Description

25-Hydroxy Montelukast is a key pharmacologically active metabolite of the leukotriene receptor antagonist Montelukast. This compound is of critical importance for pharmaceutical research and development, particularly in the study of drug metabolism, pharmacokinetics, and bioanalytical method validation. It is primarily required by pharmaceutical companies, contract research organizations (CROs), and academic institutions engaged in the development and quality control of Montelukast-based therapies.

Application

• Reference Standard for Analytical Testing: Serves as a certified reference material (CRM) for the identification and quantification of Montelukast and its metabolites in drug substances and finished pharmaceutical products using HPLC, LC-MS, or other chromatographic methods.
• Metabolite Studies & Pharmacokinetics (PK): Essential for conducting in-vitro and in-vivo metabolism studies to understand the absorption, distribution, metabolism, and excretion (ADME) profile of Montelukast.
• Bioanalytical Method Development: Used as a critical standard for developing and validating sensitive and specific assays for biological matrices (plasma, serum, urine) in clinical and non-clinical trials.
• Impurity Profiling & Control: Acts as a specified impurity or degradation product standard to establish impurity limits and ensure drug product safety and compliance with ICH guidelines.
• Pharmaceutical R&D: Utilized in research aimed at understanding structure-activity relationships (SAR) and for the potential development of novel therapeutic agents targeting the cysteinyl leukotriene receptor.

Basic Information

Product Name	25-Hydroxy Montelukast
CAS No.	200804-28-0
Molecular Formula	C35H36ClNO3S
Molecular Weight	586.18 g/mol
Synonyms	Montelukast Hydroxy Acid; Montelukast Metabolite M6; 1-(((1-(R)-(3-(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; SQ 31,636; SQ-31636
EINECS	Contact for details

Quality Control

Our 25-Hydroxy Montelukast is manufactured and controlled under a strict quality management system. Each batch undergoes comprehensive analytical testing, including identification (IR, HPLC), assay (HPLC), and impurity profile analysis (Related Substances by HPLC) to ensure it meets the high-purity standards required for pharmaceutical reference materials. A detailed Certificate of Analysis (COA) providing batch-specific data is supplied with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). The product is light-sensitive and should be handled under appropriate conditions to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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