Description

Istradefylline Impurity 10 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 (API) Istradefylline during its development and manufacturing. It is primarily required by pharmaceutical companies, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing. The availability of this well-characterized impurity is essential for compliance with stringent global regulatory standards in drug production.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Istradefylline API batches.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods in pharmaceutical R&D.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard in routine QC testing to monitor impurity profiles and ensure batch-to-batch consistency.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity data for drug master files (DMFs).
• Stability Studies: Employed in forced degradation and long-term stability studies to track the formation and levels of this specific impurity over time.
• Process Chemistry Research: Used by chemists to study and optimize synthetic pathways to minimize the formation of this impurity during API manufacturing.

Basic Information

Item	Details
Product Name	Istradefylline Impurity 10
CAS No.	1019659-02-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Istradefylline Related Compound 10; Istradefylline Impurity; KW-6002 Impurity 10; 8-[(E)-2-(3,4-Dimethoxyphenyl)ethenyl]-1,3-diethyl-7-methyl-3,7-dihydro-1H-purine-2,6-dione Impurity; 1,3-Diethyl-8-[(E)-2-(3,4-dimethoxyphenyl)ethenyl]-7-methyl-3,7-dihydro-1H-purine-2,6-dione Impurity; Adenosine A2A Receptor Antagonist Impurity 10
EINECS	Contact for details

Quality Control

Every batch of Istradefylline Impurity 10 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous testing to ensure identity, purity, and strength, meeting the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from advanced chromatographic and spectroscopic analyses. Our quality commitment aligns with cGMP principles and supports compliance with ICH Q3A/B guidelines on impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the product label or COA. Keep the container in a dry, cool, and well-ventilated place. For long-term storage, consider storing under an inert atmosphere to ensure stability.

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)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0%

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