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Australian Atomic Energy Commission Research Establishment AAEC/Ml 03 AUSTRALIAN ATOMIC ENERGY COMMISSION RESEARCH ESTABLISHMENT LUCAS HEIGHTS RESEARCH LABORATORIES THE QUALITY CONTROL OF TECHNETIUM-99m RADIOPHARMACEUTICALS PRODUCED AT THE AAEC RESEARCH ESTABLISHMENT by K.J. FARRINGTON August 1983 ISBN 0 642 59778 2 AUSTRALIAN ATOMIC ENERGY COMMISSION RESEARCH ESTABLISHMENT LUCAS HEIGHTS RESEARCH LABORATORIES THE QUALITY CONTROL OF TECHNETIUM-99m RADIOPHARMACEUTICALS PRODUCED AT THE AAEC RESEARCH ESTABLISHMENT by K.J. FARRINGTON ABSTRACT The methods of quality control used for technetium-99m radiopharmaceuticals produced at the AAEC Research Establishment are described for both non-fission and fission derived sources of sodium pertechnetate ( Tc), technetiurn-99m labelled radiopharmaceuticals, and reagent kits produced for technetium-99m labelling. National Library of Australia card number and ISBN 0 642 59778 2 The following descriptors have been selected from the INIS Thesaurus to describe the subject content of this report for information retrieval purposes. For further details please refer to IAEA-INIS-12 (INIS: Manual for Indexing) and IAEA-INIS-13 (INIS: Thesaurus) published in Vienna by the International Atomic Energy Agency. AAEC; IMPURITIES; PERTECHNETATES; QUALITY CONTROL; RADIOPHARMACEUTICALS; TECHNETIUM 99 CONTENTS 1. INTRODUCTION 1 2. SODIUM PERTECHNETATE (99mTc) STOCK SOLUTIONS 2 2.1 Description 2 2.2 Radioactive Concentration 2 2.3 Radionuclidic Purity 3 2.4 pH 3 2.5 Heavy Metals 4 2.6 Ketones 5 2.7 Aluminium Ions 6 2.8 Radiochemical Purity 7 2.9 Appearance 7 3. SODIUM PERTECHNETATE (99mTc) INJECTION 7 3.1 Description 7 3.2 Radioactive Concentration 8 3.3 pH 8 3.4 Radiochemical Purity 9 3.5 Heavy Metals 10 3.6 Biological Function Test 11 3.7 Autoclaving 11 3.8 Autoclave and Pyrogen Tests 11 3.9 Isotonicity 11 4. SODIUM PERTECHNETATE (99mTc) FROM GENERATORS 12 4.1 Description 12 4.2 Radionuclidic Purity of Molybdic (99Mo) Acid Solution 12 4.3 Molybdenum (99Mo) Specific Activity 13 4.4 Radioactive Concentration 13 4.5 Radionuclidic Purity 13 4.6 Elution Efficiency 14 4.7 pH 14 4.8 Appearance 15 4.9 Radiochemical Purity 15 4.10 Aluminium Ions 15 4.11 Chromium Ions 15 4.12 Nitrate Ions 16 4.13 Alpha-emitters 17 4.14 Strontium-89/Strontium-90 18 4.15 Long-lived Gamma-emitters 20 4.16 Sterility 21 4.17 Generator Performance 21 5. TECHNETIUM-99m SULPHIDE COLLOID 21 5.1 Description 21 5.2 Radioactive Concentration 21 5.3 pH 22 5.4 Radlochemical Purity 22 5.5 Rhenium 23 5.6 Appearance 23 5.7 Autoclaving 24 5.8 Autoclave and Pyrogen Tests 24 5.9 Biological Function Test 24 6. TECHNETIUM-99m LABELLED MACROAGGREGATED FERROUS HYDROXIDE 24 6.1 Description 24 6.2 Radioactive Concentration 24 6.3 pH 25 6.4 Appearance 25 6.5 Particle Size Distribution 25 6.6 Radiochemical Purity 26 6.7 Autoclaving 26 6.8 Autoclave and Pyrogen Tests 26 6.9 Biological Function Test 27 7. LYOPHILISED PENTASTAN REAGENT 27 7.1 Description 27 7.2 pH of Pentastan Bulk Solutions 27 7.3 DTPA Assay on Pentastan Bulk Solutions 27 7.4 Total and Stannous Tin Assays on Pentastan Bulk Solutions 27 7.5 Radiochemical Purity 28 7.6 pH 29 7.7 DTPA Assay 29 7.8 Total and Stannous Tin 30 7.9 Water Content 30 7.10 Sterility and Pyrogen Tests 31 7.11 Biological Function Test 32 7.12 Expiry Time 32 8. LYOPHILISEO RENAL AGENT 32 8.1 Description 32 8.2 pH of Renal Agent Bulk Solution 32 8.3 Calcium Gluconate Assay on Renal Agent Bulk Solution 32 8.4 Total and Stannous Tin Assay on Renal Agent Bulk Solution 33 8.5 Radiochemical Purity 33 8.6 pH 34 8.7 Calcium Gluconate Assay 34 8.8 Total and Stannous Tin 35 8.9 Water Content 35 8.10 Sterility and Pyrogen Tests 36 8.11 Biological Function Test 36 8.12 Expiry Time 36 9. REAGENT SOLUTIONS 36 10. STARTING MATERIALS 36 11. MICROBIOLOGICAL TESTING 37 12. REFERENCES 37 1. INTRODUCTION Technetium-99m Is one of the most widely used radionuclides in nuclear medicine. It has the advantage of a short half-life of 6.02 h, coupled with a low but readily detectable energy of 0.14 MeV. These properties enable the administration of high levels of activity but the patient is subjected only to a relatively low radiation dose. Technetiurn-99m is the daughter product of molybdenum-99, an isotope which can be prepared by two alternative nuclear reactions: 98 99 (i) Mo(n,Y) Mo ; (ii) 235'J (n, fission) "MO . Both methods are used at the AAEC Research Establishment. Technetium-99m is separated from the (n,y) Mo by a methyl ethyl ketone (MEK) extraction from an alkaline solution. The molybdenum-99 produced in the fission process is chemically separated and purified to remove uranium and fission contaminants produced in the reaction. The molybdenum-99 is adsorbed onto an aluminium oxide column from which the technetium-99m is removed by saline elution. The technetium-99m obtained from each method is used to manufacture radiopharmaceuticals that are despatched daily to customers within Australia. Fission-produced molybdenum-99 is also used to make chromatography generators which are despatched each week. Both types of technetium-99m have to meet different specifications to fulfil the recommendations of the British Pharmacopoeia (B.P.). As well as producing sodium pertechnetate ( Tc) injections of various strengths, the AAEC manufactures a technetium-99m labelled sulphide colloid for liver scanning and a technetiurn-99m labelled macroaggregated ferrous hydroxide lung scanning agent. Two scanning kits, Renal Agent and Pentastan, are manufactured by the AAEC for labelling with sodium pertechnetate (99mTc) injection. The manufacturing methods are described in a series of master formulations'- -" as also are the quality control methods'-2^. The quality control methods used by the AAEC for testing technetium-99m products have been selected on the basis that they are suitable for determining the limits specified in the B.P. They have been developed to minimise radiation hazards; to give a rapid reproducible test; to limit sample size; and to utilise modifications and procedures conditioned by the availability of instruments and trained personnel. Some methods used by the AAEC for the quality control of radiopharmaceuticals have been described elsewhere1-P3 J1. General aspects of the quality control of technetium-99m labelled radiopharmaceuticals have also been documented"- •*. 2. SODIUM PERTECHNETATE (99tnTc) STOCK SOLUTIONS 2.1 Description The stock solutions of sodium pertechnetate ( Tc) are obtained in QQ saline form from (n,y) Mo using the MEK extraction procedure, and from (n,f) 99Mo using the chromatography generator method. The quality control methods have been described by Farrington • 2.2 Radioactive Concentration The radioactive concentration is calculated for 0900 hours on the date of use. Procedure A 1 ml sample contained in a sealed and capped, uniform wall, glass vial is measured in an ion chamber which has been calibrated for technetium-99m. The calibration activity is then calculated as follows: -0.115t Ac = Am where Ac is the activity at the calibration time, Am is the activity at the measurement time, and the decay constant for technetium-99m, based on a half- life of 6.02 h is 0.115. 2.3 Radionuclidic Purity The radionuclidic purity is determined by gamma spectroscopy, using a lithium germanium crystal detector connected to a pile-up rejector amplifier and a 4096 channel pulse height analyser. The spectrometer is linked to a PDP11/23 computer with a print-out facility. Nuclides are identified and quantified from a library'-6-' of the radioisotopes likely to be present. Unassigned energy peaks are also reported. For technetiurn-99m obtained by MEK extraction, the molybdenum-99 content must be less than 0.1 per cent, rhenium-188 less than 0.01 per cent, and all other nuclides less than 0.01 at 2359 hours on the day of calibration (i.e. the expiry time). For fission-produced technetium-99m, the molybdenum-99 content must be less than 0.1 per cent, iodine-131 less than 0.005 per cent, and all other gamma-ray emitters less than 0.01 per cent at the expiry time. The most prominent gamma photon in technetium-99m has an energy of 0.140 MeV, and those of molybdenum-99 have energies of 0.181, 0.740 and 0.778 MeV. The gamma spectrometer is calibrated using a holmium-166m source^ ^. Procedure A 1 ml sample of the sodium pertechnetate ( mTc) stock solution in a sealed glass counting vial is placed in a calibrated lead pot and counted for 1000 s. The data are evaluated using the appropriate library and the results printed out. Note: The term 'appropriate library' indicates a library suitable for detecting gamma-emitting isotopes in the technetium-99m solution from either the fission or non-fission process. Lead pots of different thicknesses are used to examine the technetium-99m solutions obtained from the different processes. The lead pot thickness is taken into account when calculating the amount of each gamma-emitting isotope detected. 2.4 £H The pH must be 4.5 to 7.5. Procedure The pH of the solution is measured behind the lead glass window of a fume hood, using an appropriate indicator'paper. 2.5 Heavy Metals Because of the extremely high radioactive concentration of the stock solution, a spot test is used to detect heavy metals in the solution; the heavy metal content should not be greater than 40 mg L~ (40 ppm). Further tests for heavy metals are carried out at the 10 mg L" (10 ppm) level in decayed samples of sodium pertechnetate ( mTc) injection.
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