Table 2 Batch data (n = 8)
Batch No | RCP HPLC Method A [%] | RCP HPLC Method B [%] | Recovery HPLC Method A [%] | Recovery HPLC Method B [%] | PSMA I&T & related substances [µg/V] (method A)* | TLC System1 Impurity [%] | TLC System2 Impurity [%] |
|---|---|---|---|---|---|---|---|
1 | 96.4 | 96.4 | 101.7 | 101.3 | 94 | 0.02 | 0.14 |
2 | 96.6 | 95.3 | 100.8 | 99.3 | 84 | 0.03 | 0.04 |
3 | 97.3 | 95.8 | 100.8 | 99.1 | 119 | 0.02 | 0.03 |
4 | 97.1 | 96.8 | 99.6 | 98.9 | 103 | 0.01 | 0.03 |
5 | 96.3 | 95.2 | 98.1 | 102.5 | 79 | 0.10 | 0.08 |
6 | 97.7 | 97.8 | 101.1 | n.d | n.d | 0.01 | 0.02 |
7 | 96.5 | 96.3 | 98.7 | 98.9 | 87 | 0.08 | n.d |
8 | 97.0 | 96.8 | 99.1 | 99.9 | 123 | 0.01 | 0.03 |
Mean | 96.88 | 96.31 | 99.99 | 99.96 | 98.3 | 0.04 | 0.05 |
Sd | 0.49 | 0.86 | 1.30 | 1.40 | 17.3 | 0.04 | 0.04 |