Quality in Production
Carbohydrate-Derived Fulvic Acid (CHD-FA™) is produced in a South African Health Products Regulatory Authority cGMP (License Nr 0000001280) and Manufacturing Pharmacy (License Nr Y54509), as well as FSSC 22000, approved facility. For any product to be considered safe for use in human consumption, batch to batch consistency in production is of paramount importance. In contrast to CHD-FA™, environmental Fulvic Acid varies from batch to batch as it is impossible to ensure consistency.
CHD-FA™ is a unique type of Fulvic Acid, in that it is a supramolecule – it has a fixed structure with a range of backbone structures that have been proven to be consistent from batch to batch using the following methods:
Fourier-transform infrared spectroscopy (FTIR)
Nuclear magnetic resonance spectra (NMR)
Liquid chromatography-tandem mass spectrometry (LC-MSMS)
To further ensure safety and consistency, each batch of CHD-FA™ manufactured has to pass production standards that have been set up and validated. The release parameters and test specifications of CHD-FA™ are as below (see Certificate of Analyses example):
pH
Specific Gravity
Electro Conductivity
Identification by FTIR
Anti-Microbial efficacy
Concentration
Total Organic & Inorganic Impurities
Volatile Organic Impurities
Nitrate & Nitrite
Elemental impurities – No heavy metals
No Microbial contaminants