under Hydrocortisone Lotion.
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.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
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— Staff Liaison : Daniel K. Bempong, Ph.D., Scientist
Expert Committee : (MDPS05) Monograph Development-Pulmonary and Steroids
USP29–NF24 Page 1068
Phone Number : 1-301-816-8143