How to decide assay range for non pharmacopeial API
analysis by HPLC? Could you give me any reference for same
e.g Guidelines or Paper publications?
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Answer / Pragya Aparajita
To decide the assay range for non-pharmacopeial API analysis using High-Performance Liquid Chromatography (HPLC), you can follow guidelines such as the International Conference on Harmonization (ICH) Q2(R1) or USP General Chapter <5831> which provide recommendations on method validation for peptides and proteins. Other useful references include papers published in analytical chemistry journals like the Journal of Chromatography, Analytica Chimica Acta, and Journal of Pharmaceutical and Biomedical Analysis.
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