Description

Prasugrel Impurity 4 Hcl is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for the quality control and regulatory compliance of the antiplatelet drug Prasugrel, ensuring drug safety and efficacy. It is primarily needed by analytical laboratories, pharmaceutical manufacturers, and regulatory bodies for method validation, impurity profiling, and batch release testing.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Prasugrel Impurity 4 in active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing and validating chromatographic methods to monitor and control this specific impurity during manufacturing.
• Quality Control & Assurance (QC/QA): Serves as a critical component in routine quality control testing to ensure Prasugrel batches meet stringent pharmacopeial (e.g., USP, EP) and ICH guidelines for impurity limits.
• Regulatory Submissions: Provides necessary data and reference material for regulatory filings (e.g., FDA, EMA) to establish impurity profiles and justify specification limits.
• Stability Studies: Employed to track the formation and level of this impurity over time under various storage conditions, supporting shelf-life determination.
• Research & Development: Used in synthetic chemistry and process research to understand impurity formation pathways and optimize synthesis routes for cleaner API production.

Basic Information

Product Name	Prasugrel Impurity 4 Hcl
CAS No.	1618107-96-2
Molecular Formula	C20H20FNO3S • HCl
Molecular Weight	425.90 g/mol (Free base: 389.44 g/mol)
Synonyms	5-[2-Cyclopropyl-1-(2-fluorophenyl)-2-oxoethyl]-4,5,6,7-tetrahydrothieno[3,2-c]pyridin-2-yl acetate hydrochloride; Prasugrel Related Compound 4 HCl; Prasugrel EP Impurity D HCl; Prasugrel USP Impurity 4 HCl; (RS)-5-(2-Cyclopropyl-1-(2-fluorophenyl)-2-oxoethyl)-4,5,6,7-tetrahydrothieno[3,2-c]pyridin-2-yl acetate hydrochloride; Prasugrel Impurity D Hydrochloride
EINECS	Contact for details

Quality Control

Every batch of Prasugrel Impurity 4 Hcl is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure compliance with industry and pharmacopeial standards for reference materials. A comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profile 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 compound is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Purity (HPLC, Area %)	≥ 99.0%
Single Unknown Impurity	≤ 0.5%
Total Impurities	≤ 1.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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