Ivosidenib API Manufacturer in India
Ivosidenib is a targeted small-molecule anticancer active pharmaceutical ingredient that selectively inhibits mutant isocitrate dehydrogenase-1 (IDH1). It is developed for the treatment of cancers carrying susceptible IDH1 mutations, particularly acute myeloid leukemia (AML) and cholangiocarcinoma.
Ivosidenib works by inhibiting the abnormal enzymatic activity of mutant IDH1, which reduces the production of the oncometabolite 2-hydroxyglutarate (2-HG). This can help restore normal cellular differentiation and inhibit the growth of malignant cells carrying IDH1 mutations.
Ivosidenib has the molecular formula C28H22ClF3N6O3 and a molecular weight of 583.95 g/mol. It is identified by CAS Number 1448347-49-6 and is also known by its development code AG-120.
Ivosidenib is a synthetic, chiral small molecule belonging to the IDH1 inhibitor class. It is generally supplied as a pharmaceutical-grade active ingredient for use in qualified pharmaceutical manufacturing and formulation applications.
Ivosidenib selectively inhibits mutant IDH1 enzymes. Mutations in IDH1 can cause excessive production of 2-hydroxyglutarate, which interferes with normal cellular differentiation. By reducing mutant IDH1 activity and 2-HG production, Ivosidenib can promote differentiation of susceptible malignant cells.
Ivosidenib is used in pharmaceutical products for selected patients with IDH1-mutated acute myeloid leukemia (AML) and IDH1-mutated cholangiocarcinoma, according to applicable regulatory approvals and treatment guidelines.
Ivosidenib API can be evaluated using validated analytical procedures for identity, assay, related substances, residual solvents, water content and elemental impurities. Chromatographic and spectroscopic techniques may be used for identification and purity assessment.
The applicable acceptance criteria should be based on the approved drug-substance specification and current Certificate of Analysis.
Ivosidenib should be stored in a tightly closed pharmaceutical-grade container under controlled storage conditions. The material should be protected from excessive heat, moisture, direct light and contamination. Specific storage requirements should follow the applicable manufacturer's specification.
Ivosidenib API may be supplied for qualified pharmaceutical manufacturing, formulation development, research and analytical applications. Product specifications, CoA, packaging details and regulatory documentation should be confirmed according to the intended application.
Ivosidenib API is available for pharmaceutical development and manufacturing requirements subject to applicable regulatory and quality requirements. Customers can request product specifications, analytical documentation, Certificate of Analysis, packaging information and commercial details for their specific requirements.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.5% |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 1.0% |