Naloxone:降解杂质分析

文摘   2024-09-09 07:02   天津  
By taking a holistic approach, it was possible to assign structures to all 15 degradation products above the reporting threshold.

For five degradation products (A2, D1, G, G1, and H), the assignments were based upon the availability of authentic samples. For four degradation products (A, B, C, and D), the assignments were “tentative” as they were based purely on mass spectrometry data. For six degradation products (A1, A3, E, F, F1, and G2), the assignments were made following NMR analysis of components derived from a forced degradation sample. 

In all cases, the degradants were produced through oxidative pathways, with all except Degradant G incorporating additional oxygen molecules. Many of the structures identified showed significant structural differences from those of naloxone. For the ten degradants, where authentic samples were not available, the structural assignments could be verified if samples were to be prepared by chemical synthesis.


降解路径分析

降解路径分析

降解路径分析

降解路径分析

https://doi.org/10.1021/acs.oprd.4c00215 


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