1. Basic Product Profile

• Full IUPAC Name: sodium (R,E)-2-(1-((1-(3-(2-(7-chloroquinolin-2-yl)vinyl)phenyl)-3-(2-(2-hydroxypropan-2-yl)phenyl)propyl)sulfanyl)methyl)cyclopropyl)acetate
• Aliases: Montelukast Na, Singulair sodium salt
• CAS Number: 151767-02-1
• EINECS: N/A
• Molecular Formula: C35H35ClNNaO3S
• Molecular Weight: 608.17
• Chemical Classification: Leukotriene receptor antagonist API, anti-asthma & anti-allergy pharmaceutical raw material
• Core Advantages
  Orally active selective cysteinyl leukotriene receptor antagonist sodium salt. Blocks leukotriene-mediated bronchoconstriction, airway inflammation and allergic rhinitis symptoms. High oral bioavailability, stable solid form complying with USP/EP pharmacopoeia standards. Manufactured for oral tablets, chewable tablets, oral granules for pediatric and adult asthma & seasonal allergy treatment.

2. Physical & Chemical Properties

2.1 Physical Index

1. Appearance: White to off-white crystalline powder
2. Odor: Faint characteristic mild odor
3. Solubility: Soluble in methanol, ethanol, DMSO; slightly soluble in water; insoluble in hexane, ether
4. Melting Point: Decomposes above 145 °C without distinct melting point
5. Specific Optical Rotation [α]D20: -12° ~ -16° (c=1, methanol)
6. Hygroscopy: Slightly hygroscopic under high humidity
7. UV Property: Characteristic UV absorption peak at 240 nm

2.2 Chemical Properties

1. Chiral multi-aromatic skeleton with quinoline, cyclopropyl carboxylate sodium, sulfide and hydroxyl functional groups
2. Sodium carboxylate structure: Good water solubility for oral absorption; acidification precipitates free montelukast acid
3. Acid & Alkali Stability: Stable under neutral/weak alkaline conditions; strong acid triggers hydrolysis and degradation; strong oxidants cause vinyl double bond oxidation
4. Thermal Stability: Gradual degradation above 130 °C, generates related oxidative impurities
5. Photostability: Highly sensitive to UV and strong light; light exposure accelerates discoloration and impurity growth
6. Compatibility: Compatible with neutral tablet excipients; incompatible with concentrated acid, peroxide oxidants, heavy metal salts

3. Main Application Fields

3.1 Human Pharmaceutical API (Core Usage)

1. Prophylactic treatment of chronic asthma in adults and children;
2. Relief and prevention of seasonal and perennial allergic rhinitis;
3. Raw material for chewable tablets, oral dry granules and film-coated oral tablets.

3.2 Pharmaceutical Reference Standard

3.3 Synthetic Research Intermediate

4. Quality Specification Table