Ivacaftor

General Information

Ivacaftor Impurities and Ivacaftor

Daicel Pharma offers excellent-quality Ivacaftor impurities, such as Hydroxymethyl Ivacaftor. They are vital for evaluating Ivacaftor quality, stability, and biological safety. Furthermore, Daicel Pharma specializes in the custom synthesis of Ivacaftor impurities and ensures their worldwide delivery.
Developed by Vertex Pharmaceuticals, Ivacaftor [CAS: 873054-44-5] is an aromatic amide compound. It manages Cystic fibrosis, an autosomal recessive disorder caused by gene mutations of the protein- Cystic Fibrosis Transmembrane Conductance Regulator (CFTR). The CFTR protein is active in the epithelial cells of organs such as the liver, lungs, pancreas, etc. It also acts on some Class III mutations.

Ivacaftor: Use and Commercial Availability

Ivacaftor is a medicine that treats cystic fibrosis in patients with a G551D mutation in the CFTR gene. As a CFTR potentiator, Ivacaftor decreases thick mucus build-up in the lungs. It combines with other drugs to improve the lung functions of patients with cystic fibrosis symptoms. Ivacaftor is available under Kalydeco as an oral formulation.

Ivacaftor Structure and Mechanism of Action

The chemical name of Ivacaftor is N-[2,4-Bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxo-3-quinolinecarboxamide. The chemical formula for Ivacaftor is C₂₄H₂₈N₂O₃, and its molecular weight is approximately 392.49 g/mol.

Ivacaftor aids in increasing chloride transport by potentiating the channel-open probability of the G551D mutation in the CFTR protein.

Ivacaftor Impurities and Synthesis

Impurities form during Ivacaftor synthesis1 that may affect the safety and efficacy of the drug. These impurities develop during the manufacturing process, purification, or storage of Ivacaftor. It is essential to control and monitor Ivacaftor impurities for better drug development.
Daicel Pharma offers a comprehensive Certificate of Analysis (CoA) for Ivacaftor impurities, which includes Hydroxymethyl Ivacaftor. 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 Ivacaftor impurity or degradation product. Further, Daicel Pharma offers purified, stable isotope-labeled standards of Ivacaftor. We guarantee a complete characterization report on delivery.