Description

Anagrelide Impurity 1 is a designated impurity standard used in the analytical profiling and quality control of the pharmaceutical active ingredient, Anagrelide hydrochloride. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a reference marker in chromatographic methods. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in research, development, and quality assurance processes.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Anagrelide hydrochloride API and its finished dosage forms.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing, optimizing, and validating stability-indicating chromatographic methods to monitor impurity profiles.
• Quality Control & Batch Release Testing: Employed in routine QC testing to ensure drug substance and product batches comply with stringent pharmacopeial (e.g., USP, EP) and ICH guidelines for impurity limits.
• Stability Studies: Acts as a critical marker in forced degradation and long-term stability studies to track impurity formation over time and under various stress conditions.
• Regulatory Submissions: Supports the filing of regulatory documents (e.g., DMF, CMC sections) by providing necessary impurity characterization and control data.
• Research & Process Chemistry: Aids in understanding the synthetic pathway of Anagrelide and in optimizing manufacturing processes to minimize the formation of this specific impurity.

Basic Information

Product Name	Anagrelide Impurity 1
CAS No.	752151-24-9
Molecular Formula	C10H7Cl2N3O
Molecular Weight	256.09 g/mol
Synonyms	6,7-Dichloro-1,5-dihydroimidazo[2,1-b]quinazolin-2(3H)-one; Anagrelide Related Compound A; Anagrelide Impurity A; 6,7-Dichloro-3,5-dihydro-2H-imidazo[2,1-b]quinazolin-2-one; UNII-9Q4W7VX63S; 1,5-Dihydro-6,7-dichloroimidazo[2,1-b]quinazolin-2(3H)-one; AG-1 Impurity
EINECS	Contact for details

Quality Control

Every batch of Anagrelide Impurity 1 is manufactured and analyzed under strict quality management systems. The material undergoes comprehensive testing, including identification by spectroscopic methods (IR, NMR, MS), purity determination by HPLC, and control of residual solvents and moisture to ensure it meets the high standards required for use as a pharmaceutical reference standard. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming compliance with specified criteria.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C, in a dry environment. The material is hygroscopic (moisture-sensitive) and should be handled under anhydrous conditions to maintain stability and purity.

Specification

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

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