Analytical Testing for Sterile Products

We carry out rigorous analytical testing to support in-process, release, and ICH stability testing. To further support your testing needs, we can perform analytical method development, support efficient method transfers and adhere to phase appropriate method validation.

We have multiple full-service laboratories equipped with a variety of instrumentation to meet your analytical testing needs, these include:

• Mass Spectrometry
• Gas Chromatography – Standard Injection and Headspace Analysis
• Liquid Chromatography – UPLC and HPLC
• FTIR
• UV/Vis
• Residual Moisture by Karl Fischer
• Particle Sizing
• Oxygen Headspace Analysis
• Subvisible Particulate Matter (USP <788>)
• SDS-PAGE
• Appearance
• pH
• Osmolality
• Density
• Reconstitution Time
• Extractable Volume (gravimetric)

Microbiological Testing Services

Our microbiologists can limit the amount of API or BDS required to qualify your microbiological tests.

• Bioburden
• Endotoxin
• Sterility
• Container Closure Integrity
• Anti-microbial Effectiveness Test (AET)
• Preservative Efficacy Test (PET)

Our dedicated team of specialists will be happy to discuss our Analytical Testing Services with you. Contact us on +1 215-613-3600 (US) or +44 1495 711 222 (UK/EU) or email talkfuture@pci.com