Product

Imatinib mesylate（alpha form）

Cas No

220127-57-1

Batch number

HH-IM-2130603

Package

PET/AL/PE

C29H31N7O · CH4SO3      589.7

Mfg. Date

2013-06-26

Exp. Date

2015-06-25

Batch No. 

HH-IM-20130103

Quantity

   20Kg

Quantity Standard:   The factory standard of Imatinib mesylate

ITEM

【Characteristics】

Appearance

Solubility

【Identification】

IR Spectrum

HPLC

【Tests】

Impurity A

Impurity B

Any other impurity

Total impurities

Residual solvents

Water

Heavy metals

Residu on ignition

【Assay】

Specification

White to light yellow crystal power 

Freely soluble in water, soluble in methanol, Sparingly soluble in ethyl acetate

conform to the standard

conform to the standard

NMT0.1%

NMT0.1%

NMT0.1%

NMT0.5%

Pyridine-NMT 0.02%

Isopropyl-NMT0.5%

Alcohol-NMT0.5%

NMT1.0%

NMT20ppm

NMT0.1%               

98.0%~102.0%

Results

White t power

Conforms

Conforms

Conforms

0.00%

0.01%

0.05%

0.17%

0.0%

0.32%

0.01%

0.6%

Conforms

0.08%

99.4%