Montelukast Sodium

Montelukast Sodium

매개변수 사양
제품명 Montelukast Sodium
CAS 번호 151767-02-1
분자식 C35H35ClNNaO3S
분자량 608.17 g/mol
외관 흰색에서 미백색의 결정성 분말
분석법 (HPLC) 98.0% – 102.0% (on dried basis)
용해도 Soluble in methanol, ethanol, DMSO; slightly soluble in water
패키지 25 kg fiber drum with double polyethylene liners

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Montelukast Sodium Structure

동의어: 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.

작용 기전

  • 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)

Test Item 사양
식별 IR and HPLC retention time conform to reference standard
건조 손실 ≤ 0.5%
소각 잔류물 ≤ 0.1%
중금속 ≤ 20 ppm
관련 물질 Total impurities ≤ 1.0%; any unspecified impurity ≤ 0.1%
Microbial Limits Total aerobic count ≤ 1000 CFU/g; yeast and mold ≤ 100 CFU/g

Supply & Documentation

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

자주 묻는 질문

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.

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Room,5-0203, Unit 5, Beiyuanmen Street,Xi'an,Shaanxi,China

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