PT-141 Storage & Stability Datasheet

🖨️ NovaVitality Technical Datasheet
Document ID: NV-DS-PT141-001
Version: 1.0
Effective Date: 10 December 2025
Product: PT-141 Research Peptide (RUO)


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


1. Product Overview

ParameterSpecification
INN (Proposed)PT-141 (Bremelanotide analog)
CAS Status176200-75-4 (assigned)
Molecular FormulaC₅₀H₆₈N₁₄O₁₀S
Molecular Weight1025.22 g/mol (monoisotopic)
SequenceAc-Nle-c[Asp-His-DPhe-Arg-Trp-Lys]-NH₂ (cyclic, D-Phe⁴, Nle¹)
Receptor ProfileSelective agonist: MC4R (EC₅₀ ≈ 0.4 nM) > MC3R (EC₅₀ ≈ 2.1 nM) ≫ MC1R/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, or therapeutic use
UK Control StatusSchedule 2 Research Substance — requires CD register, locked storage, and licence verification

2. Recommended Storage Conditions

✅ Unopened (Lyophilised)

ConditionStability DurationNotes
−20°C, desiccated, dark, in locked CD cabinet≥24 monthsMandatory — Schedule 2 storage requirement. Use secondary airtight container with desiccant. Amber vials with argon headspace.
2–8°C (CD-locked refrigerator)≤6 monthsFor active research; log every access in CD register.
Room Temp (25°C)≤24 hoursFor verified transit only — log receipt immediately in CD register.

📌 PT-141 is stable lyophilised, but Trp and Asp² are oxidation/hydrolysis-sensitive. All NovaVitality vials are amber glass with argon backfill.

✅ 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 Asp²–Lys⁷ lactam formation

⚠️ 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, project ref, 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 PT-141Detection Method
Light exposure (UV/visible)Trp⁶ oxidation → kynurenine (+4 Da)LC-MS: +4 Da peak; ↓cAMP in HEK293-MC4R
Moisture/heatAsp²–Lys⁷ lactam formationHPLC: new peak at ~8.2 min; altered MC4R:MC3R 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
Reducing agentsDisulfide scrambling (none present)Not applicable — no Cys

🔬 Tip: Validate bioactivity pre-assay: run MC4R cAMP EC₅₀ — 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, purpose: “MC4R pharmacology research”).
  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.
  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 1025.2 ±1.0 DaAnnually, or after suspected degradation
Endotoxin<5 EU/mL in solutionBefore in vivo studies
Bioactivity (Required)EC₅₀ ≤ 0.6 nM at hMC4R (cAMP, HEK293)For all publication or longitudinal studies

6. References & Compliance

  • Wessells H et al. Int J Impot Res. 2000;12(Suppl 4):S90–S94. DOI: 10.1038/sj.ijir.3900541
  • 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

📧 CD & Technical 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.