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Contents XV
6.2.5 Quality Control ................................... 97
6.2.6 Dispensing ...................................... 98
7 Lyophilization Technique for Preparing Radiopharmaceutical Kits ... 99
E. Chiotellis
7.1 History of the Lyophilization Technique .................. 99
7.2 Principles of Lyophilization .......................... 100
7.3 Apparatus for Freeze-Drying ......................... 101
7.3.1 The Drying Chamber ............................... 101
7.3.2 The Ice Condenser ................................ 101
7.3.3 The Refrigeration Unit .............................. 101
7.3.4 The Vacuum Pump ................................ 102
8 Cellular Labeling with 99m Tc Chelates: Relevance of In Vitro
and In Vivo Viability Testing .............................. 103
H. Sinzinger, M. Rodrigues
8.1 Introduction .................................... 103
8.2 Red Blood Cells .................................. 103
8.3 Platelets ....................................... 108
8.4 White Blood Cells ................................. 114
8.5 Stem Cells ...................................... 118
8.6 Conclusions ..................................... 118
9 Quality Control Methods of 99m Tc Pharmaceuticals .............. 123
9.1 Determination of Chemical Purity ...................... 123
9.1.1 Thin-Layer Chromatography
C. Decristoforo, I. Zolle
.......................... 123
9.1.2 Column Chromatography ............................
F. Raki—s, J. Imre
136
9.1.3 Electrophoresis ...................................
J. Imre
143
9.2 Determination of Tin(II) ............................. 144
F. Raki—s
9.3 Sterility Testing of Radiopharmaceuticals .................
S. R. Hesslewood
146
9.3.1 Problems in Applying European Pharmacopeia Test to
Radiopharmaceuticals .............................. 146
9.3.2 Recommendations for Sterility Testing of Radiopharmaceuticals .. 147
9.3.3 Frequency of Testing ............................... 148
9.4 Pyrogen Testing of Radiopharmaceuticals
S. R. Hesslewood
................ 148
9.4.1 Recommendations for Endotoxin Determinations
of Radiopharmaceuticals ............................. 149