Skinnemoen K, Fagervoll R, Aanstad L, Jacobsen T
Analytical Chemistry Department, Nycomed AS, Oslo, Norway.
Acta Radiol Suppl. 1987;370:37-40.
The autoclaving studies which were performed to develop a formulation of iopentol are presented. The same formulation as used for iohexol was found to be suitable for iopentol. It was shown that it is essential to use a buffer such as trometamol to lower the pH during autoclaving in order to achieve a low level of deiodination after autoclaving. Results from the on-going stability studies indicate a good stability of iopentol finished product.
本文介绍了为开发碘海醇制剂而进行的高压灭菌研究。结果发现,与碘海醇所用的相同制剂适用于碘帕醇。结果表明,在高压灭菌过程中使用诸如氨丁三醇之类的缓冲剂来降低pH值至关重要,以便在高压灭菌后实现低水平的脱碘。正在进行的稳定性研究结果表明碘帕醇成品具有良好的稳定性。