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A LEAN approach for the determination of residual solvents using headspace gas chromatography (HS-GC) with relative response factors

Zhu, Wenya and Qiu, Wenlong and Clarke, Adrian and Kolarik, Christoph and Mozzo, Sebastiano and Liang, Guoyi (2018) A LEAN approach for the determination of residual solvents using headspace gas chromatography (HS-GC) with relative response factors. LC-GC Magazine (pharmaceutical supplement).

Abstract

External standard method with headspace gas chromatography (HS-GC) technique has been a common method for residual solvents determination. This study demonstrated a new method, 25 solvents can be simultaneously determined based on pre-determined relative respond factor (RRF) with only injection of sample solution. RRF value was finalized by 2 methods and average value was used for result calculation. Validation was carried out successfully covering specificity, linearity, reporting limit, precision, accuracy, stability and robustness. The result showed that the present method is a quick and economic approach for residual solvents testing from process control to product quality check.

Item Type: Article
Date Deposited: 31 Aug 2018 00:45
Last Modified: 31 Aug 2018 00:45
URI: https://oak.novartis.com/id/eprint/33259

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