Description

Anagrelide Impurity 5 is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the pharmaceutical agent Anagrelide, a medication used to treat thrombocythemia. It serves as an essential tool for pharmaceutical manufacturers and analytical laboratories engaged in method development, stability studies, and regulatory compliance testing. The availability of this well-characterized impurity is vital for maintaining stringent quality control in active pharmaceutical ingredient (API) production.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Anagrelide API and finished dosage forms.
• Analytical Method Development and Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Stability and Forced Degradation Studies: Used to identify and track degradation products formed under various stress conditions (e.g., heat, light, humidity).
• Quality Control & Assurance (QC/QA): Acts as a system suitability standard and for routine batch release testing in GMP environments.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research and Development: Supports synthetic chemistry research for impurity synthesis route development and metabolic pathway studies.

Basic Information

Product Name	Anagrelide Impurity 5
CAS No.	444904-63-6
Molecular Formula	C10H7Br2N3O
Molecular Weight	345.99 g/mol
Synonyms	6,7-Dibromo-1,5-dihydroimidazo[2,1-b]quinazolin-2(3H)-one; 6,7-Dibromo-1,5-dihydro-2H-imidazo[2,1-b]quinazolin-2-one; Anagrelide Related Compound B; Anagrelide Impurity B; Anagrelide EP Impurity B; Anagrelide USP Impurity; 1,5-Dihydro-6,7-dibromoimidazo[2,1-b]quinazolin-2(3H)-one
EINECS	Contact for details

Quality Control

Every batch of Anagrelide Impurity 5 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards (e.g., USP, EP). 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 in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a desiccated environment to prevent degradation. For long-term storage, consider conditions under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w
Heavy Metals	≤ 20 ppm

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