Description

Montelukast Ep Impurity E is a high-purity reference standard used in the pharmaceutical development and quality control of Montelukast Sodium, a leukotriene receptor antagonist. This impurity is critical for ensuring the safety and efficacy of the final drug product by enabling accurate identification and quantification during analytical testing. It is an essential material for research and development laboratories, quality assurance/quality control (QA/QC) units, and regulatory affairs departments within the global pharmaceutical and biotechnology industries.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Montelukast Ep Impurity E in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development and Validation: Crucial for developing, optimizing, and validating stability-indicating HPLC, UPLC, or LC-MS methods for Montelukast Sodium.
• Regulatory Compliance and Submission: Supports the preparation of regulatory documentation (e.g., for FDA, EMA, ICH) by providing impurity profiles and establishing specification limits as per ICH Q3A and Q3B guidelines.
• Stability Studies: Used to monitor impurity formation and degradation pathways in Montelukast Sodium under various stress conditions (e.g., heat, light, humidity).
• Quality Control Testing: Enables routine batch release testing and in-process control (IPC) to ensure API and drug product purity meets pharmacopeial standards (USP, EP).
• Process Chemistry Research: Aids in understanding and optimizing the synthesis pathway of Montelukast to minimize the formation of this specific impurity.

Basic Information

Product Name	Montelukast Ep Impurity E
CAS No.	1187586-58-8
Molecular Formula	C35H36ClNO3S
Molecular Weight	586.18 g/mol
Synonyms	Montelukast Impurity E; Montelukast Related Compound E; (1R)-1-[[[(1R)-1-[3-[(1E)-2-(7-Chloro-2-quinolinyl)ethenyl]phenyl]-3-[2-(1-hydroxy-1-methylethyl)phenyl]propyl]thio]methyl]cyclopropaneacetic Acid; Montelukast Diastereomer Impurity; Montelukast EP Impurity E; Montelukast USP Impurity E; Montelukast Stereoisomer Impurity
EINECS	Contact for details

Quality Control

Our Montelukast Ep Impurity E is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, identification by spectroscopic methods (IR, NMR, MS), and residual solvent analysis to ensure compliance with ICH guidelines and relevant pharmacopeial standards. A detailed Certificate of Analysis (COA) with batch-specific data is provided, confirming identity, purity, and traceability.

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 compound is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (by HPLC)	≥ 98.0%
Related Substances (HPLC)	Any 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.