Accelerated Extractable Studies Of Borosilicate Glass Containers

This article describes the use of an accelerated extractable procedure for borosilicate glass containers. The procedure, which is very similar to a protocol developed by a PDA Task Force, includes the monitoring of Si, Na, K, Al, Ba, Ca, Mg, Fe and Zn in the extracts as well as measurements of pH change and total extractables. Unlike the PDA protocol, which uses H20 as the sole extraction solution, the procedure outlined in this report used a variety of unbuffered and buffered aqueous extraction media. Studies were completed for several borosilicate glasses, including a mixture of tubing vials, moulded vials, and ampoules from US and EU suppliers. Results of these studies are presented and discussed in terms of the interactions between borosilicate glasses and aqueous solutions.

Author
S J Borchert Et Al
Origin
Upjohn Co, Usa
Journal Title
J Parenteral Sci & Technol 43 2 1989 67-79
Sector
Primary Papers
Class
PP 85

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Accelerated Extractable Studies Of Borosilicate Glass Containers
J Parenteral Sci & Technol 43 2 1989 67-79
PP 85
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