Extractable & Leachable Studies

Regulatory agencies require extractables and leachables (E&L) testing to identify any risks of product adulteration.

Whether you are evaluating pharmaceutical manufacturing equipment (such as single-use systems), container closure systems, delivery devices, or other medical devices. DALPL offers a broad range of services to support extractables and leachables testing. In addition, we conduct simulated and real-time leachables studies to evaluate the presence of leachable compounds in the drug product.

If needed, we can use our extensive experience to successfully develop and validate fully GMP-compliant methods to monitor leachables in your drug product or intermediates.

DALPL extractables studies can be designed per guidances such as USP <665>, <1663> and <1664>, as well as ISO 10993, PQRI guidelines.

We design studies to meet the expectations of FDA, EMEA, and other regulatory bodies.

Extraction Test Techniques
  • Reflux
  • Soxhlet
  • Sonication
  • Microwave
Analysis Techniques
We have established the following semi-quantitative screening methodology to analyze extraction solutions by LC/MS, GC/MS, LC/DAD, ICP/MS . If needed, quantitative methods can be developed for specific compounds.
  • Semi-quantitative screening for both volatile and semi-volatile organic compounds
    • Use of GC/MS instrumentation with direct injection sample introduction and electron impact ionization
    • Use of GC/MS instrumentation with headspace sample introduction and electron impact ionization
    • For extractables compounds detected by GC/MS analysis, we utilize up-to-date NIST databases to assist in identification
  • Semi-quantitative screening for non-volatile organic compounds
    • Analysis using LC/MS/MS Qtrap (in positive and negative mode using electrospray and atmospheric pressure chemical ionization), LC/DAD
  • Semi-quantitative analysis for metals
    • Evaluation of samples for 42 metals, including all those listed in USP <232> and ICH Q3D using ICP/MS
  • Gravimetric determination of extractables
  • pH

Instrumentation :

LCMSMS AB Sciex 5500 QTRAP and DAD with Enhanced mode for identification
LCMSMS AB Sciex 5500 triple quadrupole
GCMSMS Agilent 7010B with FID Headspace (NIST)
ICP MS Agilent 7800
Microwave Digestor Anton Paar