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Extractable substances from plastic materials used in solution contact applications: an updated review
1Technology Resources, Baxter Healthcare Corporation, Round Lake, IL, USA.
PDA Journal of Pharmaceutical Science and Technology
|November 9, 2006
Summary
This review examines organic and inorganic substances extracted from plastics like polyvinyl chloride (PVC) and polyolefins. It covers identifying these extractables, their levels, and challenges in studying leachables.
Area of Science:
- Polymer Chemistry
- Materials Science
- Analytical Chemistry
Background:
- Plastic materials, including polyvinyl chloride (PVC) and polyolefins, are widely used in various applications.
- The presence of extractable substances, such as di(2-ethylhexyl) phthalate (DEHP), from these plastics is a concern.
- Understanding the nature and levels of these extractables is crucial for safety and regulatory assessments.
Purpose of the Study:
- To provide an updated review on the identification and accumulation of organic and inorganic extractables from DEHP-plasticized PVC, polyolefin, and other plastic materials.
- To summarize reported levels of these extractables in material extracts.
- To discuss strategic issues in the investigation of extractables and leachables.
Main Methods:
- Literature review of studies on plastic extractables.
- Analysis of reported identification methods for organic and inorganic substances.
- Compilation of data on extractable levels in various plastic matrices.
- Discussion of methodologies for investigating extractables/leachables.
Main Results:
- Identification of a range of organic and inorganic extractable substances from different plastic types.
- Variability in reported levels of extractables depending on plastic composition and extraction conditions.
- Key challenges and strategic considerations in the accurate identification and quantification of plastic extractables.
Conclusions:
- Accurate identification and quantification of plastic extractables are essential for risk assessment.
- Standardized methodologies are needed for consistent and reliable investigation of extractables/leachables.
- Continued research is necessary to fully understand the implications of plastic extractables.
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