From residual solvents and process-related impurities to degradant-related impurities, Eurofins Sinensis offers a broad range of services in support of residuals testing.
Residuals Testing for Bioprocess Validation
Effective removal of impurities is a critical step in any drug development process. And because residual impurities are typically present at low concentrations within complex matrices, their detection and quantification can be quite difficult. For this reason, process validation studies require a broad set of testing capabilities and expertise.
Whether you have impurities that are being introduced in upstream steps from culture growth and harvest, in the downstream processes, or through single-use technology, we have the breadth of capabilities and depth of industry knowledge to support all of your process validation testing needs.
- We have developed and qualified thousands of highly sensitive and selective methods that can help shorten your process validation timelines and minimize costs.
- Our history of cGMP regulatory compliance ensures delivery of the highest quality data.
- Our expertise in biochemistry, molecular & cell biology, virology and chemistry provides you with a single source for all of your validation testing needs.
- Surfactants & Antifoams
- Process-Enhancing and Purification Agents
- Agilent GC/MS
- Waters Xevo Q-TOF LC-MS
- Waters Xevo TQ LC-MS/MS
- Agilent and Shimadzu GCs with either headspace or direct injection sample introduction
- Waters/Dionex/Thermo Scientific U/HPLCs
- Waters H-Class UPLCs
- Waters Classic UPLCs
- Beckman PA800+ Capillary Electrophoresis (CE)
- Evaporative Light Scattering (ELSD)
- Fluorescence (FL)
- Flame Ionization Detector (FID)
- Refractive Index (RI)
- Ultraviolet (UV)
- Photodiode Array (PDA)
- PE Flame Atomic Absorption Spectrometer
- PE Hydride Atomic Absorption Spectrometer
- PE Graphite Furnace Atomic Absorption Spectrometer
Contact us to discuss your needs