Real-Time and Accelerated Stability Testing

Real-time and accelerated stability testing of a formulated product is always a part of a formulation program for an active pharmaceutical ingredient nominated for clinical development. Long-term stability, meaning stability on storage, requirements vary widely from drug to drug, and can be months to years. Furthermore, solution stability, particularly stability in aqueous solutions, may be a deciding factor in lead selection and optimization stage, therefore become an important part of the pre-formulation program. Stability studies also are conducted on drug substances, particularly if solid state characterization studies indicate a possible concern with hygorscopicity, physical or chemical stability of a salt, or possibility of polymorph transitions.

Monitoring real-time stability under conditions that simulate real-world storage conditions of a product in its storage container is ideal. Commonly, accelerated stability testing, wherein a drug formulation is placed under controlled elevated temperature and humidity conditions, is conducted concurrently to detect possible early warning signs of potential stability problems. On the basis of real-time and accelerated stability testing modifications may be made to a solid state form, salt-form, the long-term storage formulation, or selection of container/closure system.

WLI performs stability testing following the guidelines established by the International Conference on Harmonization (ICH). We operate dedicated ICH-compliant stability chambers for room temperature, refrigerated, and accelerated stability conditions, and an ICH-compliant chamber for light sensitivity testing (photostability chamber). Customized testing conditions are available.

WLI provides real-time and accelerated stability testing with a variety of drug substances, including small molecules, peptides, proteins, oligonucleotides, and cytotoxic materials.