Description

Rac Clopidogrel-D4 Hydrogen Sulfate is a high-purity, deuterium-labeled internal standard critical for accurate quantitative analysis in pharmaceutical research and development. This stable isotope-labeled compound is essential for ensuring precision and reliability in mass spectrometry-based assays, particularly for pharmacokinetic and metabolic studies. It is primarily used by analytical laboratories, CROs, and pharmaceutical companies engaged in the development and quality control of the antiplatelet drug clopidogrel.

Application

• Internal Standard for LC-MS/MS: Serves as a critical reference compound for the precise quantification of clopidogrel and its metabolites in biological matrices like plasma and serum.
• Drug Metabolism and Pharmacokinetics (DMPK): Enables accurate tracking of drug absorption, distribution, metabolism, and excretion (ADME) profiles in preclinical and clinical studies.
• Bioanalytical Method Development and Validation: Used to establish robust, sensitive, and specific analytical methods compliant with FDA and ICH guidelines.
• Clinical Research: Supports therapeutic drug monitoring and comparative bioavailability/bioequivalence studies.
• Pharmaceutical Impurity Profiling: Aids in the identification and quantification of process-related impurities or degradants.
• Forensic and Anti-Doping Analysis: Provides a definitive standard for confirmatory testing in specialized analytical fields.

Basic Information

Product Name	Rac Clopidogrel-D4 Hydrogen Sulfate
CAS No.	1219274-96-0
Molecular Formula	C16H12D4ClNO2S • H2SO4
Molecular Weight	~ 429.90 g/mol (for monoisotopic form)
Synonyms	Clopidogrel-d4 Hydrogen Sulfate; Methyl (2S)-2-(2-chlorophenyl)-2-[(4,5,6,7-tetradeutero-4,5,6,7-tetrahydrothieno[3,2-c]pyridin-2-yl)]acetate sulfate (1:1); Clopidogrel-d4 bisulfate; Deuterated Clopidogrel Hydrogen Sulfate; rac-Clopidogrel-d4 HSO4; Clopidogrel (phenyl-d4) Hydrogen Sulfate; (RS)-Clopidogrel-d4 Hydrogen Sulfate
EINECS	Contact for details

Quality Control

Every batch of Rac Clopidogrel-D4 Hydrogen Sulfate is manufactured and analyzed under strict quality systems. We guarantee high chemical and isotopic purity as verified by advanced spectroscopic and chromatographic techniques, including NMR, HPLC, and mass spectrometry. A comprehensive Certificate of Analysis (COA) detailing purity, isotopic enrichment, and identity is provided with each shipment to support regulatory submissions and ensure data integrity.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This product 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 powder
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 98.0%
Isotopic Purity (deuterium enrichment)	≥ 98 atom % D
Chemical Purity (by NMR)	Conforms
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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