A impureza Cyclophosphamide Pyrophosphate Analog é um subproduto estruturalmente relacionado à ciclofosfamida que pode surgir durante etapas de fosfatação e formação de grupos pirofosfato | originando-se por reações secundárias de condensação | transesterificação ou hidrólise do intermediário fosforil. Sua presença impacta o perfil de qualidade | potência e estabilidade do material ativo | exigindo controle rigoroso por métodos analíticos validados como HPLC | LC-MS e NMR e por cromatografia iônica quando aplicável. Estratégias de mitigação incluem otimização de parâmetros de síntese | etapas de purificação específicas | monitoramento em linha e definição de limites baseados em avaliação toxicológica e diretrizes regulatórias ICH pertinentes.
Referências
Deffert, Christine, et al. “Phosphonoformate Crystalluria, a Warning Signal of Foscarnet-Induced Kidney Injury.†Kidney International Reports, vol. 5, no. 11, Nov. 2020, pp. 2102–8, https://doi.org/10.1016/j.ekir.2020.08.019.
To provide the best experiences, we use technologies like cookies to store and/or access device information. Consenting to these technologies will allow us to process data such as browsing behavior or unique IDs on this site. Not consenting or withdrawing consent, may adversely affect certain features and functions.
Functional
Sempre ativo
The technical storage or access is strictly necessary for the legitimate purpose of enabling the use of a specific service explicitly requested by the subscriber or user, or for the sole purpose of carrying out the transmission of a communication over an electronic communications network.
Preferences
The technical storage or access is necessary for the legitimate purpose of storing preferences that are not requested by the subscriber or user.
Statistics
The technical storage or access that is used exclusively for statistical purposes.The technical storage or access that is used exclusively for anonymous statistical purposes. Without a subpoena, voluntary compliance on the part of your Internet Service Provider, or additional records from a third party, information stored or retrieved for this purpose alone cannot usually be used to identify you.
Marketing
The technical storage or access is required to create user profiles to send advertising, or to track the user on a website or across several websites for similar marketing purposes.
To provide the best experiences, we use technologies like cookies to store and/or access device information. Consenting to these technologies will allow us to process data such as browsing behavior or unique IDs on this site. Not consenting or withdrawing consent, may adversely affect certain features and functions.
Functional
Sempre ativo
The technical storage or access is strictly necessary for the legitimate purpose of enabling the use of a specific service explicitly requested by the subscriber or user, or for the sole purpose of carrying out the transmission of a communication over an electronic communications network.
Preferences
The technical storage or access is necessary for the legitimate purpose of storing preferences that are not requested by the subscriber or user.
Statistics
The technical storage or access that is used exclusively for statistical purposes.The technical storage or access that is used exclusively for anonymous statistical purposes. Without a subpoena, voluntary compliance on the part of your Internet Service Provider, or additional records from a third party, information stored or retrieved for this purpose alone cannot usually be used to identify you.
Marketing
The technical storage or access is required to create user profiles to send advertising, or to track the user on a website or across several websites for similar marketing purposes.
