Recommendations for Improvement of Chemical Characterization Guidelines: Sample Preparation, Solvent Selection, Instrument Selectivity and Targeted Analysis
- Wednesday
- October
- 29
- 2025
Dr. Mourad Rahi Overview:
The topic describes the shortfalls and gaps of solvent selection for preparation of the samples and the cumbersome task for analyzing all extracts by all platforms.
Why you should Attend:
You should attend to recognize the persistent issues that undermine analytical data quality and impact toxicological risk assessment. The FDA’s 2024 draft revision of ISO 10993-18 does not adequately resolve these problems, focusing instead on minor editorial changes.
Key takeaways:
- A set of recommendations will be presented to streamline extraction and analysis. The recommendations are grounded in chemical principles, device construction materials, and instrument selectivity
- A call for action by FDA to convene an expert committee in chemistry, chromatography, and spectroscopy to review raw data and guide future revisions
Areas Covered in the Session:
- Shortfalls and failure of solvent selection as commonly used for chemical characterization and biocompatibility testing
- Effect of incubation on reactive extracts and identification of by-products
- Identification of compounds whose mass spectra shows no molecular mass and identification issues using extracted ions.
- Concentration effect and impact of liquid-liquid extraction on extractactbles
- Solvent and instrument selectivity for analysis of solvent extracts
Who Will Benefit:
- Medical Device Manufacturers
- Pharmaceutical Companies
- Suppliers of raw Materials for Drug Synthesis and Construction of Medical Devices
- Toxicologists Involved in Risk Assessment,
- Engineers involved in R&D
- Testing Laboratories and CROs
- Consulting firms for Study Design and Regulatory Requirements
- Quality Assurance
- FDA
- Regulatory Agencies
- Analytical Instrument Manufacturers and Suppliers
Speaker Profile
Dr. Mourad Rahi earned his Ph.D. in Chemistry from the University of Cincinnati and brings over 35 years of experience in academia, CROs, and the medical device and pharmaceutical industries. A recognized authority in the chemical characterization of extractables and leachables (E&L), he is a frequent speaker at international conferences, advancing best practices in study design, analytical data acquisition, and toxicological risk assessment.
Dr. Rahi has extensive expertise in ISO 10993-1 compliance and has established analytical laboratories supporting E&L and pre-clinical studies for pharmaceuticals and medical devices under GLP and ISO 17025 standards. His background in organic synthesis, chromatography, spectroscopy, and structure elucidation equips him to design robust studies, particularly for complex medical devices where extract-induced reactions and detection limits can pose significant analytical challenges.
He holds multiple patents in medical device design and drug formulations using NanoElectroSpray technology, and has authored peer-reviewed publications in analytical sciences and regulatory compliance. Dr. Rahi continues to play a leading role in shaping global standards for chemical characterization and toxicological evaluation of medical devices.