Pharmaceutical Montelukast Sodium Raw Powder Montelukast Sodium

• Customization: Available
• Powder: Yes
• Customized: Customized
• Model NO.: FLZ-S0807Montelukast
• Certification: GMP, HSE, ISO 9001, USP, BP
• Suitable for: Elderly, Children, Adult
• State: White Powder
• Purity: >99%
• Appearance: White Powder
• CAS No: 158966-92-8
• Shelf Life: 2 Years
• Test Method: HPLC
• MOQ: 1kg
• Storage: Store Cool Dry Place
• Resource: Natural
• Quality Requirement: Strictly Quality Control
• Mf: C35h35clnnao3s
• MW: 586.18
• Transport Package: Foil Bag
• Specification: 99%
• Trademark: Xi′an Frazer Biotech Co., Ltd.
• Origin: China
• Production Capacity: 1000kg/Month

Product Description

Pharmaceutical Montelukast Sodium Raw Powder Montelukast Sodium

 

What is montelukast Sodium?

Montelukast sodiumis a eicosane-type substance released by various kinds of cells including mast cells and eosinophils with strong inflammatory effect. These important asthma pre-inflammatory mediators can bind to the Cysteinyl leukotriene receptors (CysLT) identified in the human airways, resulting in a variety of airway responses including bronchoconstriction, mucus secretion, increased vascular permeability, and eosinophil accumulation.
Montelukast sodium is an orally active selective leukotriene receptor antagonist that can specifically inhibit the cysteinyl leukotriene receptor. It was successfully developed by the Merck Company (German) and had entered into market in Canada, Finland, and Mexican in 1997. It is suitable for the prevention and long-term treatment of adults and children asthma, including the prevention of daytime and nighttime asthma symptoms, the treatment of asthma patients who are aspirin-sensitive and prevention of exercise-induced bronchial contraction, it can also be used to relieve the seasonal allergic rhinitis symptoms of 15 year-old or over 15 year-old patients whose symptoms are invalid and intolerant to other treatment.

Function of Montelukast Sodium

Montelukast Sodium is a potent, selective, anti-inflammatory CysLT1 receptor antagonist (IC50 < 5nM) with no appreciable affecton the CysLT2 receptor. 
In rat colitis Montelukast Sodium has demonstrated the ability to increase PGE2 (Prostaglandin E2 - sc-201225) production and lower COX-2 expression.

Application of Montelukast Sodium

Montelukast Sodium is a potent, selective, anti-inflammatory CysLT1 receptor antagonist (IC50 < 5nM) with no appreciable affecton the CysLT2 receptor. In rat colitis Montelukast Sodium has demonstrated the ability to increase PGE2 (Prostaglandin E2 - sc-201225) production and lower COX-2 expression. Inhibition is competitive with respect to leukotrienes - particularly LTD4, a biologically active mediator that plays an important role in the control of several biochemical pathways involving pulmonary and immune system function. Because of its method of operation, it is not useful for the treatment of acute asthma attacks. Again because of its very specific mechanism of action, it does not interact with other asthma medications such as theophylline. Another leukotriene receptor antagonist is zafirlukast (Accolate), taken twice daily. Zileuton (Zyflo), an asthma drug taken four times per day, blocks leukotriene synthesis by inhibiting 5-lipoxygenase, an enzyme of the eicosanoid synthesis pathway.

Certification of Analysis

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.

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