ADVANCES IN GAS CHROMATOGRAPHY FOR DETECTING PROCESS IMPURITIES: A COMPREHENSIVE REVIEW ON METHOD DEVELOPMENT, VALIDATION, AND SCALABILITY

Background:Gas chromatography (GC) remains a cornerstone in analytical chemistry, extensivelyemployed for the detection and quantification of process impurities, including volatile organic compounds (VOCs) and genotoxic impurities (GTIs) in pharmaceutical and industrial applications.

Main Body:This review examines the evolution of conventional GC techniques with a focus on method development and validation in line with International Council for Harmonisation (ICH) guidelines. Special emphasis is placed on nitrosamines, scalability, cost-benefit analysis, and the integration of advanced technologies, as these aspects are pivotal in addressing modern analytical challenges.Nitrosamines, due to their carcinogenic potential, have become a focal point of regulatory scrutiny, demanding highly sensitive methods for trace-level detection. Scalability ensures that laboratory-developed GC methods can meet industrial-scale requirements efficiently. The cost-benefit analysis underscores the balance between analytical precision and economic feasibility, which is critical for widespread adoption. Additionally, the integration of advanced technologies such as sustainable practices not only enhances performance but also aligns with evolving environmental and industrial needs.

Conclusion: By synthesizing recent advancements, this article highlights emerging challenges and future directions for GCs role in ensuring pharmaceutical quality and safety. Citations throughout emphasize the fields progress.