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 97.0 percent and not more than 103.0 percent of C18H24O2.
Packaging and storage— Preserve in tight containers, suitable for maintaining sterile contents, that hold 1 Pellet each.
Solubility in chloroform— A solution of 25 mg of Pellets in 10 mL of chloroform is clear and practically free from insoluble residue.
Weight variation— Weigh 5 Pellets 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 Estradiol and under Sterility Tests 71.
Assay—
Standard preparation— Prepare as directed in the Assay under Estradiol Sterile Suspension.
Assay preparation— Weigh and finely powder not less than 10 Pellets. Transfer a portion of the powder, equivalent to about 100 mg of estradiol, to a suitable container, dissolve in a sufficient quantity of a mixture of equal volumes of alcohol and chloroform to make 5.0 mL, and mix.
Procedure— Proceed as directed for Procedure in the Assay under Estradiol Sterile Suspension. Calculate the quantity, in mg, of C18H24O2 in the portion of Pellets taken by the formula:
5C(AU / AS)
in which all terms are as defined therein.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Daniel K. Bempong, Ph.D.
Senior Scientist
1-301-816-8143		 (MDPS05) Monograph Development-Pulmonary and Steroids
Reference Standards Lili Wang, Technical Services Scientist
1-301-816-8129
RSTech@usp.org
USP32–NF27 Page 2302