Table 2.
Results of stability studies conducted on Au-GEM-AsP-Phys and Au-GEM-AsP-MOD.
|
Product Name: Au-GEM-AsP-Phys 0.1mgmL− 1 Au, 1mgmL− 1 GEM, 2.5mgmL− 1 AsP Packing: Vial 6R, Clear |
Batch No.: Au-Phys − 22,001 Mfg. Date: 06.2022 |
Stability Study Conditions Temperature (°C): 25 °C ± 2 °C Relative Humidity: 60% ± 5% |
|
| Test | Initial | M3 | M6 |
| Appearance | Clear and Light Purple in color | Clear and Light Purple in color | Clear and Light Purple in color |
|
Assay (%) Acceptance Criteria: Initial ± 5% |
87.00% | 80.67% | 77.72% |
| Size (nm) | 106.0 nm | 115.4 nm | 110.6 nm |
| PDI | 0.535 | 0.432 | 0.712 |
|
Product Name: Au-GEM-AsP-MOD 0.1mgmL− 1 Au, 1mgmL− 1 GEM, 2.5mgmL− 1 AsP Packing: Vial 6R, Clear |
Batch No.: Au-MOD-22,001 Mfg. Date: 06.2022 |
Stability Study Conditions Temperature (°C): 25 °C ± 2 °C Relative Humidity: 60% ± 5% |
|
| Test | Initial | M3 | M6 |
| Appearance | Clear and Light Purple in color | Clear and Light Purple in color | Clear and Light Purple in color |
|
Assay (%) Acceptance Criteria: Initial ± 5% |
89.50% | 84.78% | 85.76% |
| Size | 125.8 nm | 131.8 nm | 134.0 nm |
| PDI | 0.664 | 0.704 | 0.701 |