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Acta Pol Pharm

Title:		Determination of organic volatile impurities in nepafenac by GC method
Author(s):		Mucha M; Groman A; Zagrodzka J; Cybulski M;
Address:
Journal Title:		Acta Pol Pharm
Year:		2014
Volume:		71
Issue:		6
Page Number:		1013 - 1022
DOI:
ISSN/ISBN:		0001-6837 (Print) 0001-6837 (Linking)
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"
Keywords:		"Anti-Inflammatory Agents, Non-Steroidal/*analysis/standards Benzeneacetamides/*analysis/standards Chromatography, Gas/*methods *Drug Contamination/prevention & control Limit of Detection Phenylacetates/*analysis/standards Reproducibility of Results Solven;"
Notes:		"MedlineMucha, Mariola Groman, Aleksandra Zagrodzka, Joanna Cybulski, Marcin eng Research Support, Non-U.S. Gov't Poland 2015/03/10 Acta Pol Pharm. 2014 Nov-Dec; 71(6):1013-22"