Impact of formaldehyde, acetaldehyde, and N-(3-(Dimethylamino)propyl)methacrylamide on the efficacy of the human derived coagulation factor IX.

Polymer-borne leachables such as formaldehyde, acetaldehyde, and N-3-(Dimethylamino)propyl)methacrylamide (DMAPMA) may interact with therapeutic proteins. In this study, the leachables were spiked into human derived coagulation factor IX (FIX) at concentrations of 1, 10, 50, 100, and 500 µg/mL, corresponding to a leachable - FIX ratio of 0.5, 5, 25, 50 and 250 %, respectively.

A Systematic Analysis of the Effect of Extraction Solvents on the Chemical Composition of Extraction Solutions and the Analytical Implications in Extractables and Leachables Studies.

Assessment of extractables and leachables (E&L) released from the pharmaceutical container closure systems (CCS), single-use polymeric processing materials (PPM), and medical devices is one of regulatory requirements in the submission and approval of pharmaceutical products and medical devices. The analytical activities involved in E&L studies are the solvent extraction of test articles, followed by instrumental analysis to determine both concentration and identities. Most E&L publications today are centered around the latter part, and the effect of extraction solvents on the chemical composition of extracts in the number, concentration and molecular weight (M) has not been systematically delineated and conceptualized to the best of our knowledge.