SN-38 API
| CAS No. | 130194-92-2 |
| Therapeutic Category | ADC |
| Technology | Synthetic |
| Dosage Form | N/A |
| Innovator Brand | N/A |
| Registration Status | DMF under preparing |
| Polymorph | N/A |
| GMP | FDA(USA)/NMPA(China)/MFDS(Korea) approved |
| EHS | ISO 14001 & 45001 certified |
Product Description
- Grade: Active Pharmaceutical Ingredient(API)
- Chemical Name:7-Ethyl-10-hydroxycamptothecin; 1H-Pyrano3,4:6,7indolizino1,2-bquinoline-3,14(4H,12H)-dione, 4-ethyl-4,10-dihydroxy
- Molecular Formula: C20H16N2O5
- Molecular Weight: 364.35
- 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 or milling/sieving according to customer’s requirement.
- Storage: Room temperature
- Production capacity: Commercial
- Standard Package: 1kg/bag, 5kg/bag, or according to the customer’s requirement
Applications of SN-38 API
- 7-ethyl-10-hydroxycamptothecin (SN 38) is a liposomal formulation of the active metabolite of Irinotecan Irinotecan, a chemotherapeutic pro-drug approved for the treatment of advanced colorectal cancer. SN 38 has been used in trials studying the treatment of Cancer, Advanced Solid Tumors, Small Cell Lung Cancer, Metastatic Colorectal Cancer, and Triple Negative Breast Cancer, among others.
Why Choose Us as Your SN-38 API Manufacturer?
- As a China SN-38 supplier, our SN-38 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.
- Qingmu’s 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. Qingmu passed the site inspection from NMPA(China), FDA(USA) and MFDS(Korea) and also customer audits from Europe, USA and Japan, etc. You can rest assured to choose us as your manufacturer.
- Qingmu successfully exported products to more than 60 countries including Japan, USA, Germany, Spain, the Netherlands, Russia, South Korea, and Brazil.
