Description

Avatrombopag Impurity 19 is a designated reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Avatrombopag. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product purity, safety, and regulatory compliance. It is primarily utilized in research and development, method validation, and stability studies for thrombopoietin receptor agonist drugs.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Avatrombopag API and finished drug products.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing, optimizing, and validating chromatographic methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to ensure API and drug product specifications meet stringent pharmacopeial standards (e.g., ICH Q3A/B).
• Stability Studies: Employed to track the formation and levels of this specific impurity under various stress conditions (e.g., heat, light, humidity) to determine drug shelf-life.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity characterization and control strategies.
• Process Chemistry Research: Aids in understanding and optimizing synthetic pathways to minimize the formation of this impurity during Avatrombopag manufacturing.

Basic Information

Product Name	Avatrombopag Impurity 19
CAS No.	570407-26-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Avatrombopag Related Compound 19; Avatrombopag Impurity C; Avatrombopag EP Impurity C; 1-[3-Chloro-5-[[4-(4-chlorothiazol-2-yl)-5-(4-cyclohexylpiperazin-1-yl)thiazol-2-yl]carbamoyl]pyridin-2-yl]piperidine-4-carboxylic acid (IUPAC); Doptelet Impurity 19; Eltrombopag Impurity 19 (structural analog); TPO Receptor Agonist Impurity.
EINECS	Contact for details

Quality Control

Every batch of Avatrombopag Impurity 19 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic techniques, to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results against established specifications. We support compliance with ICH guidelines and relevant pharmacopeial standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). Due to its hygroscopic nature, the material should be handled in a low-humidity environment and the container kept sealed to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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