Description

Prasugrel Acetyl Impurity is a key chemical reference standard used in the pharmaceutical development and quality control of the antiplatelet drug Prasugrel. This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification and quantification of related substances. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the synthesis, purification, and batch release testing of Prasugrel.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for identifying and quantifying the acetyl impurity in Prasugrel active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development and Validation: Used as a critical standard to develop, validate, and verify HPLC, UPLC, and LC-MS methods for impurity analysis.
• Quality Control and Batch Release Testing: Essential for routine quality control testing to ensure Prasugrel batches meet stringent pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines for impurities.
• Stability Studies: Employed to monitor the formation of this specific degradation product under various stress conditions (e.g., heat, humidity, light) during drug stability studies.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity limits and demonstrate control of the manufacturing process.
• Process Chemistry Research: Used by R&D scientists to study and optimize the Prasugrel synthesis pathway to minimize the formation of this impurity.

Basic Information

Product Name	Prasugrel Acetyl Impurity
CAS No.	1443034-67-0
Molecular Formula	C20H20FNO3S
Molecular Weight	373.44 g/mol
Synonyms	5-[2-Cyclopropyl-1-(2-fluorophenyl)-2-oxoethyl]-4,5,6,7-tetrahydrothieno[3,2-c]pyridin-2-yl acetate; Prasugrel Acetyl Ester; Prasugrel Acetylated Impurity; Prasugrel Related Compound A (Acetyl); Prasugrel Acetyl Derivative; (RS)-5-(α-Cyclopropylcarbonyl-2-fluorobenzyl)-4,5,6,7-tetrahydrothieno[3,2-c]pyridin-2-yl acetate
EINECS	Contact for details

Quality Control

Our Prasugrel Acetyl Impurity is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) detailing identity, purity, and assay results is provided with every shipment to support your regulatory and quality needs.

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 material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Meets ICH Q3C guidelines

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