Description

Montelukast Cyclopropacetaneamide Impurity is a high-purity reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Montelukast Sodium. This compound is critical for ensuring the safety and efficacy of pharmaceutical products by enabling the accurate identification and quantification of process-related impurities. It is an essential material for analytical laboratories, quality assurance departments, and research institutions within the global pharmaceutical and biotechnology sectors.

Application

• Pharmaceutical Impurity Reference Standard: Primary use as a certified reference material (CRM) for method development and validation in HPLC and LC-MS analysis.
• Quality Control & Assurance (QC/QA): Used to establish impurity profiles, set specifications, and ensure batch-to-batch consistency of Montelukast Sodium API.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive impurity characterization data for drug master files (DMFs).
• Research & Development (R&D): Employed in stability studies, degradation pathway elucidation, and synthetic process optimization for Montelukast.
• Contract Research Organizations (CROs): Essential for analytical testing services offered to pharmaceutical clients.
• Pharmacopoeial Testing: Aids in compliance testing against monographs in USP, EP, and other pharmacopoeias.

Basic Information

Item	Detail
Product Name	Montelukast Cyclopropacetaneamide Impurity
CAS No.	866923-63-9
Molecular Formula	C36H39ClNO3S
Molecular Weight	601.22 g/mol
Synonyms	Montelukast Cyclopropane Carboxamide Impurity; Montelukast Cyclopropanecarboxamide Related Compound; Montelukast EP Impurity G; Montelukast USP Related Compound G; 1-(((1-(R)-(3-(2-(7-Chloro-2-quinolinyl)ethenyl)phenyl)-3-(2-(1-hydroxy-1-methylethyl)phenyl)propyl)thio)methyl)cyclopropaneacetamide; Cyclopropaneacetamide, 1-[[[[1-[[3-[2-(7-chloro-2-quinolinyl)ethenyl]phenyl]-3-[2-(1-hydroxy-1-methylethyl)phenyl]propyl]thio]methyl]methyl]-; Montelukast Carboxamide Impurity
EINECS	Contact for details

Quality Control

Every batch of Montelukast Cyclopropacetaneamide Impurity is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC, LC-MS, and NMR to ensure they meet the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability and purity. For long-term storage, consider desiccants or inert atmosphere.

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)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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