TY - JOUR T1 - Accelerated Extractable Studies of Borosilicate Glass Containers JF - PDA Journal of Pharmaceutical Science and Technology JO - PDA J Pharm Sci Technol SP - 67 LP - 79 VL - 43 IS - 2 AU - Steven J. Borchert AU - Michele M. Ryan AU - Richard L. Davison AU - William Speed Y1 - 1989/03/01 UR - http://journal.pda.org/content/43/2/67.abstract N2 - 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 ≃ 4, H2O, pH ≃ 6.5, pH ≃ 8.0, pH ≃ 9.5, and pH ≃ 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. ER -