A SEMI-AUTOMATED ~(13)NNH_3 PRODUCTION MODULE: DESIGN, QUALITY CONTROL AND OPTIMIZATION

摘要

The compound [~(13)N] NH_3 was prepared using a home-made, cost effective prototype module meeting pharmaceutical criteria. The ~(16)O(p,a)~(13)N nuclear reaction was chosen as the best method of ~(13)N production. High purity natural water was bombarded by 18 MeV protons with a current intensity of 8 μA. A production yield of 13.5 mCi·μA~(-1)·h~(-1) was obtained. Chemical modification of [~(13)N]nitrogen oxides into [~(13)N]NH_3 was accomplished using in-house made De Varda's catalyst. Chemical, radiochemical and radionu-clide purity controls performed on the final product showed high radiopharmaceutical purity in the form of [~(13)N]NH_3 produced by a prototype production module. [~(13)N]NH_3 was formulated in normal saline media under appropriate pH and sterile conditions. Microbial and LAL tests were performed on the final product in order to assure its safety for administration to experimental subjects.