Description

Prasugrel (Maleic Acid) CAS NO 389574-20-3 is a high-purity active pharmaceutical ingredient (API) and chemical intermediate, specifically the maleic acid salt form of the potent antiplatelet agent Prasugrel. This compound is critical for ensuring the efficacy and stability of finished pharmaceutical formulations. It is primarily required by pharmaceutical manufacturers and advanced research institutions engaged in the development and production of cardiovascular therapeutics.

Application

• Active Pharmaceutical Ingredient (API) in the manufacture of antiplatelet medications for the prevention of atherothrombotic events.
• Chemical Reference Standard for quality control and analytical method development in pharmaceutical laboratories.
• Research & Development for studying platelet aggregation inhibitors and novel cardiovascular drug delivery systems.
• Pharmaceutical Intermediates for the synthesis of more complex drug substances or prodrug formulations.
• Clinical Trial Material for use in the production of investigational medicinal products.

Basic Information

Product Name	Prasugrel (Maleic Acid)
CAS No.	389574-20-3
Molecular Formula	C₂₀H₂₀FNO₃S·C₄H₄O₄
Molecular Weight	521.55 g/mol
Synonyms	Prasugrel Maleate; Prasugrel Maleic Acid Salt; 5-[(1RS)-2-Cyclopropyl-1-(2-fluorophenyl)-2-oxoethyl]-4,5,6,7-tetrahydrothieno[3,2-c]pyridin-2-yl acetate maleate; LY640315; CS-747; Efient (brand name, as hydrochloride); (RS)-2-Acetoxy-5-(α-cyclopropylcarbonyl-2-fluorobenzyl)-4,5,6,7-tetrahydrothieno[3,2-c]pyridinium maleate
EINECS	Contact for details

Quality Control

Our Prasugrel (Maleic Acid) is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets stringent specifications for identity, purity, and potency, aligning with ICH guidelines. A Certificate of Analysis (COA) detailing all test results is provided with every shipment to guarantee traceability and compliance.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Conforms to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%

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