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VI Foreword The pathway to assuring the safe and effective use of short-lived radiotracers is to place the responsibility for quality assurance in the hands of nuclear pharmacists who fill physician's prescriptions for radiotracers as they do for other drugs under state pharmacy laws. Radiochemists or others working in institutions with radiopharmacies must have the expertise for the preparation of the radiotracers as well as for quality control under good manufacturing practices. This book provides guidance and safety standards applicable to Tc-99m pharmaceuticals. Baltimore, June 2006 Henry N. Wagner, Jr. M. D.
Page 2: Ilse Zolle Editor Technetium-99m Ph
Page 6: Ilse Zolle Department of Medicinal/
Page 12: Foreword Viewpoint of the Clinician
Page 16: Acknowledgments Dr. Ferenc Raki—s
Page 20: XIV Contents 4Quality Assurance of
Page 24: XVI Contents 10 Other Tc Isotopes:
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
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16 2.1 99m Technetium Chemistry Fig
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18 2.1 99m Technetium Chemistry Fig
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20 2.1 99m Technetium Chemistry 2.1
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22 2.1 99m Technetium Chemistry Sol
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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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