| 摘要 |
Sterilization process of a powder that contains glucocorticosteroid granules have a medium aerodynamic diameter (MAD) not superior than 8-9 micron and that foresees the treatment of the simple glucocorticosteroid powder, ester, salt, acetate, through a temperature of 135± 1°C for 90 minutes in dried environment, in a double polypropylene envelope. It was verified with experimental tests that after the sterilization, no new degradation products grew in the glucocorticosteroid, and that the initial impurities concentration present before the sterilization process is not increased or is increased but remains inferior to the parameters accepted by the European Pharmacopoeia.
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