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INDONESIA
Eruditio : Indonesia Journal of Food and Drug Safety
Published by Badan Pengawas Obat dan Makanan
ISSN : 27472493     EISSN : 28076222     DOI : https://doi.org/10.54384
Core Subject : Health, Science, Agriculture,
Agriculture, Biological Sciences & Forestry Biochemistry, Genetics & Molecular Biology Chemistry Medicine & Pharmacology Public Health
Eruditio : Indonesia Journal of Food and Drug Safety adalah jurnal yang diterbitkan oleh Pusat Pengembangan Sumber Daya Manusia Pengawasan Obat dan Makanan (PPSDM POM), Indonesia. Jurnal ini memuat hasil kajian dan kajian literatur di bidang keamanan Obat dan Makanan.
Arjuna Subject : Pharmacology, Toxicology and Pharmaceutics - Ilmu Farmasi
Articles 6 Documents
 1 
Search results for , issue "Vol 3 No 2 (2023): Edisi Juni" : 6 Documents clear
Analisis Potensi Peredaran Vaksin Corona Virus Disease-19 (COVID-19) Palsu di Indonesia Rinukti, Ndaru Sindi; Rastika, Gede Bayu Rastika; Triwinanti, Neti
Eruditio : Indonesia Journal of Food and Drug Safety Vol 3 No 2 (2023): Edisi Juni
Publisher : Badan Pengawas Obat dan Makanan

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.54384/eruditio.v3i2.111

Abstract

During the COVID-19 pandemic, Indonesian government has done various efforts to overcome the spread of COVID-19 outbreak, some of them are by accelerating the procurement of COVD-19 vaccine and conducting vaccination in Indonesia. However, there are several potential threats that may occur, one of them is potential entry or production of falsified COVID-19 vaccines in Indonesia. This analysis identifies the potential distribution of falsified COVID-19 vaccines in Indonesia and strategic role of Indonesian Food and Drug Authority (Indonesian FDA) to prevent its distribution. This analysis applies qualitatitve methods by using literature review correlated with relevant case studies about the finding of falsified COVID-19. The result shows that falsified COVID-19 vaccines have been found in several countries such as China, Mexico, Poland, Uganda, India, Myanmar and Islamic Republic of Iran using various modes including promotion through internet. Furthermore, sales of used COVID-19 vaccine vial also found in internet especially in darkweb, which can increase the potential for counterfeiting COVID-19 vaccine. In Indonesia, the case of falsified vaccine occurred in 2016 for Measles Vaccine, Polio Vaccine, Hepatitis B Vaccine, Tetanus Vaccine, and BCG Vaccine by refilling empty used vaccine vial using intravenous infusion fluid and antibiotics. According to that case and conditions, the case of counterfeiting COVID-19 vaccine may occur in Indonesia either through the misuse of vial waste or using the other modes considering similar case in 2016. Indonesian FDA plays important role to ensure the integrity of COVID-19 vaccine supply chain, including its vial waste handling to prevent counterfeiting that endangers public health.
Studi dan Karakterisasi Bahan Baku Resorsinol sebagai calon Baku Pembanding dan Pengembangan Metode Analisis Penetapan Kadar Resorsinol dalam Bahan Baku Isnaeni, Neni; Dwirini, Nurul
Eruditio : Indonesia Journal of Food and Drug Safety Vol 3 No 2 (2023): Edisi Juni
Publisher : Badan Pengawas Obat dan Makanan

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.54384/eruditio.v3i2.121

Abstract

Resorcinol is often misused for antiacne cosmetics. Corresponding to Indonesian FDA regulation, it is only allowed for hair dyes, hair lotion, and shampoo. Reference standard and analytical method of Resorcinol are needed for strengthening capability and capacity of Indonesian FDA for post-market controlling of cosmetics in Indonesia. Therefore, this research developed a reference standard by study and characterization and an analytical method for assay Resorcinol in raw material. Characterization of Resorcinol raw material using infrared spectrophotometry and HPLC-PDA, purity testing with TLC, HPLC, and DSC, homogeneity testing and assay by HPLC-PDA. Development analytical method for assay of Resorcinol was performed using an HPLC - PDA system with Waters Atlantis T3-C18 (5µm, 250 x 4.6 mm) column. The column temperature was set at 25°C. The mobile phase consists of ortho-phosphoric acid 0.085% pH 3 and methanol (50:50 v/v), delivered at a 1.0 mL/min flow rate. Detection was carried out at 274 nm. Resorcinol characterization using infrared spectrophotometry showed the presence of aromatic C-H bond functional groups (3100 – 3000 cm-1), C-H bonds (1374 and 773 cm-1), C-OH bonds (1311-1298, 1166; 1151 and 460 cm-1), C-C bonds (1608 and 1490 cm-1), aromatic rings (543 cm-1), and meta di-substituted ring groups (842 and 739 cm-1). Purity testing by TLC and HPLC were obtained that no spots or other peaks detected, indicating that the material has high purity. Purity by DSC of 99.05% and melting point of 109.41°C. The sample was homogenous with a content of 99.28% on a dried basis. Furthermore, the developed method has a linear range of 0.1 – 0.3 mg/mL at a coefficient correlation of 0.9999 and Vx0 of 0.5%. The limit of detection is 0.11 µg/mL, while the limit of quantification is 0.34 µg/mL and accuracy (% bias) of 0.10%. All validation parameters have met the requirement. These results meet the criteria for the candidate of a reference standard and the developed method is accurate, reliable, and valid so it can be applied to determine Resorcinol in raw material.
Identifikasi Efedrin dan Pseudoefedrin Sediaan Padat dengan Metode Ultra Performance Liquid Chromatography dan High Performance Liquid Chromatography Ichsan, Dewi Susetiyany; Ebtasari , Ma'rifah
Eruditio : Indonesia Journal of Food and Drug Safety Vol 3 No 2 (2023): Edisi Juni
Publisher : Badan Pengawas Obat dan Makanan

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.54384/eruditio.v3i2.130

Abstract

Ultra Performance Liquid Chromatography (UPLC) is an analytical separation that maintains the practicality and principles of High-Performance Liquid Chromatography (HPLC) by increasing analysis speed, sensitivity, and resolution. The methods used for the identification of ephedrine and pseudoephedrine have been carried out using HPLC according to MA PPOMN 07/NA/2010 from the National Quality Laboratory of Drug and Food (NQCLDF). The aim of the study was to assess the superiority of the UPLC method compared to HPLC in the evaluation of ephedrine and pseudoephedrine solid dosage forms. UPLC used UPLC Waters with PDA detector at wavelength 210 nm, Aqquity column UPLC® BEH C18 (50 x 2.1 mm) with particle size 1.7 μm, mobile phase of sodium lauryl sulfate solution 25 mM and acetonitrile (60:40), flow rate 0.3 ml/min, injection volume 1 μL. Comparative parameters used in the validation of ephedrine and pseudoephedrine compounds by UPLC and HPLC methods are specificity and selectivity. The validation of the UPLC method shows the retention time for ephedrine and pseudoephedrine at minutes 3,288 and 3,048 with an RSD retention time of 0.3% and an area of 0.5%. The resolution between ephedrine and pseudoephedrine was 1.9. The length of analysis time is 27 minutes on HPLC and 6 minutes on UPLC. Based on the results of this study, the UPLC method can be used as an alternative to determine ephedrine and pseudoephedrine in solid preparations with the advantages of faster, better resolution, fewer mobile phase, reference standard and samples and shorter workload than HPLC
Analisis Kepuasan Pelanggan Registrasi Pangan Olahan Menggunakan Customer Satisfaction Index (CSI) dan Importance Performance Analysis (IPA) Thamrin, Emitha; Damayanti, Suci
Eruditio : Indonesia Journal of Food and Drug Safety Vol 3 No 2 (2023): Edisi Juni
Publisher : Badan Pengawas Obat dan Makanan

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.54384/eruditio.v3i2.143

Abstract

Kualitas pelayanan publik merupakan indikator utama dalam penyelenggaraan pemerintah yang baik. Sebagai salah satu unit teknis penyelenggara pelayanan publik bidang registrasi pangan olahan di Badan POM, Direktorat Registrasi Pangan Olahan (Dit.RPO) berupaya meningkatkan kualitas pelayanannya dengan melakukan evaluasi kinerja pelayanan publik. Evaluasi diukur secara berkala melalui survei kepuasan pelanggan. Rekomendasi hasil survei sangat membantu unit dalam mengambil kebijakan yang tepat untuk melakukan perbaikan. Tulisan ini bertujuan menganalisis data survei kepuasan pelanggan Dit.RPO yang telah dilakukan pada tahun 2021, membandingkannya dengan hasil survei tahun 2020 dan memberikan rekomendasi kebijakan yang diperlukan untuk meningkatkan kualitas pelayanan. Analisis dikaitkan dengan pelayanan registrasi yang dilakukan secara online di tengah situasi pandemi Covid 19. Kepuasan pelanggan diukur dan dianalisis menggunakan metode Customer Satisfaction Index (CSI) dan Importance Performance Analysis (IPA). Hasil pengolahan data survei menunjukkan indeks kepuasan pelanggan tahun 2021 adalah 77,41 dengan kualitas pelayanan Baik (B) berdasarkan Peraturan Menteri Pendayagunaan Aparatur Negara dan Reformasi Birokrasi No 14 Tahun 2017 tentang Pedoman Penyusunan Survei Kepuasan Masyarakat Unit Penyelenggara Pelayanan Publik. Sedangkan berdasarkan metode CSI yang dikembangkan oleh Ekloè f dan Anders Westlund (1998) nilai indeks kepuasan pelanggan adalah 77,42. Adapun analisis kuadran IPA menunjukan prioritas perbaikan oleh manajemen adalah bagaimana agar pelanggan mudah memahami dan memenuhi persyaratan pendaftaran pangan olahan,  mengakses media informasi dan  mengetahui status pendaftaran. Pelaku usaha mengalami kesulitan pada faktor tersebut sebagai dampak dari pelayanan yang dilakukan secara online selama pandemi Covid 19. Sejalan dengan perbaikan situasi setelah pandemi maka layanan tatap muka di loket pelayanan pandemi sudah dapat dimulai kembali.  Bagi pelaku usaha mikro kecil (UKM), perlu dilakukan pendampingan. Selain itu juga perlu disediakan desk registrasi secara offline dan online, dilakukan sosialisasi tatacara registrasi pangan melalui kegiatan bimbingan teknis, coaching clinic bagi registration officer usaha pangan olahan.
Pengaruh Kehadiran Apoteker Terhadap Pengelolaan Obat Pada Apotek di Provinsi Banten Hartuti, Wiwi; Sasongko, Rhatih Eka
Eruditio : Indonesia Journal of Food and Drug Safety Vol 3 No 2 (2023): Edisi Juni
Publisher : Badan Pengawas Obat dan Makanan

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.54384/eruditio.v3i2.146

Abstract

Drug management under applicable guidelines greatly supports the   establishment of quality pharmaceutical care to assure the availability of safe, qualified, useful and affordable pharmaceutical products, medical devices, and medical consumables. Generally, the pharmacy cares is are related to presence of pharmacist which is not based on applicable guidelines. In facts, there is an indication  that the presence of pharmacists in pharmacy cares  have been  low. Previous studies showed the percentage of pharmacist attendance at the pharmacy cares was inadequate and it had an affect on pharmaceutical services. There are three aims of this  study namely: (1) to obtain data of the pharmacist’s presence at pharmacy cares in Banten Province, (2) to investigate the correlation  of the pharmacist's presence and drug management at the pharmacy cares, and (3) to gain information about the implementation of drug management in pharmacy cares based on BPOM Regulation No. 24 of 2021. The study was conducted using sample data of surveillance inspection of pharmacy cares in several  districts/cities located in Banten Province from February 2020 to December 2021. Data analysis was processed  using the Spearman correlation test quantitative analysis method with SPSS type 26. This study showed that the presence of pharmacists at pharmacy facilities in Banten Province was 36.25% (58 of 160 pharmacists). Spearman correlation test concludes there was a positive correlation between pharmacist presence and drug management at the pharmacy cares. Drug management in pharmacy cares under BPOM Regulation Number 24 of 2021 was insufficient in drug procurement, transfer, and storage aspects. The three highest findings in the critical category were drug procurement (14,38%), drug transfer (9,38%), and drug storage (3,13%). The three highest findings in the major category were drug storage (61,88%, drug procurement (50,63 %), and drug recording report (46,25%). Drug management in pharmacies was pharmacists' responsibility, but inadequate pharmacists' presence had an impact on discrepancy of  drug management between the guidelines.
Validasi Metode Analisis Kadar Okratoksin A pada Biji Pala (Myristica fragrans Houtt) secara Kromatografi Cair Kinerja Tinggi hernawaty, Hernawaty; Nurdiana, Indah
Eruditio : Indonesia Journal of Food and Drug Safety Vol 3 No 2 (2023): Edisi Juni
Publisher : Badan Pengawas Obat dan Makanan

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.54384/eruditio.v3i2.147

Abstract

Nutmeg (Myristica fragrans Houtt) is a superior commodity that is in demand by the European Union, and to enter the export market of the European Union, nutmeg commodities must meet several regulations and requirements, which can be grouped into Legal Requirements and Non-Legal Requirements. On April 1, 2020, there was an additional regulation in the form of the maximum level of Ochratoxins A contained in nutmeg that is allowed is 15 g/kg (EUR-Lex, 2020). So far, an assay of ochratoxin A has not been reported for the scope of nutmeg. Ochratoxin A analysis generally applies the AOAC test method ch.49.6.64 (Assessment of ochratoxin levels in barley) and the AOAC test method Ch 49.6.028 (Assessment of ochratoxin A levels in green coffee), but this method is known to be non-specific for nutmeg because of its spectral characteristics. Ochratoxin A in samples. The purpose of this study was to obtain a valid analytical method for determining levels of ochratoxin A in nutmeg seeds so that it can be widely applied as an important step in meeting the requirements of foreign export standards for ochratoxin A-free nutmeg products. The data used is primary data validation of the analytical method using an HPLC fluorescent detector. Samples were extracted using organic solvents, with PBS pH 7.4 dilution passed to the Immuno Affinity Column (IAC) and eluted with acetic acid-methanol (2:98) and water. The validation results showed specific specificity for nutmeg, linearity 0.9998588 and Vxo 1.40%, RSD precision 2.02%, accuracy 84-87% by adding a certain amount of analyte to the sample matrix to obtain recovery, detection limit 1.59 g/kg and the quantitation limit was 5.82 g/kg. This validated analytical method meets the criteria and can be used to determine levels of ochratoxin A in nutmeg seeds.

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