General Information

Ivosidenib Impurities and Ivosidenib

Daicel Pharma offers worldwide delivery options for a custom synthesis of Ivosidenib impurities, including impurities such as 2-((S)-2-(((S)-1-(2-chlorophenyl)-2-((3,3-difluorocyclobutyl)amino)-2-oxoethyl)(5-fluoropyridin-3-yl)carbamoyl)-5-oxopyrrolidin-1-yl)isonicotinamide. These impurities play a vital role in evaluating the purity and safety of Ivosidenib, an active pharmaceutical ingredient.

Ivosidenib [CAS: 1448347-49-6] is an orally available small molecule inhibitor of isocitrate dehydrogenase type 1 (IDH1) and type 2 (IDH2). It is an antineoplastic agent that treats selected cases of acute myeloid leukemia (AML).

Ivosidenib: Use and Commercial Availability  

Ivosidenib, available under Tibsovo, is a US FDA-approved medication for treating acute myeloid leukemia (AML) in patients with an isocitrate dehydrogenase-1 (IDH1) mutation. It acts as an antineoplastic agent and an inhibitor of the enzyme isocitrate dehydrogenase (IDH1), targeting the mutated form of IDH1 in the cytoplasm.

Ivosidenib Structure and Mechanism of Action

The chemical name of Ivosidenib is (2S)-N-{(1S)-1-(2-chlorophenyl)-2-[(3,3-difluorocyclobutyl)amino]-2-oxoethyl}-1(4-cyanopyridin-2-yl)-N-(5-fluoropyridin-3-yl)-5-oxopyrrolidine-2-carboxamide. Its chemical formula is C₂₈H₂₂ClF₃N₆O₃, and its molecular weight is approximately 583.0 g/mol.

Ivosidenib targets isocitrate dehydrogenase 1 (IDH1) enzyme and inhibits selected IDH1 R132 mutants. By inhibiting IDH1 and IDH2, Ivosidenib demonstrates potential in fighting cancerous cells.

Ivosidenib Impurities and Synthesis

Ivosidenib, a medication for treating acute myeloid leukemia (AML), can potentially contain impurities. Impurities in Ivosidenib can originate from the manufacturing process¹, starting materials, intermediates, or degradation products. Ivosidenib impurities include related substances, residual solvents, and degradation products. They may arise from incomplete reactions, impure starting materials, or storage conditions. It is essential to control and monitor these impurities to ensure the safety and efficacy of the medication. Regulatory authorities, such as the United States Food and Drug Administration (FDA), have established guidelines and impurity levels in pharmaceuticals, including Ivosidenib. Manufacturers comply with these regulations and conduct thorough testing to identify and quantify impurities within acceptable limits.

Daicel Pharma strictly adheres to cGMP standards and operates an analytical facility for the preparation of Ivosidenib impurity standards such as 2-((S)-2-(((S)-1-(2-chlorophenyl)-2-((3,3-difluorocyclobutyl)amino)-2-oxoethyl)(5-fluoropyridin-3-yl)carbamoyl)-5-oxopyrrolidin-1-yl)isonicotinamide. We offer deuterium-labeled Ivosidenib compounds, Ivosidenib-D4 and Ivosidenib-D4 (S, R-isomer), which are essential for bioanalytical research and BA/BE studies. Our impurities have a detailed Certificate of Analysis (CoA) that provides a comprehensive characterization report. This report includes data obtained through techniques, 1H NMR, 13C NMR, IR, MASS, and HPLC purity analysis². Upon request, we provide additional data like 13C-DEPT. We can synthesize unknown Ivosidenib impurities, degradation products, and labeled compounds to assess the effectiveness of generic Ivosidenib. Each delivery has a comprehensive characterization report.