What we deliver to our E/L customers:

  • Tailor-made extractables and leachables studies for all types of container closure systems and packaging materials, process equipment or medical devices including printings and adhesives according to MFDS, EMA and FDA requirements 
  • Consultancy for E/L studies in all phases of drug or device development of, e.g.  evaluation and assessment of already available E /L data, gap analyses
  • Toxicological assessment of the results of extractables and leachables studies
  • Validation of analytical methods for leachables studies (according to GMP)
  • Interaction studies for APIs with the packaging materials (according to GMP)
  • Additive analysis in all types of polymer
  • Assessment & analyses of process materials
  • Structural elucidation of unknowns
  • Seminars and training on extractables & leachables

Extractables / Leachables Toolbox

Intertek uses advanced analytical equipment to characterize both organic and inorganic elements and compounds:

  • GC/MS: thermodesorption, headspace, liquid injection
  •     (ESI and APCI)
  • MS: EI, CI, high resolution, commercial  and in-house mass spectral libraries
  • Elemental using and quantiative determination X-ray fluorescence, ICP-AES or ICP-MS
  • TOC determination in aqueous extracts
  • Modern tools for structural elucidation and absolute quantification (1H-, 13C-NMR, FTIR, UV, LC-HRMS, GC-HRMS, prep-LC/MS)
  • Reference standards  (commercial + in-house synthesized)

Our Experts

Our centre of excellence for cGMP-compliant extractable and leachable services is located in Reinach close to Basel (Switzerland). 

Our experts have specialized in analytical support for the pharmaceutical and medical device extractables / leachables and have over 30 years experience in this field coupled with an extensive knowledge of the polymer and packaging industries.

E/L study of Container Closure System

  • Prefilled syringe
  • Glass vial and rubber stopper
  • Infusion bag
  • Transdermal patch
  • Process contact materials (e.g. silicon tubing, bag, filter)
  • Plastic bottle for eye drop
  • Disposable bag or plastic bottle for drug substance storage
  • Medical devices
  • Secondary/tertiary package (e.g. label, paper box, pouch)

Other service

  • Particles Matter Investigation
  • GMP and CMC Laboratory Services

Our Partner

QBD (Quality by Design Inc.) is working together with us.

Dr. Tino Otte 

Site manager and E&L Consultant

Tino Otte, Scientific Consultant at Intertek, is an expert for extractables-leachables-studies. He holds a degree in polymerchemistry from the University of Halle/Saale and a Ph.D. from the Darmstadt Technical University, where he graduated in 2010. He joined Intertek Switzerland in 2016. Prior to joining Intertek, he worked with different research, development and 

manufacturing companies where he served in several functions in product management and development of analytical services. He has more than 15 years of experience in GMP regulated environment within multiple areas of product analysis including method development, validation and QC.


     주식회사 큐비디

     일산테크노타운 813호

     광교원희캐슬 D동 412호

                               +82 31 908 3009