High Quality API 98% Macitentan Powder CAS 441798-33-0

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

Macitentan is a non-chiral sulphadiazine derivative. In vitro studies have shown that it is an oral active antagonist of endothelin ETA and ETB receptor, which can block endothelin-induced vasoconstriction in trachea and aorta. Developed by Swiss company Actelion Pharmaceuticals and first marketed in the United States with FDA approval on October 18, 2013, it is mainly used to treat pulmonary hypertension (PAH) and its product name is Opsumit. Compared with other drugs for pahs, masititan can significantly reduce the morbidity and mortality of pahs patients mainly by slowing the progression of disease.

 

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.