Description

21(R)-Hydroxy Montelukast is a key pharmaceutical intermediate and a major metabolite of the leukotriene receptor antagonist Montelukast. This compound is of critical importance for analytical and research purposes, particularly in the study of drug metabolism, pharmacokinetics, and for use as a reference standard in bioanalytical method development. It is essential for pharmaceutical R&D laboratories, quality control units, and contract research organizations (CROs) focused on respiratory therapeutics.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the quantification and identification of Montelukast metabolites in biological matrices.
• Drug Metabolism and Pharmacokinetics (DMPK) Studies: Used in in vitro and in vivo studies to understand the metabolic pathways and clearance mechanisms of Montelukast.
• Bioanalytical Method Development: Critical for developing and validating sensitive HPLC-MS/MS or LC-UV methods for therapeutic drug monitoring and clinical studies.
• Impurity Profiling: Employed as a specified impurity standard to monitor and control the quality of Montelukast active pharmaceutical ingredient (API) during manufacturing.
• Pharmacological Research: Used in research to investigate the activity and role of Montelukast metabolites, contributing to a deeper understanding of its efficacy and safety profile.

Basic Information

Product Name	21(R)-Hydroxy Montelukast
CAS No.	184763-26-6
Molecular Formula	C35H36ClNO3S
Molecular Weight	586.18 g/mol
Synonyms	21-Hydroxy Montelukast (R-isomer); Montelukast Hydroxy Acid (21R); 1-[[[(1R)-1-[3-[(1E)-2-(7-Chloro-2-quinolinyl)ethenyl]phenyl]-3-[2-(1-hydroxy-1-methylethyl)phenyl]propyl]thio]methyl]cyclopropaneacetic Acid; (R)-2-(1-((1-(3-(2-(7-Chloroquinolin-2-yl)vinyl)phenyl)-3-(2-(2-hydroxypropan-2-yl)phenyl)propyl)thio)methyl)cyclopropyl)acetic Acid; Montelukast Metabolite M6; SQ 31,636 (Hydroxy Acid)
EINECS	Contact for details

Quality Control

Our 21(R)-Hydroxy Montelukast is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identification by spectroscopic methods (NMR, IR, MS), purity determination by HPLC, and control of specified impurities. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming compliance with in-house specifications suitable for use as a reference standard. We support compliance with cGMP and ICH Q7 guidelines for pharmaceutical intermediates.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment. For long-term storage, consider desiccant and inert atmosphere to ensure stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 1.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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