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This White Paper considers the chemical properties of commonly encountered acidic and basic extractables and uses these properties to address questions about establishing the proper pH (or proper pH range) for aqueous solvents in extraction studies.
This White Paper describes how General Chemistry Data obtained in controlled extraction studies, such as pH, UV absorbance and total organic carbon (TOC), is reported, used and discussed as part of a rigorous extractables assessment.
The goal of this whitepaper is to provide guidance and justify appropriate practices about the proper use of exaggerated test article surface area to extraction solution volume ratios in exaggerated extractables studies.
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...
The purpose of this paper is to consider the scientific basis for accelerated contact conditions (via the proper combination of contact temperature and duration) for studies which involve the migration of substances (either extractables or leachables) from plastics and into...
