AUDITED 21 CFR PART 111 COMPLIANT FACILITY
Tier 1: Raw Botanical Identity & Potency Assay
Every incoming raw material undergoes strict quarantine until analytical identification confirms botanical species and active compound percentages. High-Performance Liquid Chromatography (HPLC) is employed to verify that Boswellia serrata yields its stated AKBA concentration and Turmeric rhizome meets standardized curcuminoid thresholds. Any raw lot exhibiting adulteration or sub-potency is immediately rejected.
Tier 2: In-Line cGMP Environmental & Encapsulation Controls
Nervecept is encapsulated in an FDA-registered, cGMP-compliant clean-room facility following Title 21 of the Code of Federal Regulations (21 CFR Part 111). Temperature, relative humidity, and air particulate counts are continually monitored via HEPA filtration to eliminate airborne microbial contaminants and prevent cross-contact.
Tier 3: Independent ISO-17025 Laboratory Audits (COA)
Following encapsulation, representative composite samples from every batch (including active run #2026-B48) are sent to an independent, ISO-17025 accredited third-party analytical laboratory for release testing:
| Analytical Assay | Pharmacopeial Standard | Nervecept Certified Result |
|---|---|---|
| HPLC Potency Assay | >95.0% of Declared Claim | 99.42% (Passed) |
| Lead (Pb) Content | USP 2232 (<0.5 mcg/day) | <0.005 ppm (Clear) |
| Arsenic (As) Content | USP 2232 (<1.5 mcg/day) | <0.005 ppm (Clear) |
| Cadmium (Cd) & Mercury (Hg) | USP 2232 Limit Thresholds | Non-Detectable (Clear) |
| Total Aerobic Microbial Count | USP 2021 Microbiological | <10 CFU/g (Clean) |
| Yeast & Mold Bio-Burden | USP 2021 Microbiological | <10 CFU/g (Clean) |
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