Active Pharmaceutical Ingredient

Montelukast

Also known as: Singulair; Montair

CAS: 158966-92-8 Leukotriene Receptor Antagonist IP / BP / EP / USP GMP Certified Aurangabad, Maharashtra, India
Montelukast API — Mediocon Inc
Montelukast — Pharmaceutical Grade API

Product Overview

CAS No: 158966-92-8  |  MF: C₃₅H₃₆ClNO₃S  |  MW: 586.18 g/mol

Mirtazapine is a pharmaceutical-grade active ingredient classified as Leukotriene Receptor Antagonist. Mediocon Inc supplies high-purity Montelukast conforming to IP / BP / EP / USP specifications, manufactured in our GMP-certified facility in Aurangabad, Maharashtra, India.

Key Features

  • Selective leukotriene D4 receptor antagonist
  • IP/BP/EP/USP compliant
  • Full CoA and MSDS documentation
  • GMP certified manufacturing

Applications

  • Asthma prophylaxis and maintenance
  • Seasonal allergic rhinitis
  • Exercise-induced bronchoconstriction

Why Choose Mediocon

  • ISO 9001:2015 & GMP certified manufacturing
  • Consistent batch-to-batch quality with full CoA
  • Export-ready documentation: COO, MSDS, DMF
  • Flexible MOQ for both R&D and commercial scale
  • Dedicated QA support for regulatory filings

Product Specifications

Product NameMontelukast
Also Known AsSingulair; Montair
CAS Number158966-92-8
Chemical Name2-[1-[[(1R)-1-[3-[(E)-2-(7-chloroquinolin-2-yl)vinyl]phenyl]-3-[2-(propan-2-ylsulfinyl)phenyl]propyl]sulfanylmethyl]cyclopropyl]acetic acid
Molecular FormulaC₃₅H₃₆ClNO₃S
Molecular Weight586.18 g/mol
CategoryNaSSA Antidepressant
AppearanceWhite to off-white hygroscopic powder
SolubilityFreely soluble in ethanol and methanol; practically insoluble in water
GradeIP / BP / EP / USP

Analytical Specifications

ParameterSpecification
AssayNLT 98.0%
Loss on DryingNMT 0.5%
Heavy MetalsNMT 20 ppm
Residue on IgnitionNMT 0.1%
Microbial LimitsComplies with pharmacopoeia
IdentificationIR, HPLC Compliant
Packing25 kg HDPE drums / as per requirement
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