Description

Anagrelide Impurity 4 is a specified impurity of the active pharmaceutical ingredient Anagrelide hydrochloride, used in the treatment of thrombocythemia. This compound is critical for pharmaceutical research and development, serving as a key reference standard in analytical method development, stability studies, and quality control processes to ensure drug safety and efficacy. It is essential for analytical chemists, quality assurance professionals, and R&D scientists in the pharmaceutical and fine chemical industries focused on impurity profiling and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of Anagrelide and its related substances.
• Method Development and Validation: Critical for developing and validating HPLC, UPLC, or LC-MS methods for impurity profiling in Anagrelide API and finished dosage forms.
• Quality Control (QC) Testing: Employed in routine QC laboratories to monitor and control the levels of this specific impurity during API manufacturing to meet ICH guidelines.
• Stability Studies: Used to identify and quantify degradation products formed under various stress conditions (e.g., heat, light, humidity) as part of drug stability programs.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA) to demonstrate understanding and control of the impurity profile.
• Research and Development: Supports synthetic route optimization and process chemistry by helping to identify and track the formation of this impurity.

Basic Information

Product Name	Anagrelide Impurity 4
CAS No.	1092352-99-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	6,7-Dichloro-1,5-dihydroimidazo[2,1-b]quinazolin-2(3H)-one; Anagrelide Related Compound 4; Anagrelide Impurity D; 6,7-Dichloro-3,5-dihydro-2H-imidazo[2,1-b]quinazolin-2-one; UNII-9J8K3F8V8B; AG-4 Impurity; Anagrelide EP Impurity D
EINECS	Contact for details

Quality Control

Our Anagrelide Impurity 4 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and identity verification by spectroscopic methods (IR, NMR, MS), to ensure it meets the high standards required for use as a reference standard. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment. Our quality commitment aligns with cGMP principles for pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Single Unknown Impurity	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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