| Abstract | [1. Introduction] With the experience of the pharmaceutical and fine chemicals industries as a background, radiopharmaceutical manufacturers have from the first applied controls to the purity of their products. Awareness of the standards required, and the means to achieve them and to test them, have emerged only gradually. Enough is now known to merit a detailed review of the subject. The term purity, as applied to a radiopharmaceutical, can include radionuclidic purity (widely referred to as radioisotopic purity), radiochemical purity and chemical purity, together with the normal pharmaceutical requirements of sterility and freedom from pyrogens. [2. Radionuclidic Purity] (Note: The term 'radioisotope' is used almost universally in contexts where the term 'radionuclide' should be employed. It is not surprising therefore that the term 'radioisotopic purity' is used where 'radionuclidic purity' is meant. The author has a strong preference for the term 'radionuclidic purity', as the term 'radioisotopic purity' can lead to ambiguities. The term 'radiochemical purity' has often been used in the past, and indeed is still used, to denote what we now term 'radionuclidic purity'.) |
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