Batch Verification Report
Batch verification and analytical summary for Melanotan II.
Manufacture date: 13 Sep 2025
Recommended retest date: 12 Sep 2027
Molecular weight: 1024.20 Da
Structure: Cyclic (Asp²-Lys⁷ lactam bridge)
Analytical Results
The following analytical data was obtained from manufacturer testing of batch P250901-A007. Aventris has independently verified this data against our quality specifications. This Batch Verification Report summarises our review findings.
| Test | Method | Specification | Result |
|---|---|---|---|
| Appearance | Visual | White powder | Conforms |
| Identity | MS (ESI) | Conforms to structure | Conforms (1024.20 Da) |
| Purity | HPLC | ≥ 99.0% | 99.51% |
| Peptide content | Peptide content (N%) | ≥ 70.0% | 85.72% |
| Acetate content | HPLC | ≤ 20.0% | 11.12% |
| Water content | Karl Fischer | ≤ 10.0% | 2.25% |
| Mass balance | Calculated | 95.0 – 105.0% | 99.09% |
| Residual solvents – Acetonitrile | GC | NMT 410 ppm | Not detected |
| Residual solvents – Methanol | GC | NMT 3000 ppm | Not detected |
| Residual solvents – Methylene chloride | GC | NMT 600 ppm | Not detected |
| Residual solvents – N,N-Dimethylformamide | GC | NMT 880 ppm | Not detected |
| Residual solvents – Isopropyl ether | GC | NMT 5000 ppm | Not detected |
Storage & Handling
Storage Conditions:
- Store at -20°C or below in original sealed vial
- Protect from light and moisture
- Do not freeze-thaw repeatedly once reconstituted
- Recommended shelf life: 24 months when stored properly
General Laboratory Handling:
- Handle using standard laboratory safety practices
- Wear appropriate personal protective equipment (gloves, lab coat, safety glasses)
- Use in well-ventilated area or fume hood
- Avoid inhalation, ingestion, or skin/eye contact
- Wash hands thoroughly after handling
Sequence:
Ac-Nle-cyclo[Asp-His-D-Phe-Arg-Trp-Lys]-NH₂
Lactam bridge: Asp²-Lys⁷
Reconstitution:
Reconstitution methods, diluents, and working concentrations must be determined by qualified researchers
according to their specific experimental protocols and institutional guidelines. Aventris does not provide
reconstitution instructions.
Additional Documentation:
For questions about this batch or to request additional information, contact
[email protected]
Note: Any deviations from the above specification, if present, will be explicitly noted. In the absence of such notes, all parameters conform to the stated limits.