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pro vyhledávání: '"Mark Anderson Jordi"'
Autor:
Mark Anderson Jordi, Ted Heise
Publikováno v:
PDA journal of pharmaceutical science and technology. 75(3)
To address patient safety, a drug product is chromatographically screened for organic leachables. Similarly, medical device and packaging system extracts are chromatographically screened for organic extractables as probable leachables. To protect pat
Autor:
Mark Anderson Jordi, Kaitlin Lerner, Weixi Liu, Zhu Liang, Xingluan Cao, Jie Zong, Kevin Rowland, Michael Louis, Yuan Ren, Xiao Zhou
Publikováno v:
Journal of Pharmaceutical and Biomedical Analysis. 186:113334
Characterization of Extractables and Leachables (E&Ls) is an important aspect of product quality in important fields such as pharmaceuticals, medical devices and food contact materials. The main goal of an E&L study is identification and quantificati
Autor:
Mark Anderson Jordi, Nina Chen, Syed Lateef, Paige Solomon, James Woods, Liuwei Jiang, Kevin Roland, Frankie Aiello, Samantha Martin, Jenny Nelson, Leland Martin, Smriti Khera
Publikováno v:
Journal of pharmaceutical and biomedical analysis. 150
The advent of single-use bioprocess systems used for the delivery, storage or manufacture of biopharmaceuticals has introduced a new potential source for extractables and leachables (E&L) as these systems are comprised of polymeric materials. Several