Extractables and Leachables Testing
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
- 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.