Cloropiramina Impureza 3 (sal HCl) | CAS 1135085-85-6 | é uma impureza clorada observada durante a síntese da cloropiramina que pode afetar pureza e perfil de estabilidade do fármaco. Caracteriza-se como sal de cloridrato de menor polaridade relativa que o princípio ativo e apresenta solubilidade aumentada em água e solventes polares como metanol. A detecção e quantificação são tipicamente realizadas por HPLC com detecção UV e confirmação por LC-MS | com limites de identificação e quantificação definidos conforme ICH. Recomenda-se monitoramento contínuo | otimização do processo e estratégias de purificação para minimizar sua presença no produto final.
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