Eltrombopag Impurity
Time:2025-05-13
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Eltrombopag, an oral non-peptide thrombopoietin receptor agonist (TPO-RA), is primarily used to treat chronic immune thrombocytopenia (ITP) and severe aplastic anemia (SAA).
By selectively binding to the thrombopoietin receptor (TPO-R), eltrombopag activates the JAK-STAT signaling pathway, stimulating megakaryocyte differentiation and proliferation to boost platelet production. Its unique small-molecule structure avoids competitive binding with endogenous TPO, enabling safe and efficient platelet count elevation. Clinically, this mechanism reduces bleeding risks, improves patient quality of life, and decreases reliance on adjunct therapies.
Regulatory Milestones
2008: U.S. FDA approval for adult ITP.
2014: Expanded indication to SAA.
2016: Pediatric approval for ITP (ages ≥1).
2018: Chinese NMPA approval for originator drug, later included in national reimbursement lists.
With growing ITP patient populations and ongoing exploration of new indications, rigorous impurity profiling remains indispensable for generic drug bioequivalence studies and innovative drug development.
SZEB specializes in supplying a comprehensive range of eltrombopag impurities, including:EP-specified impurities、Eltrombopag olamine、Dimer-related impurities.These reference standards support acid/alkaline degradation pathway studies and stability testing, accompanied by full analytical documentation:COA (Certificate of Analysis)、1H-NMR, MS, HPLC purity data。
For detailed impurity specifications and customized solutions, visit http://www.ex-biotech.com or contact us at +86-0755-23051186.
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