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CHARACTERIZATION OF CHEMICAL SUBSTANCE

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Understanding that standards in the Brazilian market requires a high level of relative investment, ANVISA establishes the possibility of using a characterized reference of chemical substance, for use in validating analytical methods (RDC 166/2017).

This study aims to guarantee, unequivocally, the authenticity and quality of a substance regarding its identity, purity, content and potency.

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TECHNIQUES USED

The Characterization Study is planned according to the chemical structure of the substance. It may be composed, but not only, to the following analytical tests:

Thermogravimetric Analysis (TGA);
Differential Scanning Calorimetry (DSC);
Infrared Spectroscopy (FTIR);
Mass Spectrometry (HRMS);
Nuclear Magnetic Resonance (NMR);
Elemental Analysis (C, H, N);
X-Ray Diffraction;
Optical Rotation;
Chromatographic Tests.

According to the RDC-166/2017 requirements, data obtained from the techniques applicable to the characterization of each substance must be included in the final report, as well as the technical justification for choosing the tests.

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