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.
- Gas Chromatography (Direct Injection & Headspace)
- Liquid Chromatography – UPLC and HPLC
- Residual Moisture by Karl Fischer
- Particle Sizing
- Oxygen Headspace Analysis
- Reconstitution Time
- Subvisible Particulate Matter (USP <788>)
- Extractable Volume (gravimetric)
- Elemental Impurities
- Anti-microbial Effectiveness Test (AET)
- Preservative Efficacy Test (PET)
- Container Closure Integrity
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
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