Montelukast Sodium

Synonyms: Montelukast sodium, Singulair, Montelukast sodium salt, 151767-02-1, MK-0476, Montelukast Sodium API

Montelukast sodium is a selective leukotriene receptor antagonist that targets the cysteinyl leukotriene CysLT1 receptor. Its molecular framework incorporates a quinoline core linked via a thioether bridge to a cyclopropylacetic acid side chain, with the sodium salt enhancing aqueous solubility for oral formulations. This structural design allows high affinity binding to CysLT1 receptors in the airways, blocking the pro-inflammatory actions of leukotriene D4 and E4.

As an active pharmaceutical ingredient, montelukast sodium is supplied as a white to off-white crystalline powder, typically manufactured under cGMP conditions. It is indicated for the prophylaxis and chronic treatment of asthma, exercise-induced bronchoconstriction, and allergic rhinitis. The API is available in various polymorphic forms, with Form I being the most thermodynamically stable and commonly used in solid dosage forms.

In the pharmaceutical industry, montelukast sodium is formulated into film-coated tablets, chewable tablets, and oral granules. Its stability and compatibility with common excipients make it suitable for both immediate-release and modified-release applications. The growing demand for respiratory and allergy treatments continues to drive the need for high-purity montelukast sodium API.

Chemical Structure & Properties

Montelukast sodium is a synthetic organic salt with a molecular weight of 608.17 g/mol. The molecule contains a quinoline moiety, a chlorinated phenyl ring, and a cyclopropyl-substituted acetic acid group. The sodium salt form improves dissolution rate and bioavailability. It is optically active, with the S-enantiomer being the pharmacologically active form. The compound exhibits polymorphism, and consistent control of crystal form is critical for reproducible manufacturing.

Mechanism of Action

• CysLT1 receptor antagonism: Montelukast selectively binds to CysLT1 receptors in the respiratory tract, preventing leukotriene D4-induced bronchoconstriction and mucus secretion.
• Anti-inflammatory effects: By blocking leukotriene signaling, it reduces eosinophil infiltration and airway edema.
• Bronchodilation: It attenuates exercise-induced and antigen-induced bronchospasm, improving airflow.
• Allergic rhinitis relief: Montelukast alleviates nasal congestion and sneezing by inhibiting leukotriene-mediated allergic responses.

Quality Specifications (QC Tests)

Supply & Documentation

• Capacity: 5 metric tons per month
• Lead time: 3-5 business days (stock items)
• Documentation: COA, MSDS, TDS, DMF available upon request
• Packaging: 25 kg fiber drum with double polyethylene liners, or as per customer requirement

Frequently Asked Questions

What is the minimum order quantity (MOQ) for Montelukast Sodium?

Our standard MOQ is 1 kg. For larger quantities, we offer competitive pricing and can accommodate custom packaging.

How long does delivery take?

For stock items, delivery is typically 3-5 business days after order confirmation. We ship globally via express or air freight.

Can you provide a COA and samples?

Yes, we provide a COA for each batch. Samples are available upon request; please contact our sales team for details.

Contact & Ordering Information

• Company: LyvBio Co., Ltd.
• Address: Room 5-0203, Courtyard 205, Lianhu District, Xi’an, Shaanxi, China
• Email: info@lyvbio.com
• Phone: +86-29-65816888

send us your specification for a quotation.