| Ph.Eur. | Mallinckrodt Technescan MAG3™ Kit for the Preparation of Technetium Tc 99m Mertiatide, DRN 4334 | ||||||
---|---|---|---|---|---|---|---|---|
Version | 01/2008:1372(European Pharmacopoeia Edition 7.0, 2008) | CH 10.2003 (Package insert for Technescan MAG3. Mallinckrodt Suisse SA, 2003) | CH 12.2015 (Package insert for Technescan MAG3. Mallinckrodt Suisse SA, 2015) | US A096I0 R10/2015 (Package insert for Technescan MAG3, 2015) | The Netherlands 10.2015 (Package insert for Technescan MAG3, 2015) | |||
Method | HPLC + PC | HPLC | Sep-Pak C18 | HPLC | Sep-Pak C18 | Sep-Pak C18 only | HPLC | Sep-Pak C18 |
 | [%] | [%] | [%] | [%] | [%] | [%] | [%] | [%] |
Tc-Mag3 Dt:0 | ≥ 94 | ≥ 96 | ≥ 90 | ≥ 95 | ≥ 94 | ≥ 90 | ≥ 95 | ≥ 90 |
hydrophilic impurities | ≤3 | % not def. | ≤ 5 |  | ≤ 3 | % not def. | ≤ 3 | ≤ 5 |
Lipophilic impurities | ≤4 | % not def. | ≤ 5 |  | ≤ 4 * | Not measured | ≤ 4 | ≤ 5 |
Colloïd.Tc-99m (non-elutable imp.) | ≤2 (PC) | Not measured | Not measured | Not measured | Not measured | % not def. | Not measured | Not measured |