PT - JOURNAL ARTICLE AU - Tongbo Jiang AU - Maurice Phelan TI - Extractables from Filter Components in Model Solvent Streams for Pharmaceutical Filtration Processes DP - 2003 Jul 01 TA - PDA Journal of Pharmaceutical Science and Technology PG - 287--299 VI - 57 IP - 4 4099 - http://journal.pda.org/content/57/4/287.short 4100 - http://journal.pda.org/content/57/4/287.full SO - PDA J Pharm Sci Technol2003 Jul 01; 57 AB - Drug manufacturers use filters widely in their manufacturing processes for bioburden reduction and sterility assurance. In implementing a pharmaceutical filtration, it is essential to determine and profile the filter extractables that could be introduced into the product. There is an ongoing industry effort to explore the analysis of extractables. Toward this end, the use of complementary analytical techniques was evaluated to aid in extractables identification by determining whether the analysis of filters in the form of components, rather than entire assemblies, facilitated the profiling of extractables. The study examines filter components of 10-inch, 0.22-μm Durapore® cartridge filters using Fourier transform infra-red spectroscopy (FTIR) and nuclear magnetic resonance spectroscopy (NMR), as well as determines the non-volatile residues (NVR) and total organic carbon contents (TOC) of the extractables. The complementary techniques of high performance liquid chromatography (HPLC/UV) and liquid chromatography nuclear magnetic resonance spectroscopy (LC/NMR) were also used. The results of the tests indicated very low levels of extractables.