Description

Montelukast Impurity H is a specified, structurally characterized impurity used in the quality control and analytical development of the active pharmaceutical ingredient (API) Montelukast Sodium. This high-purity reference standard is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and impurity profiling.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of Montelukast Sodium.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing, validating, and verifying chromatographic methods to accurately identify and quantify this specific impurity.
• Quality Control & Batch Release Testing: Employed in routine QC testing of Montelukast API and finished drug products to monitor impurity levels against ICH guidelines.
• Stability Studies & Forced Degradation: Used to identify and track the formation of this impurity under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity control and characterization.
• Research & Development: Supports synthetic route optimization and process chemistry research to understand and minimize impurity formation.

Basic Information

Product Name	Montelukast Impurity H
CAS No.	851755-56-1
Molecular Formula	C35H36ClNO3S
Molecular Weight	586.18 g/mol
Synonyms	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; Montelukast Related Compound H; Montelukast EP Impurity H; Montelukast USP Impurity H
EINECS	Contact for details

Quality Control

Our Montelukast Impurity H is manufactured and controlled under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide a detailed Certificate of Analysis (COA) with each shipment, which includes batch-specific data and confirms compliance with relevant pharmacopeial standards (USP/EP) for impurity reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (NMR)	Spectrum consistent with reference structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Any individual impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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