Identification of a leachable compound detrimental to cell growth in single-use bioprocess containers
…, H Nunn, G Rogers, H Lee, AL Marghitoiu… - PDA Journal of …, 2013 - journal.pda.org
Out of the plethora of chemical species extractable at low levels from the materials of construction
of single-use bioprocess containers, we have identified one particularly conspicuous …
of single-use bioprocess containers, we have identified one particularly conspicuous …
Exploration of Unconventional Holistic Approach for Identification of Potential Leachable Using Product Label Contact Study with Ophthalmic Solution
SS Zokande, DK Inamdar, DA Gosar - Available at SSRN 4692791 - papers.ssrn.com
Abstract Knowledge of synthetic route of drug substance and degradation pathway of drug
product is acceptable approach for listing of impurities under drug product specification. …
product is acceptable approach for listing of impurities under drug product specification. …