Description

Ticlopidine Impurity F 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.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Ticlopidine Impurity F in drug substance and drug product testing.
• Analytical Method Development: Essential for developing and validating stability-indicating HPLC or UPLC methods to monitor impurity profiles.
• Quality Control & Assurance: A critical component in the QC release testing of Ticlopidine API to ensure compliance with pharmacopeial limits (e.g., ICH Q3A/B, USP, EP).
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Supports the filing of regulatory documents (e.g., DMF, CMC sections) by providing impurity characterization data.
• Research & Development: Used in synthetic chemistry R&D to understand and control impurity formation during the manufacturing process of Ticlopidine.

Basic Information

Product Name	Ticlopidine Impurity F
CAS No.	62019-75-4
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 F; Ticlopidine Impurity 6; Ticlopidine EP Impurity F; Ticlopidine USP Impurity F; 5-(2-Chlorobenzyl)-4,5,6,7-tetrahydrothieno[3,2-c]pyridine-2-carboxylic Acid; Ticlopidine Carboxylic Acid Impurity
EINECS	Contact for details

Quality Control

Every batch of Ticlopidine Impurity F is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced techniques like HPLC, NMR, and MS to ensure they meet the high standards required for pharmaceutical impurity analysis. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant guidelines.

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 to ensure maximum stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
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%

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