Niraparib Tosylate Monohydrate API
| CAS No. | 1613220-15-7 |
| Therapeutic Category | Anti-Cancer/Oncology |
| Technology | Synthetic |
| Dosage Form | Capsules, for oral use |
| Innovator Brand | Zejula(USA) |
| Registration Status | Technical Package |
| 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: (S)-2-(4-(piperidin-3-yl)phenyl)-2H-indazole-7-carboxamide 4-methylbenzenesulfonate hydrate;Niraparib TsOH salt hydrate
- Molecular Formula: C26H30N4O5S
- Molecular Weight: 510.605
- 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 Niraparib Tosylate Monohydrate API
- Niraparib Tosylate Monohydrate is approved to treat adults with:
- Ovarian epithelial,fallopian tube, or primary peritoneal cancer. It is used:
- As maintenance therapy in patients with advanced cancer who are having a complete or partial response to first-line platinum chemotherapy.
- As maintenance therapy in patients whose cancer came back and has a germline mutation in the BRCA1 or BRCA2 gene. It is used in patients who are having a complete or partial response to platinum chemotherapy.
- Niraparib tosylate monohydrate is also being studied in the treatment of other types of cancer.
Why Choose Us as Your Niraparib Tosylate Monohydrate Supplier?
- Qigmu is a Niraparib Tosylate Monohydrate supplier in China. Our factory is established according to ICH/USFDA/EU/JAPAN/China regulations and current GMP, totally complies with environmental law in China, no risk to removing the 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, Japan, etc.
- As a reliable Niraparib Tosylate Monohydrate API manufacturer, Qingmu successfully exported products to more than 40 countries including Japan, USA, Germany, Spain, the Netherlands, Russia, South Korea, and Brazil.
