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Gefitinib 184475-35-2 Gefitinib 184475-35-2

Gefitinib 184475-35-2
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 1.Basic information of Gefitinib 184475-35-2:

Product name

Gefitinib

Alias

AKOS 91371; n-(3-chloro-4-fluoro-phenyl)-7-methoxy-6-(3-morpholin-4-ylpropoxy)quinazolin-4-amine; N-(3-Chloro-4-fluorophenyl)-7-methoxy-6-[3-(4-morpholinyl)propoxy]-4-quinazolinamine; ZD 1839; 4-Quinazolinamine, N-(3-chloro-4-fluorophenyl)-7-methoxy-6-[3-(4-morpholinyl)propoxy]-; Gefitinib(TINIBS);  Iressa, ZD1839; Gefitinib Base

CAS No.:

184475-35-2

Appearance

White crystalline powder

MF:

C22H24ClFN4O3

MW:

446.9

Purity

99% up by HPLC

Grade

Medicine garde

Density

1.322

Packaging details

10g/bag, 1kg/bag, 1kg/drum, or as the requirement


2.Usage of Gefitinib 184475-35-2 :

Gefitinib is a selective epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor that is normally expressed in solid tumors of epithelial origin. Inhibition of EGFR tyrosine kinase activity can impede tumor growth, metastasis and angiogenesis, and increase tumor cell apoptosis. In vivo, gefitinib broadly inhibits tumor growth in human tumor cell-derived lines xenografted in nude mice and enhances the anti-tumor activity of chemotherapy, radiation therapy and hormone therapy. Gefitinib has been shown to have an objective anti-tumor response to locally advanced or metastatic non-small cell lung cancer and improve disease-related symptoms in clinical trials.

A brief overview of the mechanism of action of gefitinib is: (1) competing for the Mg-ATP binding site in the EGFR-TK catalytic region, blocking its signaling; (2) inhibiting the activation of mitogen-activated protein kinase and promoting cell apoptosis (3) inhibit tumor angiogenesis. Iressa was approved by the Japanese Ministry of Health and Welfare for the treatment of advanced NSCLC on July 5, 2002. It was approved by the FDA as a third-line treatment for NSCLC on May 5, 2003. The recommended dose is 250 mg, PO, qd. It is worth mentioning that the FDA decision was approved after Iressa had just completed Phase II clinical trials and Phase III clinical trials had not been completed. In 2003, the Chinese Anti-Cancer Association Lung Cancer Professional Committee proposed in the treatment guidelines for inoperable NSCLC: Iressa recommended for the treatment of locally advanced or distant metastasis of non-small cell lung cancer with platinum-based regimen and patients with failed Docetaxel chemotherapy.

3.COA of Gefitinib 184475-35-2 :

Tests 

Specification

Results 

Appearance 

Slight white to white crystalline powder

White crystalline powder

Identification IR(1)

Conforms to the refence

Conforms to the refence 

Melting Point 

194.0~198.0°C

196.0~197.0°C

Water(KF)

≤0.30%

0.05%

Assay (HPLC)

≥99.0%

99.9%

Individual Purity (HPLC )

≤0.20%

0.09%

Conclusion 

Conform with company standard 

 

 






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MORE_DETAIL Gefitinib 184475-35-2

 1.Basic information of Gefitinib 184475-35-2:

Product name

Gefitinib

Alias

AKOS 91371; n-(3-chloro-4-fluoro-phenyl)-7-methoxy-6-(3-morpholin-4-ylpropoxy)quinazolin-4-amine; N-(3-Chloro-4-fluorophenyl)-7-methoxy-6-[3-(4-morpholinyl)propoxy]-4-quinazolinamine; ZD 1839; 4-Quinazolinamine, N-(3-chloro-4-fluorophenyl)-7-methoxy-6-[3-(4-morpholinyl)propoxy]-; Gefitinib(TINIBS);  Iressa, ZD1839; Gefitinib Base

CAS No.:

184475-35-2

Appearance

White crystalline powder

MF:

C22H24ClFN4O3

MW:

446.9

Purity

99% up by HPLC

Grade

Medicine garde

Density

1.322

Packaging details

10g/bag, 1kg/bag, 1kg/drum, or as the requirement


2.Usage of Gefitinib 184475-35-2 :

Gefitinib is a selective epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor that is normally expressed in solid tumors of epithelial origin. Inhibition of EGFR tyrosine kinase activity can impede tumor growth, metastasis and angiogenesis, and increase tumor cell apoptosis. In vivo, gefitinib broadly inhibits tumor growth in human tumor cell-derived lines xenografted in nude mice and enhances the anti-tumor activity of chemotherapy, radiation therapy and hormone therapy. Gefitinib has been shown to have an objective anti-tumor response to locally advanced or metastatic non-small cell lung cancer and improve disease-related symptoms in clinical trials.

A brief overview of the mechanism of action of gefitinib is: (1) competing for the Mg-ATP binding site in the EGFR-TK catalytic region, blocking its signaling; (2) inhibiting the activation of mitogen-activated protein kinase and promoting cell apoptosis (3) inhibit tumor angiogenesis. Iressa was approved by the Japanese Ministry of Health and Welfare for the treatment of advanced NSCLC on July 5, 2002. It was approved by the FDA as a third-line treatment for NSCLC on May 5, 2003. The recommended dose is 250 mg, PO, qd. It is worth mentioning that the FDA decision was approved after Iressa had just completed Phase II clinical trials and Phase III clinical trials had not been completed. In 2003, the Chinese Anti-Cancer Association Lung Cancer Professional Committee proposed in the treatment guidelines for inoperable NSCLC: Iressa recommended for the treatment of locally advanced or distant metastasis of non-small cell lung cancer with platinum-based regimen and patients with failed Docetaxel chemotherapy.

3.COA of Gefitinib 184475-35-2 :

Tests 

Specification

Results 

Appearance 

Slight white to white crystalline powder

White crystalline powder

Identification IR(1)

Conforms to the refence

Conforms to the refence 

Melting Point 

194.0~198.0°C

196.0~197.0°C

Water(KF)

≤0.30%

0.05%

Assay (HPLC)

≥99.0%

99.9%

Individual Purity (HPLC )

≤0.20%

0.09%

Conclusion 

Conform with company standard 

 

 





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