Abstract
Plastic materials and systems used to manufacture, contain, store, and deliver pharmaceutical products are extracted and the extracts analyzed to establish the materials' (or systems') organic extractables profile. Such testing typically consists of multiple chromatographic approaches whose differences help to ensure that all organic extractables are revealed, measured, and identified. Nevertheless, this rigorous screening process is not infallible and certain organic extractables may elude detection. If the extraction medium is aqueous, the process of total organic carbon (TOC) reconciliation is proposed as a means of establishing when some organic extractables elude detection. In the reconciliation, the TOC of the extracts is both directly measured and calculated from the chromatographic data. The measured and calculated TOC is compared (or reconciled), and the degree of reconciliation is an indication of the completeness and accuracy of the organic extractables profiling. If the reconciliation is poor, then the extractables profile is either incomplete or inaccurate and additional testing must be performed to establish the complete and accurate profile. This article demonstrates the TOC reconciliation process by considering aqueous extracts of 10 different test articles. Incomplete reconciliations were augmented with additional testing to produce a more complete TOC reconciliation.
Published Version
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