Vismodegib Impurity 9 (CAS 1195072-86-6) is a trace process-related and degradation impurity observed during synthesis and stability testing of Vismodegib; it is routinely monitored as part of impurity profiling and control strategies. This impurity is detected at low levels by validated HPLC and LC-MS assays and further characterized using high resolution mass spectrometry and NMR where required to support structure elucidation. Formation is typically linked to off-pathway reactions or stress conditions, making it a target for upstream process optimization and purification improvements. Regulatory assessment follows ICH guidance for identification, qualification and setting specification limits to ensure product quality and safety.
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