Analysis on Osmolality of Domestic Recombinant Human Interferon α2 b Injection / 中国药师

ABSTRACT

Objective:To examine the osmolality of domestic recombinant human interferon α2b injection to provide evidence for the improvement of the national quality standard. Methods:Totally 66 batches of recombinant human interferonα2b injection produced by 9 manufacturers were withdrawn, and the osmolality was determined according to the appendix of Chinese Pharmacopoeia Ⅲ(2010 edition). The results were analyzed with statistical methods. Results:The pass rate of osmolality was 98. 5%. The osmolality of more than 90% of the batches was between 85% and 115% of the intermediate value set by the manufacturers. Conclusion:Comprehensive understanding of the quality control of osmolality of domestic recombinant human interferon α2b injection is obtained, which provides data support for the improvement of quality standard of osmolality.