Testing
Results
Independent Laboratory Analysis
Certified testing performed by Mérieux NutriSciences / CHELAB S.r.l. (ACCREDIA 00051)
Sample: QLEOS Biotech — Optimized Creatine • LOT BI10202506
Laboratory report: Lab Summary Mod. 716/SQ rev. 14 — Acceptance No. 25.299304.0001
Analyses performed at Mérieux NutriSciences Resana, under ACCREDIA accreditation n. 00051.
Dr. Enrico Nieddu (Registered Chemist), Dr. Federica Lomi (Registered Chemist), Dr. Matteo Giacomelli (Registered Biologist)
Testing performed by Eurofins Technology Service Co., Ltd.
Using a validated HPLC method to verify typical synthesis residues and degradation markers.
The absence of detectable creatinine, dicyandiamide (DCD) and dihydrotriazine (DHT) at the method detection limits further supports the high-grade purity and controlled manufacturing process of Optimized Creatine.
Scientific Assessment
- All toxic metals (As, Cd, Hg) — not detected, i.e. below the instrument’s limit of detection.
- Lead (Pb) content only 0.0057 mg/kg, which is more than 500 times lower than the maximum allowed limit set by EU Regulation 1881/2006 for food supplements.
- Residual compounds — Internal process specification PS_16009 defines strict limits for typical synthesis residues (dicyandiamide, DCD; dihydrotriazine, DHT) and degradation markers such as creatinine. Testing performed by Eurofins Technology Service Co., Ltd. using a validated HPLC method confirmed that DCD, DHT and creatinine were not detected at the method detection limit, fully consistent with the high-purity, 500 MESH high-grade production process.
- No detectable microbial growth — total viable count below 10 CFU/g, with all tested pathogenic species absent. Verified according to ISO, USP, EP, and AOAC standards under ACCREDIA accreditation n. 00051.
- Overall, Optimized Creatine meets pharmaceutical-grade purity criteria ( >99% assay on dry matter), with no tested contaminants detected above analytical limits and excellent microbiological safety.
Analytical Methods & Standards
- Heavy metals (Pb, As, Cd, Hg) – Internal method MP 1288 rev 24 (2025), based on AOAC 2015.06, EN 15763:2010, EPA 6020B (2014).
- Total Viable Count (30 °C) – ISO 4833-1:2013 / Amd 1:2022.
- E. coli (β-glucuronidase positive) – ISO 16649-2:2001.
- Coagulase-positive Staphylococci (S. aureus) – ISO 6888-2:2021 / Amd 1:2023.
- Salmonella spp. (qualitative) – ISO 6579-1:2017 / Amd 1:2020, with confirmation by MALDI-TOF where applicable.
- Yeasts & Moulds (25 °C) – NF V 08-059:2002.
- Creatine assay (dry matter) – USP-NF Creatine monograph with chromatographic method USP <621>.
- Loss on Drying – EP 07/2019:20232.
- HPLC determination of creatine, creatinine, dicyandiamide (DCD) and dihydrotriazine (DHT) – validated method based on Food Chemistry 126 (2011) 1232–1238, applied in batch testing by Eurofins Technology Service Co., Ltd. (process residues and degradation markers).
Regulatory & Quality Framework
Production of QLEOS products are manufactured exclusively in EU-certified facilities, operating under comprehensive regulatory systems aligned with international manufacturing and safety standards. These certifications are held by the contract manufacturer and reflect the controlled environment and traceable supply chain that ensure the integrity and reproducibility of each batch.
Implements a fully traceable, risk-based control framework that integrates supplier verification, raw material monitoring, and process hygiene to guarantee food-grade safety at every step.
Ensures continuous process validation, documentation accuracy, and adherence to standardized manufacturing procedures, resulting in exceptional batch-to-batch consistency and reliability.
Confirms that manufacturing operations are conducted with environmental responsibility, emphasizing sustainable energy use, emission control, and waste minimization.
Provides standardized operational guidelines for production, packaging, labeling, and storage—ensuring full compliance with EU quality and safety directives for nutraceutical-grade materials.
Establishes a preventive safety protocol identifying and controlling potential contamination points throughout the production and packaging chain, ensuring complete microbiological safety.
Ensures that food supplement production is carried out under controlled hygienic conditions, with validated procedures, documented quality assurance systems and full traceability. GMP 3-2014 certification confirms that every batch is manufactured, checked and released according to internationally recognised Good Manufacturing Practice for dietary supplements.
Internal Expert Conclusion
From a scientific and regulatory standpoint, the analytical profile of Optimized Creatine LOT: BI10202506 demonstrates an exceptionally pure creatine monohydrate — fully compliant with both European requirements and QLEOS Biotech internal high-grade specifications.
The combined absence of toxic elements, process-related residues (dicyandiamide, DCD; dihydrotriazine, DHT), degradation markers such as creatinine, and microbiological contaminants confirms the high efficiency of the purification and crystallisation process. The batch has been verified through independent testing in two laboratories — Mérieux NutriSciences / CHELAB (ACCREDIA n. 00051) for heavy metals, microbiology and assay, and Eurofins Technology Service Co., Ltd. for DCD, DHT and creatinine — placing this material within the highest percentile of purity currently attainable in nutraceutical-grade creatine manufacturing.