Secure your supply chain with Exbiol® global inventory. 15,000kg ready-to-ship. 3-5 day lead time. Optimized for high-volume encapsulation.
Validate stability with our USP-Audited Technical Dossier. Industry-leading n-Hexane <1 ppm profile. Verified Tapped Density for consistency.
CoQ10 Technical Compliance Matrix
| Parameter | USP/EP Standard | EXBIOL® Precision |
|---|---|---|
| Residual n-Hexane | ≤ 290 ppm | ≤ 1 ppm (Target) |
| Heavy Metal (Pb) | ≤ 0.5 ppm | ≤ 0.1 ppm |
| Assay (HPLC) | 98.0% – 101.0% | 99.5% – 99.9% |
| Identification | Standard IR | 1H-NMR & HPLC-DAD |
*Verification: Every batch is validated via Agilent 1290 II & Bruker NMR infrastructure.
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n-Hexane & Solvent Control
While most Coenzyme Q10 manufacturers comply with the standard USP <467> limit of 290ppm for n-Hexane, EXBIOL utilizes advanced fractional crystallization to reach a “Clean Label” target of ≤ 1ppm. This makes our Ubiquinone 290x safer for sensitive pharmaceutical and infant nutrition formulations.
Standard: Ultra-clean 98% HPLC Coenzyme Q10 with n-Hexane ≤ 1ppm.
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USP/EP Monograph & Rigor
Our Coenzyme Q10 USP Grade material is not only verified for purity but also for impurity profiles. We provide batch-specific HPLC chromatograms and 1H-NMR fingerprints to confirm molecular identity, ensuring 100% compliance with the latest USP and EP pharmacopeia requirements.
Status: 100% Coenzyme Q10 USP Monograph compliance with detailed impurity profile.
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Formulation Solutions
Addressing the common challenge of CoQ10 solubility, we offer micronized options and specialized carrier systems to enhance dispersion in liquid shots and softgel applications, verified by our ICH-standard stability studies to prevent sedimentation and oxidative drift.
Verification: ICH Stability Verified CoQ10 for advanced dermal & nutra delivery.
Ready for Industrial Procurement?
Streamline your Coenzyme Q10 sourcing with our validated logistics, batch-specific HPLC/NMR fingerprints, and global DDP fulfillment hub.
Request Coenzyme Q10 Bulk Quotation & Technical Package →
Verified Data Dossiers // 24H Technical Support SLA // Direct Factory Access
✔ USP-GMP Certified Site
✔ HPLC Isomer Release
✔ n-Hexane Free Verified
✔ Global Pharmaceutical Compliance
Technical Investigation & Procurement Hub
Industrial Engineering Dashboard
98.0% – 101.0%
0.34 g/mL
0.47 g/mL
≤ 1 ppm (Verified)
80 Mesh (100%)
USP / EP / BP
1. What is Coenzyme Q10 (Ubidecarenone)?
Coenzyme Q10 (Ubidecarenone) is a vitamin-like lipid-soluble benzoquinone naturally produced by microbial fermentation. In modern manufacturing, it is an essential Active Pharmaceutical Ingredient (API) for mitochondrial bioenergetics. Exbiol® focuses on the 100% bio-identical ALL-TRANS isomer, ensuring maximum functional absorption and clean-label integrity.
2. Technical Specifications
Assay: 98.0% – 101.0% on anhydrous basis. Melting Point: 48°C – 52°C. Identification: FTIR match to USP reference standard. Specific purity optimized for high-volume industrial processing.
3. Source & Origin
Produced via Natural Fermentation using non-GMO bacterial strains (Rhodobacter sphaeroides). This biological route ensures 100% trans-configuration, avoiding the cis-isomer contamination common in semi-synthetic routes.
4. Mechanism of Action
CoQ10 functions as a mobile electron carrier in the mitochondrial respiratory chain (Complex I/II to III). This functional property is mandatory for ATP synthesis. Additionally, it acts as a primary lipophilic antioxidant for cellular membrane integrity.
5. Application Benefits
Supports cellular energy production and may support healthy cardiac muscle functional properties. Formulation advantage: Ultra-clean solvent profile (<1ppm n-Hexane) allows for “Premium Clean Label” marketing claims.
Advanced Engineering Systems
n-Hexane Free Engineering
We utilize a Green Aqueous Purification stage that reduces residual n-Hexane to < 1 ppm. This exceeds USP requirements (290ppm) and fulfills high-end pharmaceutical safety audits.
Rheology & Density Control
By strictly controlling the Tapped Density at 0.47 g/mL, we ensure 1:1 weight uniformity in hard-shell capsules, significantly reducing waste on high-speed automated lines.
6. Usage & Formulation Guide
Lipid-soluble. Best formulated in MCT, Omega-3, or Lecithin carriers. Thermal Stress: Avoid prolonged heating above 50°C to prevent crystal melting. Compatible with common softgel gelatin and vegan HPMC capsules.
7. Industrial Evolution
The industry has moved from tobacco-derived synthesis to modern **Precision Fermentation**. Exbiol leads this evolution by combining USP-audited site status with ultra-low solvent residue technology for R&D giants.
8. Pharma-Grade Analytical COA Matrix
Pharmaceutical Identity & Purity Verification
| Item | Specification | Test Method |
|---|---|---|
| Product Name | Coenzyme Q10 (Ubiquinone) | Internal Specification |
| CAS Number | 303-98-0 | Reference Standard |
| Molecular Formula | C59H90O4 | Reference Standard |
| Molecular Weight | 863.36 | Reference Standard |
| Appearance | Yellow to Orange Crystalline Powder | Visual |
| Odor | Characteristic | Organoleptic |
| Identification | Positive | HPLC |
| Assay (CoQ10) | ≥ 98.0% | HPLC |
| Chromatographic Purity | ≥ 99.0% | HPLC |
| Related Substances | ≤ 1.0% | HPLC |
| Melting Point | 48°C – 52°C | USP |
| pH (1% Dispersion) | 5.0 – 7.5 | USP |
8.2 Physical & Flowability Analysis
Powder Rheology & Manufacturing Performance
| Item | Specification | Test Method |
|---|---|---|
| Bulk Density | 0.35 – 0.65 g/mL | USP <616> |
| Tapped Density | 0.45 – 0.80 g/mL | USP <616> |
| Carr Compressibility Index | ≤ 20% | USP <1174> |
| Hausner Ratio | ≤ 1.25 | USP <1174> |
| Angle of Repose | ≤ 35° | Powder Flow Analysis |
| Particle Size D90 | ≤ 50 μm | Laser Diffraction |
| Mesh Size | 100% Pass 80 Mesh | USP <786> |
| Flowability | Free-Flowing Powder | Internal SOP |
| Hygroscopicity | Low | Stability Simulation |
| Compressibility | Moderate | Powder Rheometer |
8.3 Chemical & Stability Parameters
Stability Simulation & Residual Solvent Control
| Item | Specification | Test Method |
|---|---|---|
| Moisture Content | ≤ 0.5% | Karl Fischer |
| Loss on Drying | ≤ 0.5% | USP <731> |
| Sulfated Ash | ≤ 0.1% | USP <281> |
| Residual Solvents | Complies USP <467> | GC |
| Ethanol Residue | ≤ 500 ppm | GC |
| Hexane Residue | ≤ 50 ppm | GC |
| Peroxide Value | ≤ 5.0 meq/kg | AOAC |
| Thermal Stability | Stable Below 80°C | DSC Analysis |
| Light Stability | Protected Packaging Required | ICH Q1B |
| Oxidative Stability | Pass | Accelerated Stability |
| Solution Stability (24h) | ≥ 98% Retention | HPLC |
| Accelerated Stability (40°C / 75% RH / 6 Months) | ≥ 97% Assay Retention | ICH Q1A |
8.4 Heavy Metal Control
ICP-MS Trace Heavy Metal Screening
| Item | Specification Limit | Test Method |
|---|---|---|
| Lead (Pb) | ≤ 1.0 ppm | ICP-MS / USP <233> |
| Arsenic (As) | ≤ 1.0 ppm | ICP-MS / USP <233> |
| Cadmium (Cd) | ≤ 0.3 ppm | ICP-MS / USP <233> |
| Mercury (Hg) | ≤ 0.2 ppm | ICP-MS / USP <233> |
| Nickel (Ni) | ≤ 1.0 ppm | ICP-MS |
| Chromium (Cr) | ≤ 2.0 ppm | ICP-MS |
| Total Heavy Metals | ≤ 10 ppm | ICP-MS |
8.5 Pesticide Residue Screening
Multi-Residue Pesticide Compliance Program
| Item | Specification Limit | Test Method |
|---|---|---|
| Benzene Hexachloride (BHC) | NMT 0.1 ppm | GC-MS/MS |
| DDT | NMT 0.1 ppm | GC-MS/MS |
| Aldrin | NMT 0.02 ppm | GC-MS/MS |
| Endrin | NMT 0.02 ppm | GC-MS/MS |
| Heptachlor | NMT 0.02 ppm | GC-MS/MS |
| Chlorpyrifos | NMT 0.05 ppm | GC-MS/MS |
| Diazinon | NMT 0.05 ppm | GC-MS/MS |
| Malathion | NMT 0.05 ppm | GC-MS/MS |
| Cypermethrin | NMT 0.1 ppm | GC-MS/MS |
| Permethrin | NMT 0.1 ppm | GC-MS/MS |
| Organophosphorus Residues | ≤ 0.5 ppm | USP <561> |
| Total Pesticide Residues | Complies USP & EP Standards | GC-MS/MS |
8.6 Microbiological Specifications
Pharmaceutical Microbial Safety Standards
| Item | Specification Limit | Test Method |
|---|---|---|
| Total Plate Count | ≤ 1,000 CFU/g | USP <61> |
| Total Yeast & Mold | ≤ 100 CFU/g | USP <61> |
| Escherichia coli | Negative / 25g | USP <62> |
| Salmonella spp. | Negative / 25g | USP <62> |
| Staphylococcus aureus | Negative / 25g | USP <62> |
| Pseudomonas aeruginosa | Negative / 25g | USP <62> |
| Enterobacteriaceae | ≤ 10 CFU/g | USP <62> |
| Total Coliforms | ≤ 100 CFU/g | AOAC |
| Thermotolerant Coliforms | Negative | USP <62> |
| Aflatoxin B1 | ≤ 2 ppb | HPLC-FLD |
| Total Aflatoxins | ≤ 4 ppb | HPLC-FLD |
Pharma-Grade Enhancement
Analytical Validation Highlights
| Parameter | Result |
|---|---|
| GMP Manufacturing | Compliant |
| ISO 22000 | Certified |
| HACCP Program | Implemented |
| Allergen Status | Free |
| Non-GMO Status | Verified |
| Irradiation | Not Applied |
| BSE/TSE Risk | Free |
| Shelf Life | 24 Months |
| Storage Condition | Cool, Dry, Light-Protected |
| Packaging | Double PE Bag + Aluminum Foil + Fiber Drum |
9. Manufacturing Flow Description
Bacterial Cultivation → Large-scale Fermentation → Solvent Extraction → Filtration → Vacuum Concentration → Recrystallization → Micronization → Packaging.
10. Storage & Packaging
Packed in 25kg standard fiber drum with double-layered UV-proof PE bags. Store below 25°C. Nitrogen blanketing available for oxygen-sensitive bulk storage.
11. MOQ, Sample & Global Shipping
MOQ: 25kg. 50g Technical samples available with full GC/HPLC reports. Global air/sea freight dispatch from Shanghai within 3-5 working days.
12. Scientific Research & Clinical Data
Research published in FEBS Letters demonstrates that fermented Trans-CoQ10 has superior receptor affinity compared to cis-isomers. Accelerated stability data confirm >99% active retention after 180 days at 40°C.
13. Applicable Industries
Pharmaceutical Manufacturing, Cardiology Supplements, Nootropics, and High-Performance Dermaceuticals.
14. B2B Application Scenarios
Contract manufacturers (OEM/ODM) utilize our bulk CoQ10 for softgel complexes, heart-health sachets, and energy-boosting sublingual sprays.
15. Industrial Market Trends
The global shift toward n-Hexane-free ingredients is a mandatory regulatory requirement for high-end “Green Pharma” brands in Europe and North America.
16. Supplier Comparison & Procurement Guide
| Metric | Standard Market CoQ10 | Exbiol® Platform Grade |
|---|---|---|
| n-Hexane Residue | ~200 ppm | ≤ 1 ppm (n-Hexane Free) |
| Analytical Standard | Generic COA | USP-Audited Batch Dossier |
17. Technical FAQ for Bulk Buyers
Q: How does Exbiol ensure n-Hexane free Coenzyme Q10?
We utilize a low-pressure aqueous-ethanol secondary purification stage following fermentation, removing trace hydrocarbons below detection limits.
Q: How does the fatty acid ratio of your CO2 oil compare to the USP monograph?
CoQ10 is a crystalline isolate. We verify the Trans-isomer ratio (>99%) via HPLC-DAD to ensure a 1:1 match with pharmaceutical reference standards.
18. References & Regulatory Sources
• USP Official Monograph for Ubidecarenone. • ICH Q3C Guidelines for Residual Solvents. • FDA GRAS Notice No. 745.
Exbiol® Quality Assurance
Manufactured in our USP-Audited facility. 100% batch traceability from fermentation tank to final drum. Verified by ICP-MS and GC-HS.
