Quality
Quality: Testing & Manufacturing Standards
Transparent quality control processes and third-party verification protocols.
Manufacturing Process
Microalgae Cultivation
Controlled fermentation in closed photobioreactors:
- Pharmaceutical-grade water source
- Temperature: 25-28°C (±0.5°C)
- pH monitoring: 7.0-7.5
- Sterile environment (ISO Class 7)
- No pesticides or herbicides
Harvesting & Extraction
Supercritical CO₂ extraction method:
- Preserves omega-3 integrity
- No chemical solvents
- Temperature-controlled (<40°C)
- Oxygen-free environment
Purification
Multi-stage refinement process:
- Molecular distillation
- Removes potential impurities
- Concentrates EPA/DHA content
- Maintains triglyceride form
Quality Testing
Comprehensive analysis before encapsulation:
- Fatty acid profile verification
- Heavy metal screening
- Microbial testing
- Oxidation markers (PV, AV, TOTOX)
Encapsulation
Pharmaceutical-grade soft gel production:
- Plant-based capsule (carrageenan/starch)
- Nitrogen flushing to prevent oxidation
- Natural fruit flavoring
- No artificial colors or preservatives
Final Verification
Third-party laboratory testing:
- Potency verification
- Stability testing
- Dissolution rate analysis
- Certificate of Analysis (COA) issued
Testing Standards
| Test Parameter | Standard | Our Specification | Method |
|---|---|---|---|
| DHA Content | ≥100mg/serving | ≥200mg/serving | GC-FID |
| EPA Content | ≥50mg/serving | ≥100mg/serving | GC-FID |
| Mercury (Hg) | <0.1 ppm | <0.01 ppm | ICP-MS |
| Lead (Pb) | <0.5 ppm | <0.1 ppm | ICP-MS |
| Cadmium (Cd) | <0.5 ppm | <0.1 ppm | ICP-MS |
| Arsenic (As) | <0.5 ppm | <0.1 ppm | ICP-MS |
| Peroxide Value | <5 meq/kg | <3 meq/kg | AOCS Cd 8-53 |
| Anisidine Value | <20 | <15 | AOCS Cd 18-90 |
| TOTOX Value | <26 | <20 | Calculated |
| Total Plate Count | <1000 CFU/g | <100 CFU/g | USP <2021> |
Product Specifications
- Omega-3 Form: Triglyceride (natural form, superior absorption)
- DHA Concentration: ≥35% of total omega-3 content
- Oxidation Protection: Mixed tocopherols (natural vitamin E)
- Shelf Life: 24 months from manufacture date
- Storage: Room temperature (15-25°C), away from direct sunlight
- Capsule Material: Plant-based (carrageenan), suitable for vegetarians
Certifications & Compliance
FDA Registered Facility
Manufactured in FDA-registered facility following Current Good Manufacturing Practices (cGMP).
Third-Party Tested
Every batch tested by independent ISO 17025 accredited laboratories for purity and potency.
Non-GMO Verified
Microalgae strains are non-genetically modified, verified through molecular testing.
Vegan Certified
100% plant-based ingredients, suitable for vegetarian and vegan diets.
Allergen-Free
Free from fish, shellfish, dairy, soy, gluten, and tree nuts. Tested for cross-contamination.
Sustainable Sourcing
Microalgae cultivation certified by independent sustainability auditors.
Transparency Commitment
We provide Certificates of Analysis (COA) for each production batch upon request. COAs include complete testing results for fatty acid profile, heavy metals, microbial content, and oxidation markers. Contact our quality assurance team at quality@asmell.com for batch-specific documentation.