Eruditio : Indonesia Journal of Food and Drug Safety

Potential Distribution of Illegal Cosmetics in the Form of Toys (Cosmetic Toys)

2024-01-18T02:36:49+00:00

Cosmetics in the form of children's toys/cosmetic toys such as eyeshadow, lipstick/lip gloss, blush on, nail polish, and others are popular among children. Cosmetic toys distributed offline in toy shops/online in the marketplace. Cosmetic toys have the potential to contain harmful ingredients such as mercury, formaldehyde, etc. These ingredients have the potential to cause health problems, especially in children who have immature skin protective functions and immune systems. Nowadays, there is still a dualism in the distribution license of cosmetic toys: as cosmetics that must have a notification number from Indonesian FDA or as toys which must have SNI standards and be produced by toys manufacturers. The research aims to determine trends in the circulation of cosmetic toys and the potential impact of license dualism to ensure the safety of cosmetic toys in circulation. The research was conducted by collecting data on cosmetic toys in 48 toy shops in Jakarta, Bogor, Depok, Tangerang, Bekasi, Denpasar, and Surabaya areas in period of April – June 2023. The results of the research showed that all cosmetic toys are decorative cosmetics, and most often as toys with SNI marking. Most of the cosmetic toys in circulation are import products from China. Besides that, in circulation it was also found there are cosmetic toys do not have a distribution permit (illegal) and/or also have a double category as toys and cosmetics. This could be a loophole for business actors who produce or sell illegal cosmetic toys that have the potential to contain dangerous ingredients and could cause losses for business actors who register their products in both categories. BPOM needs to coordinate with related sectors to review regulations on cosmetic toy products to determine the boundaries between toys and cosmetics.

Exploring the Communication, Information, and Education Strategies of the Indonesian FDA for COVID-19 Vaccine Development

2024-01-22T04:59:03+00:00

The COVID-19 pandemic has become a complicated problem faced by the world. The absence of specific antiviral drugs or vaccines at the beginning of the outbreak made the public health approach the primary strategy for preventing the spread of COVID-19. The lack of transparency at the start of the COVID-19 outbreak also led to public misinformation. WHO called it an infodemic, an excess of information, whether true or not, making it difficult for people to determine valid references. In Indonesia, misinformation on health matters is not a new difficulty and is in the top rank along with socio-political. The government utilizes social media to provide information to the citizens. Social media itself has a vital role in the infodemic as a medium for disseminating information, whether credible or not. The Indonesian FDA plays an essential role in conducting education through social media. This study aims to map the elements forming citizens' engagement in Indonesian FDA social media use, especially in disseminating information about the COVID-19 vaccine. This study uses a regression method with citizens' engagement (calculated from the number of likes and comments) as the dependent variable. Three independent variables form citizen engagement elements: media richness, content production, and content type defined by the government. The sentiment toward government Instagram posts was measured by analyzing citizens' comments using the dataset from InSet Semantic Lexicon. Based on negative binomial regression results, data obtained that the framework developed in this research was statistically significant in observing the phenomenon. Media richness and content production significantly affect citizens' engagement. On the other hand, original and informative content encourages more citizen engagement. Generally, public sentiment on Indonesian FDA Instagram content, both head office and regional offices, tends to be more positive than negative.

Validation of the Analytical Method for Determining Lapatinib Ditosylate Raw Material Contents using HPLC-DAD

2024-02-13T08:58:10+00:00

The validation analytical method of the Lapatinib ditosylate assay is crucial to increase testing capability and capacity in strengthening the supervision of post-marketing drugs in Indonesia. A fast, precise, accurate, valid, and efficient test method is needed to carry out the test. A previous study on determining Lapatinib ditosylate assay generally used a C18 column, yet for efficiency, it is also necessary to develop a test method that can use existing resources in the laboratory, where the research used a C8 column. In this study, an analytical method to determine the assay of Lapatinib ditosylate developed using a High-Performance-Liquid Chromatography-Diode Array Detector (HPLC-DAD) system equipped with an autosampler and XBridge ® C8 column (Waters); 250 x 4.6 mm i.d. 5 μm. The mobile phase consisted of pentane-1-sulfonic acid sodium salt 10 mM - acetonitrile (65:35) eluted isocratically at a 0.6 mL/min flow rate. Detection was carried out at a wavelength of 222 nm. The analytical method was validated with test parameters of selectivity, system suitability, accuracy, precision, linearity, detection limit and quantification limit. Results from the validation study demonstrated a retention time of 4.63 minutes, good linear in the concentration range of 0.06 – 0.18 mg/mL with a correlation coefficient and Vx0 of 1.00000 and 0.1%. Test accuracy (% bias) obtained a value of 0.77% with precision (system, method and intermediate) less than 2.0%. The detection and quantification limits were 0.67 µg/mL and 2.02 µg/mL. Based on the research results, it can be concluded that the method developed provides fast, accurate and valid performance. Validation of the Analytical Method for Determining Lapatinib Ditosylate Raw Material Contents using HPLC-DAD.

Implementation of ISO 16140-3:2021 for Enumeration of Enterobacteriaceae in Food Products

2023-12-11T08:53:09+00:00

Method verification is one of the steps required to ensure that all methods used meet the standards required for data reliability and accuracy in a laboratory that implements Good Laboratory Practices (GLP). In accordance with ISO 16140-3:2021, the method verification for microbiology testing implemented by calculating the Intralaboratory Reproducibility Standard Deviation (S_IR) for implementation verification and eBias value for food item verification. Method verification for enumeration of Enterobacteriaceae in food products using ISO 16140-3 has never been carried out at the Indonesian Food and Drug Authority (FDA) laboratories. Therefore, verification of this method needs to be performed. This study aimed to verify the ISO 21528-2:2017 as reference method for enumeration of Enterobacteriaceae in food products by colony count technique. The selected food item for implementation verification was pasteurized milk while for food item verification, the selected food items were yogurt, traditional preserved egg (telur pindang), sweet and hard candy, seasoning dry powder, worcester sauce and cassava chips. All of selected foods were artificially contaminated with Escherichia coli WDCM 00012. The S_IR value obtained was 0.12 ≤ 2× 0,18 (lowest mean value of S_Rfrom ISO 21528-2:2017), indicating that the acceptability limit for the implementation verification was met. While the eBias value for all selected food item were less than 0,5 log10, thus the verification study in the National Quality Contol Laboratory of Drug and Food (NQCLDF), Indonesian FDA, meets the acceptance criteria defined in the standard ISO 16140-3:2021.

Marker Analysis as Phytopharmaceutical Products Quality Control: A Case Study on Phytopharmaceutical Products of Cardiovascular Therapy Class

2024-01-18T02:35:30+00:00

Quality control of phytopharmaceutical products becomes a priority because they are included in the National Health Insurance. Quality control is carried out through active compound determination in the product. Currently, testing methods for active compounds are in herbs or plant extracts, but none for products. Phytopharmaceutical products for cardiovascular system therapy class contain Apii graveolentis herba and Orthosiphomis staminei folium extracts. The research aims to develop analytical methods that are selective, accurate and reliable to assay the active compounds of sinensetin in product contains Apii graveolentis herba extract by TLC and apigenin in product contains Orthosiphomis staminei folium extract by LC-MS/MS. From the results, it is proven that both methods are valid and reliable with linearity, precision and accuracy values that meet the requirements. The linearity of sinensetin and apigenin has correlation coefficient values of 0.9972 and 0.9995, with residual deviation values (V_x0) of 4.0% and 1.7%. Good repeatability is represented by the low number of precision values. Sinensetin precision at a concentration of 91.83; 310.33; and 586.68 µg/g were 1.11; 0.61; and 1.50%, while the apigenin precision at a concentration of 5; 15; and 25 µg/g were 5.82; 4.36; and 2.32% respectively. Accuracy of sinensetin at a concentration of 100.24; 300.72; and 601.44 µg/g were 90.8 - 92.7%; 102.5 - 103.7%; and 96.5 - 99.2%, while the accuracy of apigenin at a concentration of 5; 15; and 25 µg/g were 81.58 - 91.57%; 86.71 - 93.76%; and 89.12 - 93.31 % respectively. The developed methods were sensitive with the limit of quantitation (LoQ) values for sinensetin and apigenin were 3.34 ng/g and 6.67 µg/g. The validated methods can be applied to determine sinensetin and apigenin in cardiovascular system therapy class phytopharmaceutical products.

Criminological Review of New Modus Operandi of Circulation of Psychotropics and Certain Frequently Abused Drugs Through Cosmetic Shops

2023-01-10T06:56:16+00:00

A new modus operandi (M.O.) has been identified in the illegal distribution of psychotropics and certain frequently abused drugs (OOT), that is, by using cosmetic shops as a distribution facility. This study aims to describe this phenomenon and provide intervention recommendations. The study was conducted using a qualitative method, which involved collecting secondary data through administrative data and news tracking. The data was then verified through interviews with relevant parties and field observations. The data collected showed increasing cases in at least three provinces: DKI Jakarta, Banten, and West Java. The M.O. is characterized by the high traffic of male teenagers who transact quickly at cosmetic shops with motorcycles on standby. The shops usually sell a small number of cosmetics that are dusty or expired and compacted on the storefront to cover drugs. An exciting finding was that a specific regional community played a role in the development of this M.O. However, the authorities' actions have not been effective, as several shops that have been prosecuted have committed violations again. If examined from a criminological perspective, one of the reasons why perpetrators choose to sell drugs illegally is due to the perpetrator's adaptation to anomie conditions, where expectations of success and wealth are difficult to achieve by conventional means. In pursuing these expectations, perpetrators make rational decisions to maximize profits and minimize costs/risks. Regional community groups are also formed because of rational choices and become a cultural model of organized crime groups.

Validation of the Analytical Method for Determining 4-Amino-3-Nitrophenol Concentrations in Oxidative Hair Dyes

2024-02-13T08:54:32+00:00

4-amino-3-nitrophenol (C6H6N2O3) has been widely used as an oxidative hair colourant. This compound was a structural isomer of 2-amino-4-nitrophenol (2,4-ANP) and 2-amino-5-nitrophenol (2,5-ANP). All of these compounds have different regulations in Indonesia. The maximum concentration of 4-amino-3-nitrophenol in oxidative hair colourants was 1.5% after being mixed with oxidator agents. Otherwise, 2-amino-4-nitrophenol and 2-amino-5-nitrophenol were prohibited substances contained in cosmetic products. Therefore, it was essential to validate the method to differentiate all these three compounds with a resolution of more than 1.5. The High-Performance Liquid Chromatography with Photo Diode Array Detector using octadecylsilane (C18) column (250 mm x 4.6 mm and 5 μm particle size) has been developed and validated. Acetonitrile HPLC grade and 0.05 M acetic buffer with pH 5.9 (20:80) have been used as mobile phase isocratically. The flow rate and column temperature were 1.0 ml/minute and 40oC, respectively. The validation result showed good linearity, with the correlation coefficient of the method being 1.0. The method is also selective in differentiating all three compounds and is specific to the methylparaben compound. The precision data on the concentration of 3.68 μg/ml, 14.70 μg/ml and 18.38 μg/ml was 0.59%, 1.92% and 0.68% respectively. The percent recovery of this method on the same concentration above was 100.17-100.91, 99.06-100.39 and 100.38-101.05, respectively. The limit quantitation of this method was 0,07%. All validation parameters of the method have met the requirement so that the analysis method for determination of 4,3-ANP has been proven to be selective, accurate and reliable.