Supplied for research purposes only. These peptides are laboratory reagents intended for qualified researchers and educational institutions. Not for human use, animal use, or clinical application.
Tirzepatide Storage & Stability Datasheet
🖨️ NovaVitality Technical Datasheet
Document ID: NV-DS-TIRZ-001
Version: 1.0
Effective Date: 10 December 2025
Product: Tirzepatide Research Peptide (RUO)
1. Product Overview
| Parameter | Specification |
| INN (Proposed) | Tirzepatide |
| CAS Status | 2023788-19-2 (assigned) |
| Molecular Formula | C₂₂₅H₃₄₈N₄₈O₆₈ |
| Molecular Weight | 4813.45 g/mol (monoisotopic) |
| Sequence | H-[C20-diacid]-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Val-Ser-Ser-Tyr-Leu-Glu-Gly-Gln-Ala-Ala-Lys-Glu-Phe-Ile-Ala-Trp-Leu-Val-Lys-Gly-Arg-Gly-[mini-PEG-Lys-C18-diacid]-OH |
| Receptor Profile | Balanced dual agonist: GIPR (EC₅₀ ≈ 1.2 nM), GLP-1R (EC₅₀ ≈ 2.2 nM) |
| Form Supplied | Lyophilised Solid (white to off-white powder) |
| Purity (HPLC-UV) | ≥98% (gradient elution, C4 column, 220 nm) |
| Endotoxin | <1.0 EU/mg (LAL kinetic assay) |
| Residual Solvents | Meets ICH Q3C Class 3 limits |
| RUO Status | For research use only — not for human, veterinary, diagnostic, or therapeutic use |
2. Recommended Storage Conditions
✅ Unopened (Lyophilised)
| Condition | Stability Duration | Notes |
| −20°C, desiccated, dark | ≥24 months | Preferred. Fatty-acid domain is stable when dry. Use airtight secondary container. |
| 2–8°C (refrigerated) | ≤6 months | Acceptable for active lab use; monitor for cake collapse (indicates moisture uptake). |
| Room Temp (≤25°C) | ≤7 days | For transit only. Avoid humidity >60% RH. |
📌 Tirzepatide’s fatty-acid moieties increase hydrophobicity but reduce solubility in aqueous buffers — lyophilisation under controlled humidity is critical.
✅ Reconstituted (Solution)
| Solvent | Short-Term (2–8°C) | Long-Term (−80°C) | Notes |
| 0.1% acetic acid in 0.9% NaCl | ≤72 hours | ≤6 months (aliquoted) | Preferred — enhances solubility of fatty-acid domain |
| Bacteriostatic water (0.9% BA) | ≤48 hours | ≤3 months (aliquoted) | Acceptable; benzyl alcohol aids solubilisation |
| PBS (pH 7.4) | ≤24 hours | Not recommended | High risk of aggregation/precipitation (hydrophobic collapse) |
⚠️ Critical:
– Aliquot before freezing — limit freeze–thaw to ≤3 cycles (fatty-acid peptides aggregate irreversibly after cycle 3).
– Use low-binding tubes (e.g., LoBind Eppendorf) — hydrophobic adsorption is significant.
– Avoid repeated warming — albumin-binding domain promotes surface adhesion.
3. Stability Indicators & Degradation Risks
| Risk Factor | Effect on Tirzepatide | Detection Method |
| Moisture exposure | Hydrolysis at Asp⁹, Ser¹¹ | HPLC peak broadening, +18 Da MS shift |
| Oxidation (Met⁰ absent; Trp²⁵ present) | Trp²⁵ oxidation → kynurenine (+4 Da) | LC-MS: +4 Da peak; ↓GLP-1R potency in cAMP assay |
| Aggregation | Visible haze, precipitate, gelation | DLS (>500 nm), SEC-HPLC high-MW peak |
| pH >7.0 | Deamidation (Asn/Gln absent); backbone cleavage | Rare — monitor Glu isomerisation (HPLC splitting) |
| Repeated freeze–thaw | Irreversible oligomerisation | Loss of receptor potency (EC₅₀ shift >2-fold) |
🔬 Tip: Run a quick cAMP assay (GLP-1R HEK293) before critical in vivo studies — functional validation is more sensitive than purity alone.
4. Reconstitution Protocol (Best Practice)
- Equilibrate vial to room temp (15–30 min) before opening to prevent condensation.
- Centrifuge briefly (5 sec) to collect powder.
- Add solvent slowly down vial wall (e.g., 1 mL for 10 mg → 10 mg/mL stock).
- Gently swirl — do not vortex.
- If undissolved: warm to ≤37°C for 2–5 min + low-power sonication (≤30 sec, ice-cooled bath).
- Filter through 0.22 µm PVDF (low-protein-binding) for cell work.
- Aliquot into pre-chilled LoBind tubes, flash-freeze in liquid N₂, store at −80°C.
5. Analytical Verification (Post-Storage)
| Test | Acceptance Criteria | When to Run |
| HPLC Purity | ≥95% main peak | After >6 months storage, or pre-critical assay |
| MS Identity | Observed MW 4813.5 ±2.0 Da | Annually, or after suspected contamination |
| Endotoxin | <5 EU/mL in reconstituted solution | Before in vivo or primary cell studies |
| Bioactivity (Required) | EC₅₀ ≤ 3.0 nM at hGLP-1R (cAMP, HEK293) | For all publication or longitudinal studies |
6. References & Compliance
- Finan B et al. Lancet Diabetes Endocrinol. 2020;8(11):931–941. DOI: 10.1016/S2213-8587(20)30275-4
- ICH Q1A(R2): Stability Testing of New Drug Substances
- USP <1079>: Good Storage and Distribution Practices
- EMA Guideline on Peptide Impurities (EMA/CHMP/ICH/107464/2022)
- MHRA Guidelines on the Labelling of Unlicensed Medicines (2024) — for reference only (RUO not subject, but aligns with handling ethos)
7. Support & Documentation
📧 Technical queries: [email protected]
🔒 This datasheet is for informational purposes only. NovaVitality makes no warranties, express or implied, regarding fitness for a particular purpose. Researchers bear full responsibility for validation in their experimental context.
