Melanotan I

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

Lot-specific released result; request chromatographic purity, quantitative peptide content, counterion/water and orthogonal identity · target, verify batch COACAS 75921-69-6RUO

Research statusAfamelanotide is approved only in the named SCENESSE controlled-release implant; this free-peptide lot is Research Use Only reference context · supplied material is RUO

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: Approximately 1,646.85 Da
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: On request
Lead time: Confirmed with quote

PubChem CID 16154396

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

Define long-term storage and transit exposure separately. Cold-chain can be quoted when the buyer’s risk assessment requires it and adds cost.

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

Research areaOther research materials

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.

Factory batch documentation

Melanotan I factory batch COAs

Melanotan I 10 mg Factory batch COA protected preview

Melanotan I10 mg · WHJLP-MT110-260709-B

Representative records, refreshed periodically

Published COAs show representative factory batches and may not be the latest available. For a current quote or shipment, our sales team can confirm the applicable lot and provide its COA.

Independent testing, arranged on request

Third-party reports are not routinely published. If independent verification is required, we can agree the laboratory, method, acceptance criteria and remedy before testing. If the agreed specification is not met, an appropriate resolution—including a refund where applicable—can be discussed under the agreed terms. Unless otherwise agreed in writing, the buyer pays the cost of this optional testing.

Help reviewing your COA

Need help reading a factory COA or third-party report? Our sales team can clarify test items, specifications and how the results relate to the lot under discussion.

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.

Released-batch COARP-HPLC result and method contextIdentity result appropriate to the moleculeWater / counter-ion context where relevantSDS and handling statementAdditional testing scoped on request

Available fills

Quote the fill and pack configuration you need

Reference SKUFillBase pack

MT1-10MG10 mg10 vials

Handling

Storage in the lab and temperature during transit are different decisions

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 destination, season, acceptable transit exposure and whether your protocol requires insulated or cold-chain service. Additional temperature-control cost is quoted explicitly.

Buyer FAQ

Terms to settle before the purchase order

Can a buyer arrange third-party testing?+

Yes. Testing must be performed by a mutually accepted, established specialist laboratory. Fee allocation, specification, sampling, method and acceptance rule must be agreed before testing; if an agreed independent result shows nonconformance, the remedy follows the signed order terms. Unless otherwise agreed in writing, the buyer pays the cost of this optional testing.

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.

Is cold-chain shipping always required?+

Not always. Heat can accelerate degradation, especially during summer and long transit. Cold-chain reduces exposure but raises cost. State the destination and stability risk so the right service can be quoted.

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.

External qualification references

WHO good storage and distribution practices IATA Temperature Control Regulations ISO/IEC 17025 laboratory competence 21 CFR 211.84 component testing and supplier COA controls

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.

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
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
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
04
An unhealthy glow? A review of melanotan use and associated clinical outcomes
Performance Enhancement & Health · 2014 · peer-reviewed narrative review
Open source
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
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
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
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?+

Melanotan I

Key benefits

Specifications to confirm against the released lot

Identity, purity and content are separate release questions.

What researchers study about Melanotan I

The question the literature is testing

Research routes and exposure context

Compatibility, limitations and decision context

Interactions reported in the literature

Melanotan I factory batch COAs

Ask for the current packet, not a generic certificate

Quote the fill and pack configuration you need

Storage in the lab and temperature during transit are different decisions

Terms to settle before the purchase order

Literature behind the research context

Afamelanotide for Erythropoietic Protoporphyria

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

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

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

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

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

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

Scenesse (afamelanotide) - European Public Assessment Report

Questions buyers ask about Melanotan I

Compare adjacent molecules and documentation needs.

Melanotan II

PT-141

Lemon Bottle

Lipo-C