Nitto Avecia Pharma Services
Extractables/Leachables

Extractables / Leachables

Avoid Contamination Early in the Drug Development Process

Investigate the potentially harmful effects of your container/closure system on your drug product by partnering with Nitto Avecia Pharma Services. Avecia Pharma has more than 50 years of combined experience with polymers, metals and an array of pharmaceutical products to assist in identifying the threat of contamination to your drug products. Let Avecia Pharma leverage this expertise in a thorough examination of impurities in your drug formulation.

Regulations make extractables and leachables studies an essential part of your development process. Our team of skilled scientists is highly experienced in developing and validating new methodologies in support of various container/closure systems.

Avecia Pharma's Expertise Supports Full Analysis of Extractables and Leachables For:

  • pMDI
  • Nasal products
  • LDPE ampoules
  • PVC blister packs
  • Injectables
  • Medical devices
  • IV bags
  • Ophthalmics
  • And many more container/closure systems

Our Comprehensive Services

  • 3-Phase Systematic Approach
    • Profile extraction studies
    • Control extraction studies
    • Leachables studies
  • Routine container/closure testing
  • Formulation compatibility and stability
  • Identification, isolation and quantification of Extractables and Leachables

State-of-the-Art Instrumentation

  • GC/MS and/or GC-FID (including headspace analysis)
  • LC/MS/MS (diode array or single wavelength detector)
  • ICP

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