HoneyPezil Supplement Facts Panel, Dosage Specs & Certificate of Analysis
In accordance with federal 21 CFR Part 101.36 regulations governing dietary supplement labeling and consumer transparency, this ledger presents the complete, unabridged Supplement Facts panel for HoneyPezil, accompanied by third-party laboratory Certificate of Analysis (CoA) records from active production Lot HPZ-26/04B.
1. Verbatim Supplement Facts Transcription (21 CFR 101.36 Compliant)
The table below reproduces every element of the physical packaging label affixed to each amber 60-capsule bottle of HoneyPezil distributed through our domestic logistics network:
Servings Per Container: 30 (60 Capsules Total)
Manufactured For: HoneyPezil Clinical Retail Distribution Desk.
Facility Registration: Compounded in a certified US cGMP, FDA-registered manufacturing facility.
Storage Instructions: Store at controlled room temperature 15°C–30°C (59°F–86°F). Protect from excessive heat, moisture, and direct sunlight. Keep bottle tightly closed with tamper-evident seal intact.
2. Disclosed vs. Proprietary Actives: The Clinical Breakdown
A hallmark of our clinical ledger is explaining the precise regulatory and biological logic governing disclosed versus proprietary ingredient declarations:
Niacin (Vitamin B3) • 20 mg NE (125% DV)
Niacin has an established Recommended Dietary Allowance (RDA) set by the National Academies Institute of Medicine. Under FDA regulations, all nutrients with established Daily Values must declare exact metric quantities. At 20 mg NE, HoneyPezil provides 125% of the daily adult requirement, providing robust cellular NAD+ synthesis support while remaining well below the 35 mg upper tolerable intake level (UL) that triggers severe cutaneous flushing.
Neuroactive Complex • 1,420 mg Total Active Weight
Because amino acids (arginine, citrulline, beta-alanine) and botanicals (bacopa) do not possess formal governmental RDAs or Daily Values, federal regulations permit compounding them within a declared proprietary matrix. The 1,420 mg total active weight guarantees that over 90% of the capsule's internal volume is dedicated to functional neurovascular nutrients, with minimal inert excipients.
3. Independent Third-Party Certificate of Analysis (CoA) Ledger
To ensure complete compliance with 21 CFR Part 111 cGMP identity, purity, strength, and composition specifications, every commercial production batch of HoneyPezil is sampled and tested by independent ISO/IEC 17025 accredited analytical laboratories. Below is the audited test summary for certified Lot HPZ-26/04B:
| Test Category | Specific Analyte | Analytical Method | Specification Limit | Observed Batch Result | Disposition |
|---|---|---|---|---|---|
| Identity Assay | L-Arginine / Citrulline | HPLC-UV (Liquid Chromatography) | Conforms to Standard | Positive Peak Identification | PASS |
| Active Potency | Niacin (Vitamin B3) | HPLC Quantitative Assay | 95.0% - 120.0% Claim | 20.16 mg (100.8% Claim) | PASS |
| Botanical Marker | Bacopa Total Bacosides | HPLC Spectrophotometric | NLT 20.0% Bacosides | 21.4% Total Bacosides | PASS |
| Heavy Metal: Lead | Lead (Pb) | ICP-MS (USP <2232>) | < 0.50 ppm | 0.012 ppm | PASS |
| Heavy Metal: Arsenic | Inorganic Arsenic (As) | ICP-MS (USP <2232>) | < 1.50 ppm | 0.007 ppm | PASS |
| Heavy Metal: Cadmium | Cadmium (Cd) | ICP-MS (USP <2232>) | < 0.50 ppm | 0.003 ppm | PASS |
| Heavy Metal: Mercury | Mercury (Hg) | ICP-MS (USP <2232>) | < 0.20 ppm | < 0.001 ppm (ND) | PASS |
| Microbiological | Total Aerobic Microbial Count | USP <2021> Bioburden | < 10,000 CFU/g | < 100 CFU/g | PASS |
| Microbiological | Yeast and Mold Count | USP <2021> Bioburden | < 1,000 CFU/g | < 50 CFU/g | PASS |
| Pathogens | Salmonella & Escherichia coli | USP <2022> Pathogen Screen | Absent in 10 grams | Absent / Negative | PASS |
4. Inactive Excipients & Vegetarian Capsule Shell Specs
In accordance with cGMP standards, all non-medicinal ingredients in HoneyPezil are classified as Generally Recognized as Safe (GRAS) and selected for their clean biocompatibility:
Hypromellose (HPMC) Capsule Shell
Derived from natural plant polymer cellulose. Hypromellose capsules contain strictly less than 7% moisture, protecting hygroscopic amino acids from premature degradation while dissolving rapidly in gastric acid within 10 to 15 minutes.
Microcrystalline Cellulose
Purified, partially depolymerized plant cellulose that functions as a natural flow-agent and compressibility binder, ensuring that every capsule receives an identical volumetric weight during automated encapsulation.
Vegetable Magnesium Stearate
A plant-derived lubricating salt composed of stearic acid and magnesium. Prevents amino acid powders from adhering to stainless steel encapsulation machinery during high-speed compounding.
Silicon Dioxide
A naturally occurring mineral compound utilized as an anti-caking agent to adsorb microscopic ambient humidity, preventing crystalline amino acids from clumping inside the capsule.
5. Manufacturing Facility Compliance & Regulatory Framework
HoneyPezil is blended, encapsulated, bottled, and packaged exclusively within a state-of-the-art domestic manufacturing facility located in the United States. The facility operates under comprehensive federal regulatory compliance:
- FDA Facility Registration: Fully registered with the United States Food and Drug Administration pursuant to Section 305 of the United States Public Health Security and Bioterrorism Preparedness and Response Act of 2002.
- cGMP 21 CFR Part 111 Compliance: Adheres strictly to Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements.
- Standard Operating Procedures (SOPs): Every raw material delivery undergoes quarantine, chemical identity verification, organoleptic inspection, and microbiological screening before release into active compounding cleanrooms.
- Environmental HVAC Control: Compounding cleanrooms maintain continuous positive-pressure HEPA air filtration and relative humidity controls below 45% to prevent hygroscopic moisture absorption.
6. USP <2040> In Vitro Disintegration & Dissolution Kinetics
An often overlooked aspect of supplement manufacturing is the physical rate at which solid dosage forms dissolve and release active ingredients inside the gastrointestinal tract. A formula containing high-quality amino acids is biologically useless if the capsule shell fails to rupture promptly in stomach acid.
In accordance with United States Pharmacopeia (USP) <2040> guidelines for Disintegration and Dissolution of Dietary Supplements, production Lot HPZ-26/04B was evaluated in simulated gastric fluid (0.1 N hydrochloric acid, pH 1.2) maintained at physiological core body temperature (37.0°C ± 0.5°C):
Initial Capsule Shell Rupture: 3.8 Minutes
The hypromellose vegetable shell undergoes rapid hydration and pinhole rupture within 228 seconds of contact with acidic simulated gastric media, initiating prompt powder dispersion without requiring mechanical agitation.
Complete Powder Dispersal: 9.4 Minutes
Full dissolution and homogeneous release of active crystalline L-arginine, L-citrulline, and Niacin is achieved in 9.4 minutes, well below the stringent USP 30-minute regulatory ceiling for immediate-release solid dosage forms.
This rapid dissolution kinetic ensures that when HoneyPezil is consumed with 8 oz of water 20 to 30 minutes before breakfast, the amino acids are dissolved into free solution before solid meal proteins arrive, eliminating competitive absorption barriers at intestinal peptide transport sites.
7. ICH Q1A(R2) Accelerated Environmental Stability Testing
To validate the two-year expiration dating stamped on every bottle, retention samples from certified Lot HPZ-26/04B were subjected to International Council for Harmonisation (ICH) Q1A(R2) stability testing protocols:
- Accelerated Chamber Conditions (40°C ± 2°C / 75% RH ± 5% RH): Bottles held in environmental stress chambers for six months demonstrated zero physical deformation, capsule discoloration, or microbial bloom. Active HPLC marker assays showed less than 1.4% degradation in total amino acid and vitamin potency.
- Real-Time Long-Term Stability (25°C ± 2°C / 60% RH ± 5% RH): Ongoing real-time retention audits confirm 100% label claim retention, validating an official shelf-life of 24 full months when stored in ambient residential conditions.
Frequently Asked Questions About the HoneyPezil Label
What is the exact expiration date and shelf-life of HoneyPezil?
Does the label list any animal products or porcine gelatin?
Is there any sugar, xylitol, or artificial sweetener in the capsules?
How can I verify my bottle against the official Certificate of Analysis?
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