Description

Ticlopidine Impurity J 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 availability of this well-characterized impurity standard is essential for maintaining stringent quality control in pharmaceutical production.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Ticlopidine Impurity J in drug substances and finished products.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or GC methods to monitor impurity levels in Ticlopidine batches.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard in routine quality control testing to ensure analytical procedures remain accurate and precise.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing definitive proof of impurity characterization and control strategies.
• Stability Studies: Employed to track the formation and growth of this specific impurity during forced degradation and long-term stability testing of Ticlopidine.
• Research & Development: Used in pharmacokinetic, metabolic, and toxicological studies to understand the profile and impact of this impurity.

Basic Information

Product Name	Ticlopidine Impurity J
CAS No.	108896-78-2
Molecular Formula	C14H14ClNO2S
Molecular Weight	295.78 g/mol
Synonyms	5-[(2-Chlorophenyl)methyl]-4,5,6,7-tetrahydrothieno[3,2-c]pyridin-2(3H)-one; Ticlopidine Related Compound J; Ticlopidine EP Impurity J; Ticlopidine USP Impurity J; Ticlopidine Process Impurity; 2-Oxo-5-[(2-chlorophenyl)methyl]-4,5,6,7-tetrahydrothieno[3,2-c]pyridine
EINECS	Contact for details

Quality Control

Every batch of Ticlopidine Impurity J is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure compliance with pharmacopeial standards (USP/EP/ICH). A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, identity, and impurity profile. We support regulatory needs with full traceability and stability data.

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. For long-term storage, consider storing under an inert atmosphere.

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)	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.