Whitepaper: Establishing the proper alcohol/water proportion for simulating solvents used in controlled extraction studies
Posted: 13 May 2020 | Nelson Laboratories LLC | No comments yet
This paper provides scientific guidance as well as a case study on the effect of solvent polarity (ethanol/water proportion) on the levels of extractables.
The purpose of this paper is to provide guidance on determining the proper alcohol/water proportion for simulating solvents used in controlled extraction studies relevant to drug products that are packaged in plastic container systems, administered via plastic devices or manufactured using systems that consist of plastic components.
This paper provides scientific guidance as well as a case study on the effect of solvent polarity (ethanol/water proportion) on the levels of extractables.
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Related topics
Analytical techniques, Biopharmaceuticals, Bioprocessing, Data integrity, Excipients, Formulation, Good Manufacturing Practice (GMP), Ingredients, Labelling, Manufacturing, Outsourcing, Packaging, QA/QC, Regulation & Legislation, Research & Development (R&D)
