STABILITY SERVICES

DS InPharmatics is a full-service CMC consulting firm with experience and expertise in each of the sub-disciplines of Chemistry, Manufacturing and Controls (CMC).

Stability Services

DSI’s analytical chemists and development scientists have a thorough knowledge of chemical and physical properties of a wide range of small molecules and proteins.

Small molecules and biologics are susceptible to a number of environmental influences including temperature, pH, light, oxidation, ion effects, chemical modification, drying and microbiological contamination. Our scientists understand how different degradation and/or denaturation pathways can affect your API or drug product and can help you identify solutions to stability problems.

DSI can design and manage ICH complaint stability programs to provide the data to move your product ahead, including multi-package bracketing and matrixing studies. Our Scientists can ensure that your stability programs and shelf life extrapolations will be ICH compliant and acceptable to regulatory agencies worldwide.