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).


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Sridhar Gumudavelli
Sridhar Gumudavelli serves as the Vice President of Formulation R&D at Renejix Pharma Solutions, where he brings a wealth of knowledge and experience to the table. His leadership is instrumental in navigating the complex process of drug formulation, leveraging a variety of technologies to enhance drug absorption, bioavailability, and patient compliance.Sridhar’s expertise is not just limited to his hands-on experience; he is also an innovator with several patents filed under his name. These patents reflect his contributions to advancing drug delivery systems, showcasing his ability to tackle some of the most challenging problems in pharmaceutical sciences for the past 30+ years.

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