Laboratory Services

Extractables & Leachables Testing

Analytical Services
Drug Product Manufacturing
Laboratory Services
Specialty Capabilities

Advanced analytical techniques for extractables and leachables testing.

The assessment of extractable and leachable compounds is an essential analytical process, ensuring the drug product’s quality remains unaffected by its packaging, in-use components, or manufacturing processes. Alcami recognizes the importance of this testing and analysis, viewing it as a vital aspect of any new drug product or device submission and a key milestone on the path to drug commercialization.

Risk assessments as part of our comprehensive extractables and leachables testing program

  • Studies on manufacturing components
  • Studies on primary packaging
    • 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

Our Expertise

Our team of scientists has deep expertise in plastics, rubber, and elastomeric materials, which are commonly used in pharmaceutical manufacturing, packaging, and delivery technologies. By employing a range of compliant, qualified instruments and adhering to cGMP guidelines, we conduct precise and efficient trace analysis to support and expedite your applications.

We thoroughly assess various drug products, routes of administration, and manufacturing system components. Our evaluations include comprehensive studies to identify compounds that may leach into the drug product or be extracted from contact surfaces, ensuring the highest quality and safety standards are met.

Target Compounds

Non-volatiles

Semi-volatiles

Volatiles

Elemental Impurities
Analytical Technique

HPLC/MS

Direct Injection GC/MS

Headspace GC/MS

ICP-MS

Innovation in extractables and leachables testing 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

Related Topics
Beyond Elemental Impurities - New Applications of ICP-MS
Extractables and Leachables: Setting Up Early for Success with your CDMO
Extractables & Leachables Testing
Contact Alcami
Summary

Alcami offers comprehensive extractables and leachables testing services. Our experts evaluate potential contaminants from packaging and manufacturing to ensure drug product safety and regulatory compliance. By combining advanced analytical techniques with deep scientific understanding, we provide critical data for informed decision-making throughout the product lifecycle.

Related Topics
Beyond Elemental Impurities - New Applications of ICP-MS
Extractables and Leachables: Setting Up Early for Success with your CDMO
Extractables & Leachables Testing
Contact Alcami
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