Table 7 Results of [68Ga]Ga-EMP100 stability study in final vial
From: Fully automated radiolabeling of [68Ga]Ga-EMP100 targeting c-MET for PET-CT clinical imaging
Test | Method | Specifications | Batch 1 | Batch 2 | Batch 3 |
|---|---|---|---|---|---|
Aspect | Visual | Clear, colourless solution | Yes | Yes | Yes |
pH value | pH-strips | 4.0–8.0 | 6.0 | 6.0 | 6.0 |
Stability over 3 h (RCP %) | Radio HPLC | [68Ga]Ga-EMP100 > 95,00% | 98.63% | 98.87% | 99.52% |
Free [68Ga]GaCl3 ≤ 5% | 1.37% | 1.13% | 0.48% | ||
Radio TLC AcNH4 1 M Methanol (V/V) | [68Ga]Ga-EMP100 > 95% | 99.85% | 99% | 99.91% | |
[68Ga]Ga-colloidal ≤ 5% | 0. 15% | 1.00% | 0.09% | ||
RCP (overall) | [68Ga]Ga-EMP100 (overall) > 95.00% | 99.08% | 97.87% | 99.43% | |
Sterility | Inoculation 14 days (Ph Eur 20601) | Sterile | Sterile | Sterile | Sterile |