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.
USP Reference standards 11
USP Endotoxin RS
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.
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.
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USP35NF30 Page 3432