Mitotane Tablets
»Mitotane Tablets contain not less than 90.0percent and not more than 110.0percent of the labeled amount of mitotane (C14H10Cl4).
Packaging and storage— Preserve in tight,light-resistant containers.
Identification— Triturate a quantity of finely powdered Tablets,equivalent to about 500mg of mitotane,with 10mLof water,filter on a sintered-glass filter funnel,and wash the residue with two 5-mLportions of water.Transfer the residue to a small beaker,add 4mLof alcohol,heat to boiling,and filter immediately.Allow the filtrate to cool,filter the crystals of mitotane,wash once with 2mLof alcohol,and dry in vacuum at 60for 2hours:the IRabsorption 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 á701ñ: 15minutes,the use of disks being omitted.
Uniformity of dosage units á905ñ: meet the requirements.
Assay—
Standard preparation— Dissolve about 50mg 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 200µg per mL.
Assay preparation— Weigh and finely powder not less than 10Tablets.Transfer an accurately weighed portion of the powder,equivalent to about 100mg of mitotane,to a 250-mLvolumetric flask,add 100mLof methanol,and shake occasionally for 5minutes,then dilute with methanol to volume,and mix.Filter,rejecting the first portion of the filtrate,transfer 25.0mLof the filtrate to a 50-mLvolumetric flask,dilute with methanol to volume,and mix.
Procedure— Proceed as directed in the Assayunder Mitotane,beginning with “Concomitantly determine the absorbances of both solutions.”
Auxiliary Information— Staff Liaison:Lawrence Evans,III,Ph.D.,Scientist
Expert Committee:(PA6)Pharmaceutical Analysis 6
USP28–NF23Page 1303
Phone Number:1-301-816-8389