Melanotan I

Afamelanotide reference peptide · approval applies to the SCENESSE controlled-release implant, not this RUO lot

Lot-specific · Batch COACAS 75921-69-6RUO
Batch COA
MOQ1 kit (10 vials) per SKU
Supplied formLinear N-acetylated, C-amidated 13-residue α-MSH analogue
Lead timeConfirmed with quote
Melanotan I — Lot-specific lyophilized solid; confirm colour and physical form on the released-batch COA
Melanotan I — Lot-specific lyophilized solid; confirm colour and physical form on the released-batch COA · Representative packaging image · verify the ordered lot
Representative packaging image · verify the ordered lot

Decision summary

Key benefits

  • Research relevance includes MC1R pharmacology, eumelanin signaling, modified-peptide identity, formulation comparisons and analytical reference work
  • The approved SCENESSE evidence is product- and indication-specific; tanning, injection-speed and consumer photoprotection claims are not benefits of this RUO lot.
Published research context is presented for literature orientation only. It is not a dosing, treatment or human-use instruction.

Qualification data

Specifications to confirm against the released lot

CAS
75921-69-6
Formula
C78H111N21O19 (anhydrous free-base convention; acetate stoichiometry is product-specific)
Molecular weight
1646.8 g/mol
Appearance
Lot-specific lyophilized solid; confirm colour and physical form on the released-batch COA
Purity
Lot-specific released result; request chromatographic purity, quantitative peptide content, counterion/water and orthogonal identity · target, verify batch COA
Storage
Store and ship according to the released-lot COA and validated stability data for the exact free peptide or salt, solvent, concentration, container and intended assay. Generic 2–8°C, room-temperature shipping and post-reconstitution claims are not interchangeable. A 2026 forced-degradation study reported afamelanotide degradation under acidic, basic, neutral, oxidative, ultraviolet-light and 60°C stress; these challenge conditions identify risks but do not establish a shelf life or shipping allowance. Control light, oxidation and freeze–thaw exposure only through documented, form-specific procedures, and record excursions.
MOQ
1 kit (10 vials) per SKU
Lead time
Confirmed with quote
PubChem CID 16197727

Qualification matrix

Identity, purity and content are separate release questions.

Identity

Confirm the stated molecule and supplied form. Start with the matching batch COA; request sequence-level evidence only when the buyer's written procedure requires it and availability or a separate scope has been agreed.

Purity

Review RP-HPLC method conditions, wavelength, integration and related-peak handling. A percentage without the method is not enough.

Content

Net peptide content is not the same as gross lyophilized powder weight. Ask which assay supports the stated amount and whether water/counter-ion is addressed.

Stability

Follow the storage condition stated on the batch COA or label from receipt onward.

Research context

What researchers study about Melanotan I

Melanotan I is a historical name for afamelanotide, a synthetic linear 13-residue [Nle4,D-Phe7]-α-MSH analogue. FDA and EU authorisations apply to SCENESSE, a named 16 mg controlled-release implant for a defined indication in adults with erythropoietic protoporphyria. Those authorisations do not apply to this RUO free-peptide lot, tanning products or other formulations. Afamelanotide is structurally distinct from cyclic Melanotan II, and their evidence and regulatory status must not be combined.

  • Afamelanotide has high-quality evidence and regulatory approval only as the SCENESSE controlled-release implant for increasing pain-free light exposure in adults with EPP
  • Historical tanning studies and a randomized vitiligo study provide formulation- and protocol-specific evidence; they do not approve cosmetic tanning, free-peptide injection or general skin anti-aging use
  • Melanotan II is a distinct cyclic molecule and its effects or risks must not be transferred to Melanotan I.

Mechanism context

The question the literature is testing

Afamelanotide is a structural analogue of α-MSH and, according to the current SCENESSE label, is a melanocortin-receptor agonist that binds predominantly to MC1R. MC1R activation increases eumelanin production. Receptor pharmacology does not establish equivalence between a free-peptide lot and the controlled-release implant; exposure depends on formulation, release kinetics and the validated assay or study design.

Evidence map

Research routes and exposure context

Evidence tierApproved finished-product context
Routes reported in sources
SubcutaneousIntranasal
Dose / exposure contextProtocol-specific; verify the cited primary source
Routes and exposure contexts summarize cited studies or approved finished-product labels. They are not instructions for administering this RUO material; no customer dose is provided.

Evidence boundaries

Compatibility, limitations and decision context

  • Safety evidence for the approved SCENESSE implant cannot be transferred wholesale to unapproved free-peptide products
  • The current label reports implant-site and systemic adverse reactions and requires trained implantation and clinical precautions; it also recommends skin monitoring because pigmentation and nevi can change
  • Gray-market injectable or intranasal products add uncertain identity, peptide impurities, sterility, endotoxin and dosing risks
  • Enhanced pigmentation does not replace sun protection
  • This RUO material is not for human use, and clinical symptoms must never be used as batch testing.

Interactions reported in the literature

  • The vitiligo trial studied afamelanotide with narrowband UV-B under a clinical protocol
  • This does not support consumer UV synergy, tanning schedules or deliberate UV exposure after injection
  • Retinoid, photosensitizer and Melanotan II combination claims lack product-specific controlled evidence
  • Approved implant use must follow its label, while this raw material has no human interaction guidance.
Literature context is not a supplier release result or human-use instruction. Follow your institution's approved laboratory risk assessment.

Batch documentation

Melanotan I batch COAs

Laboratory: Manufacturer's QC laboratoryTests: HPLC purity · MS identity · endotoxin · fill amount

  • Blurred preview of a Melanotan I 10 mg batch COA10 mg

Previews are blurred on purpose so the documents cannot be reused; third-party reports show their first page only. Sales sends the clear full version for the product and strength you ask about.

Independent test fails? Full refund.

Representative records, refreshed periodically

Published COAs show recent representative batches and may not be the newest. For a quote or shipment, sales confirms the lot and sends its COA.

Third-party reports, added progressively

Previews of the first page of third-party reports are on our Quality page and on the matching product pages; sales sends the full report on request. You can also send any vial from your order to an independent laboratory of your choice. Unless agreed otherwise in writing, the buyer pays for optional testing.

Help reviewing your COA

Need help reading a batch COA or third-party report? Sales can explain the test items, specifications and how the results relate to the lot under discussion.

On every batch COA: HPLC purity · MS identity · endotoxin · fill amount · Verify LyoPep

Ask for the current packet, not a generic certificate

  • A clear solution, white powder or visible pigmentation response cannot establish identity, assay, sterility or suitability
  • Require complete sequence and terminal modifications, free-peptide or salt declaration, high-resolution intact mass and sequence-confirming MS/MS, chromatographic purity with raw data and impurity profile, quantitative peptide content, counterion and water, residual solvents and lot-specific stability
  • Product-specific forced-degradation evidence supports monitoring truncation, oxidation, methylation and deacetylation pathways, but a supplier must still provide its own validated stability-indicating method and released-lot evidence
  • Sterility, endotoxin, particulates and container closure require separate validated tests when claimed
  • Approval of SCENESSE does not validate a supplier's lyophilized vial.
Batch COA for the released lotHPLC purity with method contextMS identity resultEndotoxin resultFill amount (measured content per vial)SDS and handling statement

Available fills

Quote the fill and pack configuration you need

Reference SKUFillBase pack
MT11010 mg10 vials

Other format

Also available as a nasal spray (US stock)

Black 10 mL nasal spray bottle with a clear cap
10 mL nasal spray bottle

Besides lyophilized vials, Melanotan I is also supplied as a nasal spray solution, shipped from our US stock.

Strengths
10 mg
Bottle sizes
10 mL or 20 mL
Minimum order
10 bottles per strength and bottle size
Ships from
Our US stock

Handling

Plan storage before the parcel arrives

Store and ship according to the released-lot COA and validated stability data for the exact free peptide or salt, solvent, concentration, container and intended assay. Generic 2–8°C, room-temperature shipping and post-reconstitution claims are not interchangeable. A 2026 forced-degradation study reported afamelanotide degradation under acidic, basic, neutral, oxidative, ultraviolet-light and 60°C stress; these challenge conditions identify risks but do not establish a shelf life or shipping allowance. Control light, oxidation and freeze–thaw exposure only through documented, form-specific procedures, and record excursions.

State the destination and timing so receipt can be planned, then move the material into its stated storage condition on arrival.

Buyer FAQ

Terms to settle before the purchase order

Can a buyer arrange third-party testing?+

Yes. You can send any vial from your order to an independent laboratory of your choice. If you want the laboratory, specification, sampling, method and acceptance rule agreed with us before testing, sales confirms them in writing. Unless otherwise agreed in writing, the buyer pays the cost of this optional testing.

What if my own lab test shows the product is out of specification?+

Send any vial from your order to an independent laboratory of your choice. If the report shows the product does not meet the specification on its COA — purity below the stated minimum, or an identity that does not match — share the report with our sales team and we refund that product in full.

Does HPLC purity prove peptide content?+

No. Chromatographic purity describes the relative peak profile under a stated method. Identity, water, counter-ion, residual solvents and assay/content may require separate methods.

How should material be stored after delivery?+

Move it into the storage condition stated on the batch COA or label as soon as it arrives, and record the package condition on receipt.

How are payment terms handled?+

Available methods and milestones depend on order value, destination and project type. The pro forma invoice should state currency, bank details, fees, payment milestones and the release condition.

Why must the testing laboratory understand peptide chemistry?+

Free-base and salt forms, hydrophilic and hydrophobic sequences, aggregation and adsorption can change sample preparation and method suitability. Use a laboratory experienced with the molecule class.

These are buyer-qualification references, not claims that this RUO material is regulated, certified or released under those frameworks. Applicability depends on the buyer's workflow and jurisdiction.

Selected sources

Literature behind the research context

  • Current regulatory sources: the May 2026 DailyMed SCENESSE label, FDA NDA 210797 and the EMA SCENESSE EPAR. DailyMed identifies the named product as a 16 mg controlled-release subcutaneous implant containing afamelanotide acetate and PLGA; these formulation facts do not transfer to free peptide. Peer-reviewed EPP, historical pigmentation, vitiligo and 2026 forced-degradation studies support only their tested product, protocol or analytical stress conditions and do not approve this RUO lot, cosmetic tanning or another route.
  1. 01

    Afamelanotide for Erythropoietic Protoporphyria

    New England Journal of Medicine · 2015 · peer-reviewed original research (two parallel randomized, double-blind, placebo-controlled Phase 3 trials)

    Open source
  2. 02

    Induction of skin tanning by subcutaneous administration of a potent synthetic melanotropin

    JAMA · 1991 · peer-reviewed original research (randomized, placebo-controlled, double-blind trial)

    Open source
  3. 03

    Afamelanotide and Narrowband UV-B Phototherapy for the Treatment of Vitiligo: A Randomized Multicenter Trial

    JAMA Dermatology · 2015 · peer-reviewed original research (randomized multicenter trial)

    Open source
  4. 04

    An unhealthy glow? A review of melanotan use and associated clinical outcomes

    Performance Enhancement & Health · 2014 · peer-reviewed narrative review

    Open source
  5. 05

    Investigation of the stability profile of therapeutic α-MSH analogue: Insights from liquid chromatography-high resolution mass spectrometry analysis of afamelanotide

    Journal of Pharmaceutical and Biomedical Analysis · 2026 · peer-reviewed original research (forced degradation and stability-indicating analytical characterization)

    Open source
  6. 06

    SCENESSE (afamelanotide) implant — current U.S. prescribing information

    DailyMed, U.S. National Library of Medicine · 2026 · current FDA-approved finished-product label

    Open source
  7. 07

    FDA NDA Approval Letter for SCENESSE (afamelanotide) 16 mg implant

    US Food and Drug Administration, NDA 210797 · 2019 · official FDA approval letter

    Open source
  8. 08

    Scenesse (afamelanotide) - European Public Assessment Report

    European Medicines Agency · 2014 · regulatory document (EMA European Public Assessment Report)

    Open source

Product FAQ

Questions buyers ask about Melanotan I

Does approval of SCENESSE make this afamelanotide free-peptide lot an approved medicine?+

No. FDA and EMA authorisations apply to the named SCENESSE controlled-release implant, including its formulation, 16 mg strength, manufacturing controls and EPP indication. They do not transfer to bulk or lyophilized free peptide, a nasal or tanning product, or another route. Procurement documents must describe this catalogue lot as Research Use Only.

How is afamelanotide different from Melanotan II?+

Afamelanotide is a linear 13-residue [Nle4,D-Phe7]-α-MSH analogue that binds predominantly to MC1R according to the current SCENESSE label. Melanotan II is a distinct cyclic heptapeptide with broader melanocortin-receptor activity. Their sequence, topology, registry identity, analytical controls, evidence and regulatory status must be assessed separately; approval of SCENESSE is not evidence for Melanotan II.

What should be included in first-lot qualification for afamelanotide reference material?+

Ask sales for the matching batch COA and review the supplied form, methods, specifications and results it records. If the buyer's written procedure requires additional sequence evidence, raw chromatograms, quantitative content, counterion, water, residual solvents, bioburden, endotoxin or sterility, define those attributes in a separate agreed scope before quotation.

Evidence before order

Buyer intelligence