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extractables-leachables-analyzer

E&L study design and data analysis skill for chemical characterization of medical devices

library/specializations/domains/science/biomedical-engineering/skills/extractables-leachables-analyzer/SKILL.md

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# Extractables and Leachables Analyzer Skill

## Purpose

The Extractables and Leachables Analyzer Skill supports E&L study design and data analysis for chemical characterization of medical devices per ISO 10993-18, including extraction study design and toxicological risk assessment.

## Capabilities

- Extraction solvent and condition selection
- Analytical method recommendations (GC-MS, LC-MS, ICP)
- AET (Analytical Evaluation Threshold) calculation
- Compound identification assistance
- Toxicological risk assessment templates
- ICH Q3D elemental impurity guidance
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