Description

Ticlopidine Impurity D is a designated impurity standard used in the analytical profiling and quality control of the antiplatelet drug Ticlopidine. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) by serving as a reference marker in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and routine batch testing to comply with stringent pharmacopeial standards.

Application

• Primary use as a certified reference standard (CRS) for the identification and quantification of Ticlopidine Impurity D in Ticlopidine API and finished dosage forms.
• Essential for pharmaceutical research and development (R&D) during process optimization and impurity fate and tolerance studies.
• Critical component in quality control (QC) laboratories for routine analysis to ensure batch-to-batch consistency and compliance with ICH guidelines.
• Used in method validation and transfer activities to establish the specificity, accuracy, and robustness of analytical procedures (e.g., HPLC, UPLC).
• Supports regulatory submissions (e.g., ANDA, NDA) by providing necessary impurity data for drug master files.
• Valuable for academic and institutional research studying the degradation pathways and stability profile of Ticlopidine.

Basic Information

Product Name	Ticlopidine Impurity D
CAS No.	55142-78-4
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; 5-(2-Chlorobenzyl)-4,5,6,7-tetrahydro-2-oxothieno[3,2-c]pyridine; Ticlopidine Related Compound D; Ticlopidine EP Impurity D; Ticlopidine USP Impurity D; Ticlopidine Hydrochloride Impurity D; 5-(o-Chlorobenzyl)tetrahydro-2-oxothieno[3,2-c]pyridine
EINECS	Contact for details

Quality Control

Every batch of Ticlopidine Impurity D is manufactured and controlled under a strict quality management system. The material is characterized and qualified using advanced analytical techniques including HPLC, GC, MS, and NMR to confirm identity and purity. We provide comprehensive Certificates of Analysis (COA) that detail all testing results, ensuring traceability and compliance with relevant pharmacopeial standards (USP, EP) and ICH Q3A/B 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). This material is hygroscopic (moisture-sensitive) and must be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity ≤ 0.5% Total impurities ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%
Assay	98.0% - 102.0% (on anhydrous basis)

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