Confarma

Extractables & leachables

Solvias provides expert testing and consulting services to assess the safety and integrity of extractables and leachables in pharmaceuticals, single-use production process materials, container closure systems, and medical devices. These are carried out in accordance with FDA/EMA, BPSA, PQRI and ISO 10993 regulations.

Our services for extractables studies include:

  • Professional project management
  • Customizable workflow for quantitative extractables studies (simulation studies)
  • Semi/non-volatile screening by high mass accuracy LC/MS and LC/MS/MS (down to 1 µg/L)
  • Proprietary EXLEA LC/MS database containing over 6000 polymer additives
  • Semi-volatile screening by PTV-GC/MS up to molecular weight of 700 (down to 1 µg/L)
  • Volatile screening by HS-GC/MS up to molecular weight of 300 (down to 20 µg/L)
  • Highly automated workflow for compound identification and semi-quantification in LC/MS and GC/MS screening
  • ICP/MS and ICP/OES screening of elements (down to 1 µg/L)
  • Toxicological assessments of all compounds detected (Q-SAR method)

Our services for leachables studies include:

  • Professional project management
  • In-house storage facility (GMP compliant)
  • Validation of GC/MS and LC/MS method for trace analysis (Full GMP compliance)
  • Capability use screening methods in drug products to monitor non-validated leachables