(mye' toe tane).
Benzene, 1-chloro-2-[2,2-dichloro-1-(4-chlorophenyl)ethyl]-, (±)-.
» Mitotane contains not less than 97.0 percent and not more than 103.0 percent of C14H10Cl4, calculated on the dried basis.
[CautionHandle Mitotane with exceptional care, since it is a highly potent agent. ]
Packaging and storage Preserve in tight, light-resistant containers.
USP Reference standards 11
B: Ultraviolet Absorption 197U
Solution: 200 µg per mL.
Melting range 741: between 75 and 81.
Loss on drying 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%.
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.
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USP35NF30 Page 3937