Overview
Montelukast (CAS 158966-92-8 ) is a leukotriene receptor antagonist active pharmaceutical ingredient used in the treatment of asthma and allergic rhinitis. It is sourced by pharmaceutical manufacturers and contract formulators as a finished API for solid oral dosage development.
The primary application is in the manufacture of prescription and OTC oral tablets and chewable formulations targeting respiratory indications. Generic drug manufacturers source this API to produce bioequivalent products following patent expiry.
This material is an active procurement target across regulated and semi-regulated markets. Pediatric chewable tablet formats represent a distinct formulation segment, requiring specific particle size and excipient compatibility considerations.
These factors are highly relevant to QA and formulation teams during the development process. It also appears as a key intermediate reference in analytical method development and pharmacokinetic research programs.
The product is supplied as a white to off-white crystalline powder, typically as the sodium salt form. Standard grades available include USP , BP , and Ph. Eur. compliant material for global distribution.
Documentation packages are provided to support regulatory submissions in major markets. Bulk quantities are offered for commercial manufacturing, with smaller research-grade quantities available for formulation development.
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Physical Properties
| Melting Point | 84 °C |
| Boiling Point | 750.5±60.0 °C(Predicted) |
| Density | 1.272±0.06 g/cm3(Predicted) |
| Color | Light yellow to yellow |
| Form | A solid |
Safety & Handling
Warning GHS07 Hazard Statements H302 Harmful if swallowed H312 Harmful in contact with skin H332 Harmful if inhaled Precautionary Statements P261 Avoid breathing dust/fume/gas/mist/vapours/spray. P264 Wash … thoroughly after handling. P270 Do not eat, drink or smoke when using this product. P271 Use only outdoors or in a well-ventilated area. P280 Wear protective gloves/protective clothing/eye protection/face protection. P317 Get emergency medical help. P321 Specific treatment (see … on this label). P330 Rinse mouth. P501 Dispose of contents/container in accordance with local regulations. P301+P317 Get emergency medical help. P302+P352 IF ON SKIN: Wash with plenty of water. P304+P340 IF INHALED: Remove person to fresh air and keep comfortable for breathing. P362+P364 Take off contaminated clothing and wash it before reuse.
Other Names
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Chemical Properties
- CAS Number
- 158966-92-8
- EC Number
- 605-168-4
- Mol. Weight
- 586.2
- Category
- Heterocyclic Compounds