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Montelukast Sodium is a selective leukotriene receptor antagonist (LTRA) used for the prevention and management of asthma, exercise-induced bronchoconstriction, and allergic rhinitis. It works by blocking leukotriene D4 (LTD4) at cysteinyl leukotriene receptors in the lungs and bronchial tubes, thereby reducing inflammation, bronchoconstriction, and mucus production.
Bluepill Express provides high-purity Montelukast Sodium API manufactured under WHO-GMP, ISO 9001:2015, and cGMP-certified facilities, suitable for global pharmaceutical formulations. Our API complies with IP, BP, USP, and EP pharmacopeial standards, ensuring reliable purity, stability, and batch consistency for tablet and granule formulations.
Therapeutic Uses
- Asthma: Prevention of chronic asthma attacks
- Exercise-Induced Bronchoconstriction (EIB): Reduces exercise-triggered symptoms
- Allergic Rhinitis: Management of seasonal or perennial allergic rhinitis
- Combination Therapy: Can be combined with inhaled corticosteroids for improved outcomes
Mechanism of Action
Montelukast Sodium selectively binds to cysteinyl leukotriene receptors (CysLT1) in the respiratory tract. By inhibiting leukotriene-mediated bronchoconstriction, edema, and inflammatory cell recruitment, it improves airflow, reduces asthma symptoms, and prevents airway inflammation.
Pharmacological Information
- Chemical Name: Sodium [(R)-(-)-1-(((1-(3-(2-(7-chloroquinolin-2-yl)ethenyl)phenyl)-3-(2-(1-hydroxy-1-methylethyl)phenyl)propyl)thio)methyl)cyclopropyl]acetate
- Molecular Formula: C35H35ClNO3SNa
- Molecular Weight: 608.18 g/mol
- CAS Number: 105893-77-6
- Therapeutic Class: Leukotriene Receptor Antagonist (LTRA)
- Pharmacological Class: Anti-Asthmatic / Anti-Allergic
- ATC Code: R03DC03
Physical & Chemical Properties
| Property | Description |
|---|---|
| Appearance | White to off-white crystalline powder |
| Solubility | Soluble in water, methanol, and ethanol |
| Melting Point | 135°C – 140°C |
| pH (1% aqueous solution) | 5.5 – 7.0 |
| Storage | Store below 25°C in a dry, ventilated area, protected from light and moisture |
Technical Specifications
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR, UV, and HPLC positive |
| Assay (Purity) | ≥ 99.0% (HPLC) |
| Loss on Drying | ≤ 0.5% |
| Residue on Ignition | ≤ 0.1% |
| Heavy Metals | ≤ 10 ppm |
| Related Substances | ≤ 0.3% (individual impurity) |
| Bulk Density | 0.35 – 0.50 g/mL |
| Tapped Density | 0.50 – 0.65 g/mL |
Applications
Montelukast Sodium API is widely used in:
- Immediate-release tablets for asthma and allergic rhinitis
- Chewable tablets for pediatric use
- Granule formulations for oral suspension
- Combination therapy formulations for chronic asthma
Documentation Provided
- Certificate of Analysis (COA)
- Material Safety Data Sheet (MSDS)
- Technical Data Sheet (TDS)
- Method of Analysis (MOA)
- Stability Data (ICH-compliant)
- Regulatory Dossier / DMF (on request)
Packaging & Export Details
- Available Packs: 1 kg | 5 kg | 10 kg | 25 kg HDPE drums with double poly liners
- Labeling: Product name, batch number, manufacturing/expiry date, storage instructions
- Shelf Life: 36 months under recommended storage conditions
- Export Markets: Africa, Asia, Latin America, Europe, Middle East
