Cortisone Acetate Injectable Suspension, chemical structure, molecular formula, Reference Standards

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 90.0percent and not more than 110.0percent of the labeled amount of cortisone acetate (C23H30O6).

Packaging and storage— Preserve in single-dose or multiple-dose containers,preferably of Type Iglass.

USP Reference standards á11ñ— USP Cortisone Acetate RS.

Identification— Mix 25mLof water with a volume of Injectable Suspension equivalent to about 25mg of cortisone acetate.Centrifuge,or allow the insoluble material to settle,then decant and discard the supernatant.Add 20mLof 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 30minutes:the residue so obtained responds to Identificationtest Aunder Cortisone Acetate.

pHá791ñ: between 5.0and 7.0.

Other requirements— It meets the requirements under Injections á1ñ.

Assay—

Mobile phase— Prepare as directed in the Assay under Cortisone Acetate Tablets.

Internal standard solution— Prepare a solution of prednisone in Mobile phasehaving a concentration of 0.5mg per mL.

Standard preparation— Transfer about 12mg of USP Cortisone Acetate RS,accurately weighed,to a stoppered,50-mLconical flask.Add 20.0mLof Internal standard solution,and sonicate for 5minutes.Pass a portion through a polytef syringe filter,then combine 1mLof the filtrate and 4mLof Mobile phaseto obtain the Standard preparation.

Resolution solution— Dissolve a quantity of hydrocortisone acetate in the Standard preparationto obtain a solution containing about 0.1mg of hydrocortisone acetate per mL.

Assay preparation— Using a pipet calibrated “to contain,”transfer 2.0mLof freshly mixed Injectable Suspension to a volumetric flask of a size to give a cortisone acetate concentration of 2mg per mLwhen 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 3minutes.Deliver a 3.0-mLaliquot of this solution to a stoppered,25-mLconical flask,and evaporate on a steam bath with the aid of a current of air to dryness.Add 10.0mLof Internal standard solution,insert the stopper,and sonicate for 5minutes.Pass a portion through a polytef syringe filter,then combine approximately 1mLof the filtrate and 4mLof Mobile phaseto obtain the Assay preparation.

Chromatographic system (see Chromatography á621ñ)—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 phaseto meet this requirement).Chromatograph the Standard preparation,and record the peak responses as directed for Procedure:the relative retention times are 0.6for cortisone acetate and 1.0for 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 mLof the Injectable Suspension taken by the formula:

W(V/12)(RU/RS),

in which Vis the capacity,in mL,of the volumetric flask used for the Assay preparation;and the other terms are as defined therein.

Auxiliary Information— Staff Liaison:Clydewyn M.Anthony,Ph.D.,Scientist

Expert Committee:(PA1)Pharmaceutical Analysis 1

USP28–NF23Page 547

Phone Number:1-301-816-8139