Author(s): Mucha M, Groman A, Zagrodzka J, Cybulski M
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Abstract The methods for controlling volatile impurities, including reagent and starting material, in Nepafenac active pharmaceutical ingredient, are reported. The proposed methods were developed using gas chromatography (GC) and gas chromatography with headspace injection (GC-HS) and validated according to the requirements of the ICH (International Conference of Harmonization) validation guidelines Q2R1 and the guideline for residual solvents Q3C.
This article was published in Acta Pol Pharm
and referenced in Pharmaceutica Analytica Acta