Stability of Recombinant Human Serum Albumin and Interferon Alpha 2b Fusion Protein for Injection / 中国药学杂志

ABSTRACT

OBJECTIVE: To explore the stability of recombinant human serum albumin and interferon alpha 2b fusion protein for injection. METHODS: According to the testing methods of Ch.P, influencing factors test [high temperature test at (42±2)℃, strong light test at (4 500±500)lx and humidity test at RH of 90%], accelerated test (37 and 25 ℃)and long-term test were carried out according to the technical guidelines of biological stability study. RESULTS: The results of influencing factors test, accelerated test and long-term test showed that temperature had influence on the purity of products. The protein purity decreased with the increase of temperature. Humidity also had influence on the moisture content of products, with little influence on other indicators. Long term stability investigation found that the sample was relatively stable within 24 months and the examined indexes accorded with the quality standard. CONCLUSION: This recombinant protein can be stored at 2-8 ℃ for 24 months.