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<![CDATA[Validasi Metode Analisis Identifikasi Simultan Hidrokuinon dan Asam Retinoat Secara UHPLC-PDA dalam Produk Kosmetika ]]>
<![CDATA[Mohammad Ibnu Fajri]]>
<![CDATA[ Eruditio : Indonesia Journal of Food and Drug Safety Vol 1 No 1 (2020): Edisi Desember ]]>
Publisher : <![CDATA[Badan Pengawas Obat dan Makanan ]]>
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DOI: 10.54384/eruditio.v1i1.21
<![CDATA[Penggunaan Hidrokuinon dan Asam Retinoat pada produk kosmetik tanpa resep dokter tidak diizinkan menurut peraturan yang berlaku di Indonesia. Metode analisis yang tersedia saat ini masih menggunakan sistem HPLC yang dijalankan secara individual untuk masing-masing senyawa dan membutuhkan waktu analisis yang lama. Oleh karena itu, diperlukan pengembangan metode yang lebih cepat dan efisien. Pengembangan metode analisis identifikasi simultan Hidrokuinon dan Asam Retinoat dijalankan menggunakan Ultra High Performance Liquid Chromatography (UHPLC) dengan detektor PDA, kolom Hypersil GOLD® C18 (150 mm x 2.1 mm 3µm), fasa gerak metanol - asam format 0,1% dengan sistem gradien, laju alir 0,35 mL/menit dan dideteksi pada 290 nm untuk hidrokuinon dan 354 nm untuk asam retinoat. Parameter validasi yang dilakukan adalah selektivitas dan batas deteksi. Hasil validasi metode menunjukkan waktu retensi untuk hidrokuinon pada 1,93 menit dan untuk asam retinoat pada 11,99 menit. Tidak ada peak yang memberikan waktu retensi yang sama baik pada pelarut maupun larutan sampel. Persamaan kurva kalibrasi untuk hidrokuinon adalah y = 11591x + 1312 (r = 0.999) dan untuk asam retinoat adalah y = 37839x + 17732 (r = 0.999). Nilai batas deteksi dari hidrokuinon dan asam retinoat sebesar 5,92 µg/g dan 7,74 µg/g secara berurutan. Metode ini valid digunakan untuk analisis hidrokuinon dan asam retinoat pada sampel produk kosmetika, serta 67% cepat dan 90% lebih hemat fasa gerak dibandingkan metode yang tersedia saat ini.]]>
<![CDATA[Peningkatan Pemahaman Penyidik BPOM dan Strategi dalam Pengawasan Post Border: RIA Framework ]]>
<![CDATA[Tofa Apriansyah]]>;
<![CDATA[Khusnul Khotimah]]>;
<![CDATA[Adis Imam Munandar]]>
<![CDATA[ Eruditio : Indonesia Journal of Food and Drug Safety Vol 1 No 1 (2020): Edisi Desember ]]>
Publisher : <![CDATA[Badan Pengawas Obat dan Makanan ]]>
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DOI: 10.54384/eruditio.v1i1.23
<![CDATA[Potensi ancaman masuknya Obat dan Makanan tanpa izin edar masih menunjukan menunjukan dominasi yang mengkhawatirkan, dengan rata-rata per-tahun sebesar 70,5% dari 13 jenis perkara Obat dan Makanan pada periode tahun 2015-2017. Pemahaman PPNS BPOM menjadi krusial pada fungsi penindakan. Penelitian ini bertujuan untuk menganalisis pemahaman PPNS BPOM dan memformulasikan strategi yang tepat dalam pengawasan post border. Penelitian menggunakan pendekatan mixed methods dengan metode survei dan studi kasus. Regulatory Impact Analysis (RIA) Framework digunakan sebagai pola pikir dengan pendekatan analisa intelijen. Hasil penelitian menunjukan bahwa pemahaman PPNS BPOM masih harus ditingkatkan hingga diperoleh pemahaman yang sama dan merata di seluruh Indonesia. Asimetris informasi antar BPOM dan DJBC dihilangkan dengan melakukan pelatihan bersama. Kesadaran akan pentingnya kerjasama dengan DJBC dan kebutuhan informasi sebelum Obat dan Makanan keluar dari kawasan pabean menunjukan perlunya langkah strategi kolaborasi pengawasan post border. Pertukaran informasi intelijen merupakan strategi prioritas pengawasan post border yang dapat dibangun dari kolaborasi BPOM dan DJBC. Potential threat of non-registered entry of imported Drug and Food showed alarming domination, with an average annual rate of 70.5% of 13 types of Drug and Food cases in the 2015-2017 period. Understanding of Indonesian-FDA investigator is crucial in the enforcement function. This study aims to analyze the understanding of Indonesian-FDA investigator and formulate an efficient and effective control strategy. The study uses a mixed-methods approach using survey methods and case studies. The Regulatory Impact Analysis (RIA) Framework is used as a mindset with an intelligence analysis approach. The results show that the understanding of Indonesian-FDA investigators still needs to be improved so that an understanding is equal and evenly distributed throughout Indonesia. Asymmetric information between Indonesian-FDA and DGCE is eliminated by conducting joint training. Awareness of the importance of collaboration with DGCE and the need for information before Drug and Food leave the customs area shows the need for collaborative post-border surveillance strategic steps. The exchange of intelligence information is a priority strategy for post border control that can be built from the collaboration of Indonesian-FDA and DGCE.]]>
<![CDATA[A Review: Induced Pluripotent Stem Cells (iPS) Therapy Is the Best Method to Cure Non-Communicable Diseases? ]]>
<![CDATA[Yola Eka Erwinda]]>
<![CDATA[ Eruditio : Indonesia Journal of Food and Drug Safety Vol 1 No 1 (2020): Edisi Desember ]]>
Publisher : <![CDATA[Badan Pengawas Obat dan Makanan ]]>
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DOI: 10.54384/eruditio.v1i1.29
<![CDATA[The potency of stem cells in treatment or therapy is widely known due the properties of stem cells to differentiate into specialized cell type in the body. Application stem cells in medicine and therapy is mostly used for alternative treatment of diseases that could not be cured using chemical or other biological drugs, such as non-communicable diseases. In general, stem cells are classified in three types, namely Adult Stem Cells (ASC), Human Embryonic Stem Cells (hESC), and Induced Pluripotent Stem Cells. Each type of the cells has advantages and drawbacks for application in medicine and therapy. This review investigates whether iPS is the best approach for non-communicable disease treatment among other stem cell types.]]>
<![CDATA[Peredaran Kosmetik Pemutih Ilegal di Indonesia dan Upaya Penanggulangannya ]]>
<![CDATA[Iin Febrianti Sende]]>;
<![CDATA[Adin Wira Pramudita]]>;
<![CDATA[M. Gafur Salafuddin]]>;
<![CDATA[Edi Priyo Yunianto]]>
<![CDATA[ Eruditio : Indonesia Journal of Food and Drug Safety Vol 1 No 1 (2020): Edisi Desember ]]>
Publisher : <![CDATA[Badan Pengawas Obat dan Makanan ]]>
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DOI: 10.54384/eruditio.v1i1.30
<![CDATA[Whitening cosmetics are still popular in Indonesia, along with the stigma that white skin is idealized skin color. Woman with white skin acknowledges as beautiful woman. The increasing public demand for whitening cosmetics is exploited by crime offenders who produce and distribute illegal whitening cosmetics. The study was conducted by collecting inspection data and law enforcement data carried out by the Indonesian FDA and other criminal justice systems, direct research in the field, and online mapping through cyber patrol and Google Trends analysis to capture the distribution model of illegal whitening cosmetics in Indonesia, both those distributed offline as well as distributed online. The result of the study shows that illegal whitening cosmetics are produced then distributed offline and online in all provinces in Indonesia with various types of modus operandi, in line also with the high interest of searching for whitening cosmetics in online media. Illegal whitening cosmetics are known to have no marketing authorization and also contain prohibited ingredients, such as mercury, hydroquinone, tretinoin, and steroid. Many factors influence the supply chain stages of this illegal whitening cosmetics from upstream/supply (producers and distributors) to downstream/demand (consumers). Indonesian FDA must take the strategic step to minimize or reduce each of these factors, with repressive actions towards manufacturers and distributors, and preventive actions against consumers of illegal whitening cosmetics or through system/policy intervention.]]>
<![CDATA[Tren Baru Kosmetik "Share in Jar" Ilegal di Media Daring ]]>
<![CDATA[Iin Febrianti Sende]]>;
<![CDATA[Edi Priyo Yunianto]]>
<![CDATA[ Eruditio : Indonesia Journal of Food and Drug Safety Vol 1 No 1 (2020): Edisi Desember ]]>
Publisher : <![CDATA[Badan Pengawas Obat dan Makanan ]]>
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DOI: 10.54384/eruditio.v1i1.31
<![CDATA[The Effect of Cosmetic formula on the skin is one of the main reasons for the new consumer to buy cosmetics. Before buy, new consumers feel confused about whether the cosmetic product is suitable for their skin or not. They need product tester. Unfortunately, not every cosmetic product sold in the market has a tester size. This condition led to the emergence of new illegal cosmetics trends in online media, namely share in jar. The concept of "share in a jar" is to divide (share) the content of the cosmetic product in (in) several small packaging (jar), with the aim that someone can buy and try the cosmetic product without buying the product in its original size. The study was conducted by online mapping and Google Trends analysis to review the phenomenon of cosmetics share in jar in online media, and also literature study of crime prevention strategies to provide intervention options that can be used. The results show that share in jar cosmetics are sold through various e-commerce and social media, and based on Google Trends analysis, the level of share in jar search has increased in the last 3,5 years. Most of them are import cosmetics in relatively high prices, and the most category is skincare cosmetics. Crime prevention strategies that can be done are through social crime prevention, situational crime prevention, and community-based crime prevention approaches, by intervening factors that influence cosmetics share in the jar distribution.]]>
<![CDATA[Bacteriocin, Antimicrobial as A New Natural Food Preservative: Its Potential and Challenges ]]>
<![CDATA[Sri Surati]]>
<![CDATA[ Eruditio : Indonesia Journal of Food and Drug Safety Vol 1 No 1 (2020): Edisi Desember ]]>
Publisher : <![CDATA[Badan Pengawas Obat dan Makanan ]]>
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DOI: 10.54384/eruditio.v1i1.34
<![CDATA[Improving food safety and quality remains a major challenge in worldwide. Modern society tends to choose the foods that are fresh tasting, free of chemical additives, rich in nutrients and has been introduced to minimally processed. Bacteriocins as new natural preservatives could be produced by Gram-positive bacteria and Gram-negative bacteria, even though it is mostly originated from Lactic Acid Bacteria (LAB). Bacteriocin-producing bacteria as well as bacteriocin has long been used in some countries as alternatives to replace chemical additives. The use of these antimicrobial agents has been proven effective in food manufacturing and distribution chain, especially in increasing shelf life of food products. Other potential from the use of bio-preservatives in various types of food is still huge. However, approval of bio-preservatives and their commercially applications is still limited. This study will review the selection criteria for bacteria used, the mechanism of action, its potential application in the food and pharmaceutical industries and its potential as an anti-cancer agent. In addition, this study will explore the main challenges faced including its stability and the possible risk of resistance to microorganisms. This review will also describe a series of processes for identification, characterization, and approval of the use of bacteriocins before they are commercially marketed. In addition, the safety issue of using bacteriocin-producing bacteria, especially as probiotics, also needs to be considered as a fundamental for quality control and the improvement of drug and food safety.]]>
<![CDATA[Peredaran Ilegal Obat Aborsi melalui Media Sosial dan Upaya Penanggulangannya ]]>
<![CDATA[Adhika Primananda]]>;
<![CDATA[Dewa Gede Bayu Rastika]]>
<![CDATA[ Eruditio : Indonesia Journal of Food and Drug Safety Vol 2 No 1 (2021): Edisi Desember ]]>
Publisher : <![CDATA[Badan Pengawas Obat dan Makanan ]]>
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DOI: 10.54384/eruditio.v2i1.73
<![CDATA[The stigmatization and the strict rules of the abortion practice makes Indonesian women often seek help for abortion through non-medical personnel or by using misoprostol privately without prescription. Difficult to access the information, interactions, and transactions in the real world, coupled with the adherence of teenagers' lives to the social media, can encourage teenagers who experience unwanted pregnancies to overcome their problems from the real world to the cyberspace. This phenomenon is exploited by irresponsible persons by promoting and illegally distributing drugs that are claimed as abortion drugs. This study aims to describe the condition of the illicit trafficking of illegal abortion drugs in social media and find the best intervention that can be done to solve the problem. This study was conducted by collecting and processing big data sourced from social media using Netlytic application and then analyzing the data using the Problem Analysis Triangle concept. Interesting findings from social media analysis is that abortion drug sellers use an intimate approach to target those teenagers. They try to build intimate, trusted, interactive and communicative interaction with the potential clients by using words such as “school” and provide suggestions of drug use according to the age of the pregnancy. The illicit trafficking of illegal abortion drugs through social media that is carried out conspicuously and widely with a high amount of seller shows that there is an opportunity that motivates the prepetrators who illegally sells abortion drugs because of the absence of guardian that capable to guard the market. Therefore, it is necessary to intervene the sellers of illegal abortion drugs as criminals (offenders), consumers of abortion drugs as targets (targets/victims), and the market in the form of social media as a place of crime (Place) to prevent the crime and victimization from happening.]]>
<![CDATA[Penyimpangan Distribusi Obat Keras pada Sarana Tidak Memiliki Keahlian dan Kewenangan Melakukan Praktik Kefarmasian: Indonesia ]]>
<![CDATA[Rizki Arrahman Yovia]]>;
<![CDATA[Fauqi Elfarabi]]>;
<![CDATA[Fuji Handayani]]>;
<![CDATA[Ari Andriano Santoso]]>;
<![CDATA[Surya Dwi Putra]]>
<![CDATA[ Eruditio : Indonesia Journal of Food and Drug Safety Vol 2 No 1 (2021): Edisi Desember ]]>
Publisher : <![CDATA[Badan Pengawas Obat dan Makanan ]]>
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DOI: 10.54384/eruditio.v2i1.74
<![CDATA[The distribution diversion of prescription drugs at facilities that do not have the expertise and authority to pharmaceuticals practice dominate other types of violations, they are Illegal Drugs and Substandard Drugs. This phenomenon is also caused by public participation, the tendency of people who want to do self-medication, ease of transaction, efficiency of time, energy, and the changes of lifestyle are factors that support the rapid growth of commerce transactions through offline and online media. This trend will certainly have a major impact on the supply chain, especially on drug distribution in Indonesia. The research used qualitative and quantitative methods to obtaining an overview of drug distribution that could describe the situation of supply chain, the potential, and spot that could be used as a diversion of the distribution of prescription drugs in facilities that do not have the expertise and authority to pharmaceuticals practice. The results showed that 90.3% of drugstores sell prescription drugs with the modus dominated by salesmen at 88.4%. Drugstores that selling prescription drugs generally does not put up a drugstores name sign (28.93%). Distribution Systems of prescription drugs at facilities that do not have the expertise and authority to pharmaceuticals practice is carried out offline and online that makes the drug marketing become wider. The diversion of prescription drug distribution occurs in the process of importing medicinal ingredients, the pharmaceutical industry, and retail facilities.]]>
<![CDATA[Analisis kemurnian dan konsentrasi DNA hasil isolasi pada pembuatan DNA baku spesies tikus: Analisis kemurnian dan konsentrasi DNA hasil isolasi pada pembuatan DNA baku spesies tikus ]]>
<![CDATA[Alfi Sophian]]>;
<![CDATA[Andi Syukur]]>
<![CDATA[ Eruditio : Indonesia Journal of Food and Drug Safety Vol 1 No 2 (2021): Edisi Juni ]]>
Publisher : <![CDATA[Badan Pengawas Obat dan Makanan ]]>
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DOI: 10.54384/eruditio.v1i2.75
<![CDATA[Analysis of the purity and concentration of isolated DNA in the manufacture of standard rat DNA was carried out to see whether the isolation carried out could produce good quality DNA. The purpose of this study is to provide information on the manufacture of raw DNA in species DNA testing where the raw material that has been purchased so far made from synthetic materials can be more economical if using DNA material derived from the meat raw material of the target species. The DNA extraction method used is the column spin method or column centrifuge using the Intron Patho Gene-Spin (Viral DNA/RNA) extraction kit. Analysis method of concentration and purity of isolated DNA was analyzed based on the average value of concentration and purity which was read using a nanophotometer. Based on the results of the research conducted, the results of the isolated DNA concentration values were in the concentration range of 41,250 ng/ mL to 42,300 ng/mL, with the average concentration of isolated DNA was 41,777 ng/mL. For the value of the purity of the isolated DNA whose absorbance was read using a nanophotometer at a wavelength of A260/A280, the results were between 2,301 to 2,384 with the average value of purity being at 2,326. This study concludes that all the extracted samples that showed the results of the DNA analysis produced were included in the good DNA category.]]>
<![CDATA[Aplikasi Teknik Double Wash unutk Isolasi DNA Spesies pada Sampel Cangkang Kapsul Lunak: Application of Double Wash Technique for Species DNA Isolation in Soft Capsule Shell Samples ]]>
<![CDATA[Marcella Sutanta]]>;
<![CDATA[Diana Tri Wulan]]>;
<![CDATA[Yusrina Nabila]]>;
<![CDATA[Alfi Sophian]]>
<![CDATA[ Eruditio : Indonesia Journal of Food and Drug Safety Vol 2 No 1 (2021): Edisi Desember ]]>
Publisher : <![CDATA[Badan Pengawas Obat dan Makanan ]]>
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DOI: 10.54384/eruditio.v2i1.78
<![CDATA[The presence of gelatin components can be identified through fat, protein and DNA. DNA can be obtained through the DNA isolation process which is the process of separating DNA from other components of the cell. The DNA purification stage is the most important thing in DNA isolation because at this stage it can reduce to a minimum the number of contaminants in DNA isolates to determine the purity and concentration of the DNA isolate obtained. The purpose of this technique is to produce DNA isolates that are low inhibitors or are in the purity range of 1.7-2.1. The extraction method used in this study used the double wash technique, the technique was modified from the test stage following the manual kit used, it's just that the technique used was modified at the washing stage with each washing done twice in the washing section. first and second washing so that a total of four items of washing were carried out. The results of the DNA isolates were then analyzed for the purity and concentration of DNA obtained using a nanophotometer, the DNA isolates obtained were in the range of 4,400 - 5,500 ng/µL with an average of 4,950 ng/µL. As for the purity value measured at the wavelength A260/A280, the results were obtained with a purity range between 1,760 - 1,840 with an average of 1,800. This research concludes that all the extracted samples show the results of DNA isolates that fall into the category of good DNA and meet the requirements needed in molecular analysis.]]>
