Formulation and Quality – Chemical
End-to-End Hot Topic
ASAP employs isoconversion (time to hit the specification limit at each condition) with designed temperature/RH conditions (based on a humidity-corrected Arrhenius equation) to build a model for degradant formation or potency loss for drug products and drug substances. Once the model is built, the shelf-life inside packaging can be determined based on the calculated RH inside the packaging. These methodologies provide for far better predictions of shelf-life (expiry) than previously possible at a significantly reduced time frame (2-3-weeks). ASAPprime® employs this science in combination with statistical tools to enable accurate estimations of shelf-life with many factors determined computationally (e.g., packaging, storage conditions, storage excursions).