Displaying publications 1 - 20 of 34 in total

  1. Chooi WH, Ng PW, Hussain Z, Ming LC, Ibrahim B, Koh D
    Vaccine, 2022 Mar 15;40(12):1699-1701.
    PMID: 35210120 DOI: 10.1016/j.vaccine.2022.02.034
    Matched MeSH terms: Drug Contamination*
  2. Keah KC, Jegathesan M, Tan SC, Chan SH, Chee OM, Cheong YM, et al.
    Med J Malaysia, 1995 Dec;50(4):291-7.
    PMID: 8668045
    A study to determine contamination of diluted disinfectants at different points in preparation and use in 6 Malaysian hospitals was done using the in-use test. A growth of > or = 250 organisms/ml was taken as an indication of contamination. A total of 342 (7.9%) of the 4316 freshly diluted samples collected from disinfectant bottles in the pharmacy were found to be contaminated. The bacterial isolates obtained were Pseudomonas spp. (42.4%), Moraxella spp. (22.0%), Flavobacterium spp. (11.6%) and Enterobacter spp. (4.2%). Three hundred and sixty seven out of 2278 ward stock were contaminated. The isolates were Pseudomonas spp. (48.6%), Moraxella spp. (17.8%), Acinetobacter spp. (8.9%) and Flavobacterium spp. (7.0%). Of the 9265 disinfectants in-use, 1519 (16.4%) were contaminated. Among the organisms isolated were Pseudomonas spp. (44.3%), Bacillus spp. (13.0%), Enterobacter spp. (9.5%) and Acinetobacter spp. (7.3%). The results indicated a high level of contamination of diluted disinfectants prepared in the pharmacy, stored and used in the wards. This gave a high index of suspicion that recommendations for cleaning of disinfectant containers before refilling, handling of diluted stock solutions and using of disinfectants were not closely adhered to. Standard disinfection procedures outlined in the disinfection and sterilization policy by the Ministry of Health should therefore be followed.
    Matched MeSH terms: Drug Contamination*
  3. Reddy AVB, Yusop Z, Jaafar J, Bin Aris A, Abdul Majid Z
    J Sep Sci, 2017 Aug;40(15):3086-3093.
    PMID: 28581679 DOI: 10.1002/jssc.201700252
    An extremely sensitive and simple gas chromatography with mass spectrometry method was developed and completely validated for the analysis of five process-related impurities, viz., 4-hydroxy-l-phenylglycine, 4-hydroxyphenylacetonitrile, 4-hydroxyphenylacetic acid, methyl-4-hydroxyphenylacetate, and 2-[4-{(2RS)-2-hydroxy-3-[(1-methylethyl)amino]propoxy}phenyl]acetonitrile, in atenolol. The separation of impurities was accomplished on a BPX-5 column with dimensions of 50 m × 0.25 mm i.d. and 0.25 μm film thickness. The method validation was performed following International Conference on Harmonisation guidelines in which the method was capable to quantitate 4-hydroxy-l-phenylglycine, 4-hydroxyphenylacetonitrile, and 4-hydroxyphenylacetic acid at 0.3 ppm, and methyl-4-hydroxyphenylacetate and 2-[4-{(2RS)-2-hydroxy-3-[(1-methylethyl)amino]propoxy}phenyl]acetonitrile at 0.35 ppm with respect to 10 mg/mL of atenolol. The method was linear over the concentration range of 0.3-10 ppm for 4-hydroxy-l-phenylglycine, 4-hydroxyphenylacetonitrile, and 4-hydroxyphenylacetic acid, and 0.35-10 ppm for methyl-4-hydroxyphenylacetate and 2-[4-{(2RS)-2-hydroxy-3-[(1-methylethyl)amino]propoxy}phenyl]acetonitrile. The correlation coefficient in each case was found ≥0.998. The repeatability and recovery values were acceptable, and found between 89.38% and 105.60% for all five impurities under optimized operating conditions. The method developed here is simple, selective, and sensitive with apparently better resolution than the reported methods. Hence, the method is a straightforward and good quality control tool for the quantitation of selected impurities at trace concentrations in atenolol.
    Matched MeSH terms: Drug Contamination*
  4. Yenugu VMR, Ambavaram VBR, Moniruzzaman M, Madhavi G
    J Sep Sci, 2018 Nov;41(21):3966-3973.
    PMID: 30138541 DOI: 10.1002/jssc.201800626
    In the present study, a sensitive and fully validated liquid chromatography with mass spectrometry method was developed for the quantification of three potential genotoxic impurities in rabeprazole drug substance. The separation was achieved on Symmetry C18 column (100 × 4.6 mm, 3.5 μm) using 0.1% formic acid in water as mobile phase A and acetonitrile as mobile phase B in gradient elution mode at 0.5 mL/min flow rate. Triple quadrupole mass detection with electrospray ionization was operated in selected ion recording mode for the quantification of impurities. The calibration curves were demonstrated good linearity over the concentration range of 1.0-4.5 ppm for O-phenylenediamine, 1.8-4.5 ppm for 4-nitrolutidine-N-oxide and 1.0-4.5 ppm for benzyltriethylammonium chloride with respect to 10 mg/mL of rabeprazole. The correlation coefficient obtained in each case was >0.998. The recoveries were found satisfactory over the range between 94.22 and 106.84% for all selected impurities. The method validation was carried out following International Conference on Harmonization guidelines, from which the developed method was able to quantitate the impurities at 1.0 ppm for O-phenylenediamine, 1.8 ppm for 4-nitrolutidine-N-oxide and 1.0 ppm for benzyltriethylammonium chloride. Furthermore, the proposed method was successfully evaluated for the determination of selected impurities from bulk drug and formulation samples of rabeprazole within the acceptable limits.
    Matched MeSH terms: Drug Contamination*
  5. Reti S
    N Z Med J, 2002 Aug 9;115(1159):U125.
    PMID: 12362169
    Matched MeSH terms: Drug Contamination*
  6. Jia M, Wei Y, Ma Y, Shen Y, Zhang Y
    Zhongguo Zhong Yao Za Zhi, 1997 Aug;22(8):454-8, 510.
    PMID: 11038909
    Through the investigation on botanical origin, output and sales of Togcao in producing areas, it has been proved that there are twenty-two species of six families used as Tongcao. The medicinal parts are the pith of stems or petioles. The provinces featuring more species and larger output of Tongcao are Sichuan, Yunnan, Guizhou, Guangxi, Hunan and Shaanxi. A hundred and two pieces of commercial samples collected from twenty-six provinces in China, Hongkong area, Japan, Malaysia, Thailand, Singapore and Republic of Korea have been identified. The result shows that both Xiaotongcao and Datongcao are called by the same name Tongcao. The main species is Xiaotongcao, which takes a proportion of 70% in Tongcao. And the Tongcao(Tetrapanax papyriferus, taking a proportion of 20%) as recorded in the Chinese Pharmacopoeia (1995 edition) is seldom used.
    Matched MeSH terms: Drug Contamination
  7. Wan Mohamed Radzi CWJ, Nordin FNM
    J Cosmet Dermatol, 2022 Dec;21(12):6875-6882.
    PMID: 36181345 DOI: 10.1111/jocd.15429
    BACKGROUND: Concern on cosmetic safety has been a subject of interest in recent years and is commonly associated with the exposure of the consumers to chemicals and impurities such as mercury contamination. Moreover, cancellations of notified cosmetic products were recurrently being reported by the Malaysia authority, namely the National Pharmaceutical Regulatory Authority (NPRA). Among the cosmetic categories was skin whitening product, which is still in high demand whilst reported to cause health risks. Besides, low number of studies on cosmetic safety and mercury contamination were recorded in Malaysia. The lack of scientific evidence on the safety and risks of the ingredients used in cosmetic formulation is a major concern to many consumers.

    OBJECTIVE: The aim of this study was to identify the presence of mercury in skin whitening products, and to identify products containing mercury with the concentration exceeding the limitation of 1 ppm.

    METHODOLOGY: A total of 104 whitening products were selected from the market via random sampling technique. The mercury concentration was determined by accredited laboratory, and the results were later compared with the cosmetic guideline of Malaysia and the list of banned products issued by NPRA.

    RESULTS: A total of 51.9% (n = 54) whitening products were found registered under the NPRA Quest system and remaining 48.1% (n = 50) were non-registered products. None of the whitening products listed mercury as an ingredient, but laboratory analysis showed 15.4% (n = 16) of the products contained mercury with the concentration exceeding the maximum limit of 1 ppm. A total of 87.5% of the whitening products (14 out of 16) containing high mercury concentration were non-registered products which were not registered in NPRA Quest system. The exceeded concentration recorded ranged between 1.81 ppm and 838 123 ppm. Besides that, 50% (8 out of 16) of the products were found in the list of banned products issued by the NPRA of Malaysia.

    CONCLUSIONS: This study presents the status of cosmetic products, particularly the skin whitening products available in Malaysia market. Concern arises when some of the products were found to have presence of harmful substances such as mercury. Even though the presence of mercury in a cosmetic product can either be non-intentional or intentionally used by the manufacturer in the cosmetic formulation, the impact of the ingredient can cause health risk to the users.

    Matched MeSH terms: Drug Contamination
  8. Hajeb P, Jinap S, Ismail A, Mahyudin NA
    PMID: 22610296 DOI: 10.1007/978-1-4614-3414-6_2
    Although several studies have been published on levels of mercury contamination of the environment, and of food and human tissues in Peninsular Malaysia, there is a serious dearth of research that has been performed in East Malaysia (Sabah and Sarawak). Industry is rapidly developing in East Malaysia, and, hence, there is a need for establishing baseline levels of mercury contamination in environmental media in that part of the country by performing monitoring studies. Residues of total mercury and inorganic in food samples have been determined in nearly all previous studies that have been conducted; however, few researchers have analyzed samples for the presence of methlymercury residues. Because methylmercury is the most toxic form of mercury, and because there is a growing public awareness of the risk posed by methylmercury exposure that is associated with fish and seafood consumption, further monitoring studies on methylmercury in food are also essential. From the results of previous studies, it is obvious that the economic development in Malaysia, in recent years, has affected the aquatic environment of the country. Primary areas of environmental concern are centered on the rivers of the west Peninsular Malaysian coast, and the coastal waters of the Straits of Malacca, wherein industrial activities are rapidly expanding. The sources of existing mercury input to both of these areas of Malaysia should be studied and identified. Considering the high levels of mercury that now exists in human tissues, efforts should be continued, and accelerated in the future, if possible, to monitor mercury contamination levels in the coastal states, and particularly along the west Peninsular Malaysian coast. Most studies that have been carried out on mercury residues in environmental samples are dated, having been conducted 20-30 years ago; therefore, the need to collect much more and more current data is urgent. Furthermore, establishing baseline levels of mercury exposure to humans in Malaysia will be useful in establishing the levels at which detrimental effects in both humans and marine life may occur, and therefore the levels at which warning should be raised or limits established. In particular, we believe that two or three monitoring centers should be established in Peninsular Malaysia, and one in East Malaysia for the specific purpose of monitoring for the presence of hazardous environmental chemicals, and particularly monitoring for heavy metals such as mercury that reach food that is subject to consistent human consumption.
    Matched MeSH terms: Drug Contamination*
  9. Bujang NB, Chee CF, Heh CH, Rahman NA, Buckle MJC
    PMID: 28580889 DOI: 10.1080/19440049.2017.1336674
    Adulteration of herbal health supplements with phosphodiesterase-5 (PDE-5) inhibitors and their analogues is becoming a worldwide problem. The aim of this study was to investigate herbal and food products sold in the Malaysian market for the presence of these adulterants. Sixty-two products that claim to enhance men's sexual health were sampled between April 2014 and April 2016. These products included unregistered products seized by the Pharmacy Enforcement Division of the Ministry of Health (n = 39), products sent to the National Pharmaceutical Regulatory Agency for pre-registration testing (n = 9) and products investigated under the post-registration market surveillance programme (n = 14). The products were tested against an in-house spectral library consisting of 61 PDE-5 inhibitors and analogues using a validated liquid chromatography-mass spectrometry ion-trap-time-of-flight (LC-MS IT-TOF) method. Thirty-two (82%) of the unregistered products and two (14%) of the registered products were found to be adulterated with at least one PDE-5 inhibitor or analogue, while none of the pre-registration products contained adulterants. A total of 16 different adulterants were detected and 36% of the adulterated products contained a mixture of two or more adulterants. This study has demonstrated that the adulteration of unregistered herbal products in the Malaysian market is an alarming issue that needs to be urgently addressed by the relevant authorities.
    Matched MeSH terms: Drug Contamination*
  10. Ang HH, Lee KL, Kiyoshi M
    Int J Toxicol, 2005 May-Jun;24(3):165-71.
    PMID: 16040569 DOI: 10.1080/10915810590952942
    The DCA (Drug Control Authority) of Malaysia implemented the phase 3 registration of traditional medicines on 1 January 1992. As such, a total of 100 products in various pharmaceutical dosage forms of a herbal preparation containing Smilax luzonensis, either single or combined preparations, were analyzed for the presence of lead, using atomic absorption spectrophotometry. Results showed that 14% of the above products possessed 10.02 to 21.21 ppm of lead, and, therefore, they failed to comply with the quality requirement for traditional medicines in Malaysia ( <10 ppm). Although this study showed that 86% of the products complied with the quality requirement for traditional medicines in Malaysia pertaining to lead, they cannot be assumed safe from lead contamination because of batch-to-batch inconsistency.
    Matched MeSH terms: Drug Contamination*
  11. Rahman MB, Hussain M, Kabiraz MP, Nordin N, Siddiqui SA, Bhowmik S, et al.
    Food Chem, 2023 Nov 30;427:136761.
    PMID: 37406446 DOI: 10.1016/j.foodchem.2023.136761
    Formaldehyde is added illegally to food to extend its shelf life due to its antiseptic and preservation properties. Several research has been conducted to examine the consequences of adulteration with formaldehyde in food items. These findings suggest that adding formaldehyde to food is considered harmful as it accumulates in the body with long-term consumption. In this review includes study findings on food adulteration with formaldehyde and their assessment of food safety based on the analytical method applied to various geographical regions, food matrix types, and their sources in food items. Additionally, this review sought to assess the risk of formaldehyde-tainted food and the understanding of its development in food and its impacts on food safety in light of the widespread formaldehyde adulteration. Finally, the study would be useful as a manual for implementing adequate and successful risk assessment to increase food safety.
    Matched MeSH terms: Drug Contamination
  12. Ang HH
    Clin. Pharmacol. Ther., 2005 May;77(5):451.
    PMID: 15900291
    Matched MeSH terms: Drug Contamination/legislation & jurisprudence; Drug Contamination/statistics & numerical data
  13. Ang HH, Lee KL
    Food Chem Toxicol, 2006 Aug;44(8):1245-50.
    PMID: 16567029 DOI: 10.1016/j.fct.2006.01.014
    The DCA (Drug Control Authority), Malaysia has implemented the phase three registration of traditional medicines on 1 January 1992. As such, a total of 100 products in various pharmaceutical dosage forms of a herbal preparation found in Malaysia, containing tongkat Ali hitam, either single or combined preparations, were analyzed for the presence of a heavy toxic metal, mercury, using atomic absorption spectrophotometer, after performing a simple random sampling to enable each sample an equal chance of being selected in an unbiased manner. Results showed that 26% of these products possessed 0.53-2.35 ppm of mercury, and therefore, do not comply with the quality requirement for traditional medicines in Malaysia. The quality requirement for traditional medicines in Malaysia is not exceeding 0.5 ppm for mercury. Out of these 26 products, four products have already registered with the DCA, Malaysia whilst the rest, however, have not registered with the DCA, Malaysia.
    Matched MeSH terms: Drug Contamination
  14. Rahmani A, Jinap S, Soleimany F
    Compr Rev Food Sci Food Saf, 2009 Jul;8(3):202-251.
    PMID: 33467794 DOI: 10.1111/j.1541-4337.2009.00079.x
      Mycotoxin toxicity occurs at very low concentrations, therefore sensitive and reliable methods for their detection are required. Consequently, sampling and analysis of mycotoxins is of critical importance because failure to achieve a suitable verified analysis can lead to unacceptable consignments being accepted or satisfactory shipments unnecessarily rejected. The general mycotoxin analyses carried out in laboratories are still based on physicochemical methods, which are continually improved. Further research in mycotoxin analysis has been established in such techniques as screening methods with TLC, GC, HPLC, and LC-MS. In some areas of mycotoxin method development, immunoaffinity columns and multifunctional columns are good choices as cleanup methods. They are appropriate to displace conventional liquid-liquid partitioning or column chromatography cleanup. On the other hand, the need for rapid yes/no decisions for exported or imported products has led to a number of new screening methods, mainly, rapid and easy-to-use test kits based on immuno-analytical principles. In view of the fact that analytical methods for detecting mycotoxins have become more prevalent, sensitive, and specific, surveillance of foods for mycotoxin contamination has become more commonplace. Reliability of methods and well-defined performance characteristics are essential for method validation. This article covers some of the latest activities and progress in qualitative and quantitative mycotoxin analysis.
    Matched MeSH terms: Drug Contamination
  15. Mohammed Abubakar B, Mohd Salleh F, Shamsir Omar MS, Wagiran A
    PMID: 28536641 DOI: 10.1155/2017/1352948
    In the last two decades, there has been a tremendous increase in the global use of herbal medicinal products (HMPs) due to their claimed health benefits. This has led to increase in their demand and consequently, also, resulted in massive adulteration. This is due to the fact that most of the traditional methods cannot identify closely related species in a process product form. Therefore the urgent need for simple and rapid identification methods resulted in the discovery of a novel technique. DNA barcoding is a process that uses short DNA sequence from the standard genome for species identification. This technique is reliable and is not affected by external factors such as climates, age, or plant part. The difficulties in isolation of DNA of high quality in addition to other factors are among the challenges encountered using the DNA barcoding in the authentication of HMP. These limitations indicated that using DNA barcoding alone may ineffectively authenticate the HMP. Therefore, the combination of DNA barcoding with chromatographic fingerprint, a popular and generally accepted technique for the assessment and quality control of HMP, will offer an efficient solution to effectively evaluate the authenticity and quality consistency of HMP. Detailed and quality information about the main composition of the HMPs will help to ascertain their efficacy and safety as these are very important for quality control.
    Matched MeSH terms: Drug Contamination
  16. Ting A, Chow Y, Tan W
    J Tradit Chin Med, 2013 Feb;33(1):119-24.
    PMID: 23596824
    The increasing popularity and widespread use of traditional Chinese herbs as alternative medicine have sparked an interest in understanding their biosafety, especially in decoctions that are consumed. This study aimed to assess the level of microbial and heavy metal contamination in commonly consumed herbal medicine in Malaysia and the effects of boiling on these contamination levels.
    Matched MeSH terms: Drug Contamination*
  17. Elbashir AA, Saad B, Ali AS, Saleh MI, Aboul-Enein HY
    Biomed Chromatogr, 2009 Mar;23(3):295-301.
    PMID: 18816453 DOI: 10.1002/bmc.1113
    A capillary electrophoretic (CE) method for the baseline separation of the enantiomers of primaquine diphosphate (PQ) and quinocide (QC) (a major contaminant) in pharmaceutical formulations is proposed. Both components were separated under the following conditions: 50 mm tris phosphate buffer (pH 3.0) containing 15 mm hydroxypropyl-gamma-cyclodextrin (HP-gamma-CD) as background electrolyte; applied voltage, 16 kV; capillary temperature, 25 degrees C; detection wavelength, 254 nm; hydrostatic injection, 10 s. The separations were conducted using a 35 cm length and 50 microm i.d. uncoated fused silica capillary column. Under the optimized conditions, the components were successfully separated in about 5 min. Intraday precision of migration time and corrected peak areas when expressed as relative standard deviation ranged from 0.17 to 0.45 and 2.60 to 3.94%, respectively, while the interday precision ranged from 2.59 to 4.20 and 3.15 to 4.21%, respectively. After the validation exercise, the proposed method was applied for the determination of QC impurity in PQ formulations.
    Matched MeSH terms: Drug Contamination*
  18. Ang HH, Lee KL, Kiyoshi M
    Int J Environ Health Res, 2004 Aug;14(4):261-72.
    PMID: 15369991
    The DCA (Drug Control Authority), Malaysia implemented the phase 3 registration of traditional medicines on 1 January 1992 with special emphasis on the quality, efficacy and safety (including the presence of heavy metals) in all pharmaceutical dosage forms of traditional medicinal preparations. As such, a total of 100 traditional medicinal preparations, containing Smilax myosotiflora, in various pharmaceutical dosage forms, which were bought in the Malaysian market, were analysed for lead content using atomic absorption spectrophotometry. Results showed that 15% of the products analysed possessed 10.23-23.05 ppm of lead, and therefore, do not comply with the quality requirement for traditional medicines in Malaysia. The quality requirement for traditional medicines in Malaysia is that they should not exceed 10 ppm of lead. Out of these 15 products, five products exhibited 10.23-23.05 ppm of lead, in fact they have already been registered with the DCA Malaysia. However, the rest of the products, which possessed 12.24-20.72 ppm of lead, have still not been registered with the DCA Malaysia. Although this study successfully showed that only 85% of the products complied with the quality requirement for traditional medicines in Malaysia pertaining to lead, they cannot, however, be assumed to be safe from lead contamination because of batch-to-batch inconsistency.
    Matched MeSH terms: Drug Contamination*
  19. Ali N, Hashim NH, Saad B, Safan K, Nakajima M, Yoshizawa T
    Food Chem Toxicol, 2005 Dec;43(12):1763-72.
    PMID: 16019122
    Traditional herbal medicines, popularly known as 'jamu' and 'makjun' in Malaysia and Indonesia, are consumed regularly to promote health. In consideration of their frequent and prolonged consumption, the natural occurrence of aflatoxins (AF) in these products was determined using immunoaffinity column clean-up and high-performance liquid chromatography with pre-column derivatization. The evaluated method, which entails dilution of sample extracts with Tween 20-phosphate buffered saline (1:9, v/v) and a chromatographic system using isocratic mobile phase composed of water-methanol-acetonitrile (70:20:10, v/v/v), was effective in separating AFB1, AFG1 and AFG2 from interference at their retention times. Results were confirmed using post-column derivatization with photochemical reactor. For 23 commercial samples analyzed, mean levels (incidence) of AFB(1), AFB(2) and AFG1 in positive samples were 0.26 (70%), 0.07 (61%) and 0.10 (30%) microg/kg, respectively; one sample was positive for AFG2 at a level of 0.03 (4%) microg/kg. In contrast to the high levels of AF in crude herbal drugs and medicinal plants reported previously by other researchers, the low contamination levels reported in this study may be attributed to the higher selectivity to AF of the method applied. Based on the AFB1 levels and the daily consumption of positive samples, a mean probable daily intake of 0.022 ng/kg body weight was calculated.
    Matched MeSH terms: Drug Contamination*
  20. Ho YB, Abdullah NH, Hamsan H, Tan ESS
    Regul Toxicol Pharmacol, 2017 Aug;88:72-76.
    PMID: 28554823 DOI: 10.1016/j.yrtph.2017.05.018
    This study aims to determine concentrations of mercury in facial skin lightening cream according to different price categories (category I: Drug Administration (USFDA) permitted trace levels (<1 ppm) except for one sample from category III which was manufactured in China. Concentrations of mercury in facial skin lightening creams ranged from not detected to 1.13 mg kg-1. There was no significant association between concentrations of mercury with price categories (p = 0.12). There was no significant non-carcinogenic health risk due to daily application of the facial skin lightening creams based on assumption of 30 years exposure period (HQ 
    Matched MeSH terms: Drug Contamination*
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