Description

Anagrelide Impurity 21 is a specified impurity of the active pharmaceutical ingredient Anagrelide hydrochloride, a medication used to treat thrombocythemia. This compound is critical for pharmaceutical research and development, serving as a key reference standard in the analytical characterization and quality control of Anagrelide drug substances and products. It is essential for scientists and quality assurance professionals in the pharmaceutical industry who require high-purity chemical reference materials to ensure product safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Anagrelide hydrochloride active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Crucial for developing, optimizing, and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to ensure Anagrelide products meet stringent pharmacopeial (e.g., USP, EP) and ICH guidelines for impurity limits.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as part of drug stability profiling.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and justify specification limits in Drug Master Files (DMFs) and New Drug Applications (NDAs).
• Process Chemistry Research: Aids chemists in understanding and optimizing the Anagrelide synthesis pathway to minimize the formation of this impurity during manufacturing.

Basic Information

Item	Detail
Product Name	Anagrelide Impurity 21
CAS No.	183620-20-4
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 21; Anagrelide Impurity B (Potential); 1,5-Dihydro-6,7-dichloroimidazo[2,1-b]quinazolin-2(3H)-one; AG-21 Impurity; Anagrelide Hydrochloride Impurity 21
EINECS	Contact for details

Quality Control

Every batch of Anagrelide Impurity 21 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous testing to ensure identity, purity, and consistency, aligning with ICH Q3A/B guidelines for pharmaceutical impurities. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from advanced chromatographic and spectroscopic analyses. Our quality commitment supports your needs for reliable reference standards in GMP/GLP-compliant environments.

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 dry environment to prevent absorption of moisture. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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