White Paper

The Impact Of Water Activity On The Chemical and Physical Stability Of Oral Solid Dosage Products

By Paula Bracco, PhD., Study Manager at Lighthouse Instruments

Pills in vial

Generally, a variety of specific tests are necessary to evaluate the chemical and physical characteristics of an oral solid dosage (OSD) throughout the product life cycle. This article will present three case studies to show that direct water activity measurements can determine the impact of moisture on potency and dissolution.

The International Consortium for Innovation and Quality in Pharmaceutical Development (IQ) reports that “The science of stability has evolved since the ICH Q1A stability protocols were first published a decade ago”. An example of this is the book ‘Accelerated Predictive Stability (APS): Fundamentals and Pharmaceutical Industry Practices’ that includes 22-chapters of detailed technical information for scientists who develop and perform stability studies. One of the concepts extensively described in this book is water activity (Aw).

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