Description

Prasugrel-D5 is a deuterated stable isotope-labeled analog of the antiplatelet drug Prasugrel, specifically designed for use as an internal standard in quantitative bioanalytical methods. This high-purity reference material is essential for ensuring the accuracy and reliability of pharmacokinetic and metabolic studies, providing superior precision over non-labeled standards. It is a critical tool for pharmaceutical R&D laboratories, contract research organizations (CROs), and regulatory agencies involved in drug development and bioequivalence testing for cardiovascular therapies.

Application

• Liquid Chromatography-Mass Spectrometry (LC-MS/MS) Internal Standard: Primary application for the precise quantification of Prasugrel and its metabolites in complex biological matrices like plasma, serum, and urine.
• Pharmacokinetic (PK) and Pharmacodynamic (PD) Studies: Enables accurate tracking of drug absorption, distribution, metabolism, and excretion in clinical and pre-clinical trials.
• Drug Metabolism and Excretion (DMPK) Research: Used to elucidate metabolic pathways and identify major and minor metabolites of Prasugrel.
• Bioanalytical Method Development and Validation: Serves as a critical component in developing robust, sensitive, and selective analytical methods compliant with FDA, EMA, and ICH guidelines.
• Clinical Trial Support: Provides reliable data for dose-response studies and therapeutic drug monitoring in patients.
• Quality Control in Reference Material Production: Can be used as a system suitability standard in the quality control of non-labeled Prasugrel active pharmaceutical ingredient (API) and finished dosage forms.

Basic Information

Product Name	Prasugrel-D5
CAS No.	1189919-49-0
Molecular Formula	C20H15D5FNO3S
Molecular Weight	376.46 g/mol (approximate)
Synonyms	5-[2-Cyclopropyl-1-(2-fluorophenyl)-2-oxoethyl]-4,5,6,7-tetrahydrothieno[3,2-c]pyridin-2-yl acetate-d5; Prasugrel (phenyl-d5); Prasugrel-d5; Deuterated Prasugrel; Prasugrel Internal Standard; (5)-2-Acetoxy-5-(α-cyclopropylcarbonyl-2-fluorobenzyl)-4,5,6,7-tetrahydrothieno[3,2-c]pyridine-d5; Efient-d5 (labeled analog)
EINECS	Contact for details

Quality Control

Our Prasugrel-D5 is manufactured under strict quality systems to ensure the highest isotopic purity and chemical integrity required for sensitive analytical applications. Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing parameters such as isotopic purity (≥98% D), chemical purity (by HPLC), and confirmation of structure. We adhere to relevant industry standards for reference materials, and custom synthesis to meet specific pharmacopeial or client specifications is available.

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 compound is hygroscopic (moisture-sensitive); therefore, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥98.0%
Isotopic Purity (D)	≥98.0%
Chemical Purity	≥95.0%
Water Content (KF)	≤1.0%
Residual Solvents (GC)	Complies with ICH limits

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