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	TP
Polymorph	TBD
GMP	FDA(USA)/NMPA(China)/MFDS(Korea) approved
EHS	ISO 14001 & 45001 certified

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: 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 and micronized(D90＜10μm)
Storage: Room temperature
Production capacity: TP
Standard Package: 1kg/bag, 5kg/bag, or according to the customer’s requirement

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.

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. A new API factory is under design and is predicted to be put into use in 2025.
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.