13. November 2016

INTRODUCTION In a quality by design (QbD) environment knowledge and understanding of raw material critical quality attributes (CQAs) are essential [1]. Excipient variability is an important consideration particularly when blended with challenging APIs where manufacturing may occur close to the edge of failure, i.e. close to the acceptance limits for critical quality attributes. In such cases small variations in an excipients attribute could possibly impact the end product quality, even if the...