Packaging and storage—
Preserve in well-closed, light-resistant containers. Store at 25
, excursions permitted between 15
and 30
.
Free n-caproic acid—
Dissolve 0.20 g in 25 mL of alcohol that previously has been neutralized to a faint pink color following the addition of 2 or 3 drops of
phenolphthalein TS. Promptly titrate with 0.020 N sodium hydroxide: not more than 0.50 mL of 0.020 N sodium hydroxide is required (0.58%).
Ordinary impurities 
466
—
Test solution:
chloroform.
Standard solution:
chloroform.
Eluant:
a mixture of chloroform and ethyl acetate (3:1).
Visualization:
5; then view under long-wavelength UV light.
Assay—
Transfer about 50 mg of Hydroxyprogesterone Caproate, accurately weighed, to a 100-mL volumetric flask, add alcohol to volume, and mix. Dilute 2.0 mL of this solution with alcohol to volume in a second 100-mL volumetric 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 10 µg per mL. Concomitantly determine the absorbances of both solutions in 1-cm cells at the wavelength of maximum absorbance at about 240 nm, using alcohol as the blank. Calculate the quantity, in mg, of C
27H
40O
4 in the Hydroxyprogesterone Caproate taken by the formula:
5C(AU / AS),
in which
C is the concentration, in µg per mL, of
USP Hydroxyprogesterone Caproate RS in the Standard solution; and
AU and
AS are the absorbances of the solution of Hydroxyprogesterone Caproate and the Standard solution, respectively.
;)
