Description

Clopidogrel Acyl--D-Glucuronide is a key metabolite and reference standard of the widely prescribed antiplatelet drug clopidogrel. This compound is essential for pharmaceutical research and development, particularly in the study of drug metabolism, pharmacokinetics, and bioanalytical method validation. It is primarily utilized by pharmaceutical companies, contract research organizations (CROs), and academic institutions engaged in cardiovascular drug development and regulatory compliance testing.

Application

• Metabolite Identification and Profiling: Used as an analytical reference standard to identify and quantify the acyl glucuronide metabolite of clopidogrel in biological matrices.
• Pharmacokinetic (PK) and Bioequivalence Studies: Critical for developing and validating bioanalytical assays to measure drug and metabolite levels in plasma and serum.
• Drug Metabolism and Pharmacodynamics (DMPK) Research: Serves as a tool to understand the metabolic pathways, clearance mechanisms, and potential activity of clopidogrel metabolites.
• Impurity Characterization and Control: Employed as a known impurity standard to monitor and control the quality of clopidogrel active pharmaceutical ingredient (API) and finished drug products.
• Regulatory Submission Support: Provides essential data for Investigational New Drug (IND) and New Drug Application (NDA) submissions to agencies like the FDA and EMA.
• Stability Indicating Method Development: Aids in developing HPLC or LC-MS/MS methods to assess the stability of clopidogrel formulations under various conditions.

Basic Information

Product Name	Clopidogrel Acyl--D-Glucuronide
CAS No.	1314116-53-4
Molecular Formula	C28H30ClNO9S
Molecular Weight	616.06 g/mol
Synonyms	Clopidogrel Acyl Glucuronide; Clopidogrel Carboxylic Acid Glucuronide; (2S)-2-{2-[(1S)-1-(2-Chlorophenyl)-2-methoxy-2-oxoethyl]-4-methyl-5,6,7,8-tetrahydrothieno[3,2-c]pyridin-4-ium-3-yl}acetic acid β-D-glucopyranosiduronic acid; Clopidogrel Acyl-β-D-Glucuronide; Clopidogrel AG; Clopidogrel Metabolite (Acyl Glucuronide); Clopidogrel-AG
EINECS	Contact for details

Quality Control

Our Clopidogrel Acyl--D-Glucuronide is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A detailed Certificate of Analysis (COA) providing batch-specific data is supplied with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a dry, cool place. This product is hygroscopic (moisture-sensitive). For long-term storage, consider desiccation and storage under an inert atmosphere. Allow the sealed vial to equilibrate to room temperature before opening to minimize moisture uptake.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Meets ICH guidelines

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