Description

Anagrelide Impurity 4 is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for the quality control and regulatory compliance of Anagrelide, an active pharmaceutical ingredient used to treat thrombocythemia. It is primarily required by analytical laboratories and pharmaceutical manufacturers engaged in method development, stability studies, and impurity profiling. Ensuring the identity and purity of this impurity is essential for meeting stringent pharmacopeial standards and ensuring drug safety.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the qualitative and quantitative analysis of Anagrelide active pharmaceutical ingredient (API) and finished drug products.
• Method Development and Validation: Essential for developing and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and Ultra-Performance Liquid Chromatography (UPLC) methods, for impurity detection.
• Stability Studies: Employed to monitor the formation and levels of this specific degradation product during forced degradation and long-term stability testing of Anagrelide formulations.
• Quality Control (QC) Testing: Serves as a system suitability standard in routine QC testing to ensure the specificity and sensitivity of the analytical procedure for impurity quantification.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to establish impurity thresholds, specifications, and the overall control strategy for the drug substance.
• Research and Development: Used in synthetic chemistry R&D to study the formation pathway of this impurity and to develop mitigation strategies during the API manufacturing process.

Basic Information

Product Name	Anagrelide Impurity 4
CAS No.	2187431-31-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Anagrelide Related Compound 4; Anagrelide EP Impurity D; Anagrelide USP Impurity; 6,7-Dichloro-1,5-dihydroimidazo[2,1-b]quinazolin-2(3H)-one Impurity; Anagrelide Degradation Product; Anagrelide Process Impurity; AGR Impurity 4
EINECS	Contact for details

Quality Control

Every batch of Anagrelide Impurity 4 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including identity confirmation by spectroscopic methods (IR, NMR, MS) and purity determination by chromatographic techniques (HPLC). A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15°C and 25°C, in a dry environment. The material should be handled in accordance with good laboratory practices to prevent contamination.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 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.