Description

Prasugrel Impurity 13 Hcl is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for the analytical characterization and quality control of the antiplatelet drug Prasugrel, ensuring product safety and regulatory compliance. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, impurity profiling, and stability studies.

Application

• Pharmaceutical Reference Standard: Used as a certified standard for the identification and quantification of Prasugrel Impurity 13 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing, calibrating, and validating chromatographic methods to monitor impurity levels during manufacturing.
• Quality Control & Assurance (QC/QA): Serves as a critical benchmark in routine quality control testing to ensure batch-to-batch consistency and compliance with ICH guidelines.
• Stability Studies: Employed to track the formation and growth of this specific degradation product under various stress conditions (e.g., heat, humidity, light).
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to meet FDA, EMA, and other global health authority requirements.
• Research & Development: Used in synthetic chemistry research to study impurity formation pathways and to develop purification processes for Prasugrel API.

Basic Information

Product Name	Prasugrel Impurity 13 Hcl
CAS No.	1618108-01-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Prasugrel Related Compound 13 Hydrochloride; Prasugrel EP Impurity H HCl; Prasugrel USP Impurity 13 Hydrochloride; 5-[2-Cyclopropyl-1-(2-fluorophenyl)-2-oxoethyl]-4,5,6,7-tetrahydrothieno[3,2-c]pyridin-2-yl acetate hydrochloride (likely); Prasugrel Degradation Product 13 HCl; Prasugrel Process Impurity 13 HCl
EINECS	Contact for details

Quality Control

Our Prasugrel Impurity 13 Hcl is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the high-purity standards required for pharmaceutical analysis. Each batch is characterized using advanced techniques including HPLC, LC-MS, and NMR to confirm identity and purity. A comprehensive Certificate of Analysis (COA) is supplied with each shipment, detailing batch-specific results and confirming compliance with relevant pharmacopeial standards (e.g., USP, EP).

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 (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Assay (HPLC)	≥ 95.0%
Purity (HPLC)	≥ 98.0%
Single Unknown Impurity	≤ 1.0%
Total Impurities	≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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