Description

6-(2-Cyclopropyl-1-(2-Fluorophenyl)-2-Oxoethyl)-4,5,6,7-Tetrahydrothieno[2,3-C]Pyridin-2-Yl Acetate (Prasugrel Impurity 5) is a high-purity chemical reference standard critical for pharmaceutical research and quality control. This compound serves as a specified impurity in the synthesis and analysis of Prasugrel, a key antiplatelet medication. It is essential for analytical chemists and quality assurance professionals in the pharmaceutical industry who require reliable standards for method development, validation, and regulatory compliance to ensure drug safety and efficacy.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the quality control of Prasugrel Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing and validating HPLC, UPLC, or LC-MS methods to accurately identify and quantify this specific impurity.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity profiling data as per ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies: Used to monitor the formation and levels of Prasugrel Impurity 5 in stability samples under various ICH-prescribed conditions.
• Process Chemistry R&D: Employed in research to understand and optimize synthetic pathways to minimize the formation of this impurity.
• Pharmacopoeial Testing: Utilized as a system suitability component in testing to meet monograph requirements of USP, EP, or other pharmacopoeias.

Basic Information

Product Name	6-(2-Cyclopropyl-1-(2-Fluorophenyl)-2-Oxoethyl)-4,5,6,7-Tetrahydrothieno[2,3-C]Pyridin-2-Yl Acetate (Prasugrel Impurity 5)
CAS No.	1544531-48-7
Molecular Formula	C21H22FNO3S
Molecular Weight	387.47 g/mol
Synonyms	Prasugrel Related Compound 5; Prasugrel Impurity C; Prasugrel EP Impurity C; Prasugrel USP Impurity 5; 2-(Acetyloxy)-6-[2-cyclopropyl-1-(2-fluorophenyl)-2-oxoethyl]-4,5,6,7-tetrahydrothieno[2,3-c]pyridine; Thienopyridine derivative impurity of Prasugrel; (R)-2-(2-(2-Fluorophenyl)-1-cyclopropyl-2-oxoethyl)-4,5,6,7-tetrahydrothieno[3,2-c]pyridin-2-yl acetate (isomer reference)
EINECS	Contact for details

Quality Control

Every batch of Prasugrel Impurity 5 (CAS 1544531-48-7) is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques like HPLC and LC-MS to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting traceability and regulatory needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C. Keep the container in a dry, cool, and well-ventilated area. For long-term storage under inert atmosphere, please contact us for specific recommendations.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity ≤ 0.5% Total impurities ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5% w/w

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