| Ph.Eur. |  | MAG3 Kit Rotop |  | |||
---|---|---|---|---|---|---|---|
Version | 01/2008:1372 Corrected 7.0 [13] | CH 06.2006 (Package insert for ROTOP-MAG-3 Kit. Heider AG, 2006) | rotop-pharmaka.de SmPC-MAG3-HK-eng-01 [16] | Eu countries 2016 (Package insert for ROTOP-MAG-3 Kit, n.d.-b) | |||
Method | HPLC + PC | HPLC | Sep-Pak C18 | HPLC + PC | Sep-Pak C18 | HPLC | TLC |
 | [%] | [%] | [%] | [%] | [%] | [%] | [%] |
Tc-Mag3 Dt:0 | ≥ 94 |  | ≥ 94 | ≥ 94 | ≥ 94 |  | ≥ 94 |
hydrophilic impurities | ≤3 | According to Ph.Eur. | % not def. | ≤ 3 | % not def. | According to Ph.Eur. | ≤ 5 ** |
Lipophilic impurities | ≤4 |  | Not measured | ≤ 4 | % not def.* |  | Not measured |
Colloïd.Tc-99m (non-elutable imp.) | ≤2 (PC) |  | % not def. | Not measured | Not measured |  | ≤ 2 |