Quality Assurance
Olivaro Laboratory Testing Standards & Quality Control
Every lot of Olivaro is manufactured in a certified United States facility under current Good Manufacturing Practices (cGMP) in accordance with FDA 21 CFR Part 111 regulations. Below is a detailed review of our laboratory testing hierarchy and third-party release criteria.
1. Raw Material Botanical Identity Testing
Before any raw botanical enters production, our laboratory performs High-Performance Thin-Layer Chromatography (HPTLC) fingerprinting against reference pharmacopeial standards. This process verifies species authenticity (such as confirming true Gymnema sylvestre versus related species) and prevents accidental botanical adulteration.
2. Inductively Coupled Plasma Mass Spectrometry (ICP-MS)
Heavy metals represent a serious concern in concentrated herbal extracts. We utilize ICP-MS technology capable of detecting trace elemental contaminants down to parts per billion (ppb). Every production run must test strictly below our internal threshold of 0.3 ppm across all four primary heavy metals:
- Lead (Pb): < 0.15 ppm (Pass)
- Cadmium (Cd): < 0.05 ppm (Pass)
- Arsenic (As): < 0.20 ppm (Pass)
- Mercury (Hg): < 0.02 ppm (Pass)
3. Microbiological Pathogen Screening (USP <2021> / <2022>)
Finished liquid bottles are held in quarantine while microbiological assays are conducted by an independent ISO/IEC 17025 accredited facility, Cascade Analytical Laboratories. Testing verifies complete absence of harmful pathogens including Escherichia coli, Salmonella species, and Staphylococcus aureus, with total aerobic microbial counts maintaining strict compliance within United States Pharmacopeia dietary supplement thresholds.