Description

Ticlopidine Impurity E is a high-purity reference standard critical for pharmaceutical research and development. This compound is essential for the accurate identification, quantification, and control of process-related impurities in the active pharmaceutical ingredient (API) Ticlopidine. It is primarily required by analytical laboratories, quality control (QC) departments, and regulatory affairs teams within the pharmaceutical and fine chemical industries to ensure drug safety, efficacy, and compliance with stringent international guidelines.

Application

• Pharmaceutical Reference Standard: Serves as a certified external standard for the calibration of analytical instruments (HPLC, LC-MS) in impurity profiling.
• Method Development and Validation: Used in developing and validating precise analytical methods for impurity detection and quantification in Ticlopidine API and finished dosage forms.
• Quality Control and Assurance: Employed in routine batch testing to monitor and control the levels of Impurity E, ensuring API purity meets pharmacopeial specifications (e.g., USP, EP).
• Regulatory Compliance and Filing: A critical component in regulatory submission dossiers (e.g., for FDA, EMA) to demonstrate comprehensive impurity understanding and control strategies.
• Stability Studies: Used to track the formation of this specific impurity over time under various stress conditions, supporting shelf-life determination.
• Research and Development: Facilitates chemical and process research aimed at understanding impurity formation pathways and optimizing synthesis to minimize its presence.

Basic Information

Product Name	Ticlopidine Impurity E
CAS No.	721387-90-2
Molecular Formula	C14H14ClNO2S
Molecular Weight	295.78 g/mol
Synonyms	5-[(2-Chlorophenyl)methyl]-4,5,6,7-tetrahydrothieno[3,2-c]pyridine-2-carboxylic Acid; Ticlopidine Related Compound E; Ticlopidine EP Impurity E; Ticlopidine USP Impurity E; 5-(2-Chlorobenzyl)-4,7-dihydro-5H-thieno[3,2-c]pyridine-2-carboxylic Acid; Ticlopidine Carboxylic Acid Impurity; Ticlopidine Impurity III (Carboxylic Acid)
EINECS	Contact for details

Quality Control

Every batch of Ticlopidine Impurity E is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced techniques like HPLC and mass spectrometry to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your quality and regulatory requirements.

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, consider storing at 2-8°C. Keep the container sealed to protect from moisture.

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 single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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