Description

Rac Clopidogrel-13C,D3 Hydrogen Sulfate is a high-purity, isotopically labeled reference standard used for precise analytical quantification. This compound is critical for ensuring the accuracy and reliability of bioanalytical and pharmacokinetic studies in pharmaceutical research and development. It is primarily utilized by analytical laboratories, CROs, and pharmaceutical manufacturers engaged in method development, validation, and quality control for clopidogrel-based drug products and metabolites.

Application

• Internal Standard for LC-MS/MS Analysis: Serves as a critical internal standard for the accurate quantification of clopidogrel and its metabolites in biological matrices like plasma and serum.
• Pharmaceutical R&D Method Development: Used to develop and validate robust, sensitive, and specific bioanalytical methods for drug metabolism and pharmacokinetic (DMPK) studies.
• Clinical Trial Support: Enables precise measurement of drug concentration in patient samples during clinical trials to assess bioavailability, bioequivalence, and therapeutic drug monitoring.
• Metabolite Identification and Profiling: Aids in the identification and structural elucidation of clopidogrel metabolites using advanced mass spectrometry techniques.
• Quality Control and Assurance: Acts as a certified reference material for in-house quality control procedures to ensure the consistency and accuracy of analytical results.
• Regulatory Submission Support: Provides essential data traceability and method robustness required for regulatory filings with agencies like the FDA and EMA.

Basic Information

Item	Details
Product Name	Rac Clopidogrel-13C,D3 Hydrogen Sulfate
CAS No.	1246814-55-0
Molecular Formula	C16H16Cl13CD3NO2S • H2SO4
Molecular Weight	~ 433.9 g/mol
Synonyms	Clopidogrel-13C,D3 Hydrogen Sulfate; Clopidogrel (phenyl-13C, d3) Hydrogen Sulfate; Methyl (+)-(S)-α-(2-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4H)-acetate-13C,d3 Sulfate; Isotopically Labeled Clopidogrel Bisulfate; Clopidogrel-d3-13C Hydrogen Sulfate; Rac-Clopidogrel-13C,D3 Bisulfate; 13C,D3-Labeled Clopidogrel Hydrogen Sulfate
EINECS	Contact for details

Quality Control

Every batch of Rac Clopidogrel-13C,D3 Hydrogen Sulfate is manufactured under strict quality management systems and undergoes comprehensive analytical characterization. We guarantee high chemical and isotopic purity verified by NMR, HPLC, and mass spectrometry. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting identity, purity, isotopic enrichment, and other critical parameters to support your regulatory and research requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or CoA. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 98.0%
Isotopic Purity	≥ 99 atom % 13C; ≥ 98 atom % D
Chemical Purity (NMR)	Conforms
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH guidelines

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