Description

Anagrelide Impurity 3 is a designated impurity standard used in the pharmaceutical development and quality control of Anagrelide hydrochloride, a medication for essential thrombocythemia. This high-purity reference material is critical for ensuring the safety, efficacy, and regulatory compliance of the active pharmaceutical ingredient (API). It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and batch release testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the qualitative and quantitative analysis of Anagrelide API and its finished dosage forms.
• Analytical Method Development & Validation (HPLC/LC-MS): Used as a critical component in developing and validating chromatographic methods for impurity profiling.
• Quality Control & Batch Release Testing: Essential for routine QC testing to monitor impurity levels and ensure product specifications are met for every production batch.
• Stability Studies: Employed to identify and quantify degradation products that may form under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to meet FDA, EMA, and ICH guidelines.
• Research & Development: Used in process chemistry R&D to understand and control the formation of impurities during the synthesis of Anagrelide.

Basic Information

Product Name	Anagrelide Impurity 3
CAS No.	1092352-97-0
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 3; Anagrelide Impurity C; Anagrelide EP Impurity C; Anagrelide Hydrochloride Impurity 3; 6,7-Dichloro-3,5-dihydro-2H-imidazo[2,1-b]quinazolin-2-one
EINECS	Contact for details

Quality Control

Every batch of Anagrelide Impurity 3 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing to ensure compliance with pharmacopeial standards (e.g., USP, EP) and ICH Q3A/B guidelines. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results from advanced analytical techniques such as HPLC, GC, NMR, and MS.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. The material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0%
Assay (HPLC)	95.0% - 105.0% on anhydrous basis

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