Shandong Huashang Chemical Co., Ltd. is a high-tech enterprise focused on industry of fine chemicals research and develop, produce and sale. Shandong Huashang Chemical Co., Ltd. is located in Shan Dong Ji Nan China. we have the ability to provide you high quality products. More than 90 % of our products are exported to developed countries and regions such as north America, Europe, Japan, South Korea and the Middle East.
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
- Appearance: White to off-white crystalline powder
- Odor: Faint characteristic mild odor
- Solubility: Soluble in methanol, ethanol, DMSO; slightly soluble in water; insoluble in hexane, ether
- Melting Point: Decomposes above 145 °C without distinct melting point
- Specific Optical Rotation [α]D20: -12° ~ -16° (c=1, methanol)
- Hygroscopy: Slightly hygroscopic under high humidity
- UV Property: Characteristic UV absorption peak at 240 nm
2.2 Chemical Properties
- Chiral multi-aromatic skeleton with quinoline, cyclopropyl carboxylate sodium, sulfide and hydroxyl functional groups
- Sodium carboxylate structure: Good water solubility for oral absorption; acidification precipitates free montelukast acid
- Acid & Alkali Stability: Stable under neutral/weak alkaline conditions; strong acid triggers hydrolysis and degradation; strong oxidants cause vinyl double bond oxidation
- Thermal Stability: Gradual degradation above 130 °C, generates related oxidative impurities
- Photostability: Highly sensitive to UV and strong light; light exposure accelerates discoloration and impurity growth
- 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)
- Prophylactic treatment of chronic asthma in adults and children;
- Relief and prevention of seasonal and perennial allergic rhinitis;
- Raw material for chewable tablets, oral dry granules and film-coated oral tablets.
3.2 Pharmaceutical Reference Standard
HPLC reference substance for related substances assay of montelukast sodium bulk drug and finished formulations.
3.3 Synthetic Research Intermediate
Chiral building block for developing novel leukotriene antagonist analogues for respiratory drug research.
4. Quality Specification Table
| Test Item | Standard Index |
| CAS No. | 151767-02-1 |
| Molecular Formula | C35H35ClNNaO3S |
| Molecular Weight | 608.17 |
| Appearance | White to off-white crystalline powder |
| HPLC Assay | Pharma Grade ≥99.0%; Reference Standard ≥99.5% |
| Single Maximum Unknown Impurity | ≤0.10% |
| Total Related Substances | ≤0.50% |
| Moisture Content (KF) | ≤0.30% |
| Heavy Metals (Pb) | ≤10 ppm |
| Residue on Ignition | ≤0.10% |
| Bulk Package | 25kg light-proof nitrogen-sealed aluminum foil lined fiber drum |
| Sample Package | 1g / 10g / 100g sealed light-proof aluminum foil bag |
| Storage Requirements | Hermetic, light-proof cool dry warehouse ≤25℃; isolate humid air, intense light and oxidizing substances |
| Transportation Rule | Respiratory pharmaceutical API; light-proof moisture-proof sealed packaging mandatory during transit |
| Shelf Life | 36 months under intact nitrogen-sealed light-proof packaging |
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