Description

Avatrombopag Impurity 22 is a specified organic impurity associated with the active pharmaceutical ingredient Avatrombopag. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method validation and quality control processes. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure the purity, safety, and efficacy of Avatrombopag drug substances and products.

Application

• Primary use as a certified reference standard for the identification and quantification of impurities in Avatrombopag API.
• Essential for analytical method development and validation (HPLC, LC-MS) in pharmaceutical QC laboratories.
• Used in stability studies to monitor impurity profiles and degradation pathways of Avatrombopag formulations.
• Critical for regulatory compliance and filing, supporting ICH guidelines (Q3A, Q3B) for impurity reporting.
• Supports process chemistry research to understand and control impurity formation during synthesis.
• Employed in pharmacopoeial testing to establish monograph specifications for Avatrombopag.

Basic Information

Product Name	Avatrombopag Impurity 22
CAS No.	570403-14-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Avatrombopag Related Compound 22; Avatrombopag Impurity C; Avatrombopag EP Impurity C; Avatrombopag Process Impurity; 1-[3-Chloro-5-[[4-(4-chlorothiophen-2-yl)-5-(4-cyclohexylpiperazin-1-yl)thiazol-2-yl]carbamoyl]pyridin-2-yl]piperidine-4-carboxylic acid (proposed); Doptelet Impurity 22; Eltrombopag analogue impurity; Thrombopoietin receptor agonist impurity.
EINECS	Contact for details

Quality Control

Every batch of Avatrombopag Impurity 22 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced chromatographic (HPLC, LC-MS) and spectroscopic (NMR, IR) techniques to ensure compliance with pharmacopoeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, analytical methods, and traceability.

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 desiccated environment to prevent degradation. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 3.0%
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.