What the label states, the lot delivers — net peptide mass, not gross powder weight, purity reported as measured rather than rounded up, and a Certificate of Analysis for every lot.
Net peptide mass, not powder weight; purity as measured, not rounded up; a COA per lot.
Net peptide + purity not rounded up. COA per lot.
FDA PCAC reviews 7 peptides for the 503A bulks list (BPC-157, KPV, TB-500, MOTs-C, Emideltide, Semax, Epitalon). Read our compounder's decision tree. Read our briefing →
FDA PCAC reviews 7 peptides for the 503A bulks list in July. Read →
FDA PCAC: 7 peptides under review. Read →
α-MSH analog · approved for erythropoietic protoporphyria
Overview
Melanotan I (afamelanotide, MT-I) is a synthetic 13-amino-acid analog of endogenous alpha-melanocyte-stimulating hormone (α-MSH) that promotes eumelanin production by activating the melanocortin-1 receptor (MC1R) on melanocytes. Its subcutaneous implant formulation (SCENESSE®) received FDA approval in October 2019 for prevention of phototoxicity in adults with the rare disease erythropoietic protoporphyria (EPP). Research-grade free peptide (for injection) is mainly studied for its photoprotective and tanning effects, and is not approved for human use for that purpose. Compared with Melanotan II, MT-I is a linear (non-cyclic) peptide with higher MC1R selectivity and, correspondingly, fewer of the systemic side effects (such as sexual side effects) associated with Melanotan II. Vialdyne releases Melanotan I as a lyophilized tridecapeptide (linear, n-acetylated/c-amidated) against a ≥ 99.0% HPLC main-peak specification, with a batch-specific Certificate of Analysis covering RP-HPLC purity, mass-spec identity, water content, residual solvents, and endotoxin. Sequence / identity confirmation is documented on the released lot.
Applications & buyer fit
Cosmetic-peptide buyers fall into two groups: established beauty / med-aesthetic brands extending an existing line, and OEM clients building a private-label catalog from scratch. The first group usually wants active material plus stability data in their existing carrier matrix; the second usually wants a finished formulation under their label. Both need INCI naming verified, regulator-specific safety files (CPNP for EU, FDA OTC monograph for US where relevant), and packaging-compatibility data.
Sourced for
Buyer fit
Documentation that ships
Procurement note: INCI naming, SDS, and stability data in the chosen carrier ship with the active; finished-product safety remains the brand owner's responsibility.
Primary buyer fit: academic and contract research laboratories.
Specifications
Regulatory note
Research-use-only reference material; not for human or veterinary use.
Selected literature
Frequently asked questions
Approval of the finished product under a brand name does not make research-grade API equivalent to that medicine; the approved drug carries a manufacturing dossier, defined release specifications, and a regulatory pedigree tied to its indicated use. API supplied for laboratory work is a separate material qualified on its own certificate. A buyer should treat the peptide as MC1R-selective research material, verify identity and purity from the batch COA, and not represent it as, or substitute it for, the approved product. The receptor-selectivity science that enabled the drug's development is a property of the molecule, not a substitute for approved-product documentation.
Melanotan I is a small cyclic-lactam melanocortin analog, so batch qualification should confirm identity by mass spectrometry against the theoretical mass and purity by RP-HPLC to an area-percent acceptance limit, with the related-substances profile reflecting synthesis-derived impurities. Because the selectivity for MC1R over MC3R/MC4R/MC5R is what defines this molecule's behavior, correct identity confirmation is the load-bearing check rather than an afterthought. The certificate should also report net peptide content, counterion, water content, and residual solvents so that potency calculations and downstream handling rest on the assayed material, not nominal vial mass.
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