| CAS No.: | 220127-57-1 |
| Molecular Weight: | 589.7 g/mol |
| Chemical Formula | C30H35N7O4S |
Imatinib mesylate is a white to off-white crystalline powder. Its molecular formula is C29H31N7O-CH4SO3. Imatinib Mesylate is the mesylate salt of imatinib, a tyrosine kinase inhibitor with antineoplastic activity. Soluble in aqueous buffers =<pH 5.5, but very slightly soluble in neutral to alkaline aqueous buffers; freely soluble to very soluble in dimethyl sulfoxide, methanol, and ethanol; insoluble in n-octanol, acetone, and acetonitrile.
Chemical Name: 4-[(4-Methyl-1-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]phenyl]benzamide methanesulfonate
Specifications of Imatinib Mesylate:
CAS Number: 220127-57-1
Molecular Formula: C30H35N7O4S or C29H31N7O-CH4SO3
Molecular Weight: 589.70
Description: White to yellowish white powder.
Identification: By IR.
Solubility: Freely soluble in water and sparingly soluble in methanol.
Melting Range: 209C to 225C.
Moisture Content by KF: Not more than 0.5%.
Heavy Metals: Not more than 20 ppm In-house
Related substances by HPLC
a) Individual Impurity Not more than 0.5%
b) Total Impurities Not more than 1.0%
Assay by HPLC (on anhydrous basis): 99.0 to 101.0%.
Storage: Well-closed container, protected from direct sunlight and moisture.
Imatinib Mesilate BP Ph Eur Grade:
Ph Eur
C30H35N7SO4 --- 589.7 --- CAS 220127-57-1
Action and use: Cytotoxic.
DEFINITION
4-[(4-Methylpiperazin-1-yl)methyl]-N-[4-methyl-3-[[4-(pyridin-3-yl)pyrimidin-2-yl]amino]phenyl]benzamide methanesulfonate.
Content: 98.0 per cent to 102.0 per cent (anhydrous substance).
PRODUCTION
It is considered that alkyl methanesulfonate esters are genotoxic and are potential impurities in imatinib mesilate. The manufacturing process should be developed taking into consideration the principles of quality risk management, together with considerations of the quality of starting materials, process capability and validation. The general methods 2.5.37. Methyl, ethyl and isopropyl methanesulfonate in methanesulfonic acid, 2.5.38. Methyl, ethyl and isopropyl methanesulfonate in active substances and 2.5.39. Methanesulfonyl chloride in methanesulfonic acid are available to assist manufacturers.
CHARACTERS
Appearance: White or almost white, slightly brownish or yellowish powder; yellow or pale yellow, very hygroscopic, for the amorphous form.
Solubility: Freely soluble in water, slightly soluble in ethanol (96 per cent), practically insoluble in methylene chloride. It shows polymorphism.
IDENTIFICATION
Infrared absorption spectrophotometry: To pass the test.
