Maribavir Impurity 2 (CAS 193526-90-8) is a process-related or degradation impurity encountered during synthesis and stability assessment of the maribavir API, requiring precise identification and quantification by HPLC with UV detection, LC-MS and NMR for reliable impurity profiling and specification setting. Control strategies should focus on minimizing formation through optimized reaction conditions and purification steps, while qualification and toxicological risk assessment in line with ICH Q3A and ICH M7 support safety evaluation and specification limits. Availability of certified reference material and validated analytical methods ensures robust batch release and regulatory compliance.
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