Certificate of analysis
VQ-EX-0001, Comprehensive Release, issued 29 Sep 2026
This lot meets the Comprehensive Release specification.It is retatrutide, it is 99.1% pure, each vial holds 102% of the labelled 10 mg, and it is sterile.
Sold asGLP-3 10 mg
Identified asRetatrutide
Safety5 of 5 within limit
Holistic peptide quality5 of 5 within limit
Manufacturing discipline and control9 of 9 within limit
Chromatogram, UV 214 nm
Retatrutide99.1% of peak area12.6 min
Baseline expanded 25x so the impurities are visible. The main peak runs off scale. Select a marker to read a peak.
Results
| Test | Method | Limit | Result | Verdict |
|---|---|---|---|---|
| Safety | ||||
| Sterility | Membrane filtration, 14-day incubation, USP <71> | No growth | No growth at 14 days | Within |
| Bacterial endotoxins | Kinetic chromogenic LAL, USP <85> | Not more than 5.0 EU/mg | Less than 0.5 EU/mg | Within |
| Visible particulates | Visual inspection against black and white backgrounds, USP <790> | Essentially free of visible particles | Conforms | Within |
| Residual solvents | Headspace GC-MS, USP <467> | Meets USP <467> limits | Acetonitrile 38 ppm, others not detected | Within |
| Elemental impurities and catalyst residues | ICP-MS, USP <232> and <233>, ICH Q3D | Meets ICH Q3D parenteral limits | All elements below limits | Within |
| Holistic peptide quality | ||||
| Identity (intact mass) | LC-HRMS | Within 5 ppm of theoretical | Matches, +1.8 ppm | Within |
| Purity and related substances | RP-UPLC, UV 214 nm, with MS, ICH Q3 reporting thresholds | NLT 98.0%, no impurity above 1.0% | 99.1%, largest impurity 0.41% | Within |
| Net peptide content | UPLC assay against reference standard | 90.0 to 110.0% of label claim | 10.2 mg, 102% | Within |
| Counterion identity and content | Ion chromatography | Report | Acetate 6.8%, TFA not detected | Reported |
| Structural and conformational screen | Vibrational circular dichroism (VCD) | Spectral similarity to reference NLT 0.95 | 0.98 | Within |
| Manufacturing discipline and control | ||||
| Cake appearance | Visual inspection | Intact white cake | Conforms, photos attached | Within |
| Color | Visual comparison against color standards, USP <631> | Colourless solution | Conforms | Within |
| Clarity and degree of opalescence | Visual comparison against reference suspensions, Ph. Eur. 2.2.1 | Clear, not more opalescent than reference I | Conforms | Within |
| Reconstitution time | Timed reconstitution with the labelled diluent | Not more than 2 minutes | 45 seconds | Within |
| pH | Potentiometric, USP <791> | Report | 6.4 at 2 mg/mL | Reported |
| Osmolality | Freezing point depression, USP <785> | Report | 288 mOsm/kg at 2 mg/mL | Reported |
| Fill weight | Gravimetric | Within 5% of target | Mean 101.2%, range 99.4 to 102.8% | Within |
| Extractable volume | Volumetric withdrawal, USP <697> | Not less than labelled volume | 1.04 mL from 1.0 mL label | Within |
| Water content | Karl Fischer titration, USP <921> | Not more than 6.0% | 2.9% | Within |
Chain of custody
- Submitted online28 Aug
- Received, sealed2 Sep
- Testing started3 Sep
- Sterility read24 Sep
- COA issued29 Sep