Factory Supply Pharmaceutical Raw Material Alectinib HCl Powder CAS 1256580-46-7

• Powder: Yes
• Customized: Customized
• Certification: GMP, HSE, ISO 9001, USP, BP
• Suitable for: Elderly, Children, Adult
• Purity: >99%
• Appearance: Yellow Powder
• Model NO.: HB-Alectinib
• 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

Alectinib hydrochloride, developed by Chugai Pharmaceutical/ Hoffman-La Roche under the trade name Alecensa, was approved in Japan in April 2014 for the treatment of anaplastic lymphoma kinase (ALK) fusion-gene positive, unresectable, advanced, or recurrent non-small cell lung cancer (NSCLC).    The compound is a highly selective second-generation ALK inhibitor, and while alectinib currently remains a focus of further development in Europe and the U.S., the compound has been granted orphan drug designation in Japan after showing a 93.5% objective response rate in phase II clinical trials.    In addition to providing rapid treatment response time in a majority of patients, trials showed a 76% 2-year progression-free survival rate.    Since the initial approval of crizotinib-the first ALK inhibitor indicated for treatment of ALKrearranged NSCLC -patients treated with crizotinib have shown remarkable improvement as compared to treatment with other chemotherapeutic methods,21 although drug resistance has shown to be a major side effect of this therapy.    Preliminary preclinical and clinical studies of alectinib have shown significant promise for overcoming drug resistance developed with other ALK inhibitors.
Alectinib hydrochloride is a highly selective and potent anaplastic lymphoma kinase (ALK) inhibitor capable of blocking the resistant gatekeeper mutant, which results in reduced cell growth.    Also is an intermediate of Alectinib (C183360), a highly selective and potent anaplastic lymphoma kinase (ALK) inhibitor capable of blocking the resistant gatekeeper mutant, which results in reduced cell growth.

 

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.