Description

Prasugrel Impurity CAS NO 1618107-99-5 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient Prasugrel, a potent antiplatelet agent. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing. The availability of this well-characterized impurity is essential for maintaining compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Impurity Profiling and Identification in Prasugrel API and finished dosage forms.
• Analytical Method Development and Validation (HPLC, UPLC, LC-MS) for stability-indicating assays.
• Quality Control and Release Testing to monitor and control impurity levels per ICH Q3A/B guidelines.
• Stability Studies to identify and quantify degradation products under various stress conditions.
• Regulatory Submissions as a certified reference material for drug master files (DMFs) and new drug applications (NDAs).
• Research and Development for studying the degradation pathways and metabolism of Prasugrel.
• Calibration Standard for ensuring the accuracy and precision of analytical instrumentation.

Basic Information

Product Name	Prasugrel Impurity
CAS No.	1618107-99-5
Molecular Formula	C20H20FNO3S
Molecular Weight	373.44 g/mol
Synonyms	Prasugrel Related Compound; Prasugrel Degradant; Prasugrel Process Impurity; 5-[2-Cyclopropyl-1-(2-fluorophenyl)-2-oxoethyl]-4,5,6,7-tetrahydrothieno[3,2-c]pyridin-2-yl acetate; (RS)-5-[2-Cyclopropyl-1-(2-fluorophenyl)-2-oxoethyl]-4,7-dihydro-5H-thieno[3,2-c]pyran-2-yl acetate; Acetic acid 5-[2-cyclopropyl-1-(2-fluorophenyl)-2-oxoethyl]-4,5,6,7-tetrahydrothieno[3,2-c]pyridin-2-yl ester
EINECS	Contact for details

Quality Control

Every batch of Prasugrel Impurity CAS 1618107-99-5 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC purity determination, identity confirmation (IR, MS), and residual solvent analysis, to ensure compliance with ICH guidelines and customer-specific requirements. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

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); ensure the container is kept tightly sealed in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.10% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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