Analytical Sciences Division
Certificate of Analysis
| Accession No. | SYN-COA-2026-RET040-2105 |
|---|---|
| Issued To | Synedica Analytical Laboratories |
| Report Date | Jul 13, 2026 |
Sample Identification
| Product | Retatrutide 40mg Injection Pen Kit | Batch | SYN-RET040-2105 |
|---|---|---|---|
| Analyte | Retatrutide | Manufactured | Jul 13, 2026 |
| Format | Injection Pen | Expiry | Jul 13, 2028 |
| Nominal Amount | 40mg | Assayed Purity | 99.3% |
| Molecular Formula | C₂₂₁H₃₄₂N₄₄O₆₈ | Net Content | 39.7 mg |
| Molecular Weight | 4,731.4 Da | Appearance | Clear, colourless solution, free from visible particles |
| Storage | Store at 2–8 °C, protected from light. Do not freeze. | ||
Analytical Results
| Test Name | Method | Specification | Result | Status |
|---|---|---|---|---|
| Appearance | Visual inspection, Ph. Eur. 2.2.1 | Clear, colourless solution, free from visible particles | Conforms | ✓ PASS |
| Identity | ESI-MS, ≤ 5 ppm | Confirmed [M+5H]⁵⁺ = 947.3 | Confirmed | ✓ PASS |
| Assay (content) | RP-HPLC-UV, C18, 220 nm | 95.0 – 105.0% of label claim | 100.9% | ✓ PASS |
| Purity | RP-HPLC-UV, C18, 220 nm | ≥ 98.0% | 99.3% | ✓ PASS |
| Related substances | RP-HPLC-UV, area normalisation | ≤ 2.0% total | 0.7% | ✓ PASS |
| pH | Potentiometry, Ph. Eur. 2.2.3 | 7.0 – 8.0 | 7.30 | ✓ PASS |
| Osmolality | Ph. Eur. 2.2.35 | 270 – 330 mOsm/kg | 300 mOsm/kg | ✓ PASS |
| Preservative content | RP-HPLC-UV (m-cresol) | 85.0 – 115.0% of label claim | 104.7% | ✓ PASS |
| Extractable volume | Ph. Eur. 2.9.17 | ≥ label claim | Conforms | ✓ PASS |
| Container closure integrity | Dye ingress, ASTM F1929 | No ingress | Conforms | ✓ PASS |
| Visible particles | Ph. Eur. 2.9.20 | Practically free from visible particles | Conforms | ✓ PASS |
| Particulate matter (sub-visible) | Light obscuration, Ph. Eur. 2.9.19 | Meets Ph. Eur. limits for parenteral use | Conforms | ✓ PASS |
| Sterility | Membrane filtration, Ph. Eur. 2.6.1 | No growth at 14 days | Conforms | ✓ PASS |
| Bacterial endotoxins | LAL kinetic chromogenic, Ph. Eur. 2.6.14 | < 10.0 EU/mL | < 0.32 EU/mL | ✓ PASS |
| Elemental impurities | ICP-MS, ICH Q3D / Ph. Eur. 2.4.20 | Meets ICH Q3D parenteral limits | Conforms | ✓ PASS |
15 total · 15 passed · 0 failed · 0 pending
Instrument Data
Conclusion
Listed tests marked pass
15 of 15 tests are marked pass.
Full release panel for batch SYN-RETA40-0002. 15 tests performed against documented Synedica specifications.
Authorisation
Released by
Quality Assurance, Synedica Laboratories
Electronically authorised — no handwritten signature required.
Accreditation: ISO/IEC 17025 aligned methods
SYN-COA-2026-RET040-2105
Analytical Sciences Division
Verify this certificate at
https://syn.vercel.app/en/coa/SYN-COA-2026-RET040-2105
Valid Until: Jul 13, 2028
This Certificate of Analysis is issued by Synedica Laboratories and applies solely to the batch identified above. The formulation described is supplied for research and laboratory use only. Not for human consumption, or for clinical, diagnostic, or therapeutic application. Batch traceability and analytical records are retained by Synedica Laboratories.