Icotinib is a small-molecule epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor used as an anticancer pharmaceutical ingredient. It selectively inhibits EGFR signaling, a pathway involved in the growth and survival of certain cancer cells.
Icotinib is primarily associated with the treatment of non-small-cell lung cancer (NSCLC) in patients whose tumors have activating EGFR mutations, subject to approved indications and local regulatory requirements.
Icotinib is a synthetic pharmaceutical API requiring controlled chemical synthesis, purification and comprehensive analytical testing. API quality control focuses on identity, assay, related substances, residual solvents, water content, elemental impurities and other process-related impurities.
Consistent impurity control is important for producing pharmaceutical-grade Icotinib suitable for formulation development and manufacturing.
CAS Number: 610798-31-7
Molecular Formula: C22H23N3O4
Molecular Weight: 393.44 g/mol
Chemical Name: Icotinib
Drug Class: Antineoplastic Agent
Pharmacological Class: EGFR Tyrosine Kinase Inhibitor
Therapeutic Class: Anticancer Agent
Therapeutic Area: Oncology
Icotinib selectively inhibits the tyrosine kinase activity of the epidermal growth factor receptor (EGFR).
EGFR signaling can promote cellular proliferation, survival and tumor progression. By inhibiting EGFR phosphorylation and downstream signaling, Icotinib can reduce growth signaling in susceptible EGFR-driven cancer cells.
Its clinical activity is particularly relevant in EGFR-mutated NSCLC.
Icotinib is used in approved pharmaceutical formulations for selected patients with:
The specific indication and treatment setting depend on regional regulatory approval and product labeling.
Icotinib is an orally active targeted anticancer agent developed for tumors driven by EGFR signaling. Molecular testing for EGFR mutations can be relevant when determining whether an EGFR-targeted treatment is appropriate.
EGFR belongs to the receptor tyrosine kinase family. Activation of EGFR triggers signaling pathways involved in cell proliferation and survival.
Icotinib binds to the intracellular kinase domain of EGFR and inhibits ATP-dependent kinase activity, thereby reducing downstream signaling.
Icotinib is a synthetic heterocyclic small molecule containing nitrogen-containing aromatic structures and oxygen-containing functional groups. It is generally supplied as a crystalline solid for pharmaceutical manufacturing.
Icotinib API quality evaluation may include:
Icotinib API should be stored in a tightly closed container under controlled pharmaceutical conditions and protected from excessive moisture, heat and direct light. Storage requirements should follow validated stability data and the applicable product specification.
Icotinib is relevant to pharmaceutical research involving EGFR signaling, targeted cancer therapy, tyrosine kinase inhibition, molecularly targeted oncology and EGFR-mutated lung cancer.
Icotinib is an EGFR tyrosine kinase inhibitor with CAS Number 610798-31-7, molecular formula C22H23N3O4, and molecular weight 393.44 g/mol. It is an orally active targeted anticancer agent primarily associated with the treatment of selected EGFR-mutated non-small-cell lung cancer.
| 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% |
| Heavy Metals | NMT 20 ppm |
| pH (1% Solution) | 4.0 – 7.0 |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 2.0% |
| Water Content | NMT 1.0% |