Olaparib 763113-22-0

Product  Name

Olaparib

CAS NO.

763113-22-0

Batch No.

180701

Quantity

18.0kg

Manufacture Date

Jul05, 2018

expiry date

Jul 4, 2021

Analysis Date

Jul 06, 2018

Storage Conditions

Cool, dry place with tighten container

Tested  Items

Specifications

Results

Character

White to pale yellow crystalline powder. Non- Hygroscopic.  Easily soluble in N, N- two methyl formamide, soluble in methanol, slightly soluble in acetonitrile, almost insoluble in water.

Conform

Identification

HPLC

The retention time should consistent with control sample

Conform

UV

With maximum absorption under 277nm and 210nm wavelength.

Conform

Infrared

Should consist with the spectroscopic test result of the referenced substance.

Conform

Crystal form

A-form (according to the data of the original patented drug)

Conform

Chloride (%)

0.025

Conform

Impurity

Other single largest impurities

≤0.2

0.08

Total impurity

≤0.5

0.22

Residual solvent

Ethanol

≤0.5

Conform

Dichloromethane

≤0.06

Conform

N-hexane

≤0.029

Not found

THF

≤0.072

Not found

Moisture content

≤0.50%

0.21%

Loss on drying

≤0.5

0.21

Heavy metal

≤0.002

Conform

Purity

>99.0%

99.78%

Conclusion

Positive