Development and validation of a method for active drug identification and content determination of ranitidine in pharmaceutical products using near-infrared reflectance spectroscopy: a parametric release approach
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Application and Methodology of the Non-destructive 19F Time-domain NMR Technique to Measure the Content in Fluorine-containing Drug Products
Published on: August 22, 2017
Sílvia S Rosa1, Pedro A Barata, José M Martins
1Laboratórios Atral SA, Rua da Estação 42, Vala do Carregado, P 2600 726 Castanheira do Ribatejo, Portugal. silviarosa@ist.utl.pt
Abstract:
In this paper we describe the strategy used in the development and validation of a near-infrared diffuse reflectance spectroscopy method for identification and quantification of ranitidine in pharmaceutical products (granulates, cores and coated tablets) at-line, with a fiber optic probe. This method was developed in a pharmaceutical industry for routine application, to replace reference methods and was submitted and approved to the National Medicine Regulatory Agency (Infarmed). We consider that this is the first step of a broader parametric release approach to pharmaceutical products.
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