Description

Prasugrel Metabolite M5 CAS NO 916599-27-4 is the key active metabolite of the antiplatelet drug Prasugrel. This high-purity reference standard is critical for pharmaceutical research and development, particularly in the study of drug metabolism, pharmacokinetics, and bioanalytical method validation. It is an essential material for pharmaceutical companies, contract research organizations (CROs), and analytical laboratories focused on cardiovascular drug development and quality control.

Application

• Pharmaceutical Reference Standard: Serves as a primary standard for the identification and quantification of the active metabolite in biological matrices and finished drug products.
• Bioanalytical Method Development: Used to develop and validate sensitive HPLC, LC-MS, and LC-MS/MS methods for pharmacokinetic (PK) and pharmacodynamic (PD) studies.
• Metabolite Profiling & Characterization: Essential for studying the metabolic pathways of Prasugrel and for the structural confirmation of its derivatives.
• Impurity Identification & Control: Acts as a critical marker for monitoring related substances and process-related impurities in Prasugrel API and formulation manufacturing.
• Clinical Research: Utilized in clinical trials to correlate metabolite levels with antiplatelet efficacy and safety profiles.
• Regulatory Submissions: Provides certified material for inclusion in regulatory documentation (e.g., for FDA, EMA) to support drug approval dossiers.

Basic Information

Item	Details
Product Name	Prasugrel Metabolite M5
CAS No.	916599-27-4
Molecular Formula	C16H19FNO3S
Molecular Weight	324.39 g/mol
Synonyms	2-[2-(Acetyloxy)-6,7-dihydrothieno[3,2-c]pyridin-5(4H)-yl]-1-cyclopropyl-2-(2-fluorophenyl)ethanone; R-138727; Prasugrel Active Metabolite; (5)-2-[2-(Acetyloxy)-6,7-dihydrothieno[3,2-c]pyridin-5(4H)-yl]-1-cyclopropyl-2-(2-fluorophenyl)ethanone; Prasugrel Metabolite R-138727; Prasugrel's Active Metabolite; 2-(2-Fluorophenyl)-1-[(1S)-1-cyclopropyl-2-(2-oxo-4,6,7-tetrahydrothieno[3,2-c]pyridin-5-yl)-2-oxoethyl]cyclopropanecarboxylic acid methyl ester derivative
EINECS	Contact for details

Quality Control

Our Prasugrel Metabolite M5 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity, chiral purity, residual solvent analysis, and identity confirmation by spectroscopic methods (NMR, MS). We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing all test results against stringent in-house specifications. The material is suitable for use as a pharmaceutical reference standard in regulated environments.

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 product is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Chiral Purity (HPLC)	≥ 99.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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