1500 ng/day is the U.S. FDA’s current Acceptable Intake (AI) limit for N-nitroso-moxifloxacin (NDSRI). Refer to the FDA nitrosamine page for the latest guidance.
Descrição
N-Nitroso Moxifloxacino é uma impureza relacionada a nitrosaminas derivada do antibacteriano fluoroquinolônico moxifloxacino, caracterizada por N-nitrosação no nitrogênio piperazínico. Com fórmula molecular C21H23FN4O5 e massa molecular de 430.43 g/mol, apresenta relevância direta em avaliações regulatórias de impurezas potencialmente mutagênicas segundo ICH M7. Sua formação pode ocorrer quando o precursor amínico é exposto a agentes nitrosantes durante a síntese, o armazenamento ou por interação com excipientes. Devido à ocorrência em níveis traço e ao comportamento de ionização, a determinação costuma exigir LC-MS/MS, espectrometria de massas de alta resolução ou métodos LC-UV acoplados com elevada seletividade.
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