Description

Anagrelide Impurity 2 is a designated reference standard used in the analytical profiling and quality control of the pharmaceutical agent Anagrelide. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) by serving as a benchmark in chromatographic and spectroscopic methods. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development, production, and quality assurance of Anagrelide-based medications.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Anagrelide API and finished dosage forms.
• Analytical Method Development & Validation: Used as a critical component in developing, optimizing, and validating HPLC, UPLC, and LC-MS methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor impurity levels and ensure compliance with pharmacopeial specifications (e.g., USP, EP, ICH guidelines).
• Regulatory Submissions: Essential for preparing regulatory documentation (e.g., CMC sections for FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Stability Studies: Used to track the formation of this specific impurity during forced degradation and long-term stability studies of Anagrelide products.
• Research & Development: Utilized in synthetic chemistry research to understand degradation pathways and to support the development of purer synthetic processes.

Basic Information

Product Name	Anagrelide Impurity 2
CAS No.	742010-46-4
Molecular Formula	C10H7Br2N3O
Molecular Weight	345.99 g/mol
Synonyms	6,7-Dibromo-1,5-dihydroimidazo[2,1-b]quinazolin-2(3H)-one; Anagrelide Related Compound B; Anagrelide Impurity B; 6,7-Dibromo-1,5-dihydro-2H-imidazo[2,1-b]quinazolin-2-one; AG-2; Anagrelide Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Anagrelide Impurity 2 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous testing to ensure identity, purity, and consistency, aligning with current industry standards for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from HPLC purity assay, related substance analysis, and spectroscopic identification (IR, NMR, MS). Our quality protocols are designed to support compliance with ICH Q3A/B guidelines and relevant pharmacopeial 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. For long-term storage, consider storing desiccated at 2-8°C. Handle and store in accordance with good laboratory practices.

Specification

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

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