Subcategory & Sub-subcategory
Product Name
Osimertinib mesylate
Specifications
- CAS Number: 1421373-66-1
- Chemical Formula: C29H37N7O5S
- Assay: Osimertinib mesylate salt assay is controlled at 98.0-102.0% on an anhydrous basis by validated HPLC, in line with API requirements for NSCLC treatment.
- IUPAC Name: N-[2-[2-(dimethylamino)ethyl-methylamino]-4-methoxy-5-[[4-(1-methylindol-3-yl)pyrimidin-2-yl]amino]phenyl]prop-2-enamide;methanesulfonic acid
- EC Number: 806-779-0
- Molecular Weight: 595.7
- Purity: Chromatographic purity of ≥99.5% by HPLC, with total related substances controlled within ICH Q3A limits appropriate for an oncology-indicated API salt form.
- Particle Size: Particle size distribution of the mesylate salt (D90 typically ≤30 µm) is controlled to support consistent dissolution behaviour and downstream formulation processability.
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