Abstract
There is a close relationship between drug stability studies and the identification and quantitative determination of related impurities in drugs. Degradation products of drugs are considered transformation products of the drug substance forming on the effect of heat, solvents (including high and low pH), oxidising agents, other chemical reagents, humidity, light, etc. On the basis of this definition a considerable overlap can be observed between the categories related impurities and degradation products: related impurities of degradation product type are often formed in the course of the synthesis and isolation of the bulk drug material. More up-to-date approach is, however, the use of chromatographic or electrophoretic methods combined with suitable spectroscopic techniques that enable the decomposition products to be detected and their structure to be elucidated and the concentrations of both the undecomposed drug and its decomposition product(s) to be simultaneously determined.
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