Description

Clopidogrel Impurity 72 is a high-purity chemical 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 (API) clopidogrel bisulfate. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in drug development and quality control. The precise characterization of this impurity is essential for method validation and meeting stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Clopidogrel API and finished dosage forms.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing, validating, and transferring analytical methods in compliance with ICH Q2(R1) guidelines.
• Quality Control & Assurance (QC/QA): Serves as a system suitability and calibration standard in routine quality control testing to monitor batch-to-batch consistency.
• Regulatory Submissions: Provides necessary data for Drug Master Files (DMFs), Investigational New Drug (IND) applications, and New Drug Applications (NDA/ANDA) to regulatory agencies like the US FDA and EMA.
• Stability Studies: Employed to track the formation and level of this specific impurity during forced degradation and long-term stability studies of clopidogrel products.
• Research & Development: Used in pharmacokinetic and metabolic studies to understand the degradation pathways and impurity profile of clopidogrel.

Basic Information

Product Name	Clopidogrel Impurity 72
CAS No.	1314028-89-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Clopidogrel Related Compound 72; Clopidogrel Bisulfate Impurity 72; Clopidogrel Sulfate Impurity 72; (S)-Clopidogrel Impurity; Methyl (2S)-2-(2-chlorophenyl)-2-{6,7-dihydrothieno[3,2-c]pyridin-5(4H)-yl}acetate Impurity; Clopidogrel Process Impurity; Clopidogrel Degradant
EINECS	Contact for details

Quality Control

Our Clopidogrel Impurity 72 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC, LC-MS, and NMR, to ensure identity, purity, and conformity to the highest standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment. Our quality commitment aligns with cGMP principles and supports compliance with ICH, USP, and EP guidelines for pharmaceutical impurities.

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 under inert conditions or in a desiccator to prevent degradation upon exposure to atmospheric humidity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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