Description

Eltrombopag Impurity 1 is a specified impurity and degradation product of the active pharmaceutical ingredient Eltrombopag, a thrombopoietin receptor agonist. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control processes. It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories involved in the production and regulatory compliance of Eltrombopag-based drug products.

Application

• Primary use as a pharmaceutical reference standard for the identification and quantification of impurities in Eltrombopag API and finished drug products.
• Essential for analytical method development and validation (HPLC, UPLC, LC-MS) to ensure specificity and accuracy.
• Critical component in stability studies to monitor degradation pathways and establish shelf-life for drug substances and products.
• Used in quality control (QC) and quality assurance (QA) laboratories to comply with ICH guidelines and regulatory filings (e.g., FDA, EMA).
• Supports process chemistry research to understand and control impurity formation during API synthesis.
• Valuable for pharmacopoeial testing and meeting the specifications of compendial standards like USP or EP.

Basic Information

Product Name	Eltrombopag Impurity 1
CAS No.	1246929-02-1
Molecular Formula	C25H22N4O4
Molecular Weight	442.47 g/mol
Synonyms	Eltrombopag Related Compound 1; Eltrombopag EP Impurity B; Eltrombopag USP Impurity 1; 3'-{(2Z)-2-[1-(3,4-Dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4H-pyrazol-4-ylidene]hydrazino}-2'-hydroxy-3-biphenylcarboxylic Acid; SB-497115 Impurity 1; Promacta Impurity 1; Revolade Impurity 1
EINECS	Contact for details

Quality Control

Our Eltrombopag Impurity 1 is manufactured under strict quality systems to ensure high purity and batch-to-batch consistency. Each batch is characterized and released with a comprehensive Certificate of Analysis (COA) that includes data from advanced analytical techniques such as HPLC, LC-MS, NMR, and IR. We support compliance with ICH Q3A/B, USP, and EP guidelines for impurities. Certificates of Analysis are available upon request.

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 material is hygroscopic (moisture-sensitive) and must be kept under dry, inert conditions to maintain stability and purity.

Specification

Item	Specification
Appearance	Off-white to light yellow solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unspecified impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.2%

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