This is the primary direct-to-consumer dispensary and batch documentation center for Gelagen in the United States. Every production batch (#2026-B48) undergoes strict analytical clearance prior to domestic release.
Tier 1: US FDA-Registered, cGMP-Compliant Production (21 CFR Part 111)
Gelagen® is manufactured in the United States with globally sourced premium micronutrients inside an FDA-registered facility that strictly adheres to Current Good Manufacturing Practices (21 CFR Part 111). Each batch is blended in humidity-controlled clean rooms to prevent premature hydration of the citrus pectin hydrocolloid base and protect retinoid and tocopherol esters from oxidative photodegradation.
Tier 2: Quantitative HPLC Vitamin & Mineral Verification
Gummy supplements are notoriously difficult to formulate accurately; cheap manufacturers routinely spray vitamins onto the exterior coating, resulting in rapid degradation. Gelagen® homogenizes all 13 micronutrients uniformly throughout the buffered citrus pectin slurry, verifying finished per-serving yields via High-Performance Liquid Chromatography (HPLC) and ICP-OES mineral spectroscopy.
Tier 3: Heavy Metal & Microbiological Clearance (Batch #2026-B48)
| Analytical Assay Parameter | USP 2232 / Regulatory Limit | Batch #2026-B48 Test Result | Status |
|---|---|---|---|
| Inorganic Arsenic (As) | < 15.0 µg/day | < 0.004 ppm (Below LOQ) | ✓ PASSED |
| Cadmium (Cd) | < 5.0 µg/day | < 0.002 ppm (Below LOQ) | ✓ PASSED |
| Lead (Pb) | < 5.0 µg/day | < 0.005 ppm (Below LOQ) | ✓ PASSED |
| Total Mercury (Hg) | < 15.0 µg/day | < 0.001 ppm (Below LOQ) | ✓ PASSED |
| Total Aerobic Microbial Count | < 1,000 CFU/g | < 10 CFU/g (Conforms) | ✓ PASSED |
| Pathogens (E. coli, Salmonella, S. aureus) | Absent in 10g | 100% Absent / Negative | ✓ PASSED |