Testing Laboratory
Certificate of Analysis
Summary of Results
| Analysis Type | Method | Date Tested | Status |
|---|---|---|---|
| Sample Peptide | HPLC | MM/DD/YYYY | Complete |
| Bacterial Endotoxins | USP <85> | MM/DD/YYYY | Complete |
| Sterility | qPCR | MM/DD/YYYY | Complete |
| Fentanyl | USP <2251> | MM/DD/YYYY | Complete |
| Residual Solvents | USP <467> | MM/DD/YYYY | Complete |
| Heavy Metals | ICP-MS | MM/DD/YYYY | Pass |
| Microbiological | Petrifilm/qPCR | MM/DD/YYYY | Pass |

Label Claim Profile
| Analyte | Result | Specification | LOD |
|---|---|---|---|
| Sample Peptide | Vial 1 = 10.40mg/vial | 10mg/vial | 0.01% |
| Sample Peptide | Vial 2 = 10.42mg/vial | 10mg/vial | 0.01% |
| Sample Peptide | Vial 3 = 10.37mg/vial | 10mg/vial | 0.01% |
| Identity of the analyte was confirmed by retention time concordance with a certified reference standard, per USP <621>. | |||
| Chromatographic Purity (3 Vials) | Vials 1,2,3 = >99% | >99% | 0.01% |
| Bacterial Endotoxins (Gel-Clot: 1:10 Dilution) | <1.25 EU/ml | <5 EU/ml | λ = 0.125 EU/ml |
| Rapid Sterility (Real-Time qPCR) Validated per USP <1223> in lieu of USP <71> | No Microbial DNA/RNA Detected (Pass) | No Detection | 10 CFU |
| Fentanyl (3 Vials) | Vials 1,2,3 = Not Detected | <LOD | 10ppm |

















