Testosterone Propionate, chemical structure, molecular formula, Reference Standards

Testosterone Propionate

C22H32O3 344.49

Androst-4-en-3-one,17-(1-oxopropoxy)-,(17b)-.
Testosterone propionate [57-85-2].

»Testosterone Propionate contains not less than 97.0percent and not more than 103.0percent of C22H32O3,calculated on the dried basis.

Packaging and storage— Preserve in well-closed,light-resistant containers.

USP Reference standards á11ñ— USP Testosterone Propionate RS.

Identification—

A: Infrared Absorption á197Kñ.

B: Ultraviolet Absorption á197Uñ—

Solution: 10µg per mL.

Medium: alcohol.

Absorptivities at 241nm,calculated on the dried basis,do not differ by more than 3.0%.

C: It responds to Identificationtest Cunder Testosterone Enanthate.

Melting range á741ñ: between 118

and 123

Specific rotation á781Sñ: between +83

and +90

Test solution: 20mg,previously dried,per mL,in dioxane.

Loss on drying á731ñ— Dry it in vacuum over silica gel for 4hours:it loses not more than 0.5%of its weight.

Organic volatile impurities,Method IVá467ñ: meets the requirements.

Assay— Proceed with Testosterone Propionate as directed in the Assayunder Testosterone Enanthate,except to use USP Testosterone Propionate RSand otherwise substitute Testosterone Propionate throughout.Calculate the quantity,in mg,of C22H32O3in the Testosterone Propionate taken by the formula given therein.

Auxiliary Information— Staff Liaison:Clydewyn M.Anthony,Ph.D.,Scientist

Expert Committee:(PA1)Pharmaceutical Analysis 1

USP28–NF23Page 1878

Phone Number:1-301-816-8139