Product identification – HPLC | |||
Selectivity | |||
Specification | P* | result | 9.85 min |
Specification | S*: t(P) - t(S) = 0.05 ± 0.035 min | result | 9.80 min |
Specification | V*: t(P) - t(V) > 0.25 min | result | 9.48 min |
Specification | G*: t(P) - t(G) > 0.25 min | result | 0.68 min |
Precision | |||
Specification | P: mean + 3 s-value | result (n = 6) | 9.73 ± 0.20 min |
Radiochemical puritiy – HPLC | |||
Resolution R between G and P | |||
Specification | R > 1.5 | result | R = 56.8 |
Robustness | |||
Specification | P = 9.73 ± 0.20 min | result | 9.77 min |
Limit of determination (S/N for 5 MBq/mL) | |||
Specification | S/N > 10 | result | 37.9 |
Recovery | |||
Specification | W = 80–120% | result | 87.3–92.7% |
Comparison between RCP HPLC and TLC | |||
Variance | 0.7% | result | HPLC 98.5% TLC 99.2% |
Product identification TLC | |||
Precision | |||
Specification | P Rf = 0.6–0.9 | result | Rf = 0.72 |
Specification | G Rf = 0–0.1 | result | Rf = 0.04 |
Specification | P: mean + 3 s-value | result (n = 6) | Rf = 0.72 ± 0.08 |
Robustness | |||
Specification | P = 0.72 ± 0.08 min | result | 0.69 min |
Endotoxine test | |||
Specification | ‘pass’ < 2.5 EU/mL at 1:50 | result (n = 6) | all ‘pass‘< 2.5 EU/mL |