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Table 1 RPC testing methods for Mallinckrodt Technescan MAG3 preparations available in Switzerland, European countries, the US (Package insert for Technescan MAG3. Mallinckrodt Suisse SA, 2003; Package insert for Technescan MAG3. Mallinckrodt Suisse SA, 2015; European Pharmacopoeia Edition 7.0, 2008; Package insert for Technescan MAG3, 2015; Package insert for Technescan MAG3, 2015) in comparison to the method of the Ph.Eur. (European Pharmacopoeia Edition 7.0, 2008). Each SPC method requires detection of the sum of liphophilic and hydrophilic impurities

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

  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
  1. *Lipophilic impurities are attributed to SEP-PAK cartride activity. Normally, at the end the cartridge contains only non-elutable impurities.