Extractables and leachables

Extractables & leachables studies

ALS offers comprehensive analytical techniques and significant expertise to support extractables & leachables (E&L) studies wherever they may be required.

Performing extractables & leachables (E&L) testing is an important part of verifying medical device safety. To design an effective E&L testing study ALS wholly evaluate materials, the expected use conditions and their associated risks. Our collaborative approach combines analytical, technical and regulatory expertise to present well packaged E & L studies.

Targeted leaches

Capabilities includes:

  • OINDPs (Nasal Sprays…)
  • Dermal and Topical Applications
  • Label/Ink Migration
  • Parenteral/Injectable
  • Drug Delivery Systems
  • Primary Container Closure Systems
  • Secondary/Tertiary package materials
  • Raw Material/Polymers
  • Material Comparison
  • Residual Analysis

Analytical services include:

  • Organic analysis by GC, GC-MS/MS, HPLC, LC-MS/MS
  • Elemental analysis by ICP-MS and OES
  • FTIR and UV/VIS Spectroscopy
  • pH and Total Organic Carbon
  • Ion chromatography
  • Particle size analysis
  • Karl Fischer