Ixazomib Citrate API

Ixazomib Citrate API

CAS No.1239908-20-3
Therapeutic CategoryAnti-Cancer/ Oncology
TechnologySynthetic
Dosage FormOral Solids
Innovator BrandNinlaro, TAKEDA (JAPAN)
Registration StatusTP
PolymorphTBD
GMPFDA(USA)/NMPA(China)/MFDS(Korea) approved
EHSISO 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

Applications of Ixazomib Citrate API

  • Ixazomib Citrate 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.

Why Choose Us as Your 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. 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 API manufacturer, Qingmu successfully exported products to more than 40 countries including Japan, USA, Germany, Spain, the Netherlands, Russia, South Korea, and Brazil.

FAQ

A1: Negotiate via email→ sign the contract →ship the good

A2: We usually ship the goods by courier, Air, or Sea.

A3: We use Bag, Drum, Carton Box, Alu Tin, etc

A4: We have compliant SOP as per GMP requirement and will be handled according to SOP.

A5: Yes, we’re able to enlarge the batch size if current batch size couldn’t meet your requirement.

A6: