Extractables and Leachables Testing

November 3, 2018

Pine Lake Laboratories is the scientific leader in extractables and leachables (E&L) studies.   We have extensive experience with pharmaceutical container closures, single use system components, and combination devices.

Our experienced scientific staff utilizes the following analytical methods for expert identification of extractables observed in a forced extraction study:

  • Headspace GC-MS for identification of volatile organic extractables
  • GC-MS for identification of semi-volatile organic extractables
  • LC-QToF for identification of non-volatile organic extractables
  • ICP-MS for identification of inorganic extractables
  • Polynuclear Aromatic Hydrocarbon Screening (GC-MS)
  • Nitrosamine analysis by GC-NCD

Our team has experience developing and validating leachables methods based upon the observed extractables in a wide variety of dosage forms:

  • Orally inhaled and nasal drug products (OINDPs)
  • Parenterals (small and large volume)
  • Prefilled syringes
  • Opthamalic
  • Topicals
  • Transdermals
  • Implantable medical devices
  • Combination medical devices

Protocols are designed to be study specific and follow PQRI, BPOG or client specific.  Pine Lake Laboratories can also perform USP <661.1> and <661.2>.

A toxicological risk evaluation for E&L results can be performed by our staff toxicologists.