Estradiol Cypionate Injection
»Estradiol Cypionate Injection is a sterile solution of Estradiol Cypionate in a suitable oil.It contains not less than 90.0percent and not more than 110.0percent of the labeled amount of C26H36O3.
Packaging and storage— Preserve in single-dose or in multiple-dose,light-resistant containers,preferably of Type Iglass.
Identification— Transfer a volume of Injection,equivalent to 5mg of estradiol cypionate,to a glass-stoppered,50-mLtest tube,and add 30mLof alcohol.Shake the mixture vigorously for 5minutes,centrifuge until the two layers have separated,and transfer the alcohol layer,with the aid of a hypodermic syringe,to a 50-mLbeaker.Evaporate on a steam bath to dryness,add 5mLof potassium hydroxide solution (1in 10),and heat on the steam bath for 15minutes.Mix 50mg of sulfanilic acid with 2mLof 3Nhydrochloric acid,warm the mixture,then cool it in ice water,and slowly add,with agitation,0.3mLof sodium nitrite solution (1in 10).Add this solution to the saponified estradiol cypionate:a red color is produced.
Other requirements— It meets the requirements under Injections á1ñ.
Assay—
Mobile Phase and Internal standard solution— Prepare as directed in the Assayunder Estradiol Cypionate.
Standard preparation— Accurately weigh about 10mg of USP Estradiol Cypionate RS,and transfer to a 100-mLvolumetric flask.Add 10.0mLof Internal standard solution,dilute with tetrahydrofuran to volume,and shake vigorously to dissolve.
Assay preparation— Using a “to contain”pipet,transfer an accurately measured volume,in mL,of Injection,equivalent to about 10mg of estradiol cypionate,to a 100-mLvolumetric flask.Rinse the pipet with small portions of tetrahydrofuran,collecting the washings in the volumetric flask.Add 10.0mLof Internal standard solution,dilute with tetrahydrofuran to volume,and mix.
Procedure— Proceed as directed for Procedurein the Assayunder Estradiol Cypionate.Calculate the quantity,in mg,of C26H36O3in each mLof the Injection taken by the formula:
(100C/V)(RU/RS),
in which Cis the concentration,in mg per mL,of USP Estradiol Cypionate RSin the Standard preparation;Vis the volume,in mL,of Injection taken;and RUand RSare the ratios of the peak responses of the estradiol cypionate and internal standard peaks obtained from the Assay preparationand the Standard preparation,respectively.
Auxiliary Information— Staff Liaison:Clydewyn M.Anthony,Ph.D.,Scientist
Expert Committee:(PA1)Pharmaceutical Analysis 1
USP28–NF23Page 775
Phone Number:1-301-816-8139