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4119804 
Technical Report 
Stability of prednisolone phosphate injection 
Elema, MO; Nobus, CM; Stolk, LM; Hardy, EL; Groothuysen, H 
1997 
IPA/97/1128258 
VOL 13 ISS 1 1997 
REF 5 
17-20 
IPA COPYRIGHT: ASHP The stability of prednisolone sodium phosphate (prednisolone disodium phosphate) injection was studied to obtain more information about decomposition products. During the sterilization process, part of the drug decomposed and free prednisolone and other decomposition products were formed. The concentration of free prednisolone in the injection fluid reached concentrations close to the solubility of this compound. Therefore, precipitation could occur. By increasing the pH of the injection fluid from 7.3 to 8, the amount of free prednisolone formed was reduced to one third. However, the amount of other decomposition products remained the same. Changing the sterilization method (20 min at 121DGC) to a heat treatment of 30 min in saturated steam (103DGC) reduced the concentration of decomposition products to an acceptable level.