Accelerated extractable studies of borosilicate glass containers.

ABSTRACT

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 H2O as the sole extraction solution, the procedure outlined in this report used a variety of unbuffered (pH congruent to 4, H2O, pH congruent to 6.5, pH congruent to 8.0, pH congruent to 9.5, and pH congruent to 10.4) and buffered (pH = 8 and pH = 10) aqueous extraction media. Studies were completed for several borosilicate glasses, including a mixture of tubing vials, molded vials, and ampoules from US and European suppliers. Results of these studies are presented in this article and are discussed in terms of the interactions between borosilicate glasses and aqueous solutions.