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Dosage guide · 10 mg vial

SS-31 Dosage Protocol

Elamipretide · mitochondria-targeted tetrapeptide

The FDA label for the separate elamipretide medicine Forzinity uses 40 mg once daily for its approved Barth syndrome indication. With 1 mL in each 10 mg Peak vial, each vial is 10 mg/mL and contains 100 units (1 mL), so 40 mg is 400 units (4 mL) across four vials.

How oftenOnce daily
Starting dose40 mg
Start = units400 units
Mix1 mL BAC water

Reviewed 25 Oct 2026 · Education only, not medical advice

Peak Peptides Australia SS-31 10 mg vial

SS-31 10 mg vial

View on Peak

Exact Peak Peptides Australia product photo

01 · DOSAGE CHART

SS-31 dosage chart

FDA label daily dose · 10 mg vial + 1 mL BAC water

BAC water added
Concentration10 mg/mL
1 unit (U-100)100 mcg= 0.01 mL
How oftenOnce dailySubcutaneous injection

1 mL is the mixing example on Peak's SS-31 page and the indexed 10 mg reference protocol, giving 10 mg/mL.

SS-31 dosage chart for a 10 mg vial mixed with 1 mL of bacteriostatic water
WeekDaily doseSyringe units
Week 1 onwardsMaintenance40 mg400 units4 mL · 4 syringe drawsMore than one 10 mg vial

Once daily · same time daily · subcutaneous injection

FDA labels Forzinity at 40 mg once daily for Barth syndrome in patients weighing at least 30 kg.

A 40 mg amount requires four full 10 mg Peak vials; it cannot be measured from one vial.

This chart follows the FDA label for the separate Forzinity elamipretide product; it does not establish a dose for Peak's research vial. Education only, not medical advice. Dose amounts follow FORZINITY prescribing information (US Food and Drug Administration, 2025); units are recalculated for the vial and mix selected above.

02 · HOW TO MIX

Mixing a 10 mg vial with 1 mL of BAC water

Using a 1 mL (100-unit) insulin syringe, one full draw of bacteriostatic water gives 10 mg/mL.

  1. Bacteriostatic water running slowly down the inside wall of a peptide vial1

    Add the water slowly

    Wipe both rubber stoppers with an alcohol swab and let them dry. Draw 1 mL of bacteriostatic water and let it run slowly down the inside of the vial wall — not straight onto the powder.

  2. Hand gently swirling an upright vial in a small circle2

    Swirl gently

    Swirl or roll the vial gently until the powder has dissolved. Give it a few minutes to settle if needed.

  3. A vial being shaken with a red cross through it3

    Don't shake it

    Shaking can damage the peptide and cause foaming. Gentle swirling only.

  4. Close-up of a vial with small undissolved particles and a caution symbol4

    Check it's fully clear

    Only use it once it is fully clear with no particles. Label the vial with the date and 10 mg/mL, then store it in the fridge at 2–8 °C.

Full illustrated reconstitution guide
03 · SUPPLIES NEEDED

What you'll need

Counts follow the dosage chart above at the highest amount in each step, using a 10 mg vial mixed with 1 mL.

Length of protocol
56SS-31 10 mg vials560 mg needed in total
1121 mL insulin syringesU-100, 27–31G · one per draw + one per vial mixed
6BAC water 10 mL bottles56 mL used for mixing
224Alcohol swabsSkin + stopper, every time

Plus an approved sharps container. Syringes and swabs are sold by Australian pharmacies — Peak Peptides and Pure Performance supply the bacteriostatic water.

04 · CALCULATOR

Check a different amount

Enter your vial, water and dose to see the matching syringe units.

Concentration Calculator
mg
1 mL
mg

Concentration

10.00 mg/mL

(10000 mcg/mL)

Calculated Liquid Volume

4.000 mL

Equivalent U-100 volume scale position

400markings (not biological IU)
0102030405060708090100400 marks

Illustration of a U-100 volume scale, not preparation or injection guidance

05 · PROTOCOL DETAILS

About SS-31

Protocol overview

Starting dose
40 mg once daily in the FDA label
How it increases
No step-up schedule in the FDA label
Frequency
Once daily
When to take it
At a consistent time of day
Protocol length
No fixed duration in the FDA label
Common mix
1 mL per 10 mg vial → 10 mg/mL; four vials provide 40 mg

Storage

Before mixing
Peak's product page says to keep the lyophilised vial upright at 2–8 °C and away from light.
After mixing
Peak's preparation guide uses upright refrigeration at 2–8 °C, away from light; it does not state a fixed mixed-vial period.
Never
Do not freeze the mixed vial, and do not use it if it is cloudy, has particles or has not dissolved fully.

How it works

SS-31, also called elamipretide or MTP-131, is a synthetic four-amino-acid peptide studied for its association with cardiolipin-containing inner mitochondrial membranes.

In rat cardiac ischaemia-reperfusion research, elamipretide improved measured respiratory-complex activity and cristae-network structure. These animal and membrane findings do not establish an effect in people using a 10 mg research vial.

Illustrated mechanism explainer

What the research shows

  • A 2018 randomised dose-escalation study enrolled 36 adults with primary mitochondrial myopathy. After 5 days, the highest intravenous dose group improved six-minute walk distance by 64.5 m versus 20.4 m with placebo; the study used 0.01, 0.1 and 0.25 mg/kg/hour infusions for 2 hours, not the labelled 40 mg subcutaneous regimen.
  • In MMPOWER-2, 30 adults received 40 mg subcutaneous elamipretide daily for 4 weeks. The six-minute-walk difference versus placebo was 19.8 m and did not reach statistical significance; injection-site reactions occurred in 80%, mostly mild.
  • In MMPOWER-3, 218 people received 40 mg daily or placebo for 24 weeks. The study did not meet its six-minute-walk or fatigue primary endpoints; the between-group walk difference was −3.2 m (95% CI −18.7 to 12.3).
  • In the United States, FDA granted accelerated approval to the separate prescription product Forzinity for Barth syndrome in people weighing at least 30 kg. Its labelled dose is 40 mg subcutaneously once daily and its indication remains subject to confirmatory evidence.
  • The Peak 10 mg listing is a lyophilised research product, not the 80 mg/mL Forzinity formulation. The checked ARTG search did not identify an elamipretide therapeutic product, so this listing should not be described as TGA-approved.

Reported side effects

  • Injection-site reactions are the main documented adverse effect with prescription elamipretide. In the FDA placebo-controlled Barth syndrome safety population, local reactions occurred in 12 of 12 elamipretide recipients and 8 of 12 placebo recipients.
  • The FDA label lists injection-site erythema, pain, induration, itching, bruising and urticaria. Immediate hypersensitivity reactions have also been reported with Forzinity.
  • The FDA label notes frequent increases in absolute eosinophil counts in studies lasting 30 days or longer; the mean increase was about 0.5 to 0.6 × 10³/µL and was not associated with clinical manifestations in those studies.
  • Human safety findings from study formulations and Forzinity do not establish the safety, identity, sterility or dose of a separately supplied 10 mg research vial.

Important notes

  • Peak describes this 10 mg SS-31 listing as for in-vitro research only. It is not the FDA-approved Forzinity formulation and should not be described as an approved medicine in Australia.
  • FDA-approved Forzinity is a prescription elamipretide hydrochloride solution at 80 mg/mL with a specific Barth syndrome indication; its 40 mg daily label must not be transferred to Peak's different product formulation without medical oversight.
  • WADA's 2026 List does not name SS-31 or elamipretide. WADA says to check with the relevant anti-doping organisation when a substance is not found in the List.
  • Never use a mixed vial that is cloudy or has particles in it.

Injection basics

  • Use a new sterile 1 mL (100-unit) U-100 insulin syringe, 27–31G, every time — never reuse or share.
  • Wipe the vial stopper and the skin with an alcohol swab and let both dry first.
  • Inject under the skin (subcutaneously) of the abdomen, thigh or upper arm, and rotate sites.
  • Put used syringes straight into an approved sharps container — the NDSS lists Australian disposal options.

Guidance: World Health Organization · National Diabetes Services Scheme (NDSS)

06 · QUICK ANSWERS

SS-31 questions

How many units is the labelled 40 mg elamipretide dose?

With the default 1 mL mix in each 10 mg vial, each vial is 10 mg/mL and contains 100 units (1 mL). The 40 mg label amount is 400 units or 4 mL in total, requiring four 10 mg vials.

How many 10 mg SS-31 vials equal 40 mg?

Four 10 mg vials equal 40 mg. With 1 mL added to each vial, that total is 4 mL or 400 U-100 units across the four vials.

How much bacteriostatic water is used for SS-31 10 mg?

The default is 1 mL per 10 mg vial, matching Peak's preparation example and the indexed reference protocol. It makes 10 mg/mL, so 1 mg equals 10 units or 0.1 mL on a U-100 syringe.

How long does a 10 mg SS-31 vial last?

A 10 mg vial contains one quarter of the 40 mg FDA-labelled amount. At 40 mg once daily, four 10 mg vials are required per day; 2 weeks requires 56 vials.

07 · SOURCES

References

Related dosage guides

All dosages