Hydroxyprogesterone Caproate
;)
Pregn-4-ene-3,20-dione,17-[(1-oxohexyl)oxy]-.
17-Hydroxypregn-4-ene-3,20-dione hexanoate [630-56-8].
»Hydroxyprogesterone Caproate contains not less than 97.0percent and not more than 103.0percent of C27H40O4,calculated on the anhydrous basis.
Packaging and storage—
Preserve in well-closed,light-resistant containers.Store at 25
,excursions permitted between 15and 30.
,excursions permitted between 15and 30.
Identification,Infrared Absorption á197Kñ.
Specific rotation á781Sñ:
between +58and +64.
and +64.
Test solution:
10mg per mL,in chloroform.
Water,Method Iá921ñ:
not more than 0.1%.
Free n-caproic acid—
Dissolve 0.20g in 25mLof alcohol that previously has been neutralized to a faint pink color following the addition of 2or 3drops of phenolphthalein TS.Promptly titrate with 0.020Nsodium hydroxide:not more than 0.50mLof 0.020Nsodium hydroxide is required (0.58%).
Ordinary impurities á466ñ—
Test solution:
chloroform.
Standard solution:
chloroform.
Eluant:
a mixture of chloroform and ethyl acetate (3:1).
Visualization:
5;then view under long-wavelength UVlight.
Assay—
Transfer about 50mg of Hydroxyprogesterone Caproate,accurately weighed,to a 100-mLvolumetric flask,add alcohol to volume,and mix.Dilute 2.0mLof this solution with alcohol to volume in a second 100-mLvolumetric flask,and mix.Dissolve in alcohol a suitable quantity of USP Hydroxyprogesterone Caproate RS,and dilute quantitatively and stepwise with alcohol to obtain a Standard solution having a known concentration of about 10µg per mL.Concomitantly determine the absorbances of both solutions in 1-cm cells at the wavelength of maximum absorbance at about 240nm,using alcohol as the blank.Calculate the quantity,in mg,of C27H40O4in the Hydroxyprogesterone Caproate taken by the formula:
5C(AU/AS),
in which Cis the concentration,in µg per mL,of USP Hydroxyprogesterone Caproate RSin the Standard solution;and AUand ASare the absorbances of the solution of Hydroxyprogesterone Caproate and the Standard solution,respectively.
Auxiliary Information—
Staff Liaison:Clydewyn M.Anthony,Ph.D.,Scientist
Expert Committee:(PA1)Pharmaceutical Analysis 1
USP28–NF23Page 978
Pharmacopeial Forum:Volume No.29(5)Page 1506
Phone Number:1-301-816-8139