Gelagen Quality Control: Laboratory Assays & cGMP Standards
Gelagen is compounded under comprehensive quality assurance protocols conforming to 21 CFR Part 111 Current Good Manufacturing Practices.
Analytical Laboratory Standards
High-Performance Liquid Chromatography (HPLC)
Every batch of active raw materials and finished gummies undergoes HPLC-UV profiling to confirm the precise identity, concentration, and molecular stability of all 11 active vitamins and high-potency D-Biotin.
Inductively Coupled Plasma Mass Spectrometry (ICP-MS)
Finished units are tested via ICP-MS to guarantee heavy metals (lead, arsenic, cadmium, mercury) fall strictly below 0.20 ppm, far exceeding federal safety limits.
Microbiological USP Testing
Comprehensive microbial assays follow USP <2021> and <2022> protocols to verify total aerobic plate count, yeast and mold absence, and negative screening for pathogenic organisms such as Salmonella and E. coli.