Table 2 RPC testing methods for ROTOP MAG3 kit preparations available in Switzerland, European countries, the US (Package insert for ROTOP-MAG-3 Kit. Heider AG, 2006; Package insert for ROTOP-MAG-3 Kit, n.d.-a; Package insert for ROTOP-MAG-3 Kit, n.d.-b) in comparison to the method of the Ph.Eur. (European Pharmacopoeia Edition 7.0, 2008). Each method requires detection of the sum of liphophilic and hydrophilic impurities, except for the Rotop method from 2016 (only available for EU countries) where detection of colloidal 99mTc ((99mTcO2)n) as an individual impurity is specified and acceptance criteria are set separately
| Â | Ph.Eur. | Â | MAG3 Kit Rotop | Â | |||
|---|---|---|---|---|---|---|---|
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 |
| Â | [%] | [%] | [%] | [%] | [%] | [%] | [%] |
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 |