Stability Study Protocol — Peptide Stability Testing¶
1. Study Conditions (ICH Q1A)¶
| Condition | Temperature | Humidity | Duration |
|---|---|---|---|
| Accelerated | 40 ± 2 °C | 75 ± 5% RH | 6 months |
| Intermediate | 30 ± 2 °C | 65 ± 5% RH | 6 months |
| Long-term | 25 ± 2 °C | 60 ± 5% RH | 36 months |
| Refrigerated | 5 ± 3 °C | — | 24 months |
2. Test Schedule¶
| Time Point | Tests Required |
|---|---|
| T0 (initial) | All release tests |
| 1 month | HPLC purity, appearance, moisture |
| 3 months | HPLC, MS, moisture, appearance |
| 6 months | Full testing (HPLC, MS, moisture, solvents, endotoxin, content) |
| 12, 24, 36 months | Full testing |
3. Evaluation Criteria¶
| Parameter | Acceptance (Long-term) |
|---|---|
| HPLC purity | ≥95% of initial |
| Impurities | No new impurity >0.5% |
| Appearance | No change |
| Moisture | ≤1.0% |
| Content | 95 – 105% of initial |