Product Name: IMATINIB BASE

Appearance

Description

White to off-white to brownish or yellowish powder

Identification

IR Spectrum

Conforms to reference standard

HPLC

Conforms to reference standard

Methanesulfonic acid content

15.8~16.8%

Heavy metals

20 ppm max

Residue on ignition

0.1% max

Water

1.0% max

Related substance

N-Des-Methyl Imatinib Mesylate

0.1% max

(MePIP)MeBenzoyl Des-Me Imatinib

0.1% max

Methyl Imatinib Mesylate Analog

0.1% max

Any other impurity

0.1% max

Total impurities

0.5% max

Solvent residue

Ethanol

0.5% max

Isopropanol

0.5% max

Tert-butylmethyl ether

0.5% max

Pyridine

0.02% max

Toluene

0.03% max