Analysis on Osmolality of Domestic Recombinant Human Interferon α2 b Injection / 中国药师
China Pharmacist
;
(12): 1997-1999,2000, 2015.
Article
in Chinese
| WPRIM
| ID: wpr-671169
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Totally 66 batches of recombinant human interferonα2b injection produced by 9 manufacturers were withdrawn, and the osmolality was determined according to the appendix of Chinese Pharmacopoeia Ⅲ(2010 edition).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.
Full text:
Available
Index:
WPRIM (Western Pacific)
Language:
Chinese
Journal:
China Pharmacist
Year:
2015
Type:
Article
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