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Quality By Design and Green Analytical Chemistry: A Review of Novel Approaches to Chromatographic Method Development

Akanksha Mansing Valvi, Rakesh U. Shelke, Shantanu Sanjay Ghodke, Dinesh Rishipathak

2025Biosciences Biotechnology Research Asia9 citationsDOIOpen Access PDF

Abstract

ABSTRACT: The pharmaceutical sector is well-known for its Quality-by-Design (QbD) methodology, which has a significant impact on the analytical techniques and processes it uses. To highlight the importance of analytical chemistry in this industry's quality control system, "analytical quality-by-design" has also been advocated. All chemical industry branches do, however, have quality systems in place, with a significant portion of them being tied to chemical analysis and the corresponding quality control systems. With time, more green chemistry ideas will find their way into the manufacturing of chemicals, such as minimizing waste output, using less materials and energy, and incorporating analytical measurements into large-scale quality-control operations. The application of green chemistry principles to analytical chemistry aligns with the principles of Quality by Design (QbD) within that specific industry. This study presents a review of cases demonstrating the integration of green analytical methods into QbD.

Topics & Concepts

Quality (philosophy)Biochemical engineeringQuality by DesignComputer scienceChemistryProcess engineeringEngineeringPhilosophyEpistemologyPhysical chemistryParticle sizeChemistry and Chemical EngineeringAnalytical Chemistry and ChromatographyVarious Chemistry Research Topics
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