Packaging and storage— Preserve in single-dose or multiple-dose containers.

USP Reference standards 11— USP Diethylstilbestrol Diphosphate RS. USP Endotoxin RS.

Identification— Add 1 mL of sulfuric acid to about 0.25 mL of Injection: an orange color is produced, and it disappears on dilution with 10 volumes of water.

Bacterial endotoxins 85— It contains not more than 0.7 USP Endotoxin Unit per mg of diethylstilbestrol diphosphate.

pH 791: between 9.0 and 10.5.

Free diethylstilbestrol— Transfer 2.0 mL of the Injection to a beaker containing about 20 mL of water. Add 1 N phosphoric acid to adjust to a pH of 8.0, determined potentiometrically. Proceed as directed for Procedure in the test for Free diethylstilbestrol under Diethylstilbestrol Diphosphate, beginning with “Transfer the solution to a separator.” The limit of free diethylstilbestrol is 0.2 mg per mL of Injection.

Diethylstilbestrol monophosphate— Transfer 3.0 mL of Injection to a 10-mL volumetric flask, dilute with water to volume, and mix. Transfer 1 mL of this solution to a beaker containing about 20 mL of water, and proceed as directed in the test for Diethylstilbestrol monophosphate under Diethylstilbestrol Diphosphate, beginning with “Add 1 N sodium hydroxide or 1 N phosphoric acid.” The limit of diethylstilbestrol monophosphate is 2.0 mg per mL of Injection.

Residual solvents 467: meets the requirements.

Other requirements— It meets the requirements under Injections 1.

Assay— Transfer an accurately measured volume of Injection, equivalent to about 150 mg of diethylstilbestrol diphosphate, to a 200-mL volumetric flask, add water to volume, and mix. Transfer 5.0 mL of this solution to a 250-mL volumetric flask, and dilute with water to volume, and mix. Concomitantly determine the absorbances of this solution and a Standard solution of USP Diethylstilbestrol Diphosphate RS having a known concentration of about 15 µg per mL, and containing 1 mL of 0.02 N sodium hydroxide per 100 mL of solution, in 1-cm cells at the wavelength of maximum absorbance at about 241 nm, with a suitable spectrophotometer, using water containing 0.5 mL of 0.02 N sodium hydroxide per 100 mL, as the blank. Calculate the quantity, in mg, of diethylstilbestrol diphosphate (C18H22O8P2) in each mL of the Injection taken by the formula: in which C is the concentration, in µg per mL, of USP Diethylstilbestrol Diphosphate RS in the Standard solution, and AU and AS are the absorbances of the solution from the Injection and the Standard solution, respectively.

Expert Committee : (MDPS05) Monograph Development-Pulmonary and Steroids

USP29–NF24 Page 695

Phone Number : 1-301-816-8143