Risedronic acid monosodium salt hemi(pentahydrate); Risedronate Sodium 2.5 Hydrate, P,P’-[1-Hydroxy-2-(3-pyridinyl)ethylidene]bisphosphonic acid sodium salt hydrate (2:2:5), [1-Hydroxy-2-(3-pyridinyl)ethylidene]bisphosphonic acid monosodium salt hydrate (2:5), Risedronic acid monosodium salt hemipentahydrate
Descrição
No controle de qualidade do Prednisolone acetate CRS (CAS 52-21-1) foi identificada como impureza a Risedronic acid monosodium salt hemi(pentahydrate) | também referida como Risedronate Sodium 2.5 Hydrate ou P | P’-[1-Hydroxy-2-(3-pyridinyl)ethylidene]bisphosphonic acid sodium salt hydrate | cuja presença exige investigação técnica: trata-se de um sal bisfosfônico altamente polar com solubilidade diferencial em meios aquosos e orgânicos | perfil térmico e cristalino distinto que pode afetar a pureza e o perfil de dissolução. A detecção e quantificação devem ser realizadas por HPLC com detecção UV e confirmação por LC-MS | com limites especificados em especificações analíticas e ações corretivas como purificação por cromatografia e recristalização.
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