engleski

Use of NMR Spectroscopy in Quality Control of Pharmaceutical Products

Quality control of finished pharmaceutical product in the shelf-life consists of diverse analytical methods that are validated by manufacturer and approved by national authority. Using system suitability tests the given analytical methods are transferred to the laboratories. Laboratories in charge of monitoring the quality of pharmaceutical products in shelf life are usually a part of national governments in EU, which is also the case in Croatia. Nuclear magnetic resonance spectroscopy is not at all common as a method of choice during quality control of finished pharmaceutical products for identification of active substances or impurities. It is due to different reasons but mainly NMR is not a part of analytical procedures for finished product that are part of the drug master file, DMF. On the other hand, NMR as a method for identification of active substances used in production of the finished product is a main part of DMF. So, in the process of approval of complete drug documentation qualified persons evaluate very complex NMR spectra to be sure that suitable substances are used in the production process. Further on, analysis of counterfeit drugs is a very particular and challenging task, NMR among other analytical methods and techniques found its place in it, especially in the qualitative analytical part.

NMR spektroskopija, farmaceutski proizvodi, kontrola kakvoće

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