Analytical Services for Sterile Products

Through our cGMP analytical testing laboratories, we will reduce supply chain complexity and expedite timelines, developing product-specific methods in-house or transfer existing validated methods.

Our phase appropriate ICH validation approach for all analytical methods supports development, in-process, release, and stability testing. Our full-service laboratories are equipped with state-of-the-art instrumentation to meet testing requirements and we continually evaluate and expand our testing capabilities in-line with the growing needs of our clients.

Our Testing and Analytical Services

We provide a full analytical and Assay method development service utilizing our state-of-the-art analytical equipment to efficiently meet your parenteral development needs, providing timely, reliable, and consistent results.

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  • Gas Chromatography (Direct Injection & Headspace)
  • Liquid Chromatography – UPLC and HPLC
  • FTIR
  • UV/Vis
  • Residual Moisture by Karl Fischer
  • Particle Sizing
  • Oxygen Headspace Analysis
  • SDS-Page
  • Appearance
  • pH
  • Osmolality
  • Density
  • Reconstitution Time
  • Subvisible Particulate Matter (USP <788>)
  • Extractable Volume (gravimetric)
  • Elemental Impurities
  • Anti-microbial Effectiveness Test (AET)
  • Preservative Efficacy Test (PET)
  • Bioburden
  • Endotoxin
  • Sterility
  • Container Closure Integrity

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At PCI, we will help you build a stability program around the specific requirements of your product and manage every aspect of the ICH stability program:

  • Protocol development utilizing ICH stability guidelines
  • All ICH conditions available in validated stability chambers
  • Time point management and sampling by dedicated stability team
  • Time point testing and data reporting with quality oversight
  • Interim and final reports

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We have the capability to perform non-GMP and cGMP photostability studies for drug substance and finished product.

  • Photostability protocol development utilizing ICH Q1B stability guidelines
  • Storing products in validated photostability chambers at the recommended light intensity
  • Time point management, time point testing, and data reporting with quality oversight
  • Final report

 

 

Our dedicated team of specialists will be happy to discuss any of our Analytical Services for Sterile Products. Contact us on +1 779-208-1819 (US) or +44 1495 711 222 (UK/EU) or email talkfuture@pci.com

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