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ANALYTICAL METHODS

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DEVELOPMENT AND VALIDATION

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The analytical method development aims to create effective methodologies that perform qualitative and quantitative analyses on analytes of interest. The method developed must be able to obtain a satisfactory result even in cases when the sample presents other substances (e.g.: impurities and diluents).

To prove its effectiveness and subsequent approval by the regulatory agency, the analytical method must have several intrinsic characteristics to be considered valid. This validation aims to document, in a faithful and effective way, that the method is in accordance with its purpose and following all the requirements of  DRC 166/2017, presenting main points such as selectivity, linearity, matrix effect and accuracy.

NanoBusiness offers the service of development and validation of the method following all the requirements of RDC 166/2017. The service is applicable to all available analytical techniques.

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