A Impureza D de Diltiazem EP (forma base livre) | CAS 86408-45-9 | também referida como Diltiazem Related Compound D | N-Desmetil Diltiazem ou N-Monodemethyldiltiazem | é um produto de N-desalquilação relevante no perfil de impurezas do diltiazem; sua presença indica reações de desmetilação durante síntese ou degradação acelerada. Quimicamente mais polar que o princípio ativo | exige monitoramento por HPLC com detecção UV e confirmação por LC-MS e RMN para identificação estrutural. A quantificação e limites são estabelecidos em conformidade com monografias EP e diretrizes ICH para garantir qualidade | segurança e consistência do produto farmacêutico.
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