Mitotane
320.04Benzene, 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 97.0 percent and not more than 103.0 percent 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—
Loss on drying 
731
—
Dry it in vacuum at 60
for 2 hours: it loses not more than 0.5% of its weight.
731—
Dry it in vacuum at 60 for 2 hours: it loses not more than 0.5% of its weight.
Residue on ignition 281:
not more than 0.5%.
281:
not more than 0.5%.
Assay—
Dissolve about 0.1 g of Mitotane, accurately weighed, in methanol, and dilute quantitatively and stepwise with methanol to obtain a solution having a concentration of about 200 µg 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 200 µg per mL. Concomitantly determine the absorbances of both solutions in 1-cm cells at the wavelength of maximum absorbance at about 268 nm, with a suitable spectrophotometer, using methanol as the blank. Calculate the quantity, in mg, of C14H10Cl4 in the portion of Mitotane taken by the formula:
0.5C(AU / AS)
in which C is the concentration, in µg per mL, of USP Mitotane RS in the Standard solution, and AU and AS are the absorbances of the solution of Mitotane and the Standard solution, respectively.
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
Chromatographic Column—
| Topic/Question | Contact | Expert Committee |
| Monograph | Feiwen Mao, M.S.
Scientist 1-301-816-8320 |
(MDOOD05) Monograph Development-Ophthalmics Oncologics and Dermatologicals |
| Reference Standards | Lili Wang, Technical Services Scientist 1-301-816-8129 RSTech@usp.org |
USP32–NF27 Page 2993
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.