Montelukast Sodium is the sodium salt of montelukast, a selective leukotriene receptor antagonist used as an active pharmaceutical ingredient in respiratory and allergy-related pharmaceutical formulations. It selectively blocks the cysteinyl leukotriene receptor CysLT1, helping inhibit the effects of leukotrienes involved in airway inflammation and bronchoconstriction.
Montelukast Sodium is widely used in the development and manufacture of oral pharmaceutical dosage forms for asthma and allergic rhinitis.
Montelukast Sodium is a specialized respiratory pharmaceutical API used for formulation development and pharmaceutical manufacturing.
Important API quality attributes include identity, assay, related substances, water content, residual solvents, optical rotation, residue on ignition and polymorphic characteristics.
CAS Number: 151767-02-1
Molecular Formula: C35H35ClNNaO3S
Molecular Weight: 608.18 g/mol
Chemical Name: Sodium 2-[1-[[(1R)-1-[3-[2-(7-chloro-2-quinolinyl)ethenyl]phenyl]-3-[2-(2-hydroxypropan-2-yl)phenyl]propyl]thio]methyl]cyclopropyl]acetate
Drug Class: Leukotriene Receptor Antagonist
Therapeutic Class: Respiratory Agent
Therapeutic Area: Respiratory / Allergy
Molecule Type: Synthetic Small Molecule
Montelukast Sodium selectively antagonizes the cysteinyl leukotriene type 1 (CysLT1) receptor. Leukotrienes such as LTC4, LTD4 and LTE4 are inflammatory mediators that can contribute to bronchoconstriction, airway edema, mucus production and inflammation.
Its pharmacological activity includes:
By blocking CysLT1 receptors, montelukast reduces the biological effects of cysteinyl leukotrienes in the respiratory tract.
Montelukast Sodium API is used in pharmaceutical formulation development for:
Montelukast Sodium is particularly relevant to asthma and allergic rhinitis pharmaceutical development. It provides a non-steroidal mechanism for modulating leukotriene-mediated airway responses.
The API is commonly incorporated into oral dosage forms, including tablets, chewable tablets and granule formulations, depending on the approved product and formulation design.
Montelukast Sodium is generally described as a white to off-white hygroscopic powder. It is practically insoluble in water and soluble in selected organic solvents.
Because montelukast contains a defined stereochemical configuration and is susceptible to physicochemical degradation, appropriate control of purity, stereochemical identity, moisture and solid-state characteristics is important during API development and storage.
A controlled Montelukast Sodium API manufacturing process may involve:
The exact synthetic route and process parameters should be based on the validated manufacturing process and approved technical documentation.
Typical Montelukast Sodium API testing may include:
Store Montelukast Sodium API in a tightly closed container under controlled pharmaceutical storage conditions, protected from excessive moisture, heat and direct light. Final storage conditions should follow validated stability data and the approved API specification.
Montelukast Sodium is relevant to research involving:
Montelukast Sodium is a selective cysteinyl leukotriene receptor antagonist API with CAS Number 151767-02-1, molecular formula C35H35ClNNaO3S, and molecular weight 608.18 g/mol. It blocks CysLT1 receptors and is primarily used in pharmaceutical formulations for asthma and allergic rhinitis.
| Parameter | Specification |
|---|---|
| Appearance | White crystalline powder or crystals |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 3.0% |
| Residue on Ignition | NMT 0.5% |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 3.0% |
| Specific Rotation | −10.0° to −14.0° |