Batch Verification Report
Batch verification and analytical summary for Elamipretide (SS-31 / MTP-131 — synthetic cardiolipin-targeting tetrapeptide reference material).
Filler-free lyophilised peptide powder · No mannitol or bulking agents
Manufacture date: 21 Jan 2026
Recommended retest date: 20 Jan 2028
Amount: As specified on Aventris product label
Analytical Results
The following analytical data was obtained from manufacturer testing of the source batch. Aventris has independently verified this data against our quality specifications. This Batch Verification Report summarises our review findings for Elamipretide (SS-31).
| Test | Method | Specification | Result |
|---|---|---|---|
| Purity (HPLC) | HPLC | ≥99.0% | 99.74% |
| Peptide Content (N%) | Nitrogen analysis (N%) | ≥65.0% | 73.43% |
| Molecular Weight (ESI-MS) | ESI-MS | 639.8 ±1.0 Da | Conforms |
| Water Content (Karl Fischer) | Karl Fischer | ≤10.0% | 2.38% |
| Acetate Content (HPLC) | HPLC (ion chromatography) | <26.0% | 20.43% |
| Assay (HPLC) | HPLC | 95.0–105.0% | 96.24% |
| Bacterial Endotoxins | Pharmacopoeial method | <10 EU/mg | Conforms |
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
- Use in well-ventilated area or fume hood
- Avoid inhalation, ingestion, or skin/eye contact
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.
Peptide Sequence:
D-Arg – dimethyl-Tyr – Lys – Phe-NH₂
Tetrapeptide with D-Arg at N-terminus and C-terminal amide; dimethylated tyrosine at position 2
Molecular Identity:
- C32H49N9O5 — MW 639.8 Da — CAS 736992-21-5
Additional Documentation:
For questions about this batch or to request additional information, contact
[email protected]