XILING LAB CO.,LTD sell "Eribulin Mesylate (API)"
Basic Information
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Product Name
Eribulin Mesylate (API)
Details
Substance
Specifications
- CAS Number: 441045-17-6
- EC Number: 813-106-4
- Molecular Weight: 826
- Chemical Formula: C41H63NO14S
- IUPAC Name: (1S,3S,6S,9S,12S,14R,16R,18S,20R,21R,22S,26R,29S,31R,32S,33R,35R,36S)-20-[(2S)-3-amino-2-hydroxypropyl]-21-methoxy-14-methyl-8,15-dimethylidene-2,19,30,34,37,39,40,41-octaoxanonacyclo[24.9.2.13,32.13,33.16,9.112,16.018,22.029,36.031,35]hentetracontan-24-o
- Assay: Meets pharmacopeial assay specification (typically ≥98.0% on an anhydrous basis), confirmed by validated HPLC/titration analytical methods.
- Purity: Pharmaceutical-grade purity complying with the applicable pharmacopoeial monograph (USP/EP/BP/ChP as applicable) for this active substance.
- Impurity Profile: Individual and total related-substance impurities are controlled within ICH Q3A/Q3B limits and the relevant pharmacopoeial monograph.
Other Information
Additional Description:
Eribulin mesylate injection is indicated for metastatic breast cancer (in China, the US, the EU, Japan, and other countries), liposarcoma (in the US and EU), and soft tissue sarcoma (in Japan and other countries), referenced in NCCN (2023 v4), CSCO (2023), and ESMO (2023) guidelines, with FDA pediatric exclusivity through July 8, 2027.
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