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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

From: A new two-strip TLC method for the quality control of technetium-99m mercaptoacetyl-triglycine (99mTc-MAG3)

  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
  1. *Lipophilic impurities are attributed to the SEP-PAK cartridge activity.
  2. **Refers to 99mTc-perchtechnetate in the SPC