Description

Istradefylline M8 is a high-purity chemical intermediate and reference standard of significant importance in advanced pharmaceutical research and development. Its primary value lies in its role as a key building block for the synthesis of novel adenosine A2A receptor antagonists, a critical area of therapeutic investigation. This product is essential for pharmaceutical companies, contract research organizations (CROs), and academic institutions engaged in the development of treatments for central nervous system disorders, particularly Parkinson's disease.

Application

• Primary use as a pharmaceutical reference standard for analytical method development and validation.
• Critical chemical intermediate in the synthesis of Istradefylline and related adenosine A2A receptor antagonist candidates.
• Key material for process research and development (PR&D) and scale-up studies in active pharmaceutical ingredient (API) manufacturing.
• Essential component in impurity profiling and stability studies for regulatory filings (e.g., FDA, EMA).
• Used in preclinical and clinical research to support investigational new drug (IND) applications.
• Valuable for academic research exploring the pharmacology and structure-activity relationships (SAR) of purine-based therapeutics.

Basic Information

Product Name	Istradefylline M8
CAS No.	1798429-54-5
Molecular Formula	C20H24N8O2
Molecular Weight	408.46 g/mol
Synonyms	8-[(E)-2-(3,4-Dimethoxyphenyl)ethenyl]-1,3-diethyl-7-methyl-3,7-dihydro-1H-purine-2,6-dione; KW-6002 M8; Istradefylline Impurity M8; Istradefylline Related Compound M8; (E)-8-(3,4-Dimethoxystyryl)-1,3-diethyl-7-methylxanthine; 1,3-Diethyl-8-[(E)-2-(3,4-dimethoxyphenyl)ethenyl]-7-methyl-3,7-dihydro-1H-purine-2,6-dione
EINECS	Contact for details

Quality Control

Our Istradefylline M8 is manufactured under strict quality management systems to ensure batch-to-batch consistency and reliability. Each lot undergoes comprehensive analytical testing, including HPLC for purity, identity confirmation by IR and MS, and stringent control of specified impurities. A Certificate of Analysis (COA) detailing all test results is provided with every shipment, supporting compliance with cGMP and ICH Q7 guidelines for pharmaceutical intermediates.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption. For long-term storage, consider the use of desiccants.

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%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.