SS-31 (Elamipretide) Pen certificate of analysis, lot PL-2610-196
Certificate PL-26-00309 reports the release tests for SS-31 (Elamipretide) Pen lot PL-2610-196: 99.73% purity by reverse-phase HPLC and identity confirmed by LC-MS, tested October 8, 2026. The lot number printed on each unit matches this certificate.
| Certificate number | PL-26-00309 |
|---|---|
| Lot number | PL-2610-196 |
| Compound | SS-31 (Elamipretide) Pen 10 mg |
| Molecular formula | C32H49N9O5 |
| CAS number | 736992-21-5 |
| Purity (RP-HPLC) | 99.73% |
| Identity (LC-MS) | Conforms (639.75 Da) · expected 639.78 Da, found 639.75 Da |
| Method | RP-HPLC (UV 214 nm) + LC-MS |
| Tested | October 8, 2026 |
| Retest by | October 7, 2028 |
| Tested by | Manufacturer’s in-house laboratory (not an independent third-party test) |
| Conclusion | Conforms |
Tests run on this lot
| Test | Method | Specification | Result |
|---|---|---|---|
| Identity (mass) | LC-MS, ESI positive | Theoretical ± 1.0 Da | 639.75 Da (PASS) |
| Purity | RP-HPLC, UV 214 nm, area% | ≥ 99.0% | 99.73% (PASS) |
| Largest impurity | RP-HPLC, area% | ≤ 1.0% | 0.13% (RT 9.80) (PASS) |
| Assay (label claim) | Assay vs label claim | 9.5–10.5 mg/mL | 9.80 mg/mL (PASS) |
| Bacterial endotoxin | LAL, kinetic | ≤ 5.0 EU/mg | 0.285 EU/mg (PASS) |
| Sterility | USP <71>, 14-day | No growth | No growth (PASS) |
What these results mean
HPLC purity is the share of UV-detectable material that elutes as the target compound; it is not the same as net peptide content, which also accounts for water and counter-ions. Identity means the measured mass matched the mass calculated for the compound. A certificate reports only the tests run on this lot; endotoxin, sterility and contaminant panels are not part of standard lot release. How to read a certificate of analysis.
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