Description

Clopidogrel Impurity 20 Hcl 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 clopidogrel bisulfate. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in drug development, quality control, and stability studies. The material is supplied with comprehensive analytical data to support method validation and impurity profiling.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in clopidogrel bisulfate API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity detection in compliance with ICH guidelines.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to monitor impurity levels and ensure batch-to-batch consistency of pharmaceutical products.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, humidity, light) as part of drug stability profiling.
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings with agencies such as the FDA, EMA, and other global health authorities.
• Research & Development: Serves as a key intermediate or impurity marker in synthetic chemistry research and process development for clopidogrel.

Basic Information

Item	Details
Product Name	Clopidogrel Impurity 20 Hcl
CAS No.	2173294-67-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Clopidogrel Related Compound 20 Hydrochloride; Clopidogrel Impurity 20 Hydrochloride Salt; (S)-Methyl 2-(2-chlorophenyl)-2-(6,7-dihydrothieno[3,2-c]pyridin-5(4H)-yl)acetate Impurity 20 HCl; Clopidogrel EP Impurity H HCl; Clopidogrel USP Impurity 20 HCl; Clopidogrel Process Impurity 20 HCl
EINECS	Contact for details

Quality Control

Every batch of Clopidogrel Impurity 20 Hcl is manufactured and tested under strict quality management systems. The material undergoes comprehensive analytical characterization using advanced techniques such as HPLC, LC-MS, NMR, and IR to confirm identity and purity. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting batch-specific results for purity, related substances, and residual solvents. Our quality protocols are designed to meet the stringent requirements for pharmaceutical reference standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. Keep the container tightly sealed in a cool, dry, and well-ventilated place.

Specification

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

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