No abstract

Penentuan Kemurnian Radiokimia 99mTc-MIBI dengan Cepat Dan Praktis menggunakan Metoda Ekstraksi. Pengujian radiokimia umumnya menggunakan metoda kromatografi lapis tipis (KLT), akan tetapi memerlukan waktu pengujian lama. Oleh karena itu, perlu alternatif menggunakan metoda ekstraksi yang lebih praktis dan cepat. Pengujian dilakukan dengan cara 99mTc-MIBI diekstraksi menggunakan campuran salin dan chloroform dengan perbandingan volume = 1:1.  Campuran diekstraksi sehingga terpisah antara 99mTc-MIBI dan pengotornya, yaitu 99mTc-MIBI dalam fasa organik (Chloroform) sedangkan 99mTcO2 dan 99mTcO4- keduanya dalam fasa air (salin). Kemudian, masing-masing dicuplik dengan volume yang sama dan diukur radioaktivitasnya menggunakan Gamma Ionisation Chamber dan dihitung kemurnian radiokimianya. Hasil ekstraksi dibandingkan dengan pengujian menggunakan metoda baku KLT. Hasil penelitian menunjukkan bahwa pengujian radiokimia  kit 99mTc-MIBI menggunakan kedua metoda tersebut hasilnya hampir sama, yaitu =98,34%±0,65 (metoda baku KLT) dan 97,15%±0,56 (metode ekstraksi) dengan kepresisian pengukuran yang baik, yaitu RSD <1% (RSD metode baku KLT=0,65% dan metode ekstraksi 0,56%). Waktu pengujian yang diperlukan dengan metoda ekstraksi = 20 menit  dan metoda baku KLT =180 menit. Hasil ini menunjukkan bahwa metoda ekstraksi dapat digunakan sebagai alternatif dalam pengujian radiokimia kit MIBI. Keunggulan metoda ekstraksi adalah waktu pengujian lebih cepat dibandingkan metoda KLT.Kata kunci : Kemurnian Radiokimia, 99mTc-MIBI, metoda ekstraksi, metoda Kromatografi Lapis Tipis

Computed Tomography (CT) Scan is a means of imaging/diagnostic method which is preferable in hospitals in terms of availability, efficiency and cost. Currently, CT contrast agent most widely used is the iodinated derivatives, due to its high X-ray absorption coefficient. Contrast agent is a medical preparation used in CT-scan modality which has capability of enhancing the performance of CT-scan to differentiate between target organs and surrounding tissues, and one of them is iopamidol. Development of iopamidol contrast agent requires several steps, i.e formulation, characterization, in-vitro and in-vivo tests prior to clinical study. To do in vivo study or biodistribution study in experimental animals, a radioactive iopamidol should be used to trace the compound throughout the body to predict its pharmacokinetics, and for that purpose a radioiodine (Iodium-131 or 131I) labeled iopamidol will be used. Optimation in the synthesis of 131I iopamidol was carried out by varying pH, temperature and reaction time to obtain 131I iopamidol with high radiochemical purity of more than 90% as a requirement of radiopharmaceutical preparation. The radiolabeled product was characterized using HPLC and the labeling efficiency was measured by TLC. The optimum condition obtained was repeated 3 times and the product was tested for stability in room temperature. Characterization using HPLC showed that retention time (Rt) of radiolabeled iopamidol was close to that of native iopamidol at ∼ 6 min, indicating that 131I iopamidol was already formed. Iodium-131 labeled iopamidol has been successfully synthesized with labeling efficiency or radiochemical purity of 96% ± 1%, and the optimum condition of 131I iopamidol reaction was obtained at pH 9, temperature of 140°C in 5 minutes reaction time, and the product was stable in room temperature up to 7 days. It is concluded that radioiodinated iopamidol has been successfully synthesized and will be used in the formulation of iopamidol as a part of iopamidol contrast agent development for CT-Scan purpose.

The radiopharmaceutical kit production facilities usually use a clean room with an aseptic process. Therefore, it is very important to conduct research on clean room utilization for the production of radiopharmaceutical kits. The data was taken from radiopharmaceutical product that produced at Center for Radioisotope and Radiopharmaceutical Technology (PTRR), National Nuclear Energy Agency (BATAN) from 2015 to 2018. The results indicate the use of clean room depends on the drying duration of the radiopharmaceutical kit. Almost all radiopharmaceutical kits are dried for two days such as MIBI, MDP, Ethambutol, MAA, and Tetrofosmin kits. There are only two kits that are dried for one day, DTPA and EDTMP kits. The ratio of monitoring of drying temperatures during the drying process of DTPA kit (one day) and MDP kit (two days) shows that in 2015 the freeze dryer still showed maximum performance compared to the next three years. The optimal utilization of clean room is in 2015 as much as 100% while in 2016, 2017 and 2018 the average utilization of clean room is around 66%. The production process frequency is the lowest in June, followed by January and December due to the maintenance schedule. The longer the process of drying radiopharmaceutical kits, the longer the clean room facilities operate. The production process of radiopharmaceutical kits in 2015 is the most optimal.

VALIDASI PENGUKURAN OSMOLALITAS DENGAN MENGGUNAKAN LARUTAN STANDAR PADA ALAT AUTOMATIC OSMOMETER. Salah satu syarat sediaan farmasi khususnya sediaan injeksi intravena yaitu penentuan nilai osmolalitas. Alat yang digunakan untuk menentukan nilai osmolalitas yaitu automatic osmometer. Sebelum digunakan secara rutin untuk menentukan osmolalitas sediaan radiofarmaka, diperlukan validasi terhadap alat automatic osmometer yaitu untuk memastikan apakah hasil pengukuran alat tersebut valid atau tidak. Validasi pengukuran osmometer dilakukan dengan tiga parameter yaitu akurasi, presisi, dan  linieritas. Sebagai  obyek pengukuran diambil larutan standar 100 mOsm/kg, 290 mOsm/kg, dan 500 mOsm/kg yang masing-masing diukur sebanyak 20 kali  dan dibuat tabel akurasi, grafik presisi, dan grafik linieritas. Prosentase akurasi pada standar 100 mOsm/kg=100,05%, 290 mOsm/kg=100,05% dan 500 mOsm/kg =100,42%. Validasi presisi pengukuran standar 100mOsm/kg menunjukkan nilai ±1SD=50%, ±2SD=50%, standar 290 mOsm/kg ±1SD=80%, ±2SD=15%, dan ±3SD=5%, dan standar 500 mOsm/kg  ±1SD=75%, ±2SD=25%. Nilai linieritas pada rerata hasil pengukuran yaitu a = 1,00520, b = 0,77533 dan r2  = 0,99999. Dari hasil validasi pengukuran nilai osmolalitas larutan standar dengan  alat  automatic  osmometer  dinyatakan  alat  tersebut  valid  untuk  digunakan  dalam  pengukuran osmolalitas sediaan radiofarmaka.