Edition: BP 2025 (Ph. Eur. 11.6 update)
Action and use
Androgen.
DEFINITION
Testosterone Propionate Injection is a sterile solution of Testosterone Propionate in Ethyl Oleate or other suitable ester, in a suitable fixed oil or in any mixture of these.
The injection complies with the requirements stated under Parenteral Preparations and with the following requirements.
Content of testosterone propionate, C22H32O3
92.5 to 107.5% of the stated amount.
IDENTIFICATION
Dissolve a volume containing 50 mg of Testosterone Propionate in 8 mL of petroleum spirit (boiling range, 40° to 60°) and extract with three 8-mL quantities of a mixture of 7 volumes of glacial acetic acid and 3 volumes of water. Wash the combined extracts with 10 mL of petroleum spirit (boiling range, 40° to 60°), dilute with water until the solution becomes turbid, allow to stand for 2 hours in ice and filter. The precipitate, after washing with water and drying at 105°, complies with the following tests.
A. The infrared absorption spectrum, Appendix II A, is concordant with the reference spectrum of testosterone propionate (RS 332).
B. Complies with the test for identification of steroids, Appendix III A, using impregnating solvent III and mobile phase F.
ASSAY
To a volume containing 0.1 g of Testosterone Propionate add sufficient chloroform to produce 100 mL. Dilute 3 mL to 50 mL with chloroform and to 5 mL of the solution add 10 mL of isoniazid solution and sufficient methanol to produce 20 mL. Allow to stand for 45 minutes and measure the absorbance of the resulting solution at the maximum at 380 nm, Appendix II B, using in the reference cell a solution prepared by treating 5 mL of chloroform in the same manner. Calculate the content of C22H32O3 from the absorbance obtained by repeating the operation using a 0.006% w/v solution of testosterone propionate BPCRS in chloroform, beginning at the words ‘to 5 mL…’ and using the declared content of C22H32O3 in testosterone propionate BPCRS.
STORAGE
Testosterone Propionate Injection should be protected from light.
LABELLING
The label states that the preparation is intended for intramuscular injection only.
