Montelukast Sodium
| パラメータ | 仕様 |
|---|---|
| 製品名 | Montelukast Sodium |
| CAS番号 | 151767-02-1 |
| 分子式 | C35H35ClNNaO3S |
| 分子量 | 608.17 g/mol |
| 外観 | 白色からオフホワイトの結晶性粉末 |
| 分析(HPLC) | 98.0% – 102.0% (on dried basis) |
| 溶解度 | Soluble in methanol, ethanol, DMSO; slightly soluble in water |
| パッケージ | 25 kgの繊維製ドラム缶(ポリエチレン製ライナー2重仕様) |
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同義語: 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 | 仕様 |
|---|---|
| 識別 | IR and HPLC retention time conform to reference standard |
| 乾燥減量 | ≤ 0.5% |
| 焼失残渣 | ≤ 0.1% |
| 重金属 | ≤ 20 ppm |
| 関連物質 | Total impurities ≤ 1.0%; any unspecified impurity ≤ 0.1% |
| Microbial Limits | 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.
send us your specification for a quotation.