Mitotane
;)
Benzene,1-chloro-2-[2,2-dichloro-1-(4-chlorophenyl)ethyl]-,(±)-.
(±)-1,1-Dichloro-2-(o-chlorophenyl)-2-(p-chlorophenyl)ethane [53-19-0].
»Mitotane contains not less than 97.0percent and not more than 103.0percent of C14H10Cl4,calculated on the dried basis.
Caution—Handle Mitotane with exceptional care,since it is a highly potent agent.
Packaging and storage—
Preserve in tight,light-resistant containers.
Identification—
A:
Infrared Absorption á197Mñ.
Loss on drying á731ñ—
Dry it in vacuum at 60
for 2hours:it loses not more than 0.5%of its weight.
for 2hours:it loses not more than 0.5%of its weight.
Residue on ignition á281ñ:
not more than 0.5%.
Organic volatile impurities,Method Vá467ñ:
meets the requirements.
Solvent—
Use dimethyl sulfoxide.
Assay—
Dissolve about 0.1g of Mitotane,accurately weighed,in methanol,and dilute quantitatively and stepwise with methanol to obtain a solution having a concentration of about 200µg per mL.Similarly prepare a solution in methanol of USP Mitotane RS,diluted quantitatively and stepwise with methanol to yield a Standard solution having a known concentration of about 200µg per mL.Concomitantly determine the absorbances of both solutions in 1-cm cells at the wavelength of maximum absorbance at about 268nm,with a suitable spectrophotometer,using methanol as the blank.Calculate the quantity,in mg,of C14H10Cl4in the portion of Mitotane taken by the formula:
0.5C(AU/AS),
in which Cis the concentration,in µg per mL,of USP Mitotane RSin the Standard solution,and AUand ASare the absorbances of the solution of Mitotane and the Standard solution,respectively.
Auxiliary Information—
Staff Liaison:Lawrence Evans,III,Ph.D.,Scientist
Expert Committee:(PA6)Pharmaceutical Analysis 6
USP28–NF23Page 1302
Phone Number:1-301-816-8389