Extractables & Leachables (E&L) testing identifies and evaluates chemical entities that may migrate from device materials, packaging, processing aids, or container–closure systems into the final product. Accuprec supports end-to-end E&L programs paired with Toxicological Risk Assessment (TRA) to ensure biological safety and global regulatory acceptance.

Scope & Standards

• ISO 10993-18 — Chemical characterization of medical device materials
• ISO 10993-17 — Establishment of allowable limits for leachables
• USP <1663> / <1664> — Assessment of extractables and leachables
• Regulatory alignment with USFDA, EMA, MDR (EU) expectations

Our Capabilities

• Study Design: Material review, solvent selection, worst-case conditions, time/temperature profiles
• Analytical Methods: LC-MS/MS, GC-MS/MS, ICP-MS, FT-IR, Headspace GC for volatiles/semi-volatiles, metals & organics
• Simulation & Extraction: Exhaustive/accelerated extraction, migration studies and aging evaluations
• Identification & Quantification: Targeted & non-targeted analyses with unknown elucidation
• Leachable Studies: Real-time and accelerated conditions with matrix-matched methods
• TRA: TTC/PMI, PDE derivation, MoE/ADI calculations and patient exposure assessment

Deliverables

• Comprehensive E&L protocol and report with raw data appendices
• Validated analytical methods & detection limits, instrument chromatograms, identification confidence levels
• Toxicological Risk Assessment with allowable limits and clinical use justification
• Inputs for BER (Biological Evaluation Report) and regulatory submissions

Outcome: Clear, regulator-defensible evidence of chemical safety to support MDR/510(k)/PMA pathways.