On this page
- Quick reference
- Dosage chart and four steps
- Supplies needed
- Peptide Reconstitution Simulator
- Vial and research context
- SS-31 50 mg Vial Protocol Overview
- How to Read the SS-31 50 mg Dosage Chart
- What the 50 mg Vial Changes
- Elamipretide Dose and Schedule Evidence
- Barth Syndrome and FDA Approval Context
- How SS-31 Interacts With Mitochondria
- SS-31 Research Findings and Limitations
- Safety, Tolerability, and Monitoring Context
- Subcutaneous Measurement Context
- Reconstitution, Storage, and Handling
- Frequently Asked Questions About SS-31 50 mg
- Important Research Note
- References
- Related research, protocols, and guides
SS-31 Quick Reference (50 mg Vial)
- Vial contents
- 50 mg SS-31
- Final volume
- 3 mL
- Concentration
- 16.67 mg/mL
- One U-100 unit
- 166.67 mcg in 0.01 mL
Research context: For evidence on mechanisms, human and preclinical research, limitations, and safety, read SS-31 Peptide: Benefits, Uses, Side Effects, Dosage, and Research.
SS-31 Dosage Chart
Dosing & Reconstitution Guide
Educational guide for reconstitution and daily dosing
Standard / Gradual Approach (3.0 mL = ~16.67 mg/mL)
| Week | Daily Dose (mg) | Units (per injection) (mL) |
|---|---|---|
| Weeks 1–2 | 5 mg (5000 mcg) | 30 units (0.30 mL) |
| Weeks 3–8 | 10 mg (10,000 mcg) | 60 units (0.60 mL) |
Frequency: Inject once daily subcutaneously at a consistent time. This 50 mg vial reconstituted with 3.0 mL provides a higher concentration, keeping all standard doses within moderate syringe volumes for convenience and accuracy.
Reconstitution Steps
- Draw 3.0 mL bacteriostatic water with a sterile syringe.
- Inject slowly down the vial wall; avoid vigorous shaking to prevent foaming.
- Gently swirl/roll until fully dissolved (clear solution).
- Label with reconstitution date and refrigerate at 2–8 °C (35.6–46.4 °F), protected from light; follow product-specific use-by and sterile-handling requirements.
Advanced / Aggressive Approach (3.0 mL = ~16.67 mg/mL)
| Week | Daily Dose (mg) | Units (per injection) (mL) |
|---|---|---|
| Weeks 1–2 | 5 mg (5000 mcg) | 30 units (0.30 mL) |
| Weeks 3–4 | 10 mg (10,000 mcg) | 60 units (0.60 mL) |
| Weeks 5–8 | 15 mg (15,000 mcg) | 90 units (0.90 mL) |
| Optional Weeks 9–12 | 20 mg (20,000 mcg) | Split: 2 × 60 units (0.60 mL each) |
Note: Advanced dosing (15–20 mg/day) is based on short‑term clinical trial protocols[4][5] for severe mitochondrial conditions and should only be pursued under medical supervision. At this concentration, doses up to 15 mg fit in a single syringe (90 units); 20 mg doses should be split into two separate subcutaneous injections at different sites. Clinical trials have not extensively evaluated SS‑31 beyond 12 weeks; extended use requires careful monitoring.
Supplies Needed
Plan based on an 8–12 week daily protocol with gradual titration using 50 mg vials.
- Peptide Vials (SS‑31, 50 mg each):
- 8 weeks (Standard: 5–10 mg/day): approximately 10 vials required
- 12 weeks (Standard maintenance at 10 mg/day): approximately 16 vials required
- 12 weeks (Advanced: escalating to 15 mg/day): approximately 21 vials required
- Insulin Syringes (U‑100, 1 mL capacity):
- Per week (standard dosing): 7 syringes (1/day)
- 8 weeks: 56 syringes
- 12 weeks: 84 syringes
- Advanced protocols with split injections may require 2 syringes per day for 20 mg doses
- Bacteriostatic Water (30 mL bottles): Use 3.0 mL per vial for reconstitution.
- 8 weeks (10 vials): 30 mL - 1 bottle required (30 mL each)
- 12 weeks (16 vials): 48 mL - 2 bottles required (30 mL each)
- 12 weeks (21 vials, advanced): 63 mL - 3 bottles required (30 mL each)
- Alcohol Swabs: One for the vial stopper + one for the injection site each day.
- Per week: 14 swabs (2/day)
- 8 weeks: 112 swabs - 2 boxes required (100 swabs each)
- 12 weeks: 168 swabs - 2 boxes required (100 swabs each)
Peptide Reconstitution Simulator
Practice preparing this vial with the verified strength and final volume from this protocol.
SS-31 Vial and Research Context
- Reconstitute: Add 3.0 mL bacteriostatic water → ~16.67 mg/mL concentration for convenient dosing.
- Typical daily range: 5–10 mg once daily (gradual titration); advanced protocols may reach 15–20 mg/day under supervision.
- Easy measuring: At 16.67 mg/mL, 1 unit = 0.01 mL ≈ 167 mcg on a U‑100 insulin syringe.
- Storage: Lyophilized: freeze at −20 °C (−4 °F); after reconstitution, refrigerate at 2–8 °C (35.6–46.4 °F); follow product-specific use-by and sterile-handling requirements.
SS-31, also called elamipretide, MTP-131, or Bendavia, is a mitochondria-targeted tetrapeptide studied for its interaction with cardiolipin in the inner mitochondrial membrane[1][2]. The 50 mg vial changes concentration, syringe volume, and vial yield; it does not establish a clinical dose. FDA approval applies to the finished Forzinity product for a defined Barth syndrome population and does not make a third-party research vial interchangeable with that prescription product[3].
SS-31 50 mg Vial Protocol Overview
The 50 mg vial changes the concentration, vial yield, and U-100 syringe conversion. It does not establish a clinical dose. The dosage tables above retain this page’s existing educational schedule; the evidence sections below explain how those calculations differ from published elamipretide study protocols.
- Compound names: SS-31, elamipretide, MTP-131, and Bendavia refer to the mitochondria-targeted tetrapeptide discussed in the scientific literature.[1]
- 50 mg vial calculation: A 3.0 mL final volume produces approximately 16.67 mg/mL. One U-100 unit is 0.01 mL, or approximately 166.7 mcg at this concentration.
- Research status: Human studies used protocol-specific formulations, routes, populations, and doses. They did not validate a universal SS-31 50 mg dosage protocol.[4][5]
- Approved-product distinction: FDA approval applies to the finished Forzinity product for a defined Barth syndrome population. It does not make a third-party lyophilized 50 mg vial interchangeable with that prescription product.[3]
How to Read the SS-31 50 mg Dosage Chart
An SS-31 dosage chart combines peptide mass with liquid volume. The vial contains 50 mg before reconstitution. Adding 3.0 mL produces a concentration of approximately 16.67 mg/mL, so each 0.01 mL marking on a U-100 syringe contains about 0.1667 mg, or 166.7 mcg.
The arithmetic relationship is:
Desired mass ÷ 16.67 mg/mL = liquid volume; liquid volume à - 100 = U-100 units.
- 5 mg occupies approximately 0.30 mL, which is 30 U-100 units.
- 10 mg occupies approximately 0.60 mL, which is 60 U-100 units.
- 15 mg occupies approximately 0.90 mL, which is 90 U-100 units.
- 20 mg occupies approximately 1.20 mL, so the existing chart separates that volume into two 0.60 mL measurements.
These are concentration conversions, not dose recommendations. A peptide dosage calculator can check the same vial-strength math, but it cannot select a dose, establish safety, or replace a study protocol.
What the 50 mg Vial Changes
A larger vial changes how many measured amounts can be drawn from one container. At the page’s 3.0 mL final volume, the vial theoretically contains ten 5 mg amounts or five 10 mg amounts before accounting for unavoidable handling loss. The 50 mg vial does not change the pharmacology of elamipretide or prove that any amount is appropriate for a person.
Strength variants also should not be compared by syringe units alone. The 10 mg sibling page uses a different final volume and concentration, while this page uses 3.0 mL and approximately 16.67 mg/mL. The same number of U-100 units can therefore represent a different mass on another SS-31 vial page.
The linked Pure Lab Peptides record documents the approved supplier destination and the 50 mg vial identity used for this calculation page.[15] Supplier information is product provenance, not scientific evidence for a research schedule.
Elamipretide Dose and Schedule Evidence
Published human research does not support one universal SS-31 peptide dosage. Investigators selected different routes, durations, populations, and endpoints for different questions.
- Heart failure: PROGRESS-HF compared 4 mg and 40 mg subcutaneous elamipretide once daily for 28 days. The study did not show a significant improvement in its primary cardiac-structure outcomes.[4]
- Primary mitochondrial myopathy: MMPOWER-2 evaluated 40 mg subcutaneously once daily for four weeks. Its primary six-minute-walk comparison was not statistically significant, although selected patient-reported outcomes favored elamipretide.[5]
- Longer myopathy research: MMPOWER-3 used 40 mg once daily for 24 weeks and did not meet its primary efficacy endpoints.[16]
- Barth syndrome: TAZPOWER used 40 mg once daily. The randomized crossover phase did not meet its primary endpoints, while longer open-label follow-up reported improvements that must be interpreted with the study design in view.[6][17]
- Other routes and tissues: An acute heart-failure study used intravenous infusion rather than a daily subcutaneous vial protocol, while ReCLAIM and ReCLAIM-2 examined retinal disease under study-specific procedures.[18][19][20]
These trial designs provide clinical context, but none converts directly into the educational 50 mg vial schedule shown above.
Barth Syndrome and FDA Approval Context
Barth syndrome is an inherited disorder involving abnormal cardiolipin remodeling and mitochondrial dysfunction.[10] The TAZPOWER program studied elamipretide in this specific disease population, and subsequent evidence contributed to FDA accelerated approval.[3][6]
That regulatory decision is condition- and product-specific. It should not be generalized into an SS-31 dosage for healthy people, exercise recovery, longevity, heart failure, primary mitochondrial myopathy, or other unapproved uses. It also does not establish the concentration, sterility, excipients, or stability of a lyophilized research vial.
How SS-31 Interacts With Mitochondria
SS-31 is a synthetic, mitochondria-targeting peptide designed to concentrate near the inner mitochondrial membrane. SS-31 binds cardiolipin, a phospholipid that helps organize mitochondrial cristae and the electron transport chain involved in cellular energy production.[1][2]
Experimental studies describe a peptide that stabilizes cardiolipin-protein interactions and can influence ATP production, mitochondrial bioenergetics, mitochondrial reactive oxygen species, and proposed antioxidant effects under cellular stress.[7][8][21][22] This proposed mechanism of action explains why elamipretide has been investigated across several diseases, but it does not demonstrate a clinical benefit for every population. A broader evidence review distinguishes preclinical findings from human trial outcomes.[9]
SS-31 Research Findings and Limitations
The human evidence is mixed. Several studies reported an acceptable short-term safety profile, yet randomized trials in patients with heart failure and adults with primary mitochondrial myopathy did not meet important primary efficacy endpoints.[4][5][16]
- Population limits: Results from Barth syndrome, heart failure, mitochondrial myopathy, or retinal-disease research cannot automatically be transferred to another condition or to healthy people.
- Formulation limits: Manufactured trial material and an FDA-approved finished drug are not interchangeable with an unlabeled research vial.
- Endpoint limits: Biological activity, mitochondrial signaling, or an open-label change does not substitute for a successful randomized primary endpoint.
- Duration limits: Short trials do not establish long-term safety or effectiveness outside their studied populations.
Accordingly, this 50 mg vial page separates calculation facts from claims about efficacy. Protective effects of SS-31 in cells or animals can guide hypotheses about mitochondrial health, but they do not prove benefits in people.
Safety, Tolerability, and Monitoring Context
Injection-site redness, discomfort, itching, or other local reactions appeared frequently in subcutaneous elamipretide research.[5][6] Reported tolerability in a controlled study does not establish safety for a different product, concentration, population, duration, or unsupervised use.
Clinical research uses eligibility criteria, adverse-event collection, laboratory monitoring, and predefined stopping rules. Those safeguards cannot be reproduced by a vial calculation alone. A person with symptoms, a diagnosed mitochondrial disorder, or questions about an approved prescription product should consult a qualified healthcare professional and the exact product labeling rather than this educational chart.
Subcutaneous Measurement Context
When a research protocol uses a subcutaneous route, U-100 syringe markings express liquid volume. They are not peptide international units. General medical references describe aseptic preparation, site selection, needle angle, and site rotation principles.[11][12][13][14]
- Use a new sterile syringe for each preparation and administration.
- Clean the vial stopper and selected site using appropriate aseptic procedure.
- Rotate sites when repeated subcutaneous administration is part of a supervised protocol.
- Place used needles and syringes directly into an appropriate sharps container.
These general technique principles do not validate the dosage schedule or convert research material into an approved medicine.
Reconstitution, Storage, and Handling
The four checks in the dosage section give this page’s calculation and handling framework. Product-specific stability still comes from the exact vial label, lot documentation, or validated laboratory procedure.
- Before mixing: The calculation above uses 3.0 mL of bacteriostatic water. Follow the supplier’s written temperature, light-protection, and use-by instructions for the specific product and lot.[15]
- After mixing: Record the compound, 16.67 mg/mL concentration, preparation date, and final volume.
- Contamination control: Minimize repeated handling, protect the stopper, and discard a vial if the documented use period has elapsed or its appearance changes.
- Do not transfer labeling: The storage directions for the finished Forzinity product do not establish stability for a third-party lyophilized vial.[3]
Frequently Asked Questions About SS-31 50 mg
What does an SS-31 50 mg vial mean?
It means the vial contains 50 mg of peptide before reconstitution. On this page, a 3.0 mL final volume produces approximately 16.67 mg/mL.
How many U-100 units equal 1 mg at 16.67 mg/mL?
One milligram occupies approximately 0.06 mL. On a U-100 syringe, 0.06 mL is about 6 units. This is a concentration conversion, not a dose recommendation.
Is SS-31 the same as elamipretide?
SS-31 is the research name commonly used for elamipretide, which also appears as MTP-131 and Bendavia in scientific literature.[1]
Is a 50 mg research vial the same as Forzinity?
No. Although elamipretide is the active ingredient in Forzinity, the approved finished drug has product-specific manufacturing, labeling, concentration, indication, and handling requirements.[3]
Does a larger vial support a larger SS-31 dose?
No. Vial strength affects concentration and yield. Dose selection belongs to the applicable study record or approved product label and cannot be inferred from the amount in the vial. This page does not provide dosage recommendations or individualized dosing guidance.
Why does this page differ from the 10 mg and 30 mg pages?
Each strength has its own reconstitution volume, concentration, syringe conversion, vial yield, and supply calculation. The compound’s evidence base is shared, but the arithmetic is strength-specific.
Important Research Note
This page is an educational research reference. It does not provide medical advice, diagnosis, treatment, or a personalized dose. The displayed 50 mg schedule and syringe measurements are retained as the site’s established calculation framework; published studies cited here used their own formulations and protocol-defined schedules. FDA approval applies only to the labeled Forzinity product and population.[3]
References
- 1International Journal of Molecular Sciences (2025) — Elamipretide structure, mechanism, and therapeutic research review.
- 2British Journal of Pharmacology — Cardiolipin binding and mitochondrial membrane mechanism of SS-31.
- 3U.S. Food and Drug Administration — Accelerated approval announcement for elamipretide in Barth syndrome.
- 4Journal of the American College of Cardiology — PROGRESS-HF trial of elamipretide in heart failure.
- 5Neurology — MMPOWER-2 trial in primary mitochondrial myopathy.
- 6Genetics in Medicine — TAZPOWER phase 2/3 trial of elamipretide in Barth syndrome.
- 7Biochimica et Biophysica Acta — Cardiolipin remodeling, cristae structure, and mitochondrial function.
- 8Journal of Cardiovascular Pharmacology — SS-31, oxidative stress, and mitochondrial bioenergetics.
- 9Alzheimer’s Drug Discovery Foundation — SS-31 preclinical and clinical evidence overview.
- 10Orphanet Journal of Rare Diseases — Barth syndrome clinical presentation and emerging therapies.
- 11Centers for Disease Control and Prevention — General subcutaneous administration guidance.
- 12Johns Hopkins Arthritis Center — Subcutaneous injection procedure guide.
- 13NCBI Bookshelf — Best practices for injection preparation and administration.
- 14Pharmacologic Considerations of Subcutaneous Drug Administration — Site rotation and absorption considerations.
- 15Pure Lab Peptides — SS-31 50 mg research-vial supplier page.
- 16Neurology (2023) — MMPOWER-3 phase 3 trial in primary mitochondrial myopathy.
- 17Journal of the American College of Cardiology (2024) — Long-term open-label elamipretide outcomes in Barth syndrome.
- 18Circulation: Heart Failure (2017) — Intravenous elamipretide study in heart failure.
- 19Ophthalmology Science (2022) — ReCLAIM phase 1 study in dry age-related macular degeneration.
- 20Ophthalmology Science (2024) — ReCLAIM-2 study of elamipretide in geographic atrophy.
- 21FASEB Journal (2020) — Experimental study of elamipretide and mitochondrial bioenergetics.
- 22Scientific Reports (2020) — Mitochondrial protein interactions associated with elamipretide.
Related research, protocols, and guides
Explore the available research context, protocol variants or comparisons, and practical guides. When vial-strength variants exist, they remain separate because vial strength, concentration, and syringe-unit calculations can differ. Related compounds and blends are comparisons only, not interchangeable.
Research overview
Other vial-strength protocols
Related protocols and comparisons