Description

Montelukast Gem-Dimethylmethylene Analogue is a key pharmaceutical intermediate and reference standard used in the development and quality control of respiratory therapeutics. This compound is critical for ensuring the purity, efficacy, and safety of active pharmaceutical ingredients (APIs) targeting leukotriene receptors. It is primarily required by research institutions, analytical laboratories, and pharmaceutical manufacturers engaged in the synthesis, process optimization, and regulatory compliance of montelukast sodium and related drug substances.

Application

• Pharmaceutical Reference Standard: Serves as a critical impurity standard and system suitability marker for HPLC and LC-MS methods in the analysis of Montelukast Sodium API.
• Process Research & Development (R&D): Used as a building block or intermediate in the synthetic pathway development for leukotriene receptor antagonists.
• Quality Control & Assurance (QC/QA): Essential for method validation, impurity profiling, and establishing specification limits in accordance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Regulatory Compliance: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing characterized material for impurity identification and qualification studies.
• Academic & Contract Research: Utilized in pharmacological studies to understand structure-activity relationships (SAR) of montelukast analogues.

Basic Information

Product Name	Montelukast Gem-Dimethylmethylene Analogue
CAS No.	162489-70-5
Molecular Formula	C36H39ClNO3S
Molecular Weight	601.22 g/mol
Synonyms	1-(((1-(R)-(3-(2-(7-Chloro-2-quinolinyl)ethenyl)phenyl)-3-(2-(2-hydroxy-2-propyl)phenyl)propyl)thio)methyl)cyclopropaneacetic acid; Montelukast Gem-Dimethyl Impurity; Montelukast Related Compound G; Montelukast EP Impurity G; Montelukast USP Related Compound G; (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
EINECS	Contact for details

Quality Control

Our Montelukast Gem-Dimethylmethylene Analogue is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the stringent requirements for use as a reference standard. Certificates of Analysis (COA) with detailed chromatographic data are provided to support your regulatory and quality needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F), in a dry environment. For long-term storage, consider storing under inert atmosphere to ensure stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.