RPL Peptide
Official Technical Documentation
Stability Guide
Stability Guide — Tirzepatide¶
Stability Summary¶
| Form | Storage Condition | Stability Period |
|---|---|---|
| Lyophilized | -20°C | 2+ years |
| Lyophilized | 2–8°C | 12 months |
| Lyophilized | 25°C (Room Temp) | 30 days |
| Reconstituted | 2–8°C | 30 days |
| Reconstituted | 25°C | 7 days |
| Reconstituted (Aliquoted) | -20°C | 6 months |
Stability Testing Parameters¶
Stability is monitored using the following analytical methods:
| Test | Method | Frequency |
|---|---|---|
| Appearance | Visual inspection | Each time point |
| Purity | HPLC (214 nm) | Each time point |
| Identity | LC-MS | Initial and final time points |
| pH | pH meter | Each time point |
| Water Content | Karl Fischer | Initial only |
| Endotoxin | LAL | Initial only |
Accelerated Stability Data¶
| Condition | Duration | Expected Purity Retention |
|---|---|---|
| 40°C / 75% RH | 2 weeks | ≥98% |
| 40°C / 75% RH | 4 weeks | ≥97% |
| 25°C / 60% RH | 3 months | ≥98% |
| 25°C / 60% RH | 6 months | ≥97% |
Degradation Pathways¶
| Pathway | Risk | Mitigation |
|---|---|---|
| Hydrolysis | Medium | Keep dry; low moisture content |
| Oxidation | Low-Medium | Protect from air; inert atmosphere |
| Deamidation | Low | Maintain pH 4.0–6.5 |
| Aggregation | Low | Avoid vigorous shaking; proper reconstitution |
| Microbial Growth | Medium (reconstituted) | Use bacteriostatic water; sterile technique |
Stability Testing Protocol¶
Real-Time Stability¶
- Storage: -20°C and 2–8°C
- Time Points: 0, 1, 3, 6, 12, 18, 24 months
- Samples: Triplicate vials per time point
- Testing: Appearance, purity (HPLC), identity (LC-MS), pH, moisture
Accelerated Stability¶
- Storage: 25°C/60% RH and 40°C/75% RH
- Time Points: 0, 2, 4, 8, 12 weeks
- Samples: Triplicate vials per time point
- Testing: Appearance, purity (HPLC), pH
Freeze-Thaw Stability¶
| Freeze-Thaw Cycles | Purity Retention |
|---|---|
| 1 cycle | ≥99% |
| 3 cycles | ≥98% |
| 5 cycles | ≥97% |
| 10 cycles | ≥95% |
Note: Repeated freeze-thaw cycles are not recommended. Aliquot reconstituted peptide for single-use applications.
Handling Effects on Stability¶
| Condition | Effect on Stability | Recommendation |
|---|---|---|
| Light exposure | Moderate degradation | Store in dark; use amber vials |
| Temperature spikes | Accelerated degradation | Maintain cold chain |
| Vortexing | Potential aggregation | Swirl gently only |
| Dilution in buffers | Generally stable | Use recommended buffers |
| Metal ion contact | Potential chelation | Use low-binding labware |
Stability Indicators¶
| Indicator | Sign of Degradation |
|---|---|
| Visual | Discoloration, cloudiness, precipitation |
| HPLC | Decreased main peak area; new impurity peaks |
| pH | Significant pH shift (>1.0 unit) |
| Bioactivity | Reduced receptor binding (functional assay) |
© 2026 RPL Peptide
Official Technical Documentation
rplpeptides.com