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Pharmaceutical grade sodium [99mTc] pertechnetate from low specific activity 99Mo using an automated 99Mo/99mTc-TCM-autosolex generator
Authors:Sankha Chattopadhyay  Luna Barua  Sujata Saha Das  Anirban De  Umesh Kumar  Arpit Mitra  Tapas Mallick  Madhusmita  Md. Alam Nayer  Samarendu Sinha  Bharat Ratna Sarkar  Shantanu Ganguly  Kakali De  Malay Kanti Das  M. G. R. Rajan
Affiliation:1. Radiopharmaceuticals Laboratory, Board of Radiation & Isotope Technology (BRIT), Variable Energy Cyclotron Centre (VECC), 1/AF, Bidhan Nagar, Kolkata, 700 064, India
2. Variable Energy Cyclotron Centre, 1/AF, Bidhan Nagar, Kolkata, 700 064, India
4. Radiation Medicine Centre, BARC/BRIT, Parel, Mumbai, 400012, India
3. Regional Radiation Medicine Centre, Variable Energy Cyclotron Centre, 1/AF, Bidhan Nagar, Kolkata, 700 064, India
5. Nuclear Medicine Department, Indian Institute of Chemical Biology, Jadavpur, Kolkata, 700032, India
Abstract:Performance study of a computer controlled automated closed cyclic module for the separation and recovery of 99mTc from low specific activity (n, γ) 99Mo using methyl ethyl ketone (MEK) solvent extraction technique named 99Mo/99mTc-TCM-AUTOSOLEX (Technetium automated solvent extraction) Generator is described. The entire system is automated and controlled by a user-friendly PC based graphical user interface that actually supervises process via an embedded system based electronic controller. The average yield of separation of 99mTc was above 85 % and 99Mo breakthrough in 99mTc pertechnetate was <0.002 %. The sodium pertechnetate obtained was a clear solution having pH 6–7, Radiochemical (RC). Purity >99 %, MEK content <0.1 % (v/v), Al and Mo content <10 µg/ml. R. C. Purity of 99mTc-radiopharmaceuticals studied was not less than 96 %. Bio-Quality control studies confirm that sodium pertechnetate obtained was sterile and pyrogen free. Imaging studies in animals and humans with limited radiopharmaceuticals show that the quality of 99mTc-pertechenate obtained in the present module was good enough to do clinical study.
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