Description

2-Amino-5,6-Dichloro-3(4H)-Quinazoline Acetic Acid, also known as Anagrelide Impurity B, is a critical reference standard and synthetic intermediate in the pharmaceutical industry. This compound is essential for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient (API) Anagrelide, a medication used to treat thrombocythemia. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for research, method development, and quality control processes. The precise characterization and control of this impurity are fundamental to meeting stringent global regulatory requirements for drug substance purity.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Anagrelide Impurity B in drug substance and finished product analysis.
• Analytical Method Development & Validation: Used in HPLC, LC-MS, and other chromatographic methods to establish specificity, accuracy, and detection limits.
• Pharmaceutical Research (R&D): Employed in studies to understand the degradation pathways, stability profile, and metabolism of Anagrelide.
• Quality Control & Assurance (QC/QA): Critical for routine batch release testing of Anagrelide API to ensure compliance with pharmacopeial (e.g., USP, EP) and ICH guidelines.
• Regulatory Submissions: Provides necessary data for Drug Master Files (DMFs), Investigational New Drug (IND) applications, and New Drug Applications (NDAs).
• Process Chemistry: Acts as a key intermediate or marker in the synthesis and process optimization of Anagrelide.

Basic Information

Product Name	2-Amino-5,6-Dichloro-3(4H)-Quinazoline Acetic Acid (Anagrelide Impurity B)
CAS No.	1159977-03-3
Molecular Formula	C10H7Cl2N3O2
Molecular Weight	272.09 g/mol
Synonyms	Anagrelide Impurity B; Anagrelide Related Compound B; 2-Amino-5,6-dichloro-3,4-dihydro-4-oxoquinazoline-7-acetic acid; 7-Acetic acid-2-amino-5,6-dichloro-3,4-dihydro-4-oxoquinazoline; 5,6-Dichloro-2-amino-3(4H)-quinazolinone-7-acetic acid; AG-Imp B; AG Impurity B
EINECS	Contact for details

Quality Control

Our 2-Amino-5,6-Dichloro-3(4H)-Quinazoline Acetic Acid is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the high standards required for pharmaceutical impurity analysis. Certificates of Analysis (COA) with detailed chromatographic data are provided with every shipment. We support compliance with ICH Q3A, Q3B, USP, and EP guidelines for impurities in new drug substances and products.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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