Development and validation of standardization methods of aqueous sapropel extract

Abstract

Methodological bases and uniform standardization criteria of humic compounds as substances for drug products have not been developed yet. This is due to the structural complexity of humic compounds, the variety of ways to extract them from natural objects, the impossibility of using many classical methods of analytical chemistry to identify and quantify humic substances (HS), the lack of standard samples. The identification of humic acids (HA) in the aqueous sapropel extract (ASE) is identified after extracting from ASE by alkaline hydrolysis by the quantification method. After further precipitation with a concentrated sulfuric acid solution characteristic dark brown color is appeared. It was carried out the HA extraction from the sample of ASE, the precipitation of HA, the oxidation of HA and Mohr’s salt titration in accordance with the methodology developed on the basis of SSTU 7083:2009. It was determined that the total mass fraction of HA in the ASE sample was 83.8 mg/g± 0.12%. The methods of identification and quantification of the total mass of HA in ASE have been developed and validated. The ASE has been standardized.