Ixazomib Citrate API
| CAS No. | 1239908-20-3 |
| Therapeutic Category | Anti-Cancer/ Oncology |
| Technology | Synthetic |
| Dosage Form | Oral Solids |
| Innovator Brand | Ninlaro, TAKEDA (JAPAN) |
| Registration Status | CDE: I |
| Polymorph | / |
| GMP | FDA(USA)/NMPA(China)/MFDS(Korea) approved |
| EHS | ISO 14001 & 45001 certified |
Ixazomib Citrate API is a proteasome inhibitor API widely used in oncology drug development and oral solid formulation research. Ixazomib Citrate API plays an important role in multiple myeloma treatment studies and pharmaceutical formulation optimization.
Product Description
- Grade: Active Pharmaceutical Ingredient(API)
- Chemical Name: 2-[4-(carboxymethyl)-2-[(1R)-1-[[2-[(2,5-dichlorobenzoyl)amino]acetyl]amino]-3-methylbutyl]-5-oxo-1,3,2-dioxaborolan-4-yl]acetic acid
- Molecular Formula: C20H23BCl2N2O9
- Molecular Weight: 517.12
- Specification: In-house 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: 100kg
- Standard Package: 1kg/bag, 5kg/bag, or according to the customer’s requirement
Applications of Ixazomib Citrate API
- Ixazomib Citrate API is a kind of Human API. Ixazomib Citrate API is a protein inhibitor suitable for use in combination with lenalidomide and dexamethasone in patients with multiple myeloma who have received at least one previous treatment.
- Ixazomib Citrate induces apoptosis in multiple myeloma cell lines in vitro. Ixazomib Citrate showed in vitro cytotoxicity to myeloma cells from patients who had relapsed after various previous treatments, including bortezomib, lenalidomide, and dexamethasone. The combination of Ixazomib Citrate and lenalidomide showed a synergistic cytotoxic effect in multiple myeloma cell lines. In vivo, Ixazomib Citrate showed anti-tumor activity in a mouse model of multiple myeloma tumor xenotransplantation.
- Ixazomib Citrate API is suitable for both early-stage research and commercial formulation development. It demonstrates stable physicochemical properties, supporting capsule and tablet formulation processes. The API is widely applied in bioavailability studies, stability evaluation, and scalable manufacturing under GMP conditions, ensuring consistent quality in oncology drug development pipelines.
- Ixazomib Citrate API demonstrates excellent compatibility with combination therapies in oncology drug development, supporting synergistic effects with other anti-cancer agents. It is widely used in pre-formulation studies, impurity profiling, and process optimization to ensure robust and scalable manufacturing outcomes.
- Ixazomib Citrate API is suitable for process development optimization and scale-up studies, providing reliable performance in formulation screening and early manufacturing validation.
Why Choose Us as Your Ixazomib Citrate API Manufacturer?
- 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. Please feel free to choose us.
- 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.
- As an Ixazomib Citrate manufacturer, Qingmu successfully exported products to more than 40 countries including Japan, USA, Germany, Spain, the Netherlands, Russia, South Korea, and Brazil.
