Ixazomib
General Information
Ixazomib Impurities and Ixazomib
Daicel Pharma offers excellent-quality Ixazomib impurities, such as 2,5-dichloro-N-(2-(3-methylbutanamido)-2-oxoethyl) benzamide, 6-methoxy-1,3,5-triazine-2,4-diol, Ixazomib Impurity-B, Ixazomib Impurity-C, and Ixazomib Impurity-D. They are vital for evaluating Ixazomib quality, stability, and biological safety. Furthermore, Daicel Pharma specializes in the custom synthesis of Ixazomib impurities and ensures their worldwide delivery.
Ixazomib [CAS: 1072833-77-2] is a second-generation, reversible proteasome inhibitor. It is an alanine leucine, boronic acid dipeptide derivative. It is a small molecule that treats multiple myeloma in patients. Ixazomib is an antineoplastic agent approved by the US FDA in 2015.
Ixazomib: Use and Commercial Availability
Ixazomib treats relapsed or refractory multiple myeloma in patients sensitive or resistant to prior therapies. In addition, it treats amyloidosis, bladder cancer, and neuroblastomas. It combines with Lenalidomide and Dexamethasone for treating patients with multiple myeloma resistant to prior treatment. Ixazomib is available as an oral formulation under the brand Ninlaro.
Ixazomib Structure and Mechanism of Action
The chemical name of Ixazomib is B-[(1R)-1-[[2-[(2,5-Dichlorobenzoyl)amino]acetyl]amino]-3-methylbutyl]boronic acid. The chemical formula for Ixazomib is C14H19BCl2N2O4, and its molecular weight is approximately 361.03 g/mol.
Ixazomib blocks the chymotrypsin-like beta-5 subunit of the 20S proteasome. This activity disrupts cellular homeostasis. It thus leads to apoptosis of multiple myeloma cells.
Ixazomib Impurities and Synthesis
Impurities form during Ixazomib synthesis1 that may affect the safety and efficacy of the drug. These impurities develop during the manufacturing process, purification, or storage of Ixazomib. Therefore, the control and monitoring of Ixazomib impurities is essential throughout the drug development.
Daicel Pharma offers a comprehensive Certificate of Analysis (CoA) for Ixazomib impurities, which includes 2,5-dichloro-N-(2-(3-methylbutanamido)-2-oxoethyl) benzamide, 6-methoxy-1,3,5-triazine-2,4-diol, Ixazomib Impurity-B, Ixazomib Impurity-C, and Ixazomib Impurity-D. We provide the CoA from a cGMP-compliant analytical facility. It gives complete characterization data such as 1H NMR, 13C NMR, IR, MASS, and HPLC purity2. We provide additional analytical data on request. Daicel Pharma can prepare any unidentified Ixazomib impurity or degradation product. In addition, Daicel Pharma offers highly purified, stable isotope-labeled standards of Ixazomib. We guarantee a complete characterization report on delivery.
References
FAQ's
References
- Olhava, Edward J.; Danca, Mihaela Diana, Proteasome inhibitors, EP2178888B1, Jul 7, 2012, Millennium Pharmaceuticals, Inc., United States (https://patents.google.com/patent/EP2178888B1/ja)
- Hatokova, Paulina; Sestak, Vit; Piskackova, Hana Bavlovic; Melnikova, Iuliia; Roh, Jaroslav; Sterbova-Kovarikova, Petra, The UHPLC-UV method applied for the forced degradation study of ixazomib and HRMS identification of its degradation products, Journal of Pharmaceutical and Biomedical Analysis, Volume: 225, Pages: 115220, 2023 DOI: (10.1016/j.jpba.2022.115220)
Frequently Asked Questions
2.What causes the degradation of the Ixazomib drug?
Ixazomib degrades under oxidative and photolytic conditions.
3.What are the various Ixazomib impurities found in the drug?
2,5-dichloro-N-(2-((1-hydroxy-3-methylbutyl)amino)-2-oxoethyl)benzamide, N-(2,5-dichlorobenzoyl)glycine, and N-(2-amino-2-oxoethyl)-2,5-dichlorobenzamide are some Ixazomib impurities found in the drug.
4.Why is it crucial to remove the Ixazomib impurities from the drug?
Ixazomib impurities can affect drug safety, quality, and efficacy and need removal from the drug.
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