Impureza de (±)-Epinefrina (CAS 329-63-5) caracteriza-se por substâncias correlatas originadas de racemização | oxidação e sais residuais. Perfil analítico exige método validado HPLC com detecção UV e confirmação por LC-MS para quantificação de impurezas orgânicas e degradativas. Propriedades físicas incluem solubilidade em água e pH-dependente estabilidade | com tendência à oxidação em presença de ar e luz | formando quinonas e diméricos. Especificações típicas definem limites de impurezas relacionadas e total aceitável segundo guidelines regulatórias. Fornecemos material padrão de impureza para avaliação de estabilidade | desenvolvimento de métodos e controle de qualidade em ambientes GLP e GMP.
Referências
Kemp, S. F., Lockey, R. F., Simons, F. E. R., & World Allergy Organization ad hoc Committee on Epinephrine in Anaphylaxis. (2008). Epinephrine: the drug of choice for anaphylaxis-a statement of the world allergy organization. The World Allergy Organization Journal, 1(7 Suppl), S18-26. https://doi.org/10.1097/WOX.0b013e31817c9338
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