Diethylstilbestrol Diphosphate Injection
»Diethylstilbestrol Diphosphate Injection is a sterile,buffered solution of Diethylstilbestrol Diphosphate.It contains not less than 45.0mg and not more than 55.0mg of C18H22O8P2in each mL.
Packaging and storage— Preserve in single-dose or in multiple-dose containers.
Identification— Add 1mLof sulfuric acid to about 0.25mLof Injection:an orange color is produced,and it disappears on dilution with 10volumes of water.
Bacterial endotoxins á85ñ— It contains not more than 0.7USP Endotoxin Unit per mg of diethylstilbestrol diphosphate.
pHá791ñ: between 9.0and 10.5.
Free diethylstilbestrol— Transfer 2.0mLof the Injection to a beaker containing about 20mLof water.Add 1Nphosphoric acid to adjust to a pHof 8.0,determined potentiometrically.Proceed as directed for Procedurein the test for Free diethylstilbestrolunder Diethylstilbestrol Diphosphate,beginning with “Transfer the solution to a separator.”The limit of free diethylstilbestrol is 0.2mg per mLof Injection.
Diethylstilbestrol monophosphate— Transfer 3.0mLof Injection to a 10-mLvolumetric flask,dilute with water to volume,and mix.Transfer 1mLof this solution to a beaker containing about 20mLof water,and proceed as directed in the test for Diethylstilbestrol monophosphateunder Diethylstilbestrol Diphosphate,beginning with “Add 1Nsodium hydroxide or 1Nphosphoric acid.”The limit of diethylstilbestrol monophosphate is 2.0mg per mLof Injection.
Other requirements— It meets the requirements under Injections á1ñ.
Assay— Transfer an accurately measured volume of Injection,equivalent to about 150mg of diethylstilbestrol diphosphate,to a 200-mLvolumetric flask,add water to volume,and mix.Transfer 5.0mLof this solution to a 250-mLvolumetric flask,and dilute with water to volume,and mix.Concomitantly determine the absorbances of this solution and a Standard solution of USP Diethylstilbestrol Diphosphate RShaving a known concentration of about 15µg per mL,and containing 1mLof 0.02Nsodium hydroxide per 100mLof solution,in 1-cm cells at the wavelength of maximum absorbance at about 241nm,with a suitable spectrophotometer,using water containing 0.5mLof 0.02Nsodium hydroxide per 100mL,as the blank.Calculate the quantity,in mg,of diethylstilbestrol diphosphate (C18H22O8P2)in each mLof the Injection taken by the formula:
3.33C(AU/AS),
in which Cis the concentration,in µg per mL,of USP Diethylstilbestrol Diphosphate RSin the Standard solution,and AUand ASare the absorbances of the solution from the Injection and the Standard solution,respectively.
Auxiliary Information— Staff Liaison:Clydewyn M.Anthony,Ph.D.,Scientist
Expert Committee:(PA1)Pharmaceutical Analysis 1
USP28–NF23Page 637
Phone Number:1-301-816-8139