» Mitotane Tablets contain not less than 90.0 percent and not more than 110.0 percent of the labeled amount of mitotane (C14H10Cl4).
Packaging and storage Preserve in tight, light-resistant containers.
USP Reference standards 11
Identification Triturate a quantity of finely powdered Tablets, equivalent to about 500 mg of mitotane, with 10 mL of water, filter on a sintered-glass filter funnel, and wash the residue with two 5-mL portions of water. Transfer the residue to a small beaker, add 4 mL of alcohol, heat to boiling, and filter immediately. Allow the filtrate to cool, filter the crystals of mitotane, wash once with 2 mL of alcohol, and dry in vacuum at 60 for 2 hours: the IR absorption spectrum of a mineral oil dispersion of the mitotane so obtained exhibits maxima only at the same wavelengths as that of a similar preparation of USP Mitotane RS.
Disintegration 701: 15 minutes, the use of disks being omitted.
Uniformity of dosage units 905: meet the requirements.
Standard preparation Dissolve about 50 mg of USP Mitotane RS, accurately weighed, in methanol, and dilute quantitatively and stepwise with methanol to obtain a solution having a known concentration of about 200 µg per mL.
Assay preparation Weigh and finely powder not less than 10 Tablets. Transfer an accurately weighed portion of the powder, equivalent to about 100 mg of mitotane, to a 250-mL volumetric flask, add 100 mL of methanol, and shake occasionally for 5 minutes, then dilute with methanol to volume, and mix. Filter, rejecting the first portion of the filtrate, transfer 25.0 mL of the filtrate to a 50-mL volumetric flask, dilute with methanol to volume, and mix.
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USP35NF30 Page 3938