Duvelisib

General Information

Duvelisib Impurities and Duvelisib 

Daicel Pharma offers high-quality impurities for Duvelisib, an active pharmaceutical ingredient. These impurities, including (S)-3-(1-aminoethyl)-8-chloro-2-phenylisoquinolin-1(2H)-one, 6-Chloro-9-(9-(tetrahydro-2H-pyran-2-yl)-9H-purin-6-yl)-9H-purine, and 6-Chloro-9-(9H-purine-6-yl)-9H-purine, play a vital role in assessing the purity, reliability, and safety of Duvelisib. Daicel Pharma also offers a customized synthesis of Duvelisib impurities to cater to client requirements, with worldwide delivery options available.

Duvelisib [CAS: 1201438-56-3], a potent small molecule inhibitor, targets the delta and gamma isoforms of phosphoinositide-3 kinase (PI3K). It treats small lymphocytic lymphoma (SLL) and relapsed or refractory chronic lymphocytic leukemia (CLL). It possesses immunomodulating and antineoplastic properties.

Duvelisib: Use and Commercial Availability 

Duvelisib, available under the brand name Copiktra, treats relapsed or refractory chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and relapsed or refractory follicular lymphoma (FL) after two or more prior systemic therapies. According to a recent study, Duvelisib has demonstrated promising anticancer activity with manageable toxicities in patients with relapsed or refractory CLL or SLL.

Duvelisib Structure and Mechanism of Action

The chemical name of Duvelisib is 8-Chloro-2-phenyl-3-[(1S)-1-(9H-purin-6-ylamino)ethyl]-1(2H)-isoquinolinone. Its chemical formula is C₂₂H₁₇ClN₆O, and its molecular weight is approximately 416.9 g/mol.

Duvelisib inhibits phosphatidylinositol 3-kinase (PI3K) with inhibitory activity against PI3K-δ and PI3K-γ isoforms expressed in malignant and normal B-cells. It inhibits cell-signaling pathways, including B-cell receptor signaling.

Duvelisib Impurities and Synthesis

The analysis and control of impurities in Duvelisib, a pharmaceutical compound, are crucial for ensuring its quality and safety. Various impurities can arise during the synthesis¹, storage, or degradation of Duvelisib, which may affect its efficacy or pose potential health risks. Therefore, a comprehensive analysis of impurities identifies and quantifies these substances. Rigorous control measures help minimize impurity levels and maintain the desired quality of Duvelisib. It includes using suitable manufacturing processes, implementing storage conditions, and conducting regular quality assessments to ensure the safety and effectiveness of the final product.

Daicel Pharma offers a comprehensive Certificate of Analysis (CoA) for Duvelisib impurity standards, including (S)-3-(1-aminoethyl)-8-chloro-2-phenylisoquinolin-1(2H)-one, 6-Chloro-9-(9-(tetrahydro-2H-pyran-2-yl)-9H-purin-6-yl)-9H-purine, and 6-Chloro-9-(9H-purine-6-yl)-9H-purine. They generate from an analytical facility that complies with cGMP standards. The CoA provides a detailed characterization report with data obtained through techniques such as 1H NMR, 13C NMR, IR, MASS, and HPLC purity analysis². We provide additional data like 13C-DEPT upon request. Daicel Pharma synthesizes unknown Duvelisib impurities or degradation products. Every delivery has a complete characterization report.