Montelukast Sodium

Montelukast Sodium

Parametr Specyfikacja
Nazwa produktu Montelukast Sodium
Numer CAS 151767-02-1
Wzór cząsteczkowy C35H35ClNNaO3S
Masa cząsteczkowa 608.17 g/mol
Wygląd Biały lub prawie biały krystaliczny proszek
Oznaczenie (HPLC) 98.0% – 102.0% (on dried basis)
Rozpuszczalność Soluble in methanol, ethanol, DMSO; slightly soluble in water
Opakowanie 25 kg fiber drum with double polyethylene liners

Potrzebujesz pomocy? Skontaktuj się z naszym zespołem

Montelukast Sodium Structure

Synonimy: 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.

Struktura chemiczna i właściwości

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.

Mechanizm działania

  • 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 Specyfikacja
Identyfikacja IR and HPLC retention time conform to reference standard
Strata przy suszeniu ≤ 0,5%
Popiół po spaleniu ≤ 0,11 TP3T
Metale ciężkie ≤ 20 ppm
Substancje pokrewne Total impurities ≤ 1.0%; any unspecified impurity ≤ 0.1%
Wartości graniczne dla mikroorganizmów Total aerobic count ≤ 1000 CFU/g; yeast and mold ≤ 100 CFU/g

Dostawa i dokumentacja

  • Pojemność: 5 metric tons per month
  • Czas realizacji: 3–5 dni roboczych (towary dostępne w magazynie)
  • Dokumentacja: COA, MSDS, TDS, DMF available upon request
  • Opakowanie: 25 kg fiber drum with double polyethylene liners, or as per customer requirement

Najczęściej zadawane pytania

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.

BĄDŹ W KONTAKCIE

Zapytanie ofertowe

Nasz adres

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

✅ ×