Investigation on elemental migration and internal surface delamination of ambroxol hydrochloride injection in brown middle borosilicate glass ampoules
Objective:To examine the effect of brown midle borosilicate glass ampoules on the drug safety of ambr-oxol hydrochloride injection.Methods:By simulating the storage conditions of ambroxol hydrochloride injection,experimental studies were designed using inductively coupled plasma emission spectroscopy(ICP-OES)and scan-ning electron microscopy(SEM)to investigate element migration and internal surface detachment.Results:The Si content in the injections increased over time,and after 0 to 48 months of various stages of testing,the inner surface of the glass was intact,with no detachment or erosion;the migration of various target elements,such as Cd,Pb,As,Hg,etc.,into the injections took place,but the contents were in accordance with the limits set by the relevant regulations.Conclusion:Brown middle borosilicate glass ampoule packaging for ambroxol hydrochloride injection is safe and stable for 48 months.Brown middle borosilicate glass ampoule can be used as a good container for ambr-oxol hydrochloride injection.
万方数据
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