Description

Clopidogrel Related Compound C (20 Mg) (Methyl (-)-(R)-(o-Chlorophenyl)-6,7-Dihydrothieno[3,2-C]Pyridine-5(4H)-Acetate, Hydrogen Sulfate) is a high-purity reference standard and pharmaceutical intermediate critical for quality control and research in drug development. This compound is essential for ensuring the purity, safety, and efficacy of the widely used antiplatelet drug, Clopidogrel bisulfate. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in API synthesis, impurity profiling, and regulatory compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for HPLC, LC-MS, and other analytical methods to quantify and qualify related substances in Clopidogrel bisulfate Active Pharmaceutical Ingredients (APIs) and finished dosage forms.
• Analytical Method Development & Validation: Serves as a critical component in developing, validating, and transferring analytical procedures for impurity identification and control in compliance with ICH guidelines.
• Pharmaceutical Research & Development: Employed in stability studies, forced degradation studies, and metabolic pathway research to understand the drug's behavior and degradation profile.
• Quality Control & Assurance (QC/QA): Integral for in-process testing and release testing of Clopidogrel APIs to ensure they meet stringent pharmacopeial specifications (e.g., USP, EP).
• Regulatory Documentation: Provides essential data for regulatory filings (e.g., ANDA, NDA) with agencies like the FDA and EMA, supporting impurity identification and control strategies.
• Academic & Contract Research: Used in universities and CROs for pharmacological studies and as a teaching tool for advanced organic chemistry and pharmaceutical analysis.

Basic Information

Product Name	Clopidogrel Related Compound C (20 Mg) (Methyl (-)-(R)-(o-Chlorophenyl)-6,7-Dihydrothieno[3,2-C]Pyridine-5(4H)-Acetate, Hydrogen Sulfate)
CAS No.	120202-71-3
Molecular Formula	C16H16ClNO3S • H2SO4
Molecular Weight	419.87 g/mol (for the hydrogen sulfate salt)
Synonyms	Clopidogrel Impurity C; Clopidogrel Related Substance C; Methyl (R)-(+)-(o-chlorophenyl)-4,5,6,7-tetrahydrothieno[3,2-c]pyridine-5-acetate hydrogen sulfate; (R)-(+)-Methyl 2-(2-chlorophenyl)-2-(4,5,6,7-tetrahydrothieno[3,2-c]pyridin-5-yl)acetate sulfate; Clopidogrel Sulfate Impurity C; SR 25989 Impurity; PCRC; Clopidogrel EP Impurity C
EINECS	Contact for details

Quality Control

Our Clopidogrel Related Compound C is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, identification by IR and NMR, and residual solvent analysis, to ensure it meets the stringent requirements for use as a reference standard. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming compliance with in-house specifications and relevant pharmacopeial guidelines for impurity standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and light-sensitive; ensure the container is kept tightly sealed in a desiccated environment to maintain stability and purity.

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%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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