Description

Rac-Clopidogrel-D4 Carboxylic Acid is a high-purity, isotopically labeled derivative of the active metabolite of clopidogrel. This compound is essential for use as a certified reference standard in analytical chemistry, providing critical support for method development, validation, and regulatory compliance. It is primarily required by pharmaceutical R&D laboratories, contract research organizations (CROs), and quality control departments for precise bioanalytical studies, pharmacokinetic research, and ensuring the accuracy of mass spectrometry-based assays.

Application

• Pharmaceutical Reference Standard: Serves as a critical internal standard or certified reference material (CRM) for the quantitative analysis of clopidogrel and its metabolites in biological matrices using LC-MS/MS and GC-MS.
• Drug Metabolism and Pharmacokinetics (DMPK): Used in stable isotope dilution assays to study the absorption, distribution, metabolism, and excretion (ADME) profile of clopidogrel with high precision.
• Bioanalytical Method Development: Enables the development and validation of highly sensitive and specific analytical methods for clinical and preclinical studies, improving data reliability.
• Impurity Profiling and Characterization: Aids in the identification and quantification of process-related impurities and degradants in active pharmaceutical ingredient (API) batches.
• Clinical Research: Supports therapeutic drug monitoring (TDM) and pharmacogenomic studies investigating variable patient responses to clopidogrel therapy.
• Regulatory Submissions: Provides essential data traceability and method robustness required for FDA, EMA, and ICH regulatory filings.

Basic Information

Product Name	Rac-Clopidogrel-D4 Carboxylic Acid
CAS No.	1246814-52-7
Molecular Formula	C16H12D4ClNO2S
Molecular Weight	324.84 g/mol (for unlabeled form, contact for exact deuterated mass)
Synonyms	Clopidogrel Carboxylic Acid-d4; 2-(2-Chlorophenyl)-2-(4,5,6,7-tetradeutero-6,7-dihydrothieno[3,2-c]pyridin-5(4H)-yl)acetic Acid; Methyl (+)-(S)-α-(2-Chlorophenyl)-4,5,6,7-tetradeutero-6,7-dihydrothieno[3,2-c]pyridin-5(4H)-acetate Carboxylic Acid-d4; rac-Clopidogrel Acid-d4; Clopidogrel-d4 Metabolite; SR 26334-d4; Deuterated Clopidogrel Carboxylic Acid
EINECS	Contact for details

Quality Control

Our Rac-Clopidogrel-D4 Carboxylic Acid is manufactured under strict quality systems to ensure the highest standards of isotopic purity and chemical integrity. Each batch is comprehensively characterized using advanced spectroscopic and chromatographic techniques, including NMR, HPLC, and mass spectrometry, to confirm identity, chemical purity, and isotopic enrichment. A detailed Certificate of Analysis (COA) is provided, documenting batch-specific data. Our quality commitment aligns with the standards expected for reference materials in pharmaceutical analysis.

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 material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccant use.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (Deuterium Content)	≥ 98.0 atom % D
Chemical Purity (NMR)	Conforms
Residual Solvents (GC)	Complies with ICH limits
Water Content (KF)	≤ 1.0%

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