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Osimertinib CAS No.:1421373-66-1 Made By Hangzhou Shitai Biotech Co.,LTD In China
Mar 09, 2018

PRODUCT   NAME

Osimertinib

CAS   No.:

1421373-66-1

Synonyms

N-[2-[[2-(Dimethylamino)ethyl]methylamino]-4-methoxy-5-[[4-(1-methyl-1H-indol-3-yl)-2-pyrimidinyl]amino]phenyl]-2-propenamide   methanesulfonate;

AZD-9291   (Mesylate)

Formula:

C28H33N7O2.CH4O3S

Molecular   Weight:

595.71

PSA:

153.79000

LogP:

5.81710

 

Osimertinib is a new drug for the treatment of skin cancer. Currently, Hangzhou Shitai Biotech Co. and LTD have been developed. As a drug use inhibitor, the product has not yet been widely used. Because the production cost of the product is relatively low, and most of the factories in the market can be produced, it is relatively neglected by the pharmaceutical enterprises. But for an important inhibitor in the process of cancer treatment, our company hopes to cooperate with a large pharmaceutical company to complete the production of GMP and the preparation of DMF documents. The future can be Da


Certificate of Analysis

ProductName: Osimertinib Mesylate

Cas:        1421373-66-1

Batch No.:    20170816

MFG Date:  Aug.16.2017

Analysis Date: Aug.16.2017

 

 

Inspect Item

Quantity Standard

Inspection Result

Appearance

Off-white or   yellow powder

Yellow powder

H-NMR   identification

Matches with the standards

Conforms

Crystal form

B

Conforms

Particle size

≤45um

9.41um

Ignition residue

≤0.2%

0.10%

Purity

99%Min

99.86%

Single impurity

≤0.1%

0.04%

Total impurity

≤0.5%

0.14%

Assay

98-102%

99.69%

Residue solvents

Acetone NMT 0.5%

0.41%

Water

         1.0% Max

0.10%

Heavy metal

20ppm Max

1.12ppm

Conclusion

In accordance   with enterprise standard