Index Name

Specifications

Appearance

white or pale white crystalline powder

Identification

A: The infrared absorption of mitotane corresponds to usp reference standards

B: The ultraviolet absorption of mitotane corresponds to usp reference standards

Loss of drying

NMT 0.5%

Heavy metals

NMT 20ppm

Melting range 

75 to 81 degC

Solubility

The Practically insoluble in water, soluble in ethanol,ethyl ether, normal ethane, involatile oil and fat

Residue on ignition

NMT 0.5%

Organic volatile impurities

Methanol: NMT 2000PPM

Ethanol: NMT 3000PPM

Related substance

Total impurities: NMT 0.5%

Assay

calculated on the dried basis

Not less than 99% and not more than 103.0%