Elamipretide is now an FDA-approved active ingredient—but that does not make every vial labeled “SS-31” an FDA-approved drug.
For laboratories sourcing SS-31 / Elamipretide, this distinction has become increasingly important.
The molecule name may be familiar.
The product standard may be completely different.
What Is SS-31?
SS-31, also known as Elamipretide, MTP-131, Bendavia and Szeto-Schiller Peptide 31, is a synthetic mitochondria-targeting tetrapeptide.
Common identifiers include:
CAS: 736992-21-5
Molecular Formula: C32H49N9O5
Molecular Weight: approximately 611.78 g/mol
SS-31 has been extensively investigated in research involving cardiolipin, mitochondrial membranes, cellular bioenergetics and mitochondrial dysfunction.
But its regulatory story has now created an important sourcing question.
Is SS-31 FDA Approved?
The answer requires precision.
In September 2025, the FDA granted accelerated approval to Forzinity (elamipretide) injection for a specific Barth syndrome indication in eligible patients.
That approval applies to the regulated Forzinity finished pharmaceutical product, including its defined manufacturing process, formulation, quality controls and approved indication.
It does not mean that every research vial marketed as:
SS-31
Elamipretide
MTP-131
or
Bendavia
is FDA approved.
For a B2B research buyer, the distinction is:
Same active-molecule name ≠ same finished product.
Research-Grade SS-31 Is Not Forzinity
A research-grade SS-31 raw material should be evaluated according to its own analytical documentation.
It should not borrow the regulatory status of an approved finished medicine simply because both reference elamipretide.
Professional buyers should therefore separate:
Molecular identity → Research material specification → Finished-drug formulation → Regulatory approval
These are four different questions.
Why HPLC Purity Is Only the Starting Point
A specification such as ≥99% HPLC provides useful information about chromatographic purity.
But it does not independently prove:
- complete molecular identity;
- expected molecular mass;
- peptide sequence;
- impurity profile;
- formulation equivalence to a regulated drug;
- pharmaceutical sterility;
- approved-drug manufacturing equivalence;
- clinical interchangeability.
For research sourcing, a high purity number should therefore be supported by appropriate identity and batch documentation.
What Should B2B Buyers Verify?
When comparing an SS-31 supplier or Elamipretide supplier, professional buyers may consider several quality questions.
Identity
Does the analytical documentation support the expected SS-31 / elamipretide molecular identity?
HPLC
Does the chromatographic result correspond to the actual production batch?
MS or LC-MS
Where appropriate, does mass analysis support the expected molecular species?
Impurity Profile
Are relevant peptide-related substances appropriately controlled or documented?
Batch Traceability
Do the vial, lot number, COA and analytical records correspond to the same production lot?
Product Classification
Is the material clearly identified as research-grade material rather than presented as an approved pharmaceutical product?
What Do SS-31 Reviews Say?
Online experiences are highly mixed.
Positive anecdotal discussions sometimes describe perceived improvements in:
- energy;
- cognitive endurance;
- stamina;
- recovery;
- mental clarity.
Negative discussions include reports of:
- no noticeable effect;
- fatigue;
- nausea;
- gastrointestinal discomfort;
- brain fog;
- lethargy;
- skin reactions;
- irritability.
These reports cannot establish the safety, efficacy or quality of a specific SS-31 research batch.
Product identity, source, purity, formulation, concurrent substances and individual health conditions are frequently unknown.
SS-31 Research Peptide from Sunone
Sunone (Hong Kong) Biopharmaceutical International Technology Co., Limited supplies SS-31 / Elamipretide for qualified laboratory research and biotechnology manufacturing applications.
Current listed specifications include:
Product: SS-31
Synonyms: Elamipretide / MTP-131 / Bendavia / Szeto-Schiller Peptide 31
CAS: 736992-21-5
Molecular Formula: C32H49N9O5
Molecular Weight: 611.78 g/mol
Purity Specification: ≥99% HPLC
Form: Lyophilized Powder
Storage: 2–8°C, protected from light
Documentation: COA, SDS and Specification Sheet available
Current listed B2B formats include:
5 mg × 10 vials
10 mg × 10 vials
50 mg × 10 vials
subject to current manufacturing requirements and availability.
Looking for an SS-31 supplier with batch-specific analytical documentation?
View Sunone SS-31 / Elamipretide Specifications ：
Contact Sunone with your required quantity, purity specification, packaging format, analytical-documentation requirements and OEM/ODM project needs for a current B2B quotation.
FAQ
Is SS-31 the same molecule as elamipretide?
SS-31 is a research name widely associated with elamipretide. MTP-131 and Bendavia are also names encountered in its research and development history.
Is every SS-31 product FDA approved?
No. FDA approval applies to a specific regulated finished drug product and approved indication, not automatically to every research material carrying the same molecule name.
What is Forzinity?
Forzinity is the trade name of an FDA-approved elamipretide injection for a specific Barth syndrome indication.
Does ≥99% HPLC mean research SS-31 is equivalent to Forzinity?
No. HPLC purity does not establish equivalence to an approved finished pharmaceutical product.
What is the CAS number of SS-31?
SS-31 / elamipretide research material is commonly associated with CAS 736992-21-5.
What should buyers request from an SS-31 supplier?
Depending on the intended research application, buyers may consider requesting a batch-specific COA, HPLC chromatogram, suitable MS/LC-MS identity data, impurity information, SDS and complete lot traceability.
This content is provided for scientific and educational purposes only. SUNONE research peptide is for qualified labrtorynt, diagnois, druc tor mmatct or veteimant, use.research only, Not for human consumption, clinical treame. Purchasers are responsible for complying with applicable laws and regulations in their jurisdiction.
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