Packaging and storage— Preserve in single-dose or multiple-dose containers, preferably of Type I glass.

USP Reference standards 11— USP Endotoxin RS. USP Testosterone RS.

Identification— The testosterone obtained by filtration and washing, as directed in the Assay, and dried at 105 to constant weight, meets the requirements for Identification tests A and B under Testosterone.

Bacterial endotoxins 85— It contains not more than 3.5 USP Endotoxin Units per mg of testosterone.

Uniformity of dosage units 905: meets the requirements.

pH 791: between 4.0 and 7.5.

Residual solvents 467: meets the requirements.

Other requirements— It meets the requirements under Injections 1.

Assay— Transfer an accurately measured volume of previously well-mixed Injectable Suspension, equivalent to about 100 mg of testosterone, to a fine-porosity, sintered-glass filtering crucible, previously dried at 105 for 1 hour, and filter with suction. If the filtrate is not clear, again pass it through the same filter into a second receiver. Wash the residue in the filter with several 5-mL portions of water until 2 mL of the last washing, when evaporated on a steam bath, leaves a negligible residue. [NOTE—If the Injectable Suspension is passed through the filter twice, rinse the first receiver with the portions of water before passing them through the filter.] Dry the crucible and the collected testosterone at 105 for 1 hour. Completely dissolve the testosterone with five 25-mL portions of methanol, passing each portion through the crucible under gentle suction, and transfer the combined methanol solution to a 200-mL volumetric flask. Rinse the crucible and receiver with two 25-mL portions of methanol, add the rinsings to the main solution, dilute with methanol to volume, and mix. Transfer 5.0 mL of this solution to a 250-mL volumetric flask, dilute with methanol to volume, and mix. Concomitantly determine the absorbances of this solution and a Standard solution of USP Testosterone RS, in the same medium having a known concentration of about 10 µg per mL in 1-cm cells at the wavelength of maximum absorbance at about 241 nm, with a suitable spectrophotometer, using methanol as the blank. Calculate the quantity, in mg, of C19H28O2 in each mL of the Injectable Suspension taken by the formula: in which C is the concentration, in µg per mL, of USP Testosterone RS in the Standard solution, V is the volume, in mL, of Injectable Suspension taken, and AU and AS are the absorbances of the solution from the Injectable Suspension and the Standard solution, respectively.

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

USP29–NF24 Page 2087

Phone Number : 1-301-816-8143