Estradiol Pellets
»Estradiol Pellets are sterile pellets composed of Estradiol in compressed form,without the presence of any binder,diluent,or excipient.They contain not less than 97.0percent and not more than 103.0percent of C18H24O2.
Packaging and storage— Preserve in tight containers,suitable for maintaining sterile contents,that hold 1Pellet each.
Solubility in chloroform— Asolution of 25mg of Pellets in 10mLof chloroform is clear and practically free from insoluble residue.
Weight variation— Weigh 5Pellets singly,and calculate the average weight.The average weight is between 95%and 105%of the labeled weight of C18H24O2,and each Pellet weighs between 90%and 110%of the labeled weight of C18H24O2.
Other requirements— Pellets meet the requirements under Estradioland under Sterility Tests á71ñ.
Assay—
Standard preparation— Prepare as directed in the Assayunder Estradiol Sterile Suspension.
Assay preparation— Weigh and finely powder not less than 10Pellets.Transfer a portion of the powder,equivalent to about 100mg of estradiol,to a suitable container,dissolve in a sufficient quantity of a mixture of equal volumes of alcohol and chloroform to make 5.0mL,and mix.
Procedure— Proceed as directed for Procedurein the Assayunder Estradiol Sterile Suspension.Calculate the quantity,in mg,of C18H24O2in the portion of Pellets taken by the formula:
5C(AU/AS),
in which all terms are as defined therein.
Auxiliary Information— Staff Liaison:Clydewyn M.Anthony,Ph.D.,Scientist
Expert Committee:(PA1)Pharmaceutical Analysis 1
USP28–NF23Page 773
Phone Number:1-301-816-8139