Montelukast Sodium
| Paramètre | Spécifications |
|---|---|
| Nom du produit | Montelukast Sodium |
| Numéro CAS | 151767-02-1 |
| Formule moléculaire | C35H35ClNNaO3S |
| Poids moléculaire | 608.17 g/mol |
| Apparence | Poudre cristalline blanche à blanc cassé |
| Essai (HPLC) | 98.0% – 102.0% (on dried basis) |
| Solubilité | Soluble in methanol, ethanol, DMSO; slightly soluble in water |
| Colis | 25 kg fiber drum with double polyethylene liners |
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Synonymes : 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.
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.
| Test Item | Spécifications |
|---|---|
| Identification | IR and HPLC retention time conform to reference standard |
| Perte au séchage | ≤ 0,5% |
| Résidu au feu | ≤ 0,11 TP3T |
| Métaux lourds | ≤ 20 ppm |
| Substances apparentées | Total impurities ≤ 1.0%; any unspecified impurity ≤ 0.1% |
| Limites microbiologiques | Total aerobic count ≤ 1000 CFU/g; yeast and mold ≤ 100 CFU/g |
Our standard MOQ is 1 kg. For larger quantities, we offer competitive pricing and can accommodate custom packaging.
For stock items, delivery is typically 3-5 business days after order confirmation. We ship globally via express or air freight.
Yes, we provide a COA for each batch. Samples are available upon request; please contact our sales team for details.
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