3-[[2-[(2-Chloroethyl)amino]ethyl]amino]-1-propanol Dihydrogen Phosphate Dihydrochloride; Cyclophosphamide Impurity D Dihydrochloride; USP Cyclophosphamide Related Compound D;
Descrição
Impureza Cyclophosphamide Related Compound D (CAS 158401-51-5) | também referida como 3-[[2-[(2-cloroetil)amino]etil]amino]-1-propanol dihidrogenofosfato diidrocloreto e Cyclophosphamide Impurity D Dihydrochloride | é um subproduto polar resultante de degradação ou vias de síntese incompletas do ciclofosfamida. Sua estrutura contendo grupos cloroetil | amina e propanol confere elevada solubilidade aquosa e perfil cromatográfico distinto. Monitoramento analítico por HPLC-UV | LC-MS/MS e RMN é essencial para controle de qualidade e cumprimento de limites estabelecidos na farmacopéia USP. A caracterização | quantificação e limitação dessa impureza impactam diretamente atributos críticos de qualidade e segurança do processo de produção.
Referências
Joqueviel, Claire, et al. Urinary Excretion of Cyclophosphamide in Humans, Determined by Phosphorus-31 Nuclear Magnetic Resonance Spectroscopy. Drug Metabolism and Disposition, vol. 26, no. 5, American Society for Pharmacology and Experimental Therapeutics, May 1998, pp. 418–28, dmd.aspetjournals.org/content/26/5/418.short. ?Fraiser, Lucy H., et al. Cyclophosphamide Toxicity. Drugs, vol. 42, no. 5, Nov. 1991, pp. 781–95, doi.org/10.2165/00003495-199142050-00005.?
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