Ixabepilone is a semisynthetic epothilone B analogue and microtubule inhibitor used as an antineoplastic agent. It binds to β-tubulin and interferes with microtubule dynamics, ultimately inhibiting cell division and promoting cancer-cell death.
CAS Number: 219989-84-1
Molecular Formula: C27H42N2O5S
Molecular Weight: 506.70 g/mol
Ixabepilone is a specialized oncology pharmaceutical API requiring controlled synthesis, purification and comprehensive impurity characterization.
Important quality attributes include identity, assay, related substances, residual solvents, water content, elemental impurities, stereochemical purity and stability.
Ixabepilone binds directly to β-tubulin subunits and suppresses microtubule dynamics. This disrupts the normal formation and function of the mitotic spindle, resulting in inhibition of cancer-cell proliferation.
Ixabepilone is used in the treatment of selected cases of metastatic or locally advanced breast cancer, including disease resistant or refractory to certain prior therapies. It may also be used in combination with capecitabine in appropriate clinical settings.
Typical API manufacturing may involve:
Testing may include:
Store in a tightly closed container under controlled pharmaceutical storage conditions, protected from excessive heat, moisture and direct light. Final storage conditions should be established through validated stability studies.
Ixabepilone is a semisynthetic epothilone analogue and microtubule inhibitor with CAS 219989-84-1, molecular formula C27H42N2O5S, and molecular weight 506.70 g/mol. It acts through β-tubulin binding and microtubule inhibition and is used as an oncology therapeutic.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | NLT 98.0% by HPLC |
| 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 2.0% |