Pharmaceutical Intermediate Raw Material Ceritinib Powder Ceritinib

• Powder: Yes
• Customized: Customized
• Certification: GMP, HSE, ISO 9001, USP, BP
• Suitable for: Elderly, Children, Adult
• Purity: >99%
• Appearance: White Powder
• Model NO.: HB-Ceritinib Powder
• Assay: 99%
• Grade: Food Grade
• Place of Origin: Shaanxi, China
• Package: 1kg/Foil Bag, 25kg/Drum
• Storage: Cool Dry Place
• Transport Package: 1kg/Foil Bag, 25kg/Drum
• Specification: 99%
• Trademark: HAIBO
• Origin: China
• HS Code: 0000
• Production Capacity: 99999kg/Weeks

Product Description

Ceritinib is a drug for the treatment of lung cancer. It is an ALK inhibitor. It was approved in April 2014 by the Food and Drug Administration for the treatment of ALK-positive metastatic non-small cell lung cancer (NSCLC) following treatment with crizotinib.

1.It is a tyrosine kinase inhibitor of anaplastic lymphoma kinase (ALK). It can promote the development of cancer cells by blocking the protein and inhibit the cells expressing EML4-ALK and NPM-ALK fusion protein.
2.Cerinib, a novel ALK inhibitor, is highly active in advanced patients.

 

Analysis	Specification	Result	Test method
Physical Description
Appearance	White Powder	White Powder	Visual
Odor	Characteristic	Characteristic	Organoleptic
Particle size	90% pass 80 mesh	90% pass 80 mesh	80 Mesh Screen
Chemical Tests
Assay (Lutein)	99%	90.15%	HPLC
Loss on drying	5.0% Max	1.82%	5g/105ºC/2hrs
Ash Contents	5.0% Max	1.12%	2g/525ºC/3hrs
Residual Solvents	50.0 ppm, Only Ethanol	<30.0 ppm	/
Heavy metals	5.0 ppm Max	<3.0 ppm	AAS
Lead	3.0 ppm Max	<1.0 ppm	AAS
Arsenic	3.0 ppm Max	<1.0 ppm	AAS
Microbiology Control
Total Bacteria Count	1,000cfu/g Max	<280cfu/g	AOAC
Yeast & Mold	100cfu/g Max	<10cfu/g	AOAC
Coliform	30.0 MPN/g Max	<3.0 MPN/g	AOAC
Conclusion	Complies with the standards.
General Status	Non-GMO, ISO Certificated.