Description

Ticlopidine Impurity G is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient Ticlopidine. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling. The reliable identification and quantification of this impurity are essential for maintaining drug efficacy and meeting stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Ticlopidine HCl active pharmaceutical ingredient (API) batches.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or GC methods to monitor impurity profiles during API synthesis and purification processes.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard in routine QC testing to ensure analytical procedures remain accurate and precise for impurity detection.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Employed in forced degradation and long-term stability studies of Ticlopidine to understand impurity formation pathways under various stress conditions.
• Research & Development: Used in pharmaceutical R&D to study the metabolic pathways, degradation chemistry, and synthesis by-products of Ticlopidine.

Basic Information

Product Name	Ticlopidine Impurity G
CAS No.	55142-86-4
Molecular Formula	C14H14ClNS
Molecular Weight	263.78 g/mol
Synonyms	5-[(2-Chlorophenyl)methyl]-4,5,6,7-tetrahydrothieno[3,2-c]pyridine; 5-(2-Chlorobenzyl)-4,5,6,7-tetrahydrothieno[3,2-c]pyridine; Ticlopidine Related Compound G; Ticlopidine EP Impurity G; Ticlopidine USP Impurity G; Ticlopidine Impurity 7; Ticlopidine Hydrochloride Impurity G
EINECS	Contact for details

Quality Control

Every batch of Ticlopidine Impurity G is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing to ensure compliance with pharmacopeial standards such as USP and EP. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from advanced analytical techniques including HPLC, GC, NMR, and mass spectrometry.

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 nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption. For long-term storage, consider storing under an inert atmosphere.

Specification

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

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