Sichuan Elixir Pharmaceutical Co., Ltd. sell "Osimertinib"
Basic Information
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46
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4.3(14)
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Trade Type
Sell
Product Name
Osimertinib
Details
Substance
Manufacturer(s)
Specifications
- CAS Number: 1421373-66-1
- Molecular Weight: 595.7
- Chemical Formula: C29H37N7O5S
- Assay: Osimertinib drug substance assay is controlled at 98.0-102.0% on an anhydrous basis by validated HPLC, consistent with EGFR-mutated NSCLC therapeutic-grade API requirements.
- 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
- Purity: Chromatographic purity of ≥99.5% by HPLC, with individual unspecified impurities and total related substances controlled within ICH Q3A limits for an oncology API.
- Particle Size: Micronized particle size distribution (D90 typically ≤30 µm) is controlled to ensure consistent dissolution and content uniformity in downstream tablet formulation.
- Residual Solvents: Residual solvents from the synthesis and crystallization steps are controlled by GC within ICH Q3C Class 2/3 limits, confirmed on a per-batch Certificate of Analysis.
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