Description

Montelukast Dicyclohexylamine Salt is a non-hygroscopic, crystalline salt form of the leukotriene receptor antagonist montelukast, offering enhanced stability and handling properties for advanced pharmaceutical manufacturing. This compound is critical for ensuring the precise formulation and long-term shelf-life of finished drug products targeting respiratory conditions. It is an essential high-purity intermediate for pharmaceutical companies engaged in the development and production of anti-asthma and allergy medications.

Application

• Active Pharmaceutical Ingredient (API) Intermediate: Primary use in the synthesis of the final montelukast API for tablet and chewable dosage forms.
• Respiratory Drug Formulation: Key raw material in the manufacture of medications for chronic asthma and seasonal allergic rhinitis.
• Pharmaceutical R&D: Used in research laboratories for developing new drug delivery systems and stability studies.
• Reference Standard: Serves as a certified reference material for quality control and analytical method validation in QC laboratories.
• Process Optimization: Employed to improve crystallization and purification processes in scale-up manufacturing.

Basic Information

Product Name	Montelukast Dicyclohexylamine Salt
CAS No.	577953-88-9
Molecular Formula	C38H49ClNNaO3S • C12H23N
Molecular Weight	802.51 g/mol
Synonyms	Montelukast DCHA Salt; Montelukast Dicyclohexylammonium Salt; 1-(((1-(R)-(3-(2-(7-Chloro-2-quinolinyl)ethenyl)phenyl)-3-(2-(1-hydroxy-1-methylethyl)phenyl)propyl)thio)methyl)cyclopropaneacetic Acid Dicyclohexylamine Salt; Sodium 1-(((1-(R)-(3-(2-(7-Chloro-2-quinolinyl)ethenyl)phenyl)-3-(2-(1-hydroxy-1-methylethyl)phenyl)propyl)thio)methyl)cyclopropaneacetate Dicyclohexylamine Salt; MK-0476 Dicyclohexylamine Salt; Singulair® Intermediate Salt
EINECS	Contact for details

Quality Control

Our Montelukast Dicyclohexylamine Salt is manufactured under strict quality systems in compliance with cGMP guidelines. Every batch is subjected to comprehensive analytical testing, including HPLC for purity and chiral purity, residual solvent analysis, and identification by IR and NMR. A comprehensive Certificate of Analysis (COA) documenting all specifications is provided with each shipment to ensure traceability and regulatory compliance for our pharmaceutical partners.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). The product is hygroscopic; protect from moisture and store under inert atmosphere if the container is opened frequently.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time corresponds to reference
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Chiral Purity (HPLC)	≥ 99.5% (R-isomer)
Water Content (KF)	≤ 0.5% w/w
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Total impurities ≤ 1.0% Any single impurity ≤ 0.5%

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.