Batch Release & Stability

Release Testing

Whether you need release testing to support your new clinical batch, new commercial batch or release your intermediate for the next stage of manufacturing, Curia is able to provide the solution.  Through our network of laboratories we have the capability to test your materials in a timely manner against your specifications to ensure it has the proper potency, assay, impurity profile, physical characteristics, etc.  

Stability Storage & Testing

Stability testing is a critical part of the development cycle to develop the understanding of how the quality of your products may change over time as it is exposed to a variety of environmental conditions.  Once your product is approved continued stability testing is required to ensure that your products continue to perform as they are intended.  Within Curia’s network of laboratories we support both your development and your commercial stability on your Intermediates, APIs and Drug products.  We perform stability testing in-compliance with ICH Q1A requirements.

Standard ICH stability conditions are available in our fully mapped and CGMP compliant stability chambers:

• -70 ^oC
• -20 ^oC
• 5 ^oC
• 25 ^oC/60%RH
• 30 ^oC/65%RH
• 40 ^oC/75%RH

Curia also offers a number of specialized studies:

• Phase appropriate method development/validation
• Forced Degradation
• Solid state characterization
• Nitrosamine/genotox impurity testing
• Complex chemical structure elucidation and impurity identification
• Excipient compatibility screening
• Small-scale isolation and purification
• General USP & EP testing in addition to compound specific compendial testing
• Scanning electron microscopy (SEM), Energy dispersive X-ray analysis (EDX/EDS)

Instrumentation:

• HPLC/UPLC (UV, RI, MALS, Fluorescence, CAD)
• HS-GC, GC-FID, GC-MS
• LC-MS, LC-MS/MS, LC-QTof, MALDI-Tof
• Capillary Electrophoresis (CE)/CE-MS
• Ion Chromatography (IC)
• Particle size analysis (Malvern, Accusizer, Zetasizer, Polarized Light Microscopy)
• XRPD and Single Crystal X-ray diffraction
• Solution and solid-state NMR
• UV-Vis, FTIR, Raman spectroscopy
• Thermal analysis: TGA, TG-IR, DSC, melting point
• KF, water activity, LOD, DVS
• Surface Area (BET), Bulk and tap density
• Dissolution: Apparatus I, II and V
• Viscometer, Osmometer, Refractive Index determination