Description

Eltrombopag Impurity 90 is a designated process-related impurity or degradation product of the active pharmaceutical ingredient Eltrombopag. This high-purity reference standard is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing. It is essential for researchers and quality assurance professionals in the pharmaceutical industry who require reliable materials for ensuring drug safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Eltrombopag drug substance and finished products.
• Analytical Method Development: Critical for developing and optimizing chromatographic methods (HPLC, UPLC) to separate and detect this specific impurity.
• Quality Control & Assurance: Employed in routine batch testing to monitor impurity profiles and ensure drug product specifications are met according to ICH guidelines.
• Stability Studies: Used to track the formation of this impurity over time under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity characterization and control strategies.
• Research & Development: Supports process chemistry research to understand impurity formation pathways and optimize synthesis for minimal impurity generation.

Basic Information

Product Name	Eltrombopag Impurity 90
CAS No.	376594-07-9
Molecular Formula	C25H22N4O4
Molecular Weight	442.47 g/mol
Synonyms	3'-{(2Z)-2-[1-(3,4-Dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4H-pyrazol-4-ylidene]hydrazino}-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic Acid; SB-559457 Impurity; Promacta Impurity; Revolade Impurity; Eltrombopag Related Compound 90; (2Z)-2-[1-(3,4-Dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4H-pyrazol-4-ylidene]-N'-[2'-hydroxy-3'-(hydroxymethyl)[1,1'-biphenyl]-3-yl]hydrazinecarboxamide (alternative form)
EINECS	Contact for details

Quality Control

Every batch of Eltrombopag Impurity 90 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques (HPLC, GC, MS, NMR) to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting traceability and regulatory needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing desiccated at 2-8°C.

Specification

Item	Specification
Appearance	Off-white to light yellow solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 2.0%

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