Melanotan 2 Storage & Stability Datasheet

🖨️ NovaVitality Technical Datasheet
Document ID: NV-DS-MT2-001
Version: 1.0
Effective Date: 10 December 2025
Product: Melanotan 2 Research Peptide (RUO)


⚠️ Controlled Substance Notice: Supplied under Human Medicines Regulations 2012, Regulation 214(2) for research only. Requires institutional Controlled Drugs (CD) Licence for possession.


1. Product Overview

ParameterSpecification
INN (Proposed)Melanotan 2 (MT-2)
CAS Status121062-08-6 (assigned)
Molecular FormulaC₅₀H₆₉N₁₅O₉
Molecular Weight1024.17 g/mol (monoisotopic)
SequenceAc-Nle-c[Asp-His-DPhe-Arg-Trp-Lys]-NH₂ (cyclic, D-Phe⁴, Nle¹)
Receptor ProfileSuperagonist: MC1R (EC₅₀ ≈ 0.2 nM), MC4R (EC₅₀ ≈ 0.3 nM) > MC3R/MC5R
Form SuppliedLyophilised Solid (white to off-white powder)
Purity (HPLC-UV)≥98% (gradient elution, C18, 220 nm)
Endotoxin<1.0 EU/mg (LAL kinetic assay)
Residual SolventsMeets ICH Q3C Class 3 limits
RUO StatusFor research use only — not for human, veterinary, cosmetic, or therapeutic use
UK Control StatusSchedule 2 Research Substance — requires CD register & locked storage

2. Recommended Storage Conditions

✅ Unopened (Lyophilised)

ConditionStability DurationNotes
−20°C, desiccated, dark, in lockable CD cabinet≥24 monthsMandatory — Schedule 2 storage requirement. Use secondary airtight container with desiccant.
2–8°C (refrigerated, CD-locked)≤6 monthsAcceptable for active research; log access per CD regulations.
Room Temp (25°C)≤48 hoursFor verified transit only — must be logged in CD register upon receipt.

📌 Melanotan 2 is stable lyophilised, but light and moisture accelerate Asp cyclisation and Trp oxidation. All NovaVitality vials are amber glass with argon headspace.

✅ Reconstituted (Solution)

SolventShort-Term (2–8°C, CD-locked fridge)Long-Term (−80°C, CD-locked freezer)Notes
0.1% acetic acid in 0.9% NaCl≤72 hours≤6 months (aliquoted)Preferred — maintains cyclic integrity
Bacteriostatic water (0.9% BA)≤48 hours≤3 months (aliquoted)Acceptable; benzyl alcohol does not impair MC4R activity
PBS (pH 7.4)≤24 hoursNot recommendedRisk of lactam formation (Asp²–Lys⁷ cyclisation)

⚠️ Critical (CD Compliance):
All solutions must be stored in locked, access-controlled refrigerators/freezers
Log every aliquot withdrawal in institutional CD register (date, amount, researcher, purpose)
– Limit freeze–thaw to 3 cycles — aggregation reduces MC4R potency
– Use low-binding tubes — cyclic peptides adsorb to standard polypropylene


3. Stability Indicators & Degradation Risks

Risk FactorEffect on Melanotan 2Detection Method
Light exposure (UV/visible)Trp⁶ oxidation → kynurenine (+4 Da)LC-MS: +4 Da peak; ↓cAMP in HEK293-MC1R
Moisture/heatAsp²–Lys⁷ lactam formation (cyclic → bicyclic)HPLC: new peak at ~8.2 min (RT shift); altered MC1R:MC4R bias
Alkaline pH (>7.5)Arg⁵ deimination → citrullineMS/MS: loss of guanidino group; ↓ receptor binding
Repeated freeze–thawIrreversible dimerisation (Trp crosslinks)SEC-HPLC: high-MW peaks; ↓ solubility
Oxidising agentsMet oxidation (Nle¹ stable)Not applicable — Nle replaces Met

🔬 Tip: Validate bioactivity pre-assay: run a quick MC4R cAMP EC₅₀ curve — potency loss >2-fold indicates degradation.


4. Reconstitution Protocol (Best Practice + CD Compliance)

  1. Log withdrawal in CD register (vial lot, amount, researcher, date, project ref).
  2. Equilibrate vial to room temp (10 min) inside CD cabinet.
  3. Centrifuge briefly (3 sec) to collect powder.
  4. Add 0.1% acetic acid/saline slowly down vial wall (e.g., 1 mL for 10 mg → 10 mg/mL).
  5. Gently swirldo not vortex or sonicate (disrupts cyclic structure).
  6. Filter through 0.22 µm PVDF (low-protein-binding).
  7. Aliquot in pre-labelled, CD-compliant tubes, log volumes, flash-freeze at −80°C (CD-locked).

5. Analytical Verification (Post-Storage)

TestAcceptance CriteriaWhen to Run
HPLC Purity≥95% main peakAfter >3 months storage, or pre-critical assay
LC-MS IdentityObserved MW 1024.2 ±1.0 DaAnnually, or after suspected degradation
Endotoxin<5 EU/mL in solutionBefore in vivo studies
Bioactivity (Required)EC₅₀ ≤ 0.5 nM at hMC4R (cAMP, HEK293)For all publication or longitudinal studies

6. References & Compliance

  • Haskell-Luevano C et al. J Med Chem. 1996;39(17):3425–3431. DOI: 10.1021/jm960227u
  • UK Human Medicines Regulations 2012 (SI 2012/1916), Regulation 214(2)
  • MHRA Guidance on Supply of Unlicensed Medicinal Products for Research (Dec 2024)
  • Home Office Guidance on Controlled Drugs in Research (2023)
  • ICH Q1A(R2): Stability Testing

7. Support & Documentation

📧 Technical & CD queries: [email protected]

🔒 This datasheet is for informational purposes only. NovaVitality supplies under Regulation 214(2) for research. Researchers must hold a valid CD Licence and comply with the Misuse of Drugs Regulations 2001. NovaVitality disclaims all liability for non-compliant use.