Description

Clopidogrel Thiol Metabolite H2 Isomer Tfa Salt CAS NO 1801260-47-8 is a key synthetic intermediate and reference standard in the development and quality control of antiplatelet pharmaceuticals. This compound is critical for researchers and manufacturers requiring high-purity materials for analytical method development, impurity profiling, and metabolic studies. It is primarily utilized by the pharmaceutical industry, contract research organizations (CROs), and academic institutions focused on cardiovascular drug research and development.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of the H2 isomer metabolite in analytical methods, including HPLC and LC-MS.
• Impurity Profiling: Essential for characterizing and controlling process-related impurities and degradation products in clopidogrel bisulfate active pharmaceutical ingredient (API) and finished dosage forms.
• Metabolite Research: Serves as a critical tool in preclinical and clinical studies to understand the pharmacokinetics, pharmacodynamics, and bioactivation pathway of clopidogrel.
• Method Development & Validation: Employed in the development and validation of stability-indicating assays and dissolution testing methods for clopidogrel-based formulations.
• Synthetic Intermediate: Used in the chemical synthesis of related metabolites or labeled analogs (e.g., deuterated standards) for advanced mass spectrometry applications.
• Regulatory Submissions: Provides necessary data and materials for regulatory filings (e.g., FDA, EMA) to establish specification limits for this specific isomer in drug substances and products.

Basic Information

Product Name	Clopidogrel Thiol Metabolite H2 Isomer Tfa Salt
CAS No.	1801260-47-8
Molecular Formula	C17H16ClNO2S • C2HF3O2 (as TFA salt)
Molecular Weight	Contact for details
Synonyms	Clopidogrel Thiol Metabolite H2 Isomer Trifluoroacetate Salt; (S)-2-(2-Chlorophenyl)-2-(6,7-dihydrothieno[3,2-c]pyridin-5(4H)-yl)acetic acid thiol isomer TFA salt; Clopidogrel Active Metabolite H2 Isomer TFA Salt; Clopidogrel Thiol Derivative H2 Isomer; SR 26334 H2 Isomer TFA Salt; 2-Oxo-clopidogrel Thiol Metabolite Isomer H2 TFA Salt
EINECS	Contact for details

Quality Control

Our Clopidogrel Thiol Metabolite H2 Isomer Tfa Salt is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity assay, chiral purity determination, identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the stringent requirements for pharmaceutical reference standards. Certificates of Analysis (COA) with detailed chromatographic data are provided for traceability and compliance.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at 2-8°C. This material is hygroscopic (moisture-sensitive) and should be handled under anhydrous conditions to maintain stability and purity. Allow the sealed container to reach room temperature before opening to prevent condensation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Chiral Purity (Chiral HPLC)	≥ 99.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Meets ICH guidelines

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