Cortisone Acetate Injectable Suspension
» Cortisone Acetate Injectable Suspension is a sterile suspension of Cortisone Acetate in a suitable aqueous medium. It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of cortisone acetate (C23H30O6).
Packaging and storage Preserve in single-dose or multiple-dose containers, preferably of Type I glass.
USP Reference standards 11
Identification Mix 25 mL of water with a volume of Injectable Suspension equivalent to about 25 mg of cortisone acetate. Centrifuge, or allow the insoluble material to settle, then decant and discard the supernatant. Add 20 mL of methanol and, using agitation and warming as necessary, dissolve the residue. Evaporate the solvent on a steam bath with the aid of a current of air, then dry the residue at 105 for 30 minutes: the residue so obtained responds to Identification test A under Cortisone Acetate.
pH 791: between 5.0 and 7.0.
Other requirements It meets the requirements under Injections 1.
Internal standard solution Prepare a solution of prednisone in Mobile phase having a concentration of 0.5 mg per mL.
Standard preparation Transfer about 12 mg of USP Cortisone Acetate RS, accurately weighed, to a stoppered, 50-mL conical flask. Add 20.0 mL of Internal standard solution, and sonicate for 5 minutes. Pass a portion through a polytef syringe filter, then combine 1 mL of the filtrate and 4 mL of Mobile phase to obtain the Standard preparation.
Resolution solution Dissolve a quantity of hydrocortisone acetate in the Standard preparation to obtain a solution containing about 0.1 mg of hydrocortisone acetate per mL.
Assay preparation Using a pipet calibrated to contain, transfer 2.0 mL of freshly mixed Injectable Suspension to a volumetric flask of a size to give a cortisone acetate concentration of 2 mg per mL when diluted to volume. Rinse the suspension remaining in the pipet into the flask with isopropyl alcohol, dilute with isopropyl alcohol to volume, and sonicate for 3 minutes. Deliver a 3.0-mL aliquot of this solution to a stoppered, 25-mL conical flask, and evaporate on a steam bath with the aid of a current of air to dryness. Add 10.0 mL of Internal standard solution, insert the stopper, and sonicate for 5 minutes. Pass a portion through a polytef syringe filter, then combine approximately 1 mL of the filtrate and 4 mL of Mobile phase to obtain the Assay preparation.
Chromatographic system (see Chromatography 621)Prepare as directed in the Assay under Cortisone Acetate Tablets. Chromatograph the Resolution solution, and record the peak responses as directed for Procedure: the resolution, R, between cortisone acetate and hydrocortisone acetate is not less than 2.2 (if necessary, add equal parts of n-butyl chloride and water-saturated n-butyl chloride to the Mobile phase to meet this requirement). Chromatograph the Standard preparation, and record the peak responses as directed for Procedure: the relative retention times are 0.6 for cortisone acetate and 1.0 for prednisone; and the relative standard deviation for replicate injections is not more than 2.0%.
Procedure Proceed as directed in the Assay under Cortisone Acetate Tablets. Calculate the quantity, in mg, of cortisone acetate (C23H30O6) in each mL of the Injectable Suspension taken by the formula:
W(V / 12)(RU / RS)in which V is the capacity, in mL, of the volumetric flask used for the Assay preparation; and the other terms are as defined therein.
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USP35NF30 Page 2775