EXTRACTABLES & LEACHABLES TESTING

Assessment of extractable and leachable compounds is an analytical imperative, one that ensures the overall quality of the drug product is not impacted by its packaging system, in-use componentry, or manufacturing train. Alcami understands this fundamental course of testing and analysis is an important aspect of any new drug product or device submission and an important milestone on the critical path to drug commercialization. We also offer risk assessments as part of our extensive extractables and leachables service program.

    • Extractables Study on Manufacturing Components
    • Extractables and Leachables Studies on Primary Packaging (may perform separately or as one study)
      • Aged drug product/substance may be provided by the client or Alcami can perform simulated aging of the samples for testing
      • Extractables – Aggressive solvent extractions on primary packaging to liberate the maximum possible organic and inorganic compounds
      • Leachables – Performed on aged drug substance and drug product to test for potential leachable organic and inorganic compounds
    • Identification of extractable and leachable compounds
secondary packaging

Our scientists have a thorough working knowledge of plastics, rubber, and elastomeric materials, those compounds most frequently used in today’s pharmaceutical manufacturing, packaging, and delivery technologies. Equipped with a wide range of compliant qualified instrumentation and working under cGMP guidelines, Alcami’s analysts are able to perform timely, efficient trace analysis necessary to support your applications and speed them to market.

Alcami’s expertise includes the assessment of a broad variety of drug products, routes of administration, and manufacturing system components. A proper assessment includes studies to not only understand which compounds have the ability to leach into the drug product, but also studies to identify which compounds the drug product may extract from the surfaces it contacts.


Target Compounds

Analytical Technique

Non-volatiles

HPLC/MS

Semi-volatiles

Direct Injection GC/MS

Volatiles

Headspace GC/MS

Elemental Impurities

ICP-MS


Innovation in extractables and leachables is arriving quickly

 

DRUG DELIVERY DEVICES AND PRIMARY PACKAGING MATERIALS TO BE CONSIDERED AND CONSEQUENTLY ASSESSED FOR THEIR RISK:

  • Dry powdered inhalers
  • Metered dose inhalers
  • Nasal spray pumps
  • Liquid oral products
  • Lyophilized products
  • Ophthalmic products
  • Parenteral solutions in bags and vials
  • Prefilled syringes
  • Surfaces contacted during manufacture including piping, tubing, flanges and connectors, filters, valves, and single-use disposable bags and containers
Download Extractables & Leachables White Paper
 

Ready to Get Started?

 

 

Complete this form to connect to a member of the Alcami team.