Description

Ticlopidine Ep Impurity E Bromide is a high-purity chemical reference standard critical for pharmaceutical research and development. This compound serves as a specified impurity in the quality control and regulatory compliance of Ticlopidine hydrochloride, an antiplatelet medication. It is essential for analytical chemists and quality assurance professionals in the pharmaceutical industry who require reliable standards for method validation, stability studies, and ensuring drug safety. The precise characterization of such impurities is fundamental to meeting stringent pharmacopoeial guidelines like EP, USP, and ICH.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Ticlopidine-related impurities in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development and Validation: Critical for developing, calibrating, and validating High-Performance Liquid Chromatography (HPLC) and other chromatographic methods in QC laboratories.
• Stability Indicating Studies: Used to monitor the formation of degradation products in Ticlopidine formulations under various stress conditions (e.g., heat, light, humidity).
• Regulatory Compliance and Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity profiles and data required for drug master files (DMFs).
• Pharmacopoeial Testing: Employed in testing to comply with monographs in the European Pharmacopoeia (EP), United States Pharmacopeia (USP), and other international standards.
• Research and Synthesis: Serves as a key intermediate or analytical marker in organic synthesis research and process chemistry for developing improved synthetic routes.

Basic Information

Product Name	Ticlopidine Ep Impurity E Bromide
CAS No.	73099-88-4
Molecular Formula	C14H14BrNS
Molecular Weight	308.24 g/mol
Synonyms	5-[(2-Bromophenyl)methyl]-4,5,6,7-tetrahydrothieno[3,2-c]pyridine; Ticlopidine Impurity E; Ticlopidine Related Compound E; Ticlopidine Bromo Impurity; Ticlopidine EP Impurity E; 2-Bromobenzyl Ticlopidine Impurity; (2-Bromobenzyl)tetrahydrothienopyridine
EINECS	Contact for details

Quality Control

Every batch of Ticlopidine Ep Impurity E Bromide is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced techniques like HPLC, GC, NMR, and mass spectrometry to ensure compliance with pharmacopoeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH Q3A/B, EP, and USP guidelines for impurities in new drug substances and products.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%
Heavy Metals	≤ 20 ppm

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