Analytical Services for Sterile Drug Products

Through our GMP analytical testing laboratories, we will reduce supply chain complexity and expedite timelines, developing product-specific methods in-house or through the transfer of 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.

We provide a full analytical and Assay method development service utilizing our industry leading analytical equipment to efficiently meet your parenteral development needs, providing timely, reliable, and consistent results.

• 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

At PCI, we will help you build, manage and, execute every aspect of your ICH stability program based on the specific requirements of your product.

This includes:

• 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