Description

Clopidogrel-D3 Hydrogen Sulphate is a deuterated isotopologue of the active pharmaceutical ingredient clopidogrel bisulfate, specifically labeled with three deuterium atoms. This compound is of critical importance as an internal standard in quantitative bioanalytical methods, ensuring the accuracy and reliability of pharmacokinetic and metabolic studies. It is primarily needed by pharmaceutical research laboratories, contract research organizations (CROs), and analytical testing facilities engaged in drug development, bioequivalence studies, and clinical research for antiplatelet therapies.

Application

• Primary use as an Internal Standard in Liquid Chromatography-Mass Spectrometry (LC-MS/MS) for the quantification of clopidogrel and its metabolites in biological matrices.
• Supporting Pharmacokinetic (PK) and Bioequivalence (BE) Studies for generic and novel clopidogrel formulations.
• Facilitating Drug Metabolism and Pharmacokinetics (DMPK) research to understand the absorption, distribution, metabolism, and excretion (ADME) profile.
• Use in Clinical Research and therapeutic drug monitoring (TDM) to correlate drug plasma levels with therapeutic efficacy.
• Application in Forensic and Anti-Doping Analysis for the precise identification and quantification of clopidogrel.
• Serving as a critical reagent in the development and validation of Regulatory-Compliant Analytical Methods (e.g., for FDA, EMA submissions).

Basic Information

Product Name	Clopidogrel-D3 Hydrogen Sulphate
CAS No.	1217643-68-9
Molecular Formula	C16H13D3ClNO2S • H2SO4
Molecular Weight	~ 422.32 g/mol (for monoisotopic mass)
Synonyms	Clopidogrel-d3 Bisulfate; Clopidogrel-d3 Hydrogen Sulfate; (S)-(+)-Clopidogrel-d3 Bisulfate; Methyl (S)-α-(2-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4H)-acetate-d3 Sulfate; Clopidogrel (deuterated, D3) Bisulfate; Isotopically Labeled Clopidogrel Bisulfate; Clopidogrel Internal Standard (D3); Plavix-d3 (deuterated analog)
EINECS	Contact for details

Quality Control

Our Clopidogrel-D3 Hydrogen Sulphate is manufactured under strict quality control protocols to ensure the high chemical and isotopic purity required for sensitive analytical applications. Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing parameters such as isotopic enrichment, chemical purity, and absence of interfering impurities. We adhere to relevant industry standards for reference materials, ensuring reliable and reproducible performance in your LC-MS/MS assays. Certificates of Analysis are available upon request.

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); therefore, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time corresponds to reference
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D3)	≥ 98.0 atom % D
Chemical Purity	≥ 95.0%
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.5%

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