Ivosidenib
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.
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FAQ's
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Frequently Asked Questions
How are Ivosidenib impurities reported in the drug's labeling information?
Impurities in Ivosidenib are in the drug's labeling information, including the package insert or prescribing information. This information may provide details on the impurity profile, acceptable limits, and potential risks with impurities.
Can Ivosidenib impurities be removed or reduced during the manufacturing process?
Manufacturers use purification techniques and optimized manufacturing processes to minimize impurities in Ivosidenib. These measures aim to remove or reduce them to ensure the highest possible purity of the final product.
Which solvent helps in analyzing Ivosidenib impurities?
Methanol is commonly used as a solvent when analyzing the impurities in Ivosidenib.
How should Ivosidenib impurities be stored in terms of temperature?
The recommendation is to store Ivosidenib impurities at a controlled room temperature, within 2-8 °C.
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