Description

Prasugrel Metabolite M6-D3 (Stabilzed) is a deuterium-labeled, stabilized form of the active metabolite of the antiplatelet drug Prasugrel. This high-purity reference standard is critical for ensuring the accuracy and reliability of bioanalytical methods in pharmaceutical research and development. It is primarily used by analytical laboratories and pharmaceutical companies engaged in pharmacokinetic studies, drug metabolism research, and quality control for generic drug development.

Application

• Pharmacokinetic and Bioanalytical Studies: Serves as a stable isotope-labeled internal standard for the precise quantification of the active Prasugrel metabolite in biological matrices (e.g., plasma, serum) using LC-MS/MS.
• Drug Metabolism and Pharmacokinetics (DMPK): Used in ADME (Absorption, Distribution, Metabolism, Excretion) studies to track and understand the metabolic pathway of Prasugrel.
• Method Development and Validation: Essential for developing, optimizing, and validating robust analytical methods in compliance with regulatory guidelines (e.g., FDA, EMA).
• Quality Control & Assurance: Acts as a certified reference material for the quality control testing of Prasugrel active pharmaceutical ingredient (API) and finished dosage forms.
• Clinical Research: Supports clinical trial sample analysis to determine drug exposure and patient response.
• Generic Drug Development: A vital tool for demonstrating bioequivalence in the development of generic versions of Prasugrel.

Basic Information

Product Name	Prasugrel Metabolite M6-D3 (Stabilzed)
CAS No.	1234692-58-0
Molecular Formula	C₁₇H₁₅D₃FNO₃S⁺
Molecular Weight	338.39 g/mol
Synonyms	2-[2-(Acetyloxy)-6,7-dihydrothieno[3,2-c]pyridin-5(4H)-yl]-1-cyclopropyl-2-(2-fluorophenyl)ethanone-d3; Prasugrel Active Metabolite-d3; (R)-2-(2-(Acetyloxy)-6,7-dihydrothieno[3,2-c]pyridin-5(4H)-yl)-1-cyclopropyl-2-(2-fluorophenyl)ethanone-d3; R-138727-d3; AM-d3; Deuterated Prasugrel Metabolite; Prasugrel M6-d3
EINECS	Contact for details

Quality Control

Our Prasugrel Metabolite M6-D3 (Stabilzed) is manufactured under strict quality systems to ensure the highest standards of purity and isotopic enrichment, suitable for sensitive analytical applications. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing results for identity, purity (HPLC), isotopic purity, and related substances. We support compliance with cGMP and ICH Q7 guidelines for active pharmaceutical ingredients (APIs).

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F), or as indicated on the label or COA. Keep the container in a dry, cool, and well-ventilated place.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Isotopic Purity (LC-MS)	≥ 98.0 atom % D
Related Substances (HPLC)	Individual impurity ≤ 0.5%; Total impurities ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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