Description

Dimethindene Impurity H (2-[(1Rs)-1-(2-Ethenyl-1H-Inden-3-Yl)Ethyl]Pyridine) is a high-purity chemical reference standard critical for analytical method development and validation in pharmaceutical quality control. This compound serves as a specified impurity for the antihistamine drug substance Dimethindene, enabling precise monitoring and control to ensure final product safety and efficacy. It is an essential material for pharmaceutical R&D laboratories, quality assurance departments, and regulatory affairs teams focused on meeting stringent pharmacopeial requirements for impurity profiling.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the identification and quantification of Dimethindene Impurity H in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development: Used to develop, optimize, and validate stability-indicating HPLC, UPLC, or GC methods for impurity analysis.
• Quality Control & Assurance: Critical for routine batch release testing to confirm impurity levels are within International Council for Harmonisation (ICH) and pharmacopeial limits.
• Stability Studies: Employed as an analytical marker to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate comprehensive impurity control.
• Research & Development: Used in synthetic chemistry research to study the formation pathway and mitigation strategies for this impurity during the manufacturing process of Dimethindene.

Basic Information

Product Name	Dimethindene Impurity H
CAS No.	1346597-95-2
Molecular Formula	C18H17N
Molecular Weight	247.34 g/mol
Synonyms	2-[(1R)-1-(2-Ethenyl-1H-inden-3-yl)ethyl]pyridine; (R)-2-[1-(2-Vinyl-1H-inden-3-yl)ethyl]pyridine; Dimethindene Related Compound H; Dimethindene Impurity H; Forapine Impurity; Fenistil Impurity H
EINECS	Contact for details

Quality Control

Every batch of Dimethindene Impurity H is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic (HPLC, GC) and spectroscopic (NMR, MS) techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, analytical methods, and traceability.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage under inert atmosphere, please contact us for specific recommendations.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity ≤ 1.0% Total impurities ≤ 2.0%
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.