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12.3 99m Tc-Labeled Colloids ............................ 201 12.3.1 99m Tc-Labeled Microcolloids I. Zolle ......................... 201 12.3.1.1 99m Tc-Tin Colloid (Size Range: 0.2±0.8 lm) ................ I. Zolle 201 12.3.1.2 99m Tc-Rhenium Sulfide Colloid ........................ I. Zolle 207 12.3.1.3 99m Tc-Albumin Microcolloid I. Zolle ......................... 213 12.3.1.4 99m Tc-Albumin Millimicrospheres I. Zolle ..................... 218 12.3.2 99m Tc-Labeled Nanocolloids ......................... 224 12.3.2.1 99m Tc-Rhenium Sulfide Nanocolloid I. Zolle .................... 224 12.3.2.2 99m Tc-Albumin Nanocolloid .......................... I. Zolle 230 12.4 12.4.1 12.4.2 12.5 12.5.1 12.5.2 12.6 12.7 12.7.1 12.7.2 99m Tc-Labeled Myocardial Perfusion Agents .............. 237 99m Tc-MIBI (Methoxyisobutyl Isonitrile) F. Raki—s and I. Zolle .................. 237 99m Tc-Tetrofosmin ................................ 245 J. Imre and I. Zolle 99m Tc-Labeled Brain Perfusion Agents .................. 251 99m Tc-HMPAO (Hexamethylpropylene Amine Oxime) ......... F. Raki—s and I. Zolle 251 99m Tc-ECD (Ethyl Cysteinate Dimer) .................... 260 J. Imre and I. Zolle 99m Tc-Labeled Leukocytes .......................... 266 I. Zolle and Gy. J—noki 99m Tc-Labeled Bone Imaging Agents ................... 271 99m Tc-Pyrophosphate (PYP) .......................... S. Kladnik and I. Zolle 271 99m Tc-Diphosphonates ............................. 280 I. Zolle and S. Kladnik Contents XVII 12.8 99m Tc-Labeled Renal Imaging Agents .................. 291 12.8.1 99m Tc-DMSA (Dimercaptosuccinic Acid) .................. J. Kærnyei and I. Zolle 291 12.8.2 99m Tc-DPTA (Diethylenetriaminepentaacetate) J. Kærnyei and I. Zolle ............. 297 12.8.3 99m Tc-EC (Ethylene Dicysteine) ........................ J. Kærnyei 303 12.8.4 99m Tc-MAG3 (Mercaptoacetyltriglycine) F. Raki—s and I. Zolle .................. 308
Page 2: Ilse Zolle Editor Technetium-99m Ph
Page 6: Ilse Zolle Department of Medicinal/
Page 10: VI Foreword The pathway to assuring
Page 14: Preface 99m Tc pharmaceuticals mark
Page 18: Contents Part I 1 Drug Safety .....
Page 22: Contents XV 6.2.5 Quality Control .
Page 28: XVIII Contents 12.9 12.9.1 99m Tc-L
Page 32: XX List of Contributors Hans-Juerge
Page 36: I. Zolle Chapter 1 Drug Safety 1 Th
Page 40: Sterile labeling units (kits) and c
Page 44: 8 2.1 99m Technetium Chemistry 2.1.
Page 48: 10 2.1 99m Technetium Chemistry Tab
Page 52: 12 2.1 99m Technetium Chemistry 2.1
Page 56: 14 2.1 99m Technetium Chemistry Fig
Page 68: 20 2.1 99m Technetium Chemistry 2.1
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24 2.1 99m Technetium Chemistry Hol
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26 2.1 99m Technetium Chemistry Sub
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28 2.2 The Technetium and Rhenium T
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40 2.3 Technetium Coupled to Biolog
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60 3.1 Introduction Fig. 3.1. Reduc
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62 3.2 Stannous Chloride: the Prefe
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64 3.2 Stannous Chloride: the Prefe
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66 References Noronha OPD (1978) Ti
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68 4.2 Definitions · Sterility ·
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70 4.2 Definitions Other relevant G
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72 Appendix QC on Products Intended
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74 Appendix Ph. Eur. 5.0 USP 28 Str
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I. Zolle Chapter 5 Performance and
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The 99 Mo parent radionuclide decay
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Chapter 5 Performance and Quality C
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Calculation of the available 99m Tc
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2. Purity of generator eluate (Ph.
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96 6.2 Kit Preparations approved co
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98 References Radiochemical purity
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100 7.2 Principles of Lyophilizatio
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102 References 7.3.4The Vacuum Pump
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104 8.2 Red Blood Cells Technetium
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106 8.2 Red Blood Cells Fig. 8.2. T
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108 8.3 Platelets Table 8.2. Clinic
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110 8.3 Platelets Fig. 8.6. Anticoa
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112 8.3 Platelets (Sinzinger et al.
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114 8.4 White Blood Cells 8.4White
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116 8.4 White Blood Cells 1993; Bec
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118 8.5 Conclusions Peptides, prote
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120 References Eckleman W, Richards
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122 References Wagner X, Granegger
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124 9.1 Determination of Radiochemi
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144 9.2 Determination of Tin(II) 9.
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146 9.3 Sterility Testing of Radiop
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148 9.4 Pyrogen Testing of Radiopha
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150 9.4 Pyrogen Testing of Radiopha
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152 10.3 Methods of Separation Tabl
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Chapter 11 The Rules Governing Medi
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an application has been submitted.
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11.2 The European Pharmacopeia A. V
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training courses, public inquiries,
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larly faced with substantial diffic
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References Chapter 11 The Rules Gov
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Chapter 12 Monographs of 99m Tc Pha
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Time of Examinations · Thyroid sci
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Pharmacokinetic Data Chapter 12 Mon
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The effective dose in adults (70 kg
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12.2 99m Tc-Labeled Human Serum Alb
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cation is no longer accepted. The p
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The absorbed radiation dose to the
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12.2.2 99m Tc-Albumin Macroaggregat
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tein concentration to 1 mg of MAA p
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Results of 99m Tc-MAA analysis (12
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Fractions with distinct size ranges
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99m Tc-HAM should not be injected t
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HSA microspheres with a size distri
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Rhodes BA, Stern HS, Buchanan JW, Z
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Additional Information 99m Tc-tin c
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ide is rapidly cleared from the cir
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12.3.1.2 99m Tc-Rhenium Sulfide Col
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coprecipitates with larger aggregat
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surement of plasma clearance, a hig
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12.3.1.3 99m Tc-Albumin Microcolloi
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99m Tc-albumin microcolloid is iden
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99m Tc eluate used for labeling the
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99m Tc-milli-HAM (%) =100 ± F wher
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Description of the Kit 99m Tc-(Re)-
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99m Tc-(Sn)-sulfide nanocolloid is
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tion site has been calculated as 40
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99m Tc eluate used for labeling the
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thetic agents or hyaluronidase prio
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Data on the acute toxicity of intra
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12.4 99m Tc-Labeled Myocardial Perf
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The performance of myocardial scint
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· Apply 1 drop of ethanol (95%), u
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The mechanism of localization in va
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12.4.2 99m Tc-Tetrofosmin J. Imre a
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The performance of myocardial scint
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Pharmacokinetic Data The lipophilic
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Sridhara B, Sochor H, Rigo P, Braat
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Stabilization of the 99m Tc-HMPAO c
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A comparison of results obtained wi
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Description of the Kit The kit form
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Procedure: · Pour enough ethyl ace
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References Brass LM, Walovitch RC,
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D (%)=%(A + C + D + E) ± % (A + C
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12.7 99m Tc-Labeled Bone Imaging Ag
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Description of the Kit Kits contain
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Legal Aspects. Quality requirements
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Radiation Dose 99m 99m Tc-PYP is us
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99m Tc-HEDSPA (Hydroxyethylidene di
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5.5 and 7.5. Thirty minutes later,
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Legal Aspects. Quality requirements
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EHDP, MDP, and HDP, differing by th
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12.8 99m Tc-Labeled Renal Imaging A
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Recommended Activities for Indicati
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Pentavalent 99m Tc(V)-DMSA differs
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12.8.2 99m Tc-DPTA (Diethylenetriam
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and 10% of the nebulized activity.
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Pharmacokinetic Data After intraven
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Wagner HNJr (1995) Regional ventila
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also evaluated for the diagnosis of
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Radiation Dose Kidneys, bladder wal
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· Method 2: To obtain higher activ
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Quality Control Radiochemical Purit
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The renal clearance is dependent on
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Van Duzee BF, Bugaj JE (1981) The e
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Additional Information Chapter 12 M
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Results of analysis (12 samples) Re
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crease in the radiation absorbed do
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The vial must not be cooled under r
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A fraction of the injected activity
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Preparation The carcinoembryonic an
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The analysis should be performed pr
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Wegener W, Petrelli NJ, Serafini A,
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340 Appendix 1 Table A.2. European
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342 Appendix 1 Webber D, Zimmer AM,
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344 Appendix 2 France: Service Mede
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