Study on Quality Control and Stability of Recombinant Human Interferon a-2b Suppository

OBJECTIVE In order to provide a formulation of recombinant interferon α-2b suppository for clinical application, a systemic studies of its quality control and stabity was carried out. METHODS Methods used for quality control and stability studies were based on protocols published in China Pharmacopeia 2005. RESULTS For quality control, the apperance, melting time limit, microbal limit and biogical activity were all to be in line with the standards published in China Pharmacopeia 2005. The stability study data showed that recombinant interferon α-2b suppository can be stored for 24 months at the temperaure of 2-8℃. CONCLUSION Recombinant interferon α-2b suppository prepared above exhibit a high quality control and very good stabity.