Nilotinib Impurities
General Information
Nilotinib Impurities and Nilotinib
Daicel Pharma provides high-quality Nilotinib impurities, including Nilotinib Regio isomer (Nilotinib impurity-9), NTB Amine Regio Isomer, 2- Methyl Isomer Impurity of Nilotinib, Nilotinib Impurity E CRS, Nilotinib Impurity F CRS, and so on. These impurities are essential for evaluating Nilotinib quality, stability, and safety. Furthermore, Daicel Pharma provides custom synthesis of Nilotinib impurities and ships them worldwide.
Nilotinib [CAS: 641571-10-0] is a tyrosine kinase inhibitor that treats Chronic Myeloid Leukemia (CML).
Nilotinib: Use and Commercial Availability
Nilotinib treats Chronic Myeloid Leukemia (CML) in patients who have failed or are resistant to other therapies. It is available commercially under the brand name Tasigna. Tasigna is approved to treat adults and children with newly diagnosed Philadelphia Chromosome-Positive Chronic Myelogenous Leukaemia (CML) in the chronic phase.
Nilotinib Structure and Mechanism of Action 
The chemical name of Nilotinib is 4-Methyl-N-[3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl]-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]benzamide. Its chemical formula is C28H22F3N7O, and its molecular weight is approximately 529.5 g/mol.
Nilotinib inhibits Bcr-Abl kinase. It stabilizes and binds to the kinase domain of the Abl protein.
Nilotinib Impurities and Synthesis
Unwanted components or by-products that might be present in the Nilotinib drug are known as impurities. These impurities may develop due to the drug’s synthesis1, storage, or deterioration. Nilotinib’s purity, safety, and effectiveness must be controlled and monitored.
Daicel provides a Certificate of Analysis (CoA) of Nilotinib impurity standards like Nilotinib Regio isomer (Nilotinib impurity-9), NTB Amine Regio Isomer, 2- Methyl Isomer Impurity of Nilotinib, Nilotinib Impurity E CRS, Nilotinib Impurity F CRS, and so on. The CoA is offered from a cGMP-compliant analytical facility and includes comprehensive characterization data, such as 1H NMR, 13C NMR, IR, MASS, and HPLC purity2. If requested, we give additional characterization data, such as 13C-DEPT. Daicel Pharma can provide unknown Nilotinib impurities or degradation products. Each delivery comes with a complete characterization report.
References
FAQ's
References
- Breitenstein, Werner; Furet, Pascal; Jacob, Sandra; Manley, Paul William, Inhibitors Of Tyrosine Kinases, Novartis A.-G., Switzerland, EP1532138B1, November 19, 2008
- Pursche, S.; Ottmann, O. G.; Ehninger, G.; Schleyer, E., High-performance liquid chromatography method with ultraviolet detection for the quantification of the BCR-ABL inhibitor nilotinib (AMN107) in plasma, urine, culture medium and cell preparations, Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences, Volume: 852, Issue: 1-2, Pages: 208-216, 2007
Frequently Asked Questions
How are Nilotinib Impurities controlled?
Nilotinib impurities' control is through strict quality control measures during manufacturing. Regulatory authorities set specific limits for impurity levels that must be adhered to.
Can Nilotinib Impurities affect its effectiveness?
Nilotinib impurities can affect its effectiveness by altering the drug's pharmacokinetics, pharmacodynamics, or stability. It is crucial to control and monitor impurities so that the drug maintains its therapeutic potency and delivers the desired therapeutic outcomes.
Are generic versions of Nilotinib tested for Impurities?
Nilotinib generics are thoroughly checked for impurities to assure their quality, safety, and efficacy. Comparative studies and thorough quality control help guarantee that generic versions are equal regarding purity and drug efficacy.
What are the temperature conditions required to store Nilotinib Impurities?
Nilotinib impurities should be stored at a controlled room temperature between 2-8°C or as indicated on the Certificate of Analysis (CoA).
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