Description

Istradefylline Impurity 7 is a designated impurity standard used in the analytical profiling and quality control of Istradefylline, an adenosine A2A receptor antagonist. This high-purity reference material is critical for ensuring the safety and efficacy of the active pharmaceutical ingredient by accurately identifying and quantifying related substances. It is an essential tool for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development, production, and quality assurance of Istradefylline-based drug products.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the identification and quantification of Istradefylline Impurity 7 in drug substance and drug product.
• Method Development & Validation: Critical for developing and validating stability-indicating analytical methods, such as HPLC and UPLC, for Istradefylline.
• Quality Control & Batch Release: Used in routine QC testing to monitor impurity levels and ensure compliance with ICH guidelines and regulatory specifications.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to establish impurity profiles and justify specification limits.
• Research & Development: Supports process chemistry optimization by helping to identify and control the formation of this impurity during synthesis.

Basic Information

Product Name	Istradefylline Impurity 7
CAS No.	1453190-01-6
Molecular Formula	C20H24N6O2
Molecular Weight	380.45 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 Impurity 7; Istradefylline Related Compound 7; (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

Every batch of Istradefylline Impurity 7 is manufactured and analyzed under strict quality management systems. The material undergoes comprehensive analytical characterization using techniques including HPLC, GC, NMR, and MS to confirm identity and ensure high purity suitable for use as a reference standard. A detailed Certificate of Analysis (COA) is provided with each shipment, containing batch-specific results for identity, purity, and impurity profile. Our quality commitment aligns with cGMP principles for pharmaceutical impurities and reference materials.

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 should be kept in a desiccated environment to prevent moisture uptake, which could affect stability and analytical performance. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unspecified impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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