3-Amino-1-Propanol; Cyclophosphamide USP Related Compound E; 1-Amino-3-hydroxypropane;3-Propanolamine;beta-Alaninol;N-(3-Hydroxypropyl)amine;Dexpanthenol EP Impurity A;
Descrição
A Impureza EP G da ciclofosfamida corresponde a 3-amino-1-propanol, CAS 156-87-6, fórmula molecular C3H9NO e massa molecular 75.11 g/mol. Trata-se de uma alkanolamina polar e de baixa massa molecular, associada a impureza de processo durante a fabricação de ciclofosfamida ou à fragmentação hidrolítica de intermediários aminoalquílicos. Embora não seja uma nitrosamina, sua presença é relevante no perfil de impurezas por poder gerar artefatos de derivatização e indicar controle incompleto de etapas de aminação ou de matérias-primas contendo função álcool. A quantificação em níveis traço normalmente requer GC-MS ou LC-MS/MS, muitas vezes com derivatização pré-coluna para melhorar retenção, ionização e seletividade.
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