Description

Aatrombopag Impurity 17 is a specified organic impurity associated with the active pharmaceutical ingredient Aatrombopag. 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 required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure the purity, safety, and efficacy of Aatrombopag drug substances and products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Aatrombopag active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating chromatographic methods, such as HPLC and UPLC, to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to ensure compliance with stringent pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines for impurity thresholds.
• Stability Studies: Used to track the formation and levels of this specific degradation product during forced degradation and long-term stability studies of Aatrombopag formulations.
• 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 the formation pathway of this impurity during the synthesis of Aatrombopag, enabling process optimization for impurity minimization.

Basic Information

Item	Details
Product Name	Aatrombopag Impurity 17
CAS No.	1268118-96-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Aatrombopag Related Compound 17; Aatrombopag EP Impurity 17; Aatrombopag USP Impurity 17; Eltrombopag Impurity 17 (related compound); 2-[(3Z)-3-[(2-Amino-4-oxo-1,4-dihydro-3H-pyrrolo[2,3-d]pyrimidin-5-yl)hydrazono]-2-oxo-2,3-dihydro-1H-indol-1-yl]acetic acid (probable structure); SB-497115-GR Impurity 17; Thrombopoietin Receptor Agonist Impurity.
EINECS	Contact for details

Quality Control

Our Aatrombopag Impurity 17 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity assay, identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data are provided to support your regulatory and research needs.

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 Certificate of Analysis. Keep the container in a dry, cool, and well-ventilated area. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
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.