Description

Eltrombopag Impurity 50 is a designated reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Eltrombopag. This impurity standard is critical for pharmaceutical manufacturers and analytical laboratories to ensure product safety, efficacy, and regulatory compliance. It is primarily utilized in research and development, method validation, and stability studies for thrombopoietin receptor agonists.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Eltrombopag Olamine API and finished drug products.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing, optimizing, and validating chromatographic methods to monitor impurity profiles.
• Stability Indicating Studies: Used to assess the degradation pathways and stability of Eltrombopag under various stress conditions (e.g., heat, light, humidity).
• Quality Control & Batch Release Testing: A critical component in the QC laboratory for routine analysis to ensure batches meet stringent pharmacopeial (e.g., USP, EP) and internal specifications.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing necessary data on impurity characterization and control strategies.
• Research into Degradation Pathways: Facilitates studies to understand the formation and behavior of this specific impurity during synthesis and storage.

Basic Information

Product Name	Eltrombopag Impurity 50
CAS No.	1201816-68-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Eltrombopag Related Compound 50; Eltrombopag Impurity 50 (CAS 1201816-68-3); SB-497115 Impurity 50; 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 (putative); Eltrombopag Process Impurity; Eltrombopag Degradant
EINECS	Contact for details

Quality Control

Our Eltrombopag Impurity 50 is manufactured and handled under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis and spectroscopic identification (NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

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 COA. The material should be kept in a dry environment to prevent moisture uptake. 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 (MS)	Mass spectrum consistent with structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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