Alberto Álvarez González, Yanet Támbara Hernández, Félix Álvarez Gil, Vladimir A Besada Pérez, Luis Javier González López

Language: Spanish
References: 13
Page: 350-358
PDF size: 219.86 Kb.

ABSTRACT

Introduction: the drug manufacture is governed by strict international standards that guarantee reproducibility and consistency of results. The qualification of the instruments used in the productive processes, as well as in the characterization of products and their quality control are prerequisites to the validation of any analytical technique using them. One of the instrumental techniques used in the biotechnical industry is Gas Chromatography.
Objective: to develop and to perform a protocol that allows the qualification of an Agilent Technologies 7890A Gas Chromatograph.

Methods: a standard of pure caffeine was used for analysis in addition to a HP-5 30 m × 0,32 mm d.i. and 0,33 µm thick film column was used in a Gas Chromatograph coupled with a Flame Ionization Detector. For the testing of the different modules involved in the analysis (injector, column, oven and detector), an experimental design was made to estimate several parameters.
Results: the obtained documented tests proved that each of the studied parameters (injector linearity, injector precision, injector dragging, flow precision, flow accuracy, detector linearity, detector accuracy, detector noise and detector drift) met the set acceptance criteria.
Conclusions: the final protocol allows the qualification of an Agilent Technologies 7890A Gas Chromatograph and it can be extrapolated to other models.

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