Zobrazeno 1 - 2
of 2
pro vyhledávání: '"Nina J. Xiao"'
Publikováno v:
Journal of Pharmaceutical Sciences. 110:1615-1624
Health authorities require that suitable stability of the drug substance be shown in relevant materials of construction. ICH Q1A(R2) explicitly states that "stability studies should be conducted on drug substance packaged in a container closure syste
Autor:
Viswanatham Katta, Jennifer Zhang, Judy Yi-Huei Chang, Ed Hoff, Steven J. Shire, Stephen J. Russell, Nina J. Xiao, Min Zhu
Publikováno v:
Pharmaceutical Research. 27:2402-2413
To investigate the cause of the observed instability of dulanermin in 100 ml polyolefin (PO) infusion bags containing saline. Diluted dulanermin in IV bags was collected and frozen prior to analysis by size exclusion chromatography. The UV absorption