Description

6,7-Dichloro-3,5-Dihydro-1-Hydroxyimidazo[1,2-A]Quinazolin-2(1H)-One (Anagrelide Impurity) is a high-purity chemical reference standard critical for pharmaceutical research and quality control. This compound serves as a specified impurity in the synthesis and analysis of Anagrelide, an essential medication used to treat thrombocythemia. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure drug safety, efficacy, and compliance with stringent pharmacopeial standards. The availability of this well-characterized impurity is fundamental for method validation, stability studies, and batch release testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Anagrelide Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, and LC-MS methods to monitor impurity profiles in accordance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Indicating Studies: Employed in forced degradation and long-term stability studies of Anagrelide to understand degradation pathways and establish shelf-life.
• Quality Control & Batch Release: A critical component in the quality control (QC) testing of Anagrelide batches to ensure they meet the specified impurity limits for regulatory submission and commercial release.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing necessary impurity data for drug master files (DMFs) and other submission documents.
• Research & Process Chemistry: Used in synthetic route development and optimization to identify, control, and minimize the formation of this specific impurity during the manufacturing process.

Basic Information

Product Name	6,7-Dichloro-3,5-Dihydro-1-Hydroxyimidazo[1,2-A]Quinazolin-2(1H)-One (Anagrelide Impurity)
CAS No.	875467-41-7
Molecular Formula	C₁₁H₇Cl₂N₃O₂
Molecular Weight	284.10 g/mol
Synonyms	Anagrelide Impurity; Anagrelide Related Compound; 6,7-Dichloro-1-hydroxy-3,5-dihydroimidazo[1,2-a]quinazolin-2(1H)-one; Imidazo[1,2-a]quinazolin-2(1H)-one, 6,7-dichloro-3,5-dihydro-1-hydroxy-; AG-1 Impurity; AG Impurity
EINECS	Contact for details

Quality Control

Every batch of 6,7-Dichloro-3,5-Dihydro-1-Hydroxyimidazo[1,2-A]Quinazolin-2(1H)-One is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical characterization using advanced techniques like HPLC, LC-MS, NMR, and IR to ensure identity, purity, and conformity to client specifications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing all test results. We support compliance with ICH guidelines, USP standards, and cGMP principles for pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere to maintain stability.

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)	Total impurities ≤ 2.0% Any single unknown 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.