Also known as: Singulair; Montair; Lukast
Montelukast is a high-purity Active Pharmaceutical Ingredient (API) classified as a Leukotriene Receptor Antagonist (LTRA). Manufactured by Mediocon Inc in Aurangabad, Maharashtra, India at a GMP-certified facility, it is supplied in bulk for pharmaceutical formulations worldwide. CAS No: 158966-92-8.
| Parameter | Specification |
|---|---|
| CAS Number | 158966-92-8 |
| Molecular Formula | C₃₅H₃₆ClNO₃S |
| Molecular Weight | 586.13 g/mol |
| Grade | IP / BP / EP / USP |
| Category | Leukotriene Receptor Antagonist (LTRA) |
| Appearance | White to off-white hygroscopic powder |
| Solubility | Practically insoluble in water; freely soluble in ethanol and methanol |
| Assay | NLT 98.0% |
| Loss on Drying | NMT 0.5% |
| Heavy Metals | NMT 20 ppm |
| Residue on Ignition | NMT 0.1% |
| Microbial Limits | Complies with pharmacopoeia |
| Identification | IR, HPLC Compliant |
| Batch No | MON/24032026 |
| Mfg Date | MAR 2026 |
| Exp Date | FEB 2031 |
| Packing | 25 kg HDPE drums / as per requirement |