Description

Clopidogrel Impurity 31 Hcl is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for pharmaceutical quality control, specifically in the development and validation of analytical methods for the antiplatelet drug Clopidogrel. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure drug purity, safety, and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Clopidogrel active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, calibrating, and validating High-Performance Liquid Chromatography (HPLC) and other chromatographic methods in QC laboratories.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing necessary impurity data for health authorities like the FDA and EMA.
• Stability Studies: Employed in forced degradation and long-term stability studies to monitor impurity formation in Clopidogrel products under various storage conditions.
• Research & Development: Serves as a key intermediate or impurity standard in synthetic chemistry research and process development for Clopidogrel.
• Quality Assurance/Quality Control (QA/QC): Acts as a primary standard for routine batch release testing to ensure impurity levels are within specified limits.

Basic Information

Product Name	Clopidogrel Impurity 31 Hcl
CAS No.	1015247-86-5
Molecular Formula	C15H15Cl2NO2S • HCl
Molecular Weight	396.71 g/mol
Synonyms	Clopidogrel Related Compound 31 Hydrochloride; (S)-Methyl 2-(2-chlorophenyl)-2-(6,7-dihydrothieno[3,2-c]pyridin-5(4H)-yl)acetate Hydrochloride Impurity; Methyl (2S)-2-(2-Chlorophenyl)-2-(4H,5H,6H,7H-thieno[3,2-c]pyridin-5-yl)acetate Hydrochloride; Clopidogrel EP Impurity H HCl; Clopidogrel USP Impurity; Clopidogrel Process Impurity
EINECS	Contact for details

Quality Control

Our Clopidogrel Impurity 31 Hcl is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

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 product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

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%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Single Unknown Impurity (HPLC)	≤ 0.5%
Total Impurities (HPLC)	≤ 2.0%

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