2. Physical PropertiesAppearance: White to off-white crystalline powderSolubility: Soluble in water and methanol; slightly soluble in ethanolStorage: Store at 2-8°C, protected from light and moisture in airtight containers
3. Pharmaceutical UsesIndications: Treatment of non-small cell lung cancer (NSCLC) with EGFR mutations.Mechanism: Reversible tyrosine kinase inhibitor targeting EGFR (HER1), HER2, and HER4.Route: Oral administration (tablets, as the maleate salt form).
4. Quality StandardsPharmacopoeias: USP, EP, ChP (where applicable)Key Specs:Purity ≥99.0% (HPLC)Related substances ≤0.5% (individual impurity limits)Residual solvents compliant with ICH guidelinesMaleic acid ratio: Consistent with stoichiometric composition
