XILING LAB CO.,LTD sell "Lurbinectedin (API)"
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Product Name
Lurbinectedin (API)
Details
Substance
Specifications
- EC Number: 881-505-0
- Chemical Formula: C41H44N4O10S
- CAS Number: 497871-47-3
- IUPAC Name: [(1R,2R,3R,11S,12S,14R,26R)-5,12-dihydroxy-6,6'-dimethoxy-7,21,30-trimethyl-27-oxospiro[17,19,28-trioxa-24-thia-13,30-diazaheptacyclo[12.9.6.13,11.02,13.04,9.015,23.016,20]triaconta-4(9),5,7,15,20,22-hexaene-26,1'-2,3,4,9-tetrahydropyrido[3,4-b]indole]-22
- Molecular Weight: 784.9
- Assay: Meets pharmacopoeial assay limits, typically 98.0%-102.0% on the dried/anhydrous basis, as determined by HPLC or titration.
- Impurity Profile: Total related substances ≤0.5%, with any single unspecified impurity ≤0.10%, controlled per ICH Q3A/Q3B guidelines.
Other Information
Additional Description:
This lyophilized lurbinectedin powder is indicated for adult patients with metastatic small cell lung cancer whose disease has progressed during or after platinum-based chemotherapy. Originated by Pharma Mar and approved in the US in June 2020, it carries FDA new chemical entity exclusivity through June 2025 and orphan drug exclusivity through June 2027.
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