Description

Prasugrel Metabolite Hydrochloride, Mixture Of Isomers is a key active pharmaceutical ingredient (API) intermediate and a crucial reference standard for analytical development and quality control in the pharmaceutical industry. This compound is essential for the research, development, and manufacturing of antiplatelet therapies, ensuring the efficacy and safety of the final drug product. It is primarily utilized by pharmaceutical companies, contract research organizations (CROs), and analytical laboratories involved in cardiovascular drug development and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a primary standard for the identification, assay, and impurity profiling of prasugrel and its metabolites in drug substances and products via HPLC, LC-MS, and other analytical methods.
• Active Pharmaceutical Ingredient (API) Intermediate: A critical synthetic building block in the manufacturing process of prasugrel hydrochloride and related antiplatelet agents.
• Metabolite Research: Used in pharmacokinetic and pharmacodynamic studies to understand the metabolism, distribution, and biological activity of prasugrel.
• Quality Control & Assurance: Employed in in-house QC laboratories to validate analytical methods, calibrate equipment, and ensure batch-to-batch consistency of pharmaceutical preparations.
• Regulatory Submission Support: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) submitted to agencies like the FDA and EMA.

Basic Information

Product Name	Prasugrel Metabolite Hydrochloride, Mixture Of Isomers
CAS No.	150322-39-7
Molecular Formula	C20H20FNO3S • HCl
Molecular Weight	409.90 g/mol (Free base: 373.44 g/mol)
Synonyms	2-[2-(Acetyloxy)-6,7-dihydrothieno[3,2-c]pyridin-5(4H)-yl]-1-cyclopropyl-2-(2-fluorophenyl)ethanone hydrochloride (Mixture of Isomers); Prasugrel Active Metabolite Hydrochloride; R-138727 Hydrochloride; (5)-2-Acetoxy-5-(α-cyclopropylcarbonyl-2-fluorobenzyl)-4,5,6,7-tetrahydrothieno[3,2-c]pyridinium Chloride; LY640315 Metabolite Hydrochloride; Effient Metabolite Hydrochloride
EINECS	Contact for details

Quality Control

Our Prasugrel Metabolite Hydrochloride is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing to ensure high purity and consistency, meeting the stringent requirements for pharmaceutical reference standards and intermediates. Certificates of Analysis (COA) are provided, detailing results for identity, purity, and impurity profiles as determined by HPLC, NMR, and mass spectrometry. We support compliance with cGMP, ICH guidelines, and relevant pharmacopeial standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product 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 powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0% (Area Percent)
Isomeric Ratio	Specified on COA
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm

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