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radiopharmaceutical purity - retraction
I made a mistake on stating that the _FDA_ has limits on radionulidic
impurities. The limits, for all aspects of a pharmaceutical, are submitted
to the FDA as part of a New Drug Application (NDA). The FDA then reviews the
specifications. If the NDA is approved, then those specifications must be
met for production of the radiopharmaceutical. Therefore, radionuclidic
impurity limits may differ between us (Mallinckrodt), DuPont and Amersham.
Sorry for any confusion. Next time I'll check before opening my mouth.
Roger Moroney
Health Physicist
Mallinckrodt, Inc.
314.654.7457 voice
314.654.7571 fax
roger.moroney@mkg.com
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