Description

Prasugrel α-Hydroxy Impurity is a key pharmaceutical reference standard and impurity used in the quality control of the antiplatelet drug Prasugrel. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) during development and manufacturing. It is primarily required by pharmaceutical companies, analytical laboratories, and regulatory bodies for method validation, stability studies, and batch release testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of Prasugrel.
• Impurity Profiling & Control: Essential for monitoring and controlling the levels of the α-hydroxy impurity in Prasugrel API and finished dosage forms to meet ICH Q3A/B guidelines.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating HPLC, UPLC, or LC-MS methods for Prasugrel.
• Stability Indicating Studies: Used to assess the degradation pathways and stability of Prasugrel under various stress conditions.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing necessary impurity identification and characterization data.
• Quality Assurance/Quality Control (QA/QC): Employed in routine batch testing within pharmaceutical QC laboratories to ensure product specifications are met.

Basic Information

Product Name	Prasugrel α-Hydroxy Impurity
CAS No.	1100905-45-0
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 α-hydroxyacetate; Prasugrel Related Compound A; Prasugrel Hydroxyacetate Impurity; Prasugrel Metabolite R138727; (RS)-Prasugrel α-Hydroxy Impurity; 2-[5-[2-Cyclopropyl-1-(2-fluorophenyl)-2-oxoethyl]-4,7-dihydro-6H-thieno[3,2-c]pyridin-2-yl]-2-oxoethyl acetate
EINECS	Contact for details

Quality Control

Every batch of Prasugrel α-Hydroxy Impurity is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced chromatographic (HPLC, GC) and spectroscopic (NMR, MS) techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results.

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 powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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