Description

Montelukast Ep Impurity D / E is a high-purity reference standard used in the pharmaceutical development and quality control of Montelukast Sodium, a leukotriene receptor antagonist. This compound is critical for ensuring the safety and efficacy of the final drug product 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 contract manufacturing sectors.

Application

• Primary use as a pharmaceutical reference standard for method development and validation.
• Critical component in impurity profiling and stability studies of Montelukast Sodium API and finished dosage forms.
• Used for calibrating analytical equipment (HPLC, UPLC, LC-MS) in quality control laboratories.
• Supports regulatory compliance and filing by providing authentic impurity samples for identification in accordance with ICH guidelines.
• Essential for research and development activities aimed at understanding degradation pathways and optimizing synthesis processes.
• Utilized by contract research organizations (CROs) and testing laboratories offering analytical services to the pharmaceutical industry.

Basic Information

Product Name	Montelukast Ep Impurity D / E
CAS No.	2125943-58-8
Molecular Formula	C35H36ClNO3S
Molecular Weight	586.18 g/mol
Synonyms	Montelukast EP Impurity D; Montelukast EP Impurity E; (1R)-1-[[3-[(1E)-2-(7-Chloro-2-quinolinyl)ethenyl]phenyl][3-[(1R)-1-hydroxy-1-methylethyl]phenyl]thio]methyl]cyclopropaneacetic Acid; Montelukast Diastereomer Impurity; Montelukast Related Compound D/E; Montelukast Sulfoxide Diastereomer; SQ-30763 Impurity
EINECS	Contact for details

Quality Control

Every batch of Montelukast Ep Impurity D / E is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, NMR, and MS, to ensure identity, purity, and conformity with in-house specifications aligned with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing all test results is provided with each shipment to support your regulatory and quality assurance requirements.

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 must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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