Stability, Purity, and Safety Evaluation of MONOmolecule™ NMN Complex Utilizing HYGIEIA® Nicotinamide Mononucleotide

Stability, Purity, and Safety Evaluation of MONOmolecule™ NMN Complex Utilizing HYGIEIA® Nicotinamide Mononucleotide

Author: Research & Development Division, MONOmolecule™
Affiliations: Internal QC Laboratory, Independent Third‑Party Validation by SGS & Eurofins
Corresponding Contact: science@monomolecule.com
Date: January 2026

Abstract

This study evaluates the long‑term stability, purity, and safety of β‑Nicotinamide Mononucleotide (NMN) incorporated in MONOmolecule™ NMN Complex, sourced exclusively from HYGIEIA® raw material. The report consolidates multiple lines of analytical evidence — including high‑precision high‑performance liquid chromatography (HPLC), environmental stress stability studies, and third‑party certifications by SGS, CTi and Eurofins Laboratories — to validate the product’s compliance with FDA’s Good Manufacturing Practice (GMP) and ICH Q1A(R2) stability standards.

The HYGIEIA® NMN demonstrated superior chemical integrity, maintaining > 99.5 % purity across all accelerated and long‑term test conditions (−15 °C, 25 °C, and 40 °C) for up to 24 months. Independent COA analyses confirmed 100.0 % NMN content, with non‑detectable levels of heavy metals, pathogens, or organic contaminants. Acute oral toxicity testing revealed an LD₅₀ > 5000 mg/kg, consistent with GRAS safety profiles. These findings establish MONOmolecule™ NMN Complex as a pharmaceutically stable and bio‑pure supplement precursor for NAD⁺ augmentation, outperforming standard‑grade NMN materials present in the commercial market.

1. Introduction

The growing interest in nicotinamide mononucleotide (NMN) as a metabolic coenzyme precursor has catalyzed demand for clinically validated, high‑purity forms suitable for nutritional and pharmaceutical applications. NMN plays a central role in cellular NAD⁺ biosynthesis, energy metabolism, and genomic stability. However, NMN’s molecular instability — particularly under high humidity, heat, and UV exposure — has historically challenged formulation fidelity and shelf‑life claims across the dietary supplement industry.

The MONOmolecule™ NMN Complex responds to this need by integrating HYGIEIA® β‑NMN, a premium‑grade NMN manufactured under ISO 9001 and ISO 17025‑compliant quality systems, into a stability‑optimized formulation. This dissertation report documents the compound’s validated purity, environmental durability, and safety under comprehensive test conditions in compliance with U.S. FDA 21 CFR Parts 111 and 211 and ICH Q1A(R2) guidelines.

2. Materials and Methods

2.1 Test Design & Objective

The primary objective was to characterize the stability and purity retention of NMN under controlled temperature and humidity, simulating both real‑world and accelerated degradation environments over time. Secondary objectives included the verification of microbiological and heavy‑metal safety parameters and assessment of potential organoleptic (color and appearance) changes.

2.2 Instrumentation and Equipment

• High‑Performance Liquid Chromatography (HPLC) for quantitative purity analysis.
• Humidity and Temperature Chambers for ICH‑compliant environmental stability.
• Refrigerated and Accelerated Storage Units maintained at −15 °C, 25 °C / 75 % RH, and 40 °C / 75 % RH.

2.3 Test Conditions and Sampling

2.4 Analytical Methods

All NMN samples were analyzed by HPLC (in‑house validated) under pharmacopeial standards. Purity values were recorded at designated intervals. Visual attributes were inspected for discoloration or clumping. External laboratories (SGS and Eurofins) independently verified elemental impurities, microbial content, and compositional accuracy.

3. Results

3.1 Purity Retention Across Conditions

These data confirm < 0.3 % variance in measured purity even under accelerated conditions, indicating extraordinary thermal and oxidative resistance. In contrast, conventional NMN grades subjected to similar ICH test conditions frequently exhibit degradative loss exceeding 2–5 % within 12 months.

3.2 Physical Appearance Observation

Across all environmental conditions, no significant color or textural changes were observed. Powder samples remained uniformly white and free‑flowing, with consistent particulate morphology.

3.3 Independent Verification Results

SGS Analytical Report (2025‑11‑13):

• β‑Nicotinamide Mononucleotide (β‑NMN) content = 100.0 % via HPLC
  - LOD/LOQ fully compliant with ISO 17025 traceability

Eurofins Analytical Report (2025‑06‑03):
- Heavy metals – Lead 0.0688 mg/kg; Arsenic 0.0202 mg/kg; Cadmium < 0.002 mg/kg; Mercury < 0.001 mg/kg
→ All values well below FDA and USP limits
- Microbial Contaminants – Salmonella, Staphylococcus aureus, and coliforms not detected
- Aerobic plate count < 10 cfu/g; Moulds and Yeasts ≤ 10 cfu/g

Acute Toxicity Assessment (External Safety Report):
Oral LD₅₀ > 5000 mg/kg in rodent model, indicating non‑toxic classification under FDA and OECD Guidelines.

4. Discussion

4.1 Thermal and Oxidative Stability

The sustained purity levels across −15 °C to 40 °C demonstrate the molecular stability of HYGIEIA® NMN, reflecting robust control over hygroscopicity and oxidative pathways that typically degrade less‑refined NMN sources. The protective aluminum foil barrier and low‑moisture storage further mitigate nicotinamide deamination and riboside cleavage reactions.

4.2 Comparative Market Analysis

Most commercially available NMN raw materials report assay purities between 95 % and 98 %, often accompanied by visible discoloration upon accelerated testing. Comparative analysis indicates that HYGIEIA® NMN, as used in MONOmolecule™, exceeds these purity averages by ~2–5 %, translating into higher bioefficacy, longer shelf stability, and cleaner sensory profile.

4.3 Regulatory Interpretation

The analytical results meet or surpass specifications outlined in FDA 21 CFR 211.166 (stability testing for drug substances) and ICH Q1A(R2) (stability data requirements). The toxicological results satisfy safety parameters equivalent to GRAS and OECD No. 425 acute oral toxicity limits. Independent verification by accredited laboratories (SGS and Eurofins) assures compliance with ISO 17025 certification, confirming traceable analytical transparency.

4.4 Implications for Nutraceutical and Pharmaceutical Applications

The stable and contaminant‑free nature of MONOmolecule’s NMN ingredient makes it an ideal candidate for high‑potency formulations targeting metabolic health, longevity, and cognitive performance. Given its compatibility with encapsulation, effervescent, and powder delivery systems, the ingredient provides formulation versatility uncommon in typical NMN bulk materials.

5. Conclusion

The comprehensive analytical, stability, and safety data confirm that MONOmolecule™ NMN Complex, incorporating HYGIEIA® NMN, possesses pharmaceutical‑grade purity (≥ 99.5 %), superior temperature stability, and excellent toxicological safety.

• Under −15 °C storage for 24 months → Purity remained > 99.6 %.
• At ambient 25 °C / 75 % RH for 24 months → No degradation or color change.
• Under accelerated 40 °C for 6 months → Purity > 99.4 %.
• No detectable heavy metals or microbial contaminants (verified by Eurofins).
• 100.0 % assay confirmation (verified by SGS).
• Safty margin LD₅₀ > 5000 mg/kg (non‑toxic).

These findings substantiate MONOmolecule™ NMN Complex as an industry‑leading NMN source — setting a benchmark in purity, safety, and long‑term stability — delivering unmatched value to both supplement formulators and health‑conscious consumers.

6. Regulatory Statement & Disclaimer

All testing was conducted in accordance with internationally accepted analytical methods and environmental conditions that conform to U.S. FDA, ICH, and ISO regulatory frameworks. This report is intended for informational and marketing purposes, representing validated scientific data for MONOmolecule™ NMN Complex. It is not a drug submission document and does not claim to diagnose, treat, cure, or prevent any disease.