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APPLICABILITY OF BACTERIAL ENDOTOXIN TEST (BET) FOR SOME RADIOPHARMACEUTICAL STERILE KITS BY THE USE OF TACHYPLEUS AMEBOCYTE LYSATE (TAL)

Jurnal Farmasi Sains dan Komunitas (Journal of Pharmaceutical Sciences and Community) Article in Press
Publisher : Sanata Dharma University

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The application of bacterial endotoxin test (BET) using TAL reagent on radiopharmaceutical kits is very important to conduct. The radiopharmaceutical kits that will be tested are macroaggregated albumin (MAA), tetrofosmin and ethambutol kits. Endotoxin testing stage was TAL 0.25 EU/mL verification test, inhibition/enhancement test, and endotoxin test for sample. Pyrogen testing using rabbits was also performed as a comparison test. The results of the TAL reagent verification test were all samples showed values corresponding to the standards of 2λ = (+), 1λ = (+), 1/2λ = (-), 1/4λ = (-), and negative water control (NWC) = (-). Furthermore, inhibition/enhancement tests for MAA, tetrofosmin, and ethambutol products show non-inhibiting or gel-inducing results, these results are in accordance with acceptability standards, so that the samples can be tested using TAL reagents. The pH measurement results in each sample were MAA of 6.0, tetrofosmin of 7.0, and ethambutol of 8.0. The results of MAA, tetrofosmin, and ethambutol product testing were a sample = (-), positive product control (PPC) = (+), positive water control (PWC) = (+), and NWC = (-). In addition, the results of pyrogen testing also showed negative for MAA, tetrofosmin, and ethambutol.

EVALUASI PROSES PRODUKSI RADIOISOTOP Sm-153 DAN SEDIAAN RADIOFARMAKA Sm-153 EDTMP

Jurnal Radioisotop dan Radiofarmaka Vol 9 (2006): jurnal PRR 2006
Publisher : Jurnal Radioisotop dan Radiofarmaka

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EVALUASI PROSES PRODUKSI RADIOISOTOP Sm-153 DAN SED1AAN RADIOFARMAKA Sm-153 EDTMP. Telah dilakukan percobaan proses produksi radioisotop Sm-153 dan proses penandaan sediaan radiofarmaka Sm-153 EDTMP, yang bertujuan untuk mengevaluasi proses produksi radioisotop Sm-153 dan sediaan radiofarmaka Sm-153 EDTMP di Pusat Radioisotop dan Radiofarmaka, BATAN. Dalam percobaan ini mencakup penyiapan bahan sasaran Sm2O3, pelarutan pasca irradiasi, penetapan konsentrasi radioaktivitas isotop Sm-153, kemurnian radionuklida, proses penandaan senyawa EDTMP, penetapan kemurnian radiokimia dan pH. Dalam percobaan ini diperoleh produk radioisotop Sm-153 dengan radioaktivitas total antara 2845,83 mCi s/d 36963,31 mCi atau dengan konsentrasi radioaktivitas antara 474,30 mCi/ml sampai dengan 6160,55 mCi/ml) berbentuk larutan SmCl3yang masing-masing mempunyai volume 6,0 ml, kandungan samarium 5,76 mg/ml dan dengan kemurnian radionuklida dari produk radioisotop Sm-153 adalah 100 %. Semua produk sediaan radiofarmaka Sm-153 EDTMP memenuhi syarat konsentrasi radioaktivitas, kandungan Sm, kemurnian radiokimia dan pH. Konsentrasi radioaktivitas sediaan radiofarmaka Sm-153 EDTMP minimum 37,50 mCi/ml dan yang terbesar 283,50 mCi/ml, sebanyak 8 buah larutan mempunyai pH 7,5, sedangkan yang lainnya ( 2 buah larutan ) mempunyai pH sebesar 8,5. Kemurnian radiokimia sediaan raiofarmaka Sm-153 EDTMP berkisar antara 90,00 % sampai dengan 98,76 %. Kata Kunci : Evaluasi, Radioisotop, Radiofarmaka, Sm-153, Sm-153 EDTMP EVALUATION OF RADIOISOTOPE PRODUCTION PROCESS OF Sm-153 AND Sm-153 EDTMP RADIOPHARMACEUTICALS. Experiments on the process of Sm-153 radioisotope and labeling of Sm-153 EDTMP radiopharmaceuticals were carried out, as a purpose for evaluation of Sm-153 radioisotope and Sm-153 EDTMP process production in Center for Radioisotope and Radiopharmaceuticals, National Nuclear Energy Agency. This experiments included preparation of Sm2O3target, dissolution of post irradiation, determination of radioactivity concentration of Sm-153 radioisotope, radionuclide purity, EDTMP labeling, determination of radiochemicals purity and pH. In these experiments the total radioactivity Sm-153 product is about 2845.83 mCi to 36963,31 mCi, or with the radioactivity concentration between 474,30 mCi/ml and 6160,55 mCi/ml in the SmCl3solution form. The volume is 6.0 ml, the samarium content is 5.76 mg/ml and the radionuclide purity of Sm-153 is 100 %. All of the Sm-153 EDTMP radiopharmaceuticals product are fullfilled requirements the radioactivity concentration, Sm content, radiochemical purity and pH. The radioactivity concentration of Sm-153 EDTMP radiopharmaceuticals is 37,50 mCi/ml(minimum) to 283,50 mCi/ml (highest). The pH 7.5 were 8 products, and the rest are pH 8.5. Radiochemical purity of Sm-153 EDTMP are round about 90.00 % to 98,76 %. Key Words : evaluation, radioisotope, radiopharmaceutical, Sm-153, Sm-153 EDTMP

OPTIMASI KONDISI SPEKTROMETER ALFA DENGAN DETEKTOR ION-IMPLATED SILIKON DI PUSAT PRODUKSI RADIOISOTOP

Jurnal Radioisotop dan Radiofarmaka Vol 1, No 1 (1998): Jurnal PRR 1998
Publisher : Jurnal Radioisotop dan Radiofarmaka

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OPTIMASI KONDISI SPEKTROMETER ALFA DENGAN DETEKTOR ION­IMPLATED SILIKON DI PUSAT PRODUKSI RADIOISOTOP. Telah dilakukan penetapan kondisi optimum spektrometer alfa yang dibubungkan dengan detektor silikon yang diimplantasi ion dengan standar sumber radiasi alfa campuran 239Pu, 241Am dan 244Cm.Pengamatan meliputi penetapan jarak antara cuplikan dengan detektor, tingkat kevakuman, batas deteksi alat dan penetapan efisiensi pencacahan dari masing-masing radionuklida. Dari percobaan diperoleh hasil kondisi optimum yaitu, jarak antara detektor dengan standar 1- 2 cm, tekanan kevakuman -1050 mbar, batas deteksi 5,1 dpm dan efisiensi pencacahan masing-masing untuk 239Pu (5157 keV) 10.6%, 241Am(5486 keV) 10,3% dan 244Cm(5805 keV) 9,9%. OPTIMIZATION OF ALPHA SPECTROMETER COUPLED TO ION-IMPLANTED SILICON DETECTOR IN RADIOISOTOPE PRODUCTION CENTER. The optimization of alpha spectrometer coupled to an ion-implanted silicon detector was carried out using an alpha radiation mixed standard source containing radionuclides of 239Pu, 241Am and 244Cm. This experiment involved the determination of the optimum distance between a radiation source and the detector surface, the pressure of the vacuum chamber, and the detection limit and the efficiency of the detector. The results show that the optimum distance between the radiation source and the detector is 1-2 cm; the pressure is -1050 mbar; the detection limit is 5.1 dpm, and the efficiencies for 239Pu ( 5157 keV), 24lAm (5486 keV) and 244Cm(5805 keV) are 10.6%, 10.3% and 9.9%, respectively.

PROSES UJI KUALITAS PRODUK Mo-99 HASIL BELAH U-235 DI PUSAT PRODUKSI RADIOISOTOP PERIODE 1995 -1996

Jurnal Radioisotop dan Radiofarmaka Vol 1, No 2 (1998): JURNAL PRR 1998
Publisher : Jurnal Radioisotop dan Radiofarmaka

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Abstract

ROSES UJI KUALIT AS PRODUK 99Mo HASIL BELAH 235U DI PUSAT PRODUKSI RADIOISOTOP PERIODE 1995 -1996. Telah dilakukan evaluasi kualitas produk 99Mo hasil belah 235U. Konsentrasi radioaktivitas, kemurnian radionuklida, pengotor radionuklida pemancar gamma dan alfa telah dibahas. Sebanyak 44 buah cuplikan produk 99Mo yang diproses dari Januari 1995 sampai dengan Juni 1996 di Pusat Produksi Radioisotop - BATAN, telah diperiksa dan dievaluasi memenuhi persyaratan kualitas sesuai yang ditetapkan oleh Medy-Physics Inc dan layak digunakan untuk pembuatan generator 99Mo - 99mTc. Konsentrasi radioaktivitas produk 99Mo berkisar dari 280 mCi/mL sampai dengan 4500 mCi/mL pada saat kalibrasi. Konsentrasi radioaktivitas total pengotor radionuklida pemancar alfa yang ditetapkan dengan pencacah alfa Eberlin berkisar antara 0,04 x 10-7 µCi/mCi 99Mo sampai dengan 4,55x10-7 µCi/mCi 99Mo, yang menunjukkan semua produk 99Mo yang dianalisis memenuhi persyaratan yang telah ditetapkan, maksimum 1,0 x 10-6 µCi/mCi 99Mo. Demikian juga konsentrasi radioaktivitas pengotor radionuklida pemancar gamma tidak ada yang melampaui persyaratan yang telah ditetapkan, yaitu 131I < 0,05 µCi/mCi 99Mo, 103Ru < 0,05 µCi/mCi 99Mo dan total nuklida pemancar gamma yang lain < 0,1 µCi/mCi 99Mo. Konsentrasi radioaktivitas nuklida pengotor 131I terbesar adalah 0,0125 µCi/mCi 99Mo, untuk 103Ru 0,032 µCi/mCi 99Mo, dan untuk total nuklida lainnya 0,08031 µCi/mCi 99Mo. Nuklida pemancar gamma yang paling dominan mengotori produk 99Mo hasil belah 235U adalah radioiodium yang terdiri dari isotop 133I(dalam 42 batch), 132I(dalam 37 batch) dan isotop 133I (dalam 39 batch). Sedangkan yang paling sedikit adalah nuklida 140Ba dan 132Tc, masing­ masing dalam 1 batch dari jumlah 44 batch. QUALITY CONTROL PROCESS OF 99Mo FISSION PRODUCT IN RADIOISOTOPE PRODUCTION CENTER 1995 - 1996. Quality evaluation of 99Mo fission was carried out. Radioactive concentration, impurities of gamma and alpha emitting radionuclides were investigated. Fourty four batches of 99Mo were processed from January 1995 to June 1996 in Radioisotope Production Center - BATAN, were investigated for the agreement with the quality requirement set out by Medy-Physics Inc. and their suitability for 99mTc generator production. Radioactive concentration of 99Mo solutions were found between 280 mCi/mL to 4500 mCi/mL at calibration time. Radioactive concentration of total alpha emitting impurities were between 0,04 x 10-7 µCi/mCi 99Mo to 4,55 x 10-7 µCi/mCi 99Mo which complied with the impurity limit of 1.0 x 10-6 µCi/mCi 99Mo at calibration time. Radioactive concentration of gamma emitting impurities of all 44 99Mo solutions complied with quality requirements set out by Medy-Physics Inc. i.e. 131I < 0.05 µCi/mCi 99Mo, 103Ru <0.05 µCi/mCi 99Mo and others gamma emitter < 0.1 µCi/mCi 99Mo. The highest radioactive concentartion of impurities observed were 0.0125 µCi 131I/mCi 99Mo, 0.032 µCi 103Ru/mCi 99Mo and other was 0.0803 µCi/mCi 99Mo. Major gamma enitting impurities were radioiodine, i.e: 131I in 42 batches, 132I in 37 batches and 133I in 39 batches, while 140Ba and 132Te were only observed in one batch.

UJI KUALITAS PRODUK I-131 HASIL BELAH U-235

Jurnal Radioisotop dan Radiofarmaka Vol 3, No 1 (2000): JURNAL PRR 2000
Publisher : Jurnal Radioisotop dan Radiofarmaka

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UJI KUALITAS PRODUK 131I HASIL BELAH 235U. Telah dilakukan uji kualitas terhadap 10 buah cuplikan produk 131I hasil belah 235U. Pemeriksaan cuplikan meliputi penetapan konsentrasi radioaktivitas 131I, pH, kemurnian radiokimia, kontaminasi radionuklida pemancar gamma dan alfa. Semua produk 131I hasil belah dalam percobaan ini pH-nya memenuhi persyaratan yang telah ditetapkan oleh Medi Physic Inc. Konsentrasi radioaktivitas 131I hasil belah 235U tidak ada yang memenuhi syarat. Sembilan cuplikan dari 10 cuplikan memenuhi persyaratan kemurnian radiokimia yang dianalisis dengan cara kromatografi kertas. Delapan cuplikan memenuhi syarat kontaminasi radionuklida pemancar alfa. Sebanyak 6 cuplikan produk 131I memenuhi syarat kontaminasi radionuklida pemancar gamma, dan ada 4 cuplikan yang tidak memenuhi syarat. Dengan demikian semua produk tidak ada yang memenuhi semua persyaratan sesuai dengan persyaratan yang telah ditetapkan oleh Medi Physic Inc. QUALITY CONTROL TESTS OF FISSION PRODUCT 131I. Quality control tests were carried out for 10 samples of fission product 131I obtained from irradiated high enriched uranium target (UI25 = 93%) from 235U. The analysis of samples covered the determination of 131I radioactivity concentration, pH of solution, and radiochemical purity as well as gamma and alpha radionuclide impurities. Results were compared to the Medi Physics quality requirements. The fission produced 131I samples in this experiment met the required pH value but no one met the required radioactive concentration. The radiochemical purity determined by paper chromatography method shows the yield more than 95 %. It was found that eight samples showed alpha emitter contaminants under the permissible value, and two others were higher than the permissible value.

PREP ARASI 99mTc_MDP Untuk Penatah Tulang

Jurnal Radioisotop dan Radiofarmaka Vol 13, No 1 (2010): Jurnal PRR 2010
Publisher : Jurnal Radioisotop dan Radiofarmaka

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ABSTRAKPREPARASI 99mTc- MDP UNTUK PENATAH TULANG Dalam rangka memenuhi  kebutuhan sediaan radiofarmaka untuk penelitian di Iingkungan BATAN maupun permintaan rumah sakit maka dilakukan proses pembuatan kit metilen difosfonat (MDP). sediaan radiofarmaka di rumahsakit tentu meningkat seperti kit MDP, DTPA dan MIBI. Oleh karena itu di PRR telah dilakukan proses pembuatan kit/sediaan radiofarmaka MDP yang lyophilized dengan cara dikeringkan (freeze . drying) Tujuannya agar kit MDP buatan PRR sebagai penatah tulang dapat digunakan untuk uji klinik di rumahsakit. Sebagai sediaan radiofarmaka 99mTc-MDP harus memenuhi persyaratan sebagai sediaan obat suntik dan 10 los dari kendali mutu. Penguj ian kualitas  di lakukan terhadap beberapa parameter diantaranya sterlIitas,pirogenitas, kemurnian radiokimia, biodistribusi, dan pencitraan tulang menggunakan kamera gamma. Hasil pengujian kualitas menunjukkan, kit MDP steriL bebas pirogen, kemurnian radiokimia rata-rata 99,93%.Penimbunan aktivitas tertinggi pada tulang mencit rata-rata 14,46 % per gram organ setelah 2 jam penyuntikan dan hasil pencitraan tulang sangat jelas. Hasil uji klinik dari rumah sakit juga menunjukkan pencitraan tulang yang sangat jelas dan kontras. Proses pembuatan kit MDP yang dikeringkan ini menghasilkan kit dengan kekeringan yang baik dan stabil lebih dari 10 bulan. Kata kunci: radiofamaka, kit MDP, penatah tulang, uji klinik. ABSTRACT PREPARATION OF 99mTc_MDP  FOR BONE SCANNING. Productions of MDP kit were carried out in order to fulfil  radiopharmaceuticals  not only for research purposes in BATAN but also for hospital. Demand for radiopharmaceutical kit in many hospitals increases for  MDP, DTPA, and MIBI.Therefore lyophilized MDP has been produced by freeze dried method in PRR. This product will be usedfor cllinical trial as bone scanning agent. The requirement of 99mTc_MDP as radiopharmaceutical has to fulfil  requirements for injection medicine and quality control recommended. The quality control is performed by using parameter of sterility, pirogenity, radiochemical purity, biodistribution, and bone scanning  using gamma camera. The results of quality control showed that MDP was sterile, pyrogen-free, radiochemical purity  was 99,93 %. The highest accumulation of activity in the bone of mice was 14,46 % i.d/g.organ at 2hour post-injection and the result of bone scanning was very clear. Clinical test from hospital showed that the  image was very clear and contrast. Lyophilized MDP by freeze drying method provided good dryness and stabile for more than 10 months. Keywords: radiopharmaceutical, MDP kit, bone scanning, clinical trial.   

VALIDASI METODE PEMBUATAN DAN KENDALl MUTU KIT UBIQUICIDINE UNTUK DETEKSI INFEKSI

Jurnal Radioisotop dan Radiofarmaka Vol 12 (2009): JurnaL PRR 2009
Publisher : Jurnal Radioisotop dan Radiofarmaka

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ABSTRAK VALIDASI  METODE  PEMBUATAN  DAN  KENDALl  MUTU  KIT UBIQUICIDINE  UNTUK  DETEKSI INFEKSI. Telah dilakukan pembuatan dan uji mutu radiofarmaka Ubiquicidine 29-41 (UBI 2941)untuk ditandai dengan teknesium 99mTcyang akan digunakan untuk preparat diagnosis infeksi bakteriGram posistif dan jamur. Kit kering UBI telah dibuat secara aseptis dan dianalisis kemumian radiokimia, sterilitas dan apirogenitasnya. HasH penandaan UBI dengan 99mTcdianalisis dengan kromatografi lapis tipis dan kromatografi kertas menggunakan ITLC-SG dengan eluen campuran dapar ammonium asetat 0.1 M 5.2 - metanol (1: I) serta kertas Whatman-l dengan e1uen aseton, sedangkan uji sterilitasnya dilakukan menggunakan medium perbenihan cair Fluid Thioglycolate (FTG) dan Trypton Soy Broth (TSB). Uji in vivo pada hewan percobaan dilakukan pada mencit normal dan yang diinduksi infeksi, sedangkan uji klinis pendahuluan dilakukan pada 5 orang relawan di RS. Hasan Sadikin Bandung dan RSPAD Gatot Soebroto Jakarta yang I orang diantaranya mewakili pasien sehat, dan waktu pengamatan dilakukan pada I jam dan 2 jam setelah penyuntikan dengan 99mTc_UBI.Hasil percobaan menunjukkan efisiensi penandaan sebesar 99,34%, uji sterilitas menunjukkan tidak terjadi pertumbuhan mikroba dalam media uji, uji pirogenitas tidak menunjukkan kenaikan temperatur yang berarti pada kelinci percobaan dan stabilitas kit kering UBI pada penyimpanan di suhu 4°C tidak berubah hingga 12 bulan pengamatan. Biodistribusi pada mencit normal menunjukkan akumulasi radioaktivitas pada ginjal dan kandung kemih, sedangkan pad a mencit yang diinfeksi terlihat adanya penangkapan yang signifikan pada jaringan yang mengalami infeksi (paha kanan) dibandingkan jaringan yang sehat (paha kiri). Studi pendahuluan pada pasien normal menunjukkan akumulasi radioaktivitas pad a ginjal dan kandung kemih sedangkan pada pasien dengan gejala diare maupun hemoroid terlihat juga adanya penangkapan yang signifikan pada usus dan penangkapan radioaktivitas terse but terlihilt lebih jelas setelah 2 jam. Telah dibuktikan pula kespesifikan dalam pencitraan infeksi bakteri dibandingkan dengan non bakteri (amuba). Hal ini menunjukkan bahwa radiofarmaka 99mTc-Ubiquicidine 29-41 dapat digunakan untuk mendeteksi adanya infeksi secara umum dalam tubuh menggunakan kamera gama dengan waktu pencitraan optimal 2 jam sekaligus juga dapat membedakan antara infeksi yang disebabkan oleh bakteri dan non bakteri. Kata kunci: 99mTc,penandaan, Ubiquicidine, biodistribusi, infeksi ABSTRACT VALIDATION OF PREPARATION AND QUALITY CONTROL METHODS OF UBIQUICIDINE KIT TO BE USED AS INFECTION IMAGING AGENT. Preparation and Quality Control of Ubiquicidine 29-41 (UBI 29-41) to be labelled with 99mTchave been carried out and will be prepared as infection imaging agent specifically for Gram positive bacteria-and fungi. Lyophilised UBI kits was prepared aseptically and analysed for its sterility, apyrogenicity and radiochemical purity. Labeling efficiency of UBI was analysed by thin layer chromatography using ITLC-SG with ammonium acetate 0.1 M pH 5.2-methanol (1: I) as eluants and paper chromatography using Whatman-I paper with acetone as eluant, and its sterility was assesed using bacterial and fungal culture media, i.e fluid thioglycolate (FTG)and trypton soy broth (TSB). In vivo study was carried out in normal mice and infection induced mice, whereas initial clinical study was carried out on 5 volunteers at Hasan Sadikin General Hospital and Gatot Soebroto Army Hospital, which 1 of them represents normal patient. The images were taken I hour and 2 hours post administration. QC results showed labelling efficiency of UBI of 99.34%, no microorganisms growth in culture media, no significant increase in temperature of experimental rabbits and the stability of unlabeled UBI kits during storage at 4°C was unchanged up to 12 months. Biodistribution study in normal mice showed high accumulation in kidneys and bladder, whereas in infected mice higher uptake was alsoobserved in infected area (right thigh) rather than in uninfected one (left thigh). Initial clinical study in normal patient showed high accumulation of radioactivity in kidneys and bladder whereas in 2 patients with symptoms of diarrhoea and haemorroid respectively the uptake was also seen in colon which increased after 2 hours. Uptake of radioactivity was also seen in patient with spondy litis TB but none in patient with amoebic infection who was previously proven infected using other modality. From this experiment it can be concluded that Ubiquicidine 29-41 labeled with 99mTccan be used as infection imaging agent using gamma camera with optimum scanning time of 2 hours post injection and enable to differentiate between bacterial infection and amoebic infection.Keywords: 99mTc,labeling, Ubiquicidine, biodistribution, infection

GAMBARAN FUNGSI KOGNITIF PADA PASIEN PASCA STROKE DI POLIKLINIK SARAF RSUD ARIFIN ACHMAD PROVINSI RIAU

Jurnal Online Mahasiswa (JOM) Bidang Kedokteran Vol 3, No 1 (2016): Wisuda Februari 2016
Publisher : Jurnal Online Mahasiswa (JOM) Bidang Kedokteran

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ABSTRACTStroke is vascular disorders caused by occlusions or ruptures of the brain vessels. Cognitive impairment is results of the occurrence of stroke. This study aimed to describe the cognitive functions of post stroke patients in the Neurology Polyclinic of RSUD Arifin Achmad Riau Province.This study was descriptive study with cross sectional approach. The instrument in this research was Montreal Cognitive Assessment – Indonesian version (MoCA-INA). Samples of the study were post stroke patients who visited Neurology Polyclinic of RSUD Arifin Achmad Riau Province in the period of November – December 2015.This study used consecutive sampling method with total number was 41 respondents. The results showed that 92,68% of post stroke patients had cognitive impairment with the highest percentage at age >65 years old (34,14%), male (65,85%), education time ≤ 12 year (56,10%), ischemic stroke (78,05%), and stroke period >6 months (75,61%). As a conclusion, most of the post stroke patients in the Neurology Polyclinic of RSUD Arifin Achmad Riau Province showed cognitive impairments.Keywords: stroke, cognitive function, MoCA-INA.

Stability of Silver Nanoparticles as Imaging Materials

The Journal of Pure and Applied Chemistry Research Vol 5, No 3 (2016)
Publisher : Chemistry Department, The University of Brawijaya

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Determining the stability of silver nanoparticles is a very important process. It was associated with unwanted metal charge and materials properties. Therefore, we studied to synthesis and stability of silver nanoparticles (AgNPs). The synthesis was performed by reduction method used sodium borohydride (NaBH4). Silver nitrate solution 0.0005 M in 1 mL was reduced using 1 mL 0.002 M of NaBH4. Then a 40.0 mL of polyvinylpyrrolidone 0.3% and 20 mL of 1.5 N NaCl was added to the mixture. Characterization of silver nanoparticles is undertaken using spectrophotometer UV-Vis, transmission electron microscopy, particle size analyzer and zeta potential. The stability of products is observed for 5 times using spectrophotometer UV-Vis. The product was characterized by determining its surface plasmon resonance (SPR) of AgNPs and the result was obtained at 403 nm. The size of AgNPs was 20 nm using tomography emission microscopy analysis and the particle size distribution give 5.8 nm. The dielectric charge was 53 mV. The stable AgNPs showed no significant SPR shift at 402±0.89 nm wavelength during 5 days observation. Based on the size and stability, it was suitable for imaging materials.

Effect of Radioactivity of Technetium-99m on the Autosterilization Process of non-sterile Tetrofosmin Kits

The Journal of Pure and Applied Chemistry Research Vol 6, No 1 (2017): Edition of January - April 2017
Publisher : Chemistry Department, The University of Brawijaya

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Technetium-99m labeled radiopharmaceutical is commonly used in nuclear medicines as a diagnostic agent, by mixing the sterile kit with Tc-99m. Manufacturing of kits requires an aseptic facility which need to be well designed and maintained according to cGMP, since mostly kits can not be terminally sterilized. Radiopharmaceuticals as pharmaceuticals  containing radionuclide is assumed to have an autosterilization property, but correlation between radioactivity and capability of killing microorganisms has to be studied so far.  The aim of this study is to investigate the effect of radioactivity on the autosterilization process of radiopharmaceuticals.  The study was carried out by adding Tc-99m of various radioactivity into non-sterile tetrofosmin kits, then the samples were tested for sterility. Sterile tetrofosmin kit and non-sterile kit with no Tc-99m added will be used as a negative control and positive control respectively. The sterility was tested using standard direct inoculation method, by inoculating samples in culture media for both bacteria and fungi and observing qualitatively within 14 days. The results showed that the samples with radioactivity of 1, 3 and 5 mCi changed the clarity of the media to turbid,  conformed with the performance of positive controls but samples with radioactivity of 10 mCi and 20 mCi did not change the clarity of the media, conformed with the performance of negative control, indicating neither growth of bacteria nor fungi.  It is concluded that Tc-99m behaves as an autosterilizing agent at certain radioactivity. Therefore the preparation of Tc-99m radiopharmaceutical can be considered as terminal sterilization rather than aseptic preparation.