Testosterone Enanthate
;)
Androst-4-en-3-one,17-(1-oxoheptyl)oxy-,(17b)-.
Testosterone heptanoate [315-37-7].
»Testosterone Enanthate contains not less than 97.0percent and not more than 103.0percent of C26H40O3.
Packaging and storage—
Preserve in well-closed containers,in a cool place.
Identification—
A:
Infrared Absorption á197Kñ.
Solution:
10µg per mL.
Medium:
alcohol.
Absorptivities at 240nm,calculated on the anhydrous basis,do not differ by more than 3.0%.
C:
Reflux 25mg with 2mLof a 1in 100solution of potassium hydroxide in methanol for 1hour.Cool the mixture,add 10mLof water,filter,and wash the precipitate with water until the last washing is neutral to litmus.Dry the precipitate in vacuum at 60
for 3hours:the testosterone so obtained melts between 151and 157.
for 3hours:the testosterone so obtained melts between 151and 157.
Specific rotation á781Sñ:
between +77and +82.
and +82.
Test solution:
20mg per mL,in dioxane.
Water,Method Iá921ñ:
not more than 0.05%.
Free heptanoic acid—
Dissolve 500mg in 10mLof alcohol that previously has been neutralized to a faint blue color following the addition of 2or 3drops of bromothymol blue TS,and promptly titrate with 0.01Nsodium hydroxide VS:not more than 0.6mLof 0.01Nsodium hydroxide is required (0.16%of heptanoic acid).
Ordinary impurities á466ñ—
Test solution:
methanol.
Standard solution:
methanol.
Eluant:
a mixture of cyclohexane and ethyl acetate (2:1).
Visualization:
19.
Limits—
No individual impurity exceeds 1.0%,and the total of observed impurities does not exceed 2.0%.
Organic volatile impurities,Method Vá467ñ:
meets the requirements.
Solvent—
Use dimethyl sulfoxide.
Assay—
Dissolve about 40mg of Testosterone Enanthate,accurately weighed,in chloroform to make 100mL,and mix.Pipet 10mLof this solution into a 100-mLvolumetric flask,add chloroform to volume,and mix.Dissolve a suitable quantity of USP Testosterone Enanthate RS,accurately weighed,in chloroform,and dilute quantitatively and stepwise with chloroform to obtain a Standard solution having a known concentration of about 40µg per mL.Pipet 5mLeach of the solution of Testosterone Enanthate and the Standard solution into separate,glass-stoppered,50-mLconical flasks,and place 5.0mLof chloroform in a similar flask to provide a blank.Treat each flask as follows.Add 10.0mLof a solution of 375mg of isoniazid and 0.47mLof hydrochloric acid in 500mLof methanol,mix,and allow to stand for 45minutes.Concomitantly determine the absorbances of the solutions at the wavelength of maximum absorbance at about 380nm,with a suitable spectrophotometer,using the blank to set the instrument.Calculate the quantity,in mg,of C26H40O3in the Testosterone Enanthate taken by the formula:
C(AU/AS),
in which Cis the concentration,in µg per mL,of USP Testosterone Enanthate RSin the Standard solution,and AUand ASare the absorbances of the solution of Testosterone Enanthate and the Standard solution,respectively.
Auxiliary Information—
Staff Liaison:Clydewyn M.Anthony,Ph.D.,Scientist
Expert Committee:(PA1)Pharmaceutical Analysis 1
USP28–NF23Page 1877
Pharmacopeial Forum:Volume No.30(5)Page 1648
Phone Number:1-301-816-8139