ANALYSIS

SPECIFICATIONGS

RESULTS

ASSAY

98.0-102.0%

99.8%

CHEMICAL CONTROL

Identification

IR

HPLC

UV

Comform with standard IR

Comform

Comform

Related substances

Related substances A

0.3%(max)

0.04%

Any other impurity

0.1%(max)

0.04%

All other impurities

0.3%(max)

0.09%

Organic volatile impurities

Conforms with ICH requirements

RESIDUAL SOLVENTS

Dichloromethane

600ppm（max）

Complies

Merhanol

3000ppm（max）

Complies

Acetone

5000ppm（max）

Complies

Ethanol

5000ppm（max）

Complies

PHYSICAL COMTROL

Description

White to yellowish crystalline

Powder

Complies

Water by KF

0.3%(max)

0.1%

Residue on ignition

0.1%(max)

0.02%

Heavy metals

0.001%(max)

Complies

Storage conditions

Cool and dry

                    (Conclusion):In conformity with USP36