Lurbinectedin API
| CAS No. | 497871-47-3 |
| Therapeutic Category | Anti-Cancer/ Oncology |
| Technology | Synthetic |
| Dosage Form | Injection |
| Innovator Brand | ZEPZELCA |
| Registration Status | DMF under preparing |
| Polymorph | N/A |
| GMP | FDA(USA)/NMPA(China)/MFDS(Korea) approved |
| EHS | ISO 14001 & 45001 certified |
Product Description of Lurbinectedin API
- Grade: Active Pharmaceutical Ingredient(API)
- Chemical Name: Spiro[6,16-(epithiopropanoxymethano)-7,13-imino-12H-1,3-dioxolo[7,8]isoquino[3,2-b][3]benzazocine-20,1′-[1H]pyrido[3,4-b]indol]-19-oneChemicalbook,5-(acetyloxy)-2′,3′,4′,6,6a,7,9′,13,14,16-decahydro-8,14-dihydroxy-6′,9-dimethoxy-4,10,23-trimethyl-,(1’R,6R,6aR,7R,13S,14S,16R)-(9CI)
- Molecular Formula: C41H44N4O10S
- Molecular Weight: 784.87
- Specification: Enterprise Standard established according to ChP/USP/EP
- Appearance: Powder
- Total impurities: not more than 0.5%
- Purity: not less than 99%
- Residual Solvents: fully comply with ICH Q3C
- Mutagenic impurities: fully comply with ICH M8
- Nitrosamine assessment: available
- Particle size: regular grade.
- Storage: -20℃
- Production capacity: Commercial
- Standard Package: 1g/bag, 2g/bag, 3g/bag……
Applications of Lurbinectedin API
- ZEPZELCA(Lurbinectedin API) is a prescription medicine used to treat adults with a kind of lung cancer called small cell lung cancer (SCLC).
- ZEPZELCA(Lurbinectedin API) may be used when your lung cancer has spread to other parts of the body (metastatic), and you have received treatment with chemotherapy that contains platinum, and it did not work or is no longer working.
- ZEPZELCA(Lurbinectedin API) is approved based on response rate and how long the response lasted.
Why Choose Us as Your Lurbinectedin API Factory?
- Qigmu is a Lurbinectedin API manufacturer, our Lurbinectedin API is manufacturing under cGMP, DMF in CTD format can be supported for registration worldwide.
- Qingmu’s factory is established according to ICH/USFDA/EU/JAPAN/China regulations and current GMP, totally complies with environmental law in China, no risk to remove factory.
- As a Lurbinectedin API factory, our team has rich experience in patent challenges on crystalline form & synthesis processes and also synthetic route development and scale-up & quality research.
- Qingmu’s lab is equipped with HPLC, GC, ICP-MS, GC-MS, CAD, microbalance, Malvern particle analyzer, etc. We passed the site inspection from NMPA(China), FDA(USA) and MFDS(Korea) and also customer audits from Europe, USA, Japan, etc.
- Qingmu successfully exported products to more than 40 countries including Japan, USA, Germany, Spain, the Netherlands, Russia, South Korea, and Brazil. You can rest assured to choose our products.
