1.
Bioorg Khim
; 35(1): 55-61, 2009.
Artigo
em Russo
| MEDLINE
| ID: mdl-19377522
RESUMO
A method for monitoring the manufacture of genetically engineered human insulin by HPLC was developed. The method was validated by the estimation of its linearity, correctness, accuracy, specificity, and stability; the limits of detection and quantitative assessment were also determined. It was proven that HPLC analysis enables reliable and reproducible results to be obtained and can be used for monitoring insulin manufacture.