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Sectionpm E] Analytical Кгейг“' Control Radiopharmaceuticals

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Sectionpm E] Analytical Кгейг“' Control Radiopharmaceuticals section P m e ] Analytical кгейг“' Control i - ¡ Q f Radiopharmaceuticals Proceedings of a Panel Vienna, • ° 7-11 July 1969 INTERNATIONAL ATOMIC ENERGY AGENCY, VIENNA, 1970 ANALYTICAL CONTROL OF RADIOPHARMACEUTICALS The following States are Members of the International Atomic Energy Agency: AFGHANISTAN GREECE .NORWAY ALBANIA GUATEMALA PAKISTAN ALGERIA HAITI PANAMA ARGENTINA HOLY SEE PÂRAGUAY AUSTRALIA HUNGARY PERU AUSTRIA ICELAND PHILIPPINES BELGIUM INDIA POLAND BOLIVIA INDONESIA PORTUGAL BRAZIL IRAN ROMANIA BULGARIA IRAQ' SAUDI ARABIA BURMA IRELAND SENEGAL BYELORUSSIAN SOVIET ISRAEL SIERRA LEONE SOCIALIST REPUBLIC ITALY SINGAPORE CAMBODIA IVORY COAST SOUTH AFRICA CAMEROON JAMAICA SPAIN CANADA JAPAN SUDAN CEYLON JORDAN SWEDEN CHILE KENYA SWITZERLAND CHINA KOREA, REPUBLIC OF SYRIAN ARAB REPUBLIC COLOMBIA KUWAIT THAILAND CONGO, DEMOCRATIC LEBANON TUNISIA REPUBLIC OF LIBERIA TURKEY COSTA RICA LIBYAN ARAB REPUBliC UGANDA CUBA LIECHTENSTEIN UKRAINIAN'SOVIET SOCIALIST CYPRUS LUXEMBOURG REPUBLIC CZECHOSLOVAK SOCIALIST MADAGASCAR UNION OF SOVIET SOCIALIST REPUBLIC MALAYSIA REPUBLICS DENMARK MALI UNITED ARAB REPUBLIC DOMINICAN REPUBLIC MEXICO UNITED KINGDOM OF GREAT ECUADOR MONACO BRITAIN AND NORTHERN EL SALVADOR MOROCCO IRELAND ETHIOPIA NETHERLANDS UNITED STATES OF AMERICA FINLAND NEW ZEALAND URUGUAY FRANCE NICARAGUA VENEZUELA GABON NIGER VIET-NAM GERMANY, FEDERAL REPUBLIC OF NIGERIA YUGOSLAVIA GHANA *• ZAMBIA The Agency’s Statute was approved on 23 October 1956 by the Conference on the Statute of the IAEA held at United Nations Headquarters, New York; it entered into force on 29 July 1957. The Headquarters of the Agency are situated in Vienna. Its principal objective is "to accelerate and enlarge the contribution of atomic energy to peace, health and prosperity throughout the world". Printed by the IAEA in Austria July 1970 PANEL PROCEEDINGS SERIES ANALYTICAL CONTROL OF RADIOPHARMACEUTICALS PROCEEDINGS OF A PANEL ON ANALYTICAL CONTROL OF RADIOPHARMACEUTICALS ORGANIZED BY THE INTERNATIONAL ATOMIC ENERGY AGENCY AND HELD IN VIENNA, 7-11 JULY, 1969 INTERNATIONAL ATOMIC ENERGY AGENCY VIENNA, 1970 ANALYTICAL CONTROL OF RADIOPHARMACEUTICALS IAEA, VIENNA, 1970 STI/PUB/253 FOREWORD Many countries are now producing radioisotopes and labelled compounds, and it is a common experience that the bulk of such materials is for medical use. Any chemical, whether radioactive or not, which is intended for ad­ ministration to patients must be regarded as being a drug'and thus should be subject to rigorous and stringent quality control. To ensure that the necessary information is made available, the Inter­ national Atomic Energy Agency convened in Vienna on 7 - 11 July 1969 a panel of experts on the Analytical Control of Radiopharmaceuticals.- The panel was attended by 25 participants from 14 Member States and three inter­ national organizations. The panel participants represented producers and users of radiopharmaceuticals, developed and developing countries,and a variety of professions. Since the matter is of interest to the International Atomic Energy Agency and to the World Health Organization, both have collaborated in the evalua­ tion of the analytical methods used for the control of radiopharmaceuticals. The World Health Organization was among the international organizations represented at the panel meeting. It is hoped that the present book, containing the papers presented at the panel, will be found useful to the nuclear centres of both developed and developing countries which are producing radiopharmaceuticals, and will create a widespread awareness of the need for careful quality control. It is also hoped that the publication will facilitate the incorporation of the neces­ sary specifications and regulations in the -various national and international pharmacopoeia. CONTENTS Purity criteria and general specifications of radiopharmaceuticals (IAEA PL-336/1).......................................................................................... 1 Y . Cohen Quality control of radiopharmaceuticals and its organizational aspects (IAEA-PL-336/2) ................................................................. .. 31 V.K. I y a and N.G.S. Gopal Analytical control of radiopharmaceuticals by the Spanish Nuclear Energy Board (JEN) (IA EA -PL-336/3)................................................ 51 M. del Val Cob, D.V. Rebollo Garrido and F. Casas Medina Methods of testing radiopharmaceuticals used by the Argentine National Atomic Energy Commission (IAEA-PL-336/4)............. 61 A.E.A.- Mitta and R. Radicella Analytical control of radiopharmaceuticals in Norway (IAEA-PL-336/5)................; ....................................................................... 63 E.Steinnes Analytical control of radiopharmaceuticals in the Department of Chemistry, Reactor Centre, Seibersdorf (IAEA-PL-336/6). .. 69 H. Sorantin Quality control and chemical analysis of radiopharmaceuticals at a small research centre (IAEA-PL-336/7)........................................ .. 83 Y . S. Kim Role of the hospital radiopharmacy (IAEA-PL-336/8)........................... 99 J'. L . Quinn III Testing procedures for individual batches of radiopharmaceuticals (IA E A -P L -336/9)........................................................, ............................... I ll K . Frühauf Limits of accuracy in the determination of purity by thin-layer and ' paper chromatography (IAEA-PL-336/10)........................................ 115 С . E . Me llis h Determination of inorganic radioiodides in 131I~labelled compounds -by means of thin-layer chromatography (IAEA-PL-336/11). 127 J . Alvarez, N.G.B. de Salas, P. Raban and A.E.A. Mitta Self-decomposition of some 131I-labelled radiopharmaceuticals (IAEA-PL-336/12)...................................... ................................................. 131 I. Galatzeanu and G.B. Cook Radiochemical purity and stability of some radiopharmaceuticals (IA EA -PL-336/13)........................................................................................ 153 J . С i f к a Degradation of 131I-hippuran, 131I-lipiodol, 131I-Rose Bengal and 198 Au colloidal gold (IA EA -PL-336/14)............................................... 181 F . Casas Medina, D.V. Rebollo Garrido and M. del Val Cob Possible artifacts in the chromatographical determination of radio­ chemical purity of 35S- and 75Se-labelled methionine (IA EA -PL-336/15)....................................................................................... 189 I. Galatzeanu Radiometric titration of inactive and radio-pharmaceuticals (IAEA-PL-336 /16)....................................................................................... 201 J. Tölgyessy and T. Braun Summary of the activities of COMECON with regard to the control of radioactive medical products (IA EA -PL-336/17)......................... 213 D. Ostrovski Conclusions and Recommendations of the P an el....................................... 217 List of Participants.............................................................................................. 221 IAEA-PL-336/1 PURITY CRITERIA AND GENERAL SPECIFICATIONS OF RADIOPHARMACEUTICALS Y . COHEN CEA Centre d'Etudes de Saclay, Gif-sur-Yvette, France Abstract PURITY CRITERIA AND GENERAL SPECIFICATIONS OF RADIOPHARMACEUTICALS. A limiting definition of radiopharmaceuticals is given. They are defined as compounds (radionuclides or labelled compounds) intended for administration to human beings for therapeutic or diagnostic purposes. Sealed sources are not considered as radiopharmaceuticals. The useful purity criteria, i.e. radionuclide, radiochemical and chemical purity, are distinguished and explained. The general methods of quality control are briefly reviewed and their limitations indicated. Various radiopharmaceuticals for different uses are described, including solutions for oral administration and parenteral injection, capsules and isotope generators. The purity criteria applied will differ, depending on the accuracy of the available production methods and the intended m edical use. Specifications laid down by the World Health Organization (WHO) and national pharmacopoeias may vary slightly from country to country without any adverse effect on the users and without the intrinsic quality of the radiopharmaceutical products in question being affected. 1. PRESENT POSITION The quality control of radiopharmaceutical substances raises a number of interrelated problems which are frequently the responsibility of different authorities and administrative bodies. These problems may be classified under the following headings: technical, medical, administrative, legal and international. The technical reasons for quality control are connected with the desire of producers to ensure that their products are able to satisfy market requirements. Hospital services which are users of radiopharmaceuticals see in quality control a guarantee that these products are harmless for admini­ stration to their patients and an assurance that the therapeutic results will not give rise to undesirable side effects and that the diagnostic indications will not be impaired by errors attributable to poor quality of the products. The administrative departments of health ministries responsible for pharmaceutical substances insist that radiopharmaceutical products should be subject to control and should satisfy the purity criteria laid down by the pharmacopoeia commissions with a view to protecting public health in general. A concept of legal liability enters at this point and in case of culpable negligence
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