Extractables / Leachables Testing

PPD provides full analytical support for extractables/leachables testing. Our dedicated and highly specialized team has more than 12 years of experience supporting numerous studies for various container/closure selections as well as process qualification and validation for different manufacturing processes.

Also, PPD’s cGMP labs have representation on the Product Quality Research Institute (PQRI) committee, which provides our scientists access to the latest regulatory guidelines. In addition, PPD can deliver an integrated toxicity/safety evaluation by experienced and American Board of Toxicology-certified toxicologists familiar with the application of PQRI recommendations. Our extractables / leachables team and toxicology experts work together to help clients make informed decisions on which extractable compounds will be monitored as leachables in long-term stability studies.

Wide Range of Extractables / Leachables Capabilities

Our extractables and leachables capabilities include:

  • Full extractables / leachables program support for (but not limited to):
    • Pressurized metered dose inhalers (pMDIs)
    • Nasal spray solution/suspension
    • Injectables in bags/vials
    • Lyophilized product
    • Stoppers, vials, syringes, bags, nasal spray pumps, labels, adhesives/inks, implantable devices, tubing, resin, film, caps, foil, e-flow device, gasket, valves and disposable materials used in bioprocess (single-use) manufacturing
  • Material and process qualification and validation for in-process manufacturing from an extractables/leachables perspective
  • Controlled extraction studies with LC-MS, GC-MS direct injection and GC-MS headspace injection sample analyses with data interpretation and toxicity assessment services
  • Leachables method development and validation studies
  • Material qualification for polynuclear aromatic hydrocarbons (PAH), N- nitrosamines and other toxicologically concerned compounds
  • Leachables monitoring for stability studies and routine extractables testing

Unique Reference Standards for Extractable Compounds

PPD's cGMP labs offer reference standards for many extractable compounds commonly formed during the manufacturing process of the container/closure systems or their resins, including some that are not commercially available, such as:

  • 1-(3-(2-hydroxypropan-2-yl)phenyl)ethanone (commonly known as 1, 3-isopropanol acetophenone)
  • 1-(4-(2-hydroxypropan-2-yl)phenyl)ethanone (commonly known as 1, 4-isopropanol acetophenone)
  • Poly(butylene terephthalate) cyclic dimer
  • Poly(butylene terephthalate) cyclic trimer
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