Elamipretide

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Elamipretide Raw Material

Product Name: Elamipretide Raw Material

Synonym: SS-31, MTP-131, Bendavia

CAS No.: 736992-21-5

Document Version: V1.0

Application: For Laboratory Research Only

Date: 2026

1. Basic Chemical Information

Item	Specification
Full Name	Elamipretide (SS-31, MTP-131, Bendavia)
Chemical Name	D-arginyl-2,6-dimethyl-L-tyrosyl-L-lysyl-L-phenylalaninamide
Molecular Formula	C32H49N9O5
Molecular Weight	639.80 Da (free base)
1-Letter Sequence	D-Arg-Dmt-Lys-Phe-NH₂ (Dmt = 2′,6′-dimethyltyrosine)
3-Letter Sequence	H-D-Arg-Dmt-Lys-Phe-NH₂
Peptide Structure	Linear tetrapeptide, contains D-amino acid & unnatural amino acid, C-terminal amidated
Biological Function	Mitochondria-targeted Szeto-Schiller peptide; binds cardiolipin on inner mitochondrial membrane, stabilizes mitochondrial cristae, reduces ROS, alleviates oxidative stress, protects mitochondrial function, anti-apoptosis

2. Physical Characteristics

Appearance: White to off-white lyophilized powder
Odor: Odorless
Solubility: Freely soluble in sterile purified water / neutral PBS (pH 6.5–8.0); soluble in DMSO; insoluble in non-polar organic solvents
pH (1 mg/mL aqueous solution): 6.0 – 8.0
Hygroscopicity: Moderately hygroscopic; avoid long exposure to air and high humidity

3. Quality Specification

Test Item	Test Method	Specification
Identity	RP-HPLC, ESI-MS	Consistent with reference standard; Measured MW ±2 Da
Chromatographic Purity (RP-HPLC, Area %)	RP-HPLC	≥98.0% (Typical ≥99.0%)
Largest Single Unknown Impurity	RP-HPLC	≤0.50%
Total Related Impurities	RP-HPLC	≤2.0%
Peptide Assay Content	HPLC Quantitation / Potentiometric Titration	98.0% ~ 102.0%
Water Content	Karl Fischer Titration	≤1.0%
Residual TFA / Acetate	Ion Chromatography	≤0.5%
Endotoxin (LAL, USP <85>)	Turbidimetric LAL Method	≤100 EU/mg
Heavy Metals (Pb, As, Cd, Hg)	ICP-MS	Each ≤10 ppm
Residual Organic Solvents	GC	Comply with ICH Q3C requirements
Amino Acid Composition Analysis	Amino Acid Analyzer	Within ±10% theoretical stoichiometry

4. Storage & Stability

Lyophilized Solid Powder

Long-term storage: ≤ -80 ℃, sealed, dry, protected from light — Shelf life: 24 months
Medium-term storage: -20 ℃, sealed & desiccated — Shelf life: 12 months
Important: Avoid repeated freeze-thaw cycles

Reconstituted Aqueous Stock Solution

-80 ℃: Stable up to 6 months
-20 ℃: Stable up to 1 month
Do not store aqueous solution at 4 ℃ or room temperature for extended periods

5. Stock Solution Preparation Guidance

Molecular Weight = 639.80

1 mM solution: 0.640 mg Elamipretide per 1 mL solvent
Recommended solvent: Sterile purified water or pH7.0–7.4 PBS buffer
Suggestion: Prepare fresh working solution for in vivo experiments.

6. Safety & Handling Notes

This synthetic peptide may irritate skin, eyes and respiratory tract.
Required PPE: Lab coat, nitrile gloves, safety goggles.
Prevent inhalation of powder dust and direct skin contact.
Waste shall be disposed as chemical waste following local regulations.
Disclaimer: THIS MATERIAL IS FOR LABORATORY RESEARCH ONLY. Not approved for human administration, clinical use or veterinary medication.

7. RP-HPLC Analytical Conditions

Column: C18 analytical column (250×4.6 mm, 5 μm)
Mobile Phase A: 0.1% TFA in Water
Mobile Phase B: 0.1% TFA in Acetonitrile
Detection wavelength: 220 nm / 280 nm
Flow rate: 1.0 mL/min
Column temperature: 30 ℃

**End of Document**

📄 JTX-EL20260702COA.pdf 📄 ElamipretideSS-31-HPLC3458-0626-02-02.pdf 📄 ElamipretideSS-31-MS3458-0626-02-02.pdf

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