Danish Formulation TechnologyCertificate of Analysis
| Accession No. | COA-A26Q2SSN0087 |
| Client | Alpha Nordisk |
| Report Date | 6/9/2026 |
| Product | SS-31 | Lot | A26Q2SSN0087 |
| Chemical | Elamipretide | Mfg Date | 2026-Q2 |
| Form | Lyophilized Powder | Exp Date | EXP 05/28 |
| Dose | 10mg | Purity | 99.7% |
| Formula | C₃₂H₅₇N₉O₅ | Net Content | 9.9 mg |
| Mol. Weight | 639.8 Da | Appearance | White lyophilized powder |
All chemical analysis performed in accordance with European Pharmacopoeia (Ph. Eur.) reference methods — HPLC-UV (C18, 220 nm) for purity; ESI-MS (≤5 ppm) for identity confirmation
| Test | Method | Specification | Result | Status |
|---|---|---|---|---|
| Appearance | Visual inspection | White lyophilized powder | Conforms | ✓ PASS |
| Identity | ESI-MS (≤5 ppm) | Confirmed [M+H]⁺ = 640.8 | Confirmed | ✓ PASS |
| Purity | HPLC-UV (C18, 220 nm) | ≥99.0% | 99.7% | ✓ PASS |
| Related substances | HPLC-UV | ≤1.0% total | <0.3% | ✓ PASS |
| Endotoxin | LAL (gel-clot) | <1.0 EU/mg | <0.5 EU/mg | ✓ PASS |
| Water content | Karl Fischer | <8.0% | <5.2% | ✓ PASS |
| Counterion | Ion chromatography | Acetate (TFA-free) | Acetate | ✓ PASS |
| Sterility | USP <71> visual | No visible contamination | Conforms | ✓ PASS |
HPLC-UV Chromatogram (220 nm)
ESI Mass Spectrum
Alpha Nordiskalphanordisk.com/verifyalphanordisk.com/methodology — Analytical methodology standardVerify this certificate at alphanordisk.com/verify/A26Q2SSN0087
A26Q2SSN0087Danish Formulation Technology
This Certificate of Analysis is issued by Alpha Nordisk for research and laboratory use documentation. The peptide described is intended exclusively for research and laboratory use. Not for human consumption, clinical, diagnostic, or therapeutic application. Lot traceability and analytical data are maintained by Alpha Nordisk under Danish Formulation Technology standards.