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 |
Mediocon Inc is a GMP-certified API manufacturer and bulk pharmaceutical ingredient supplier based in Aurangabad, Maharashtra, India. We specialise in supplying Montelukast — CAS 158966-92-8 (CAS 158966-92-8) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.
Our Montelukast — CAS 158966-92-8 is manufactured under strict quality management protocols compliant with WHO-GMP, ISO 9001:2015, and major pharmacopoeial standards (IP, BP, USP, EP). Every batch undergoes full analytical testing — identity (IR/HPLC), assay, related substances, residual solvents (ICH Q3C), heavy metals, and microbial limits — before release with a Certificate of Analysis.
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