🔬 REGULATORY COMPLIANCE & INTENDED USE
Shaanxi Sunrise Pharmaceutical operates exclusively as a B2B manufacturer of Active Pharmaceutical Ingredients (APIs) and research peptides. The Melanotan II (MT-2) compound detailed in this dossier is strictly designated for in-vitro laboratory research, pre-clinical MC1R agonism studies, and industrial biochemical formulation. This raw material is NOT approved for direct human consumption, retail distribution, or unapproved medical applications.
TECHNICAL WHITE PAPER
Melanotan II (CAS 121062-08-6) Synthesis: Overcoming Lactam-Bridge Complexities in API Manufacturing
In dermatological research targeting melanocortin receptors (MC1R), relying on unverified peptide sources introduces critical study variables. This document outlines the biochemical hurdles of synthesizing cyclic heptapeptides and establishes the baseline purity required for reproducible clinical assays.
The demand for Melanotan II (MT-2) in photoprotection and melanogenesis research is driven by its profile as a highly potent, non-selective agonist of melanocortin receptors. By engaging MC1R, it facilitates eumelanin production independent of ultraviolet (UV) exposure. However, securing high-fidelity API is a persistent challenge for CDMOs and R&D directors. When bulk MT-2 is procured from substandard synthesis facilities, high concentrations of structural impurities can drastically skew receptor binding kinetics, jeopardizing downstream in-vitro and pre-clinical data.
The Challenge of Cyclic Heptapeptide Architecture
Structurally, Melanotan II is a lactam-bridged, cyclic heptapeptide (Sequence: Ac-Nle-cyclo[Asp-His-D-Phe-Arg-Trp-Lys]-NH2). The core synthetic challenge lies not in the linear assembly of these amino acids, but in the precise intramolecular cyclization—specifically forming the internal lactam bridge between the Aspartic acid (Asp) and Lysine (Lys) side chains.
Facilities utilizing outdated Solid-Phase Peptide Synthesis (SPPS) protocols frequently fail to drive this cyclization to completion. The result is an API contaminated with linear MT-2 precursors and deletion sequences. These impurities are molecularly similar to the target active but possess entirely unpredictable pharmacodynamics—often demonstrating antagonistic behavior. Shaanxi Sunrise utilizes advanced macrocyclization kinetics to ensure the spatial conformation is perfectly locked, yielding true MT-2.
The Imperative of ≥99.0% HPLC Purity in Formulation
For formulation engineers designing aqueous solutions or liposomal delivery systems, raw material purity defines the stability curve. Trace amounts of trifluoroacetic acid (TFA) or unreacted cleavage solvents in low-grade MT-2 can lower the formulation pH, accelerating peptide hydrolysis. Our rigorously purified Melanotan II API undergoes extensive preparative chromatography, stripping out these residuals to guarantee a highly stable, transparent dissolution in standard physiological buffers.
API Release Standards & Technical Specifications
| Product Identity | Melanotan II Acetate (Synthetic Cyclic Heptapeptide) |
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| CAS Registry Number | 121062-08-6 |
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| Molecular Formula / Weight | C50H69N15O9 / 1024.18 g/mol |
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| Chromatographic Purity | HPLC ≥ 99.0% |
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| Identity Verification | Mass Spectrometry (MS) conforming to 1024.18 Da |
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| Physical State & Storage | White lyophilized powder. Store strictly at -20°C. |
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Procurement Quality Control FAQ
How does API purity affect solubility for R&D formulations?
Achieving ≥99.0% purity eliminates hydrophobic truncated sequences and cross-linked polymers. This guarantees rapid, completely clear dissolution in standard aqueous buffers (such as PBS or bacteriostatic water) without the risk of particulate suspension or micelle formation during your formulation processes.
How is the -20°C temperature requirement managed during shipping?
To prevent peptide oxidation and hydrolysis during transit, we deploy validated cold-chain logistics. The MT-2 lyophilized powder is vacuum-sealed in moisture-barrier pouches and packed into insulated containers with regulated cooling agents (e.g., dry ice), ensuring sub-zero stability.
Do you supply full COA and MS documentation for QA audits?
Absolutely. Transparency is the core of B2B chemical procurement. Every commercial batch is dispatched with a comprehensive Certificate of Analysis (COA), including raw HPLC chromatograms and Mass Spectrometry (MS) spectra, enabling seamless integration into your facility's internal compliance audits.
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