Quality by Design (QbD) is a well-known pharmaceutical industry strategy for enhancing production processes, including active pharmaceutical ingredients and medicinal products. Companies may get useful insights throughout development by employing QbD concepts to build the design space and select relevant process controls. This case study shows how Renejix a QbD strategy to address an analytical method challenge involving high-performance liquid chromatography (HPLC). The approach showed fluctuating retention periods of impurity peaks, making identification and quantification difficult. Furthermore, the reported lack of consistency prompted concerns about properly detecting impurity levels, which might impair the medication product’s safety, quality, identity, purity, and potency (SQIPP).
