Transcription of RADIOPHARMACEUTICALS - WHO
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Document November 2008 RADIOPHARMACEUTICALS Final text for addition to T he International Pharm acopoeia (November 2008) This text was adopted at the Forty-third WHO Expert Committee on Specifications for Pharmaceutical Preparations in October 2008 for addition to the 4th edition of The International Pharmacopoeia. Contents Introduction Monographs General monograph Specific monographs Methods of Analysis Supplementary Information Introduction RADIOPHARMACEUTICALS are unique medicinal formulations containing radioisotopes which are used in major clinical areas for diagnosis and/or therapy. The facilities and procedures for the production, use, and storage of RADIOPHARMACEUTICALS are subject to licensing by national and/or regional authorities.
container, it should be used within 24 hours of aseptic withdrawal of the first dose. Radiopharmaceutical injections for which the shelf-life is greater than one day and that do contain an antimicrobial preservative may be supplied in multidose containers.
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