Description

Istradefylline Impurity 2 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient, Istradefylline, through precise impurity profiling and method validation. It is an essential material for pharmaceutical development and quality control laboratories engaged in regulatory compliance and advanced research. Professionals rely on this standard to maintain stringent pharmacopeial specifications and support robust analytical procedures.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the identification and quantification of Istradefylline-related substances.
• Analytical Method Development & Validation (HPLC/LC-MS): Critical for developing, optimizing, and validating chromatographic methods to separate and analyze impurities.
• Quality Control & Assurance (QC/QA): Used in routine batch testing of Istradefylline API to ensure compliance with ICH guidelines and regulatory filings (e.g., FDA, EMA).
• Stability Studies: Employed to monitor the formation of degradation products under various stress conditions to determine drug shelf-life.
• Regulatory Submission Support: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Serves as a key intermediate or impurity marker in synthetic route optimization and metabolic studies.

Basic Information

Product Name	Istradefylline Impurity 2
CAS No.	606080-73-3
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 2; Istradefylline Related Compound 2; 1,3-Diethyl-8-[(E)-2-(3,4-dimethoxyphenyl)vinyl]-7-methyl-3,7-dihydro-1H-purine-2,6-dione; (E)-8-(3,4-Dimethoxystyryl)-1,3-diethyl-7-methylxanthine
EINECS	Contact for details

Quality Control

Every batch of Istradefylline Impurity 2 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with ICH Q3A/B guidelines and other relevant industry standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality assurance requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. This material is hygroscopic (moisture-sensitive); ensure the container is sealed after each use to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Water Content (KF)	≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C

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