Displaying publications 61 - 80 of 120 in total

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  1. Farah, A.A., Sukor, R., Fatimah, A.B., Jinap, S.
    MyJurnal
    Nanotechnology contribute to significant impacts in every way in our daily life. Recently,
    the application of nanotechnology in biosensors has been a trend in developing a highly
    sensitive, selective, quick response, inexpensive, high volume production, great reliability
    and miniaturized sensors. High demands on the production of rapid sensors for food safety
    and quality control purposes are increasingly become the interest for researchers all over the
    world. This is because, in food sector, the quality of a certain product is based on their periodic
    chemical and microbilogical analysis. The uses of nanomaterials in biosensors are very
    promising because they mediate current flow. Surface modification of the electrode based on
    various nanomaterials including nanoparticle, nanofiber, nanowire and nanotube significantly
    increase the performance of the biosensor. Ultimately, this implementation will enhance the
    sensor’s sensitivity and stability. This review explores the previous research and development
    work on nanomaterials-based sensors for food applications.
    Matched MeSH terms: Quality Control
  2. Kuwawenaruwa A, Remme M, Mtei G, Makawia S, Maluka S, Kapologwe N, et al.
    PMID: 30461049 DOI: 10.1002/hpm.2702
    Health care financing reforms are gaining popularity in a number of African countries to increase financial resources and promote financial autonomy, particularly at peripheral health care facilities. The paper explores the establishment of facility bank accounts at public primary facilities in Tanzania, with the intention of informing other countries embarking on such reform of the lessons learned from its implementation process. A case study approach was used, in which three district councils were purposively sampled. A total of 34 focus group discussions and 14 in-depth interviews were conducted. Thematic content analysis was used during analysis. The study revealed that the main use of bank account revenue was for the purchase of drugs, medical supplies, and minor facility needs. To ensure accountability for funds, health care facilities had to submit monthly reports of expenditures incurred. District managers also undertook quality control of facility infrastructure, which had been renovated using facility resources and purchases of facility needs. Facility autonomy in the use of revenue retained in their accounts would improve the availability of drugs and service delivery. The experienced process of opening facility bank accounts, managing, and using the funds highlights the need to strengthen the capacity of staff and health-governing committees.
    Matched MeSH terms: Quality Control
  3. Hizam NDA, Ung NM, Jong WL, Zin HM, Rahman ATA, Loh JPY, et al.
    Phys Med, 2019 Nov;67:34-39.
    PMID: 31655398 DOI: 10.1016/j.ejmp.2019.10.023
    PURPOSE: Intensity Modulated Radiotherapy (IMRT) has changed the practice of radiotherapy since its implementation in the 1990s. The purpose of this study is to review current practice of IMRT in Malaysia.

    METHODS: A survey on medical physics aspects of IMRT is conducted on radiotherapy departments across Malaysia to assess the usage, experience and QA in IMRT, which is done for the first time in this country. A set of questionnaires was designed and sent to the physicist in charge for their responses. The questionnaire consisted of four sections; (i) Experience and qualification of medical physicists, (ii) CT simulation techniques (iii) Treatment planning and treatment unit, (iv) IMRT process, delivery and QA procedure.

    RESULTS: A total of 26 responses were collected, representing 26 departments out of 33 radiotherapy departments in operation across Malaysia (79% response rate). Results showed that the medical physics aspects of IMRT practice in Malaysia are homogenous, with some variations in certain areas of practices. Thirteen centres (52%) performed measurement-based QA using 2D array detector and analysed using gamma index criteria of 3%, 3 mm with variation confidence range. In relation to the IMRT delivery, 44% of Malaysia's physicist takes more than 8 h to plan a head and neck case compared to the UK study possibly due to the lack of professional training.

    CONCLUSIONS: This survey provides a picture of medical physics aspects of IMRT in Malaysia where the results/data can be used by radiotherapy departments to benchmark their local policies and practice.

    Matched MeSH terms: Quality Control
  4. Afzan A, Kasim N, Ismail NH, Azmi N, Ali AM, Mat N, et al.
    Metabolomics, 2019 Mar 04;15(3):35.
    PMID: 30830457 DOI: 10.1007/s11306-019-1489-2
    BACKGROUND: Ficus deltoidea Jack (Moraceae) is a plant used in Malaysia for various diseases including as a supplement in diabetes management. Morphology distinction of the 7 main varieties (var. angustifolia, var. bilobata, var. deltoidea, var. intermedia, var. kunstleri, var. motleyana and var. trengganuensis) is challenging due to the extreme leaf heterophylly and unclear varietal boundaries, making it difficult for quality control of F. deltoidea products.

    OBJECTIVE: We aimed to compare the phytochemical composition of 7 varieties growing in different conditions at various geographical locations. We also aimed to establish the quality control markers for the authentication of these varieties.

    METHODS: We applied untargeted UHPLC-TOFMS metabolomics to discriminate 100 leaf samples of F. deltoidea collected from 6 locations in Malaysia. A genetic analysis on 21 leaf samples was also performed to validate the chemotaxonomy differentiation.

    RESULTS: The PCA and HCA analysis revealed the existence of 3 chemotypes based on the differentiation in the flavonoid content. The PLS-DA analysis identified 15 glycosylated flavone markers together with 1 furanocoumarin. These markers were always consistent for the respective varieties, regardless of the geographical locations and growing conditions. The chemotaxonomy differentiation was in agreement with the DNA sequencing. In particular, var. bilobata accession which showed divergent morphology was also differentiated by the chemical fingerprints and genotype.

    CONCLUSION: Chemotype differentiation based on the flavonoid fingerprints along with the proposed markers provide a powerful identification tool to complement morphology and genetic analyses for the quality control of raw materials and products from F. deltoidea.

    Matched MeSH terms: Quality Control
  5. Noordin MI, Chung LY
    Drug Dev Ind Pharm, 2004;30(9):925-30.
    PMID: 15554216
    This study adopts Differential Scanning Calorimetry (DSC) to analyze the thermal properties of samples (2.5-4.0 mg) from the tip, middle, and base sections of individual paracetamol suppositories, which were sampled carefully using a stainless steel scalpel. The contents of paracetamol present in the samples obtained from these sections were determined from the enthalpies of fusion of paracetamol and expressed as % w/w paracetamol to allow comparison of the amount of paracetamol found in each section. The tip, middle, and base sections contained 10.1+/-0.2%, 10.1+/-0.2%, and 10.3+/-0.2% w/w paracetamol, and are statistically similar (One-way anova; p>0.05). This indicates that the preparation technique adopted produces high quality suppositories in terms of content uniformity. The contents of paracetamol in the 120-mg paracetamol suppositories determined by DSC and UV spectrophotometry were statistically equivalent (Students's t-test; p>0.05), 120.8+/-2.6 mg and 120.8+/-1.5 mg, respectively, making DSC a clear alternative method for the measurement of content of drug in suppositories. The main advantages of the method are that samples of only 2.5-4.0 mg are required and the procedure does not require an extraction process, which allows for the analysis to be completed rapidly. In addition, it is highly sensitive and reproducible, with the lower detection limit at 4.0% w/w paracetamol, which is about 2.5 times lower than the content of paracetamol (10% w/w) present in our 120-mg paracetamol suppositories and commercial paracetamol suppositories, which contained about 125 mg paracetamol. Therefore, this method is particularly suited for determination of content uniformity in individual suppositories in quality control (QC) and in process quality control (PQC).
    Matched MeSH terms: Quality Control
  6. 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: Quality Control
  7. Sharma D, Patel RP, Zaidi STR, Sarker MMR, Lean QY, Ming LC
    Front Pharmacol, 2017;8:546.
    PMID: 28871228 DOI: 10.3389/fphar.2017.00546
    Ciprofloxacin, a second generation broad spectrum fluoroquinolone, is active against both Gram-positive and Gram-negative bacteria. Ciprofloxacin has a high oral bioavailability and a large volume of distribution. It is used for the treatment of a wide range of infections including urinary tract infections caused by susceptible bacteria. However, the availability and use of substandard and spurious quality of oral ciprofloxacin formulations in the developing countries has been thought to have contributed toward increased risk of treatment failure and bacterial resistance. Therefore, quality control and bioequivalence studies of the commercially available oral ciprofloxacin formulations should be monitored. Appropriate actions should be taken against offending manufacturers in order to prevent the sale of substandard and spurious quality of ciprofloxacin formulations.
    Matched MeSH terms: Quality Control
  8. Okuma HS, Yoshida H, Kobayashi Y, Arakaki M, Mizoguchi C, Inagaki L, et al.
    Cancer Sci, 2023 Jun;114(6):2664-2673.
    PMID: 36919757 DOI: 10.1111/cas.15790
    Tissue specimen quality assurance is a major issue of precision medicine for rare cancers. However, the laboratory standards and quality of pathological specimens prepared in Asian hospitals remain unknown. To understand the methods in Southeast Asian oncology hospitals and to clarify how pre-analytics affect the quality of formalin-fixed paraffin-embedded (FFPE) specimens, a questionnaire surveying pre-analytical procedures (Part I) was administered, quality assessment of immunohistochemistry (IHC) staining and DNA/RNA extracted from the representative FFPE specimens from each hospital (Part II) was conducted, and the quality of DNA/RNA extracted from FFPE of rare-cancer patients for genomic sequencing (Part III) was examined. Quality measurements for DNA/RNA included ΔΔCt, DV200, and cDNA yield. Six major cancer hospitals from Malaysia, Philippines, and Vietnam participated. One hospital showed unacceptable quality for the DNA/RNA assessment, but improved by revising laboratory procedures. Only 57% (n = 73) of the 128 rare-cancer patients' specimens met both DNA and RNA quality criteria for next-generation sequencing. Median DV200 was 80.7% and 64.3% for qualified and failed RNA, respectively. Median ΔΔCt was 1.25 for qualified and 4.89 for failed DNA. Longer storage period was significantly associated with poor DNA (fail to qualify ratio = 1579:321 days, p 
    Matched MeSH terms: Quality Control
  9. Chanakit T, Low BY, Wongpoowarak P, Moolasarn S, Anderson C
    Am J Pharm Educ, 2014 Nov 15;78(9):161.
    PMID: 26056400 DOI: 10.5688/ajpe789161
    To explore the current status of pharmacy education in Thailand.
    Matched MeSH terms: Quality Control
  10. Axtner J, Crampton-Platt A, Hörig LA, Mohamed A, Xu CCY, Yu DW, et al.
    Gigascience, 2019 Apr 01;8(4).
    PMID: 30997489 DOI: 10.1093/gigascience/giz029
    BACKGROUND: The use of environmental DNA for species detection via metabarcoding is growing rapidly. We present a co-designed lab workflow and bioinformatic pipeline to mitigate the 2 most important risks of environmental DNA use: sample contamination and taxonomic misassignment. These risks arise from the need for polymerase chain reaction (PCR) amplification to detect the trace amounts of DNA combined with the necessity of using short target regions due to DNA degradation.

    FINDINGS: Our high-throughput workflow minimizes these risks via a 4-step strategy: (i) technical replication with 2 PCR replicates and 2 extraction replicates; (ii) using multi-markers (12S,16S,CytB); (iii) a "twin-tagging," 2-step PCR protocol; and (iv) use of the probabilistic taxonomic assignment method PROTAX, which can account for incomplete reference databases. Because annotation errors in the reference sequences can result in taxonomic misassignment, we supply a protocol for curating sequence datasets. For some taxonomic groups and some markers, curation resulted in >50% of sequences being deleted from public reference databases, owing to (i) limited overlap between our target amplicon and reference sequences, (ii) mislabelling of reference sequences, and (iii) redundancy. Finally, we provide a bioinformatic pipeline to process amplicons and conduct PROTAX assignment and tested it on an invertebrate-derived DNA dataset from 1,532 leeches from Sabah, Malaysia. Twin-tagging allowed us to detect and exclude sequences with non-matching tags. The smallest DNA fragment (16S) amplified most frequently for all samples but was less powerful for discriminating at species rank. Using a stringent and lax acceptance criterion we found 162 (stringent) and 190 (lax) vertebrate detections of 95 (stringent) and 109 (lax) leech samples.

    CONCLUSIONS: Our metabarcoding workflow should help research groups increase the robustness of their results and therefore facilitate wider use of environmental and invertebrate-derived DNA, which is turning into a valuable source of ecological and conservation information on tetrapods.

    Matched MeSH terms: Quality Control
  11. Hand RM, Senarathna SMDKG, Page-Sharp M, Gray K, Sika-Paotonu D, Sheel M, et al.
    Pharmacol Res Perspect, 2020 12;8(6):e00668.
    PMID: 33090729 DOI: 10.1002/prp2.668
    Benzathine penicillin G (BPG) is used as first-line treatment for most forms of syphilis and as secondary prophylaxis against rheumatic heart disease (RHD). Perceptions that poor quality of BPG is linked to reported adverse effects and therapeutic failure may impact syphilis and RHD control programs. Clinical networks and web-based advertising were used to obtain vials of BPG from a wide range of countries. The quality of BPG was assessed using a high performance liquid chromatography assay capable of detecting relevant impurities and degradation products. Tests for water content, presence of heavy metals and physical characteristics of BPG, including particle size analysis and optical microscopy, also were conducted. Thirty-five batches of BPG were sourced from 16 countries across 4 WHO regions. All batches passed the US Pharmacopeia requirements for BPG injection (content), with no evidence of breakdown products or other detected contaminants. Water content and heavy metal analysis (n = 11) indicated adherence to regulatory standards and Good Manufacturing Practice. Particle size analysis (n = 20) found two batches with aggregated particles (>400 µm) that were dispersed following sonication. Current batches of BPG were of satisfactory pharmaceutical quality but aggregated particles were found in a modest proportion of samples. Future studies should focus on the physical characteristics of BPG which may contribute to variations in plasma penicillin concentrations an observed needle blockages in clinical practice. Pharmacopeial monographs could be revised to include standards on particle size and crystal morphology of BPG.
    Matched MeSH terms: Quality Control*
  12. A VBR, Yusop Z, Jaafar J, Aris AB, Majid ZA, Umar K, et al.
    J Pharm Biomed Anal, 2016 Sep 05;128:141-148.
    PMID: 27262107 DOI: 10.1016/j.jpba.2016.05.026
    In this study a sensitive and selective gradient reverse phase UPLC-MS/MS method was developed for the simultaneous determination of six process related impurities viz., Imp-I, Imp-II, Imp-III, Imp-IV, Imp-V and Imp-VI in darunavir. The chromatographic separation was performed on Acquity UPLC BEH C18 (50 mm×2.1mm, 1.7μm) column using gradient elution of acetonitrile-methanol (80:20, v/v) and 5.0mM ammonium acetate containing 0.01% formic acid at a flow rate of 0.4mL/min. Both negative and positive electrospray ionization (ESI) modes were operated simultaneously using multiple reaction monitoring (MRM) for the quantification of all six impurities in darunavir. The developed method was fully validated following ICH guidelines with respect to specificity, linearity, limit of detection (LOD), limit of quantification (LOQ), accuracy, precision, robustness and sample solution stability. The method was able to quantitate Imp-I, Imp-IV, Imp-V at 0.3ppm and Imp-II, Imp-III, and Imp-VI at 0.2ppm with respect to 5.0mg/mL of darunavir. The calibration curves showed good linearity over the concentration range of LOQ to 250% for all six impurities. The correlation coefficient obtained was >0.9989 in all the cases. The accuracy of the method lies between 89.90% and 104.60% for all six impurities. Finally, the method has been successfully applied for three formulation batches of darunavir to determine the above mentioned impurities, however no impurity was found beyond the LOQ. This method is a good quality control tool for the trace level quantification of six process related impurities in darunavir during its synthesis.
    Matched MeSH terms: Quality Control
  13. Teoh WL, Khoo MB, Teh SY
    PLoS One, 2013;8(7):e68580.
    PMID: 23935873 DOI: 10.1371/journal.pone.0068580
    Designs of the double sampling (DS) X chart are traditionally based on the average run length (ARL) criterion. However, the shape of the run length distribution changes with the process mean shifts, ranging from highly skewed when the process is in-control to almost symmetric when the mean shift is large. Therefore, we show that the ARL is a complicated performance measure and that the median run length (MRL) is a more meaningful measure to depend on. This is because the MRL provides an intuitive and a fair representation of the central tendency, especially for the rightly skewed run length distribution. Since the DS X chart can effectively reduce the sample size without reducing the statistical efficiency, this paper proposes two optimal designs of the MRL-based DS X chart, for minimizing (i) the in-control average sample size (ASS) and (ii) both the in-control and out-of-control ASSs. Comparisons with the optimal MRL-based EWMA X and Shewhart X charts demonstrate the superiority of the proposed optimal MRL-based DS X chart, as the latter requires a smaller sample size on the average while maintaining the same detection speed as the two former charts. An example involving the added potassium sorbate in a yoghurt manufacturing process is used to illustrate the effectiveness of the proposed MRL-based DS X chart in reducing the sample size needed.
    Matched MeSH terms: Quality Control
  14. Lim WK
    BMC Med Educ, 2012;12:89.
    PMID: 23009729 DOI: 10.1186/1472-6920-12-89
    Problem-based learning (PBL) has become the most significant innovation in medical education of the past 40 years. In contrast to exam-centered, lecture-based conventional curricula, PBL is a comprehensive curricular strategy that fosters student-centred learning and the skills desired in physicians. The rapid spread of PBL has produced many variants. One of the most common is 'hybrid PBL' where conventional teaching methods are implemented alongside PBL. This paper contends that the mixing of these two opposing educational philosophies can undermine PBL and nullify its positive benefits. Schools using hybrid PBL and lacking medical education expertise may end up with a dysfunctional curriculum worse off than the traditional approach.
    Matched MeSH terms: Quality Control
  15. Saadi S, Ariffin AA, Ghazali HM, Miskandar MS, Abdulkarim SM, Boo HC
    J Food Sci, 2011 Jan-Feb;76(1):C21-30.
    PMID: 21535649 DOI: 10.1111/j.1750-3841.2010.01922.x
    The ability of palm oil (PO) to crystallize as beta prime polymorph has made it an attractive option for the production of margarine fat (MF). Palm stearin (PS) expresses similar crystallization behavior and is considered one of the best substitutes of hydrogenated oils due to its capability to impart the required level of plasticity and body to the finished product. Normally, PS is blended with PO to reduce the melting point at body temperature (37 °C). Lipid phase, formulated by PO and PS in different ratios were subjected to an emulsification process and the following analyses were done: triacylglycerols, solid fat content (SFC), and thermal behavior. In addition, the microstructure properties, including size and number of crystals, were determined for experimental MFs (EMFs) and commercial MFs (CMFs). Results showed that blending and emulsification at PS levels over 40 wt% significantly changed the physicochemical and microstructure properties of EMF as compared to CMF, resulting in a desirable dipalmitoyl-oleoyl-glycerol content of less than 36.1%. SFC at 37 °C, crystal size, crystal number, crystallization, and melting enthalpies (ΔH) were 15%, 5.37 μm, 1425 crystal/μm(2), 17.25 J/g, and 57.69J/g, respectively. All data reported indicate that the formation of granular crystals in MFs was dominated by high-melting triacylglycerol namely dipalmitoyl-oleoyl-glycerol, while the small dose of monoacylglycerol that is used as emulsifier slowed crystallization rate. Practical Application: Most of the past studies were focused on thermal behavior of edible oils and some blends of oils and fats. The crystallization of oils and fats are well documented but there is scarce information concerning some mechanism related to crystallization and emulsification. Therefore, this study will help to gather information on the behavior of emulsifier on crystallization regime; also the dominating TAG responsible for primary granular crystal formations, as well as to determine the best level of stearin to impart the required microstructure properties and body to the finished products.
    Matched MeSH terms: Quality Control
  16. Mirsadeghi SA, Zakari MP, Yap CK, Shahbazi A
    J Environ Sci (China), 2011;23(2):336-45.
    PMID: 21517010
    The concentration of carcinogenic polycyclic aromatic hydrocarbons (c-PAHs) present in the sediment and water of Peninsular Malaysia as well as in the cockle Anadara granosa was investigated. Samples were extracted and analysed with gas chromatography-mass spectrometry. The concentrations of total carcinogenic polycyclic aromatic hydrocarbons (t-PAHs) were measured between 0.80 +/- 0.04 to 162.96 +/- 14.74 ng/g wet weight (ww) in sediment, between 21.85 +/- 2.18 to 76.2 +/- 10.82 ng/L in water samples and between 3.34 +/- 0.77 to 46.85 +/- 5.50 ng/g ww in the cockle tissue. The risk assessment of probable human carcinogens in the Group B2 PAHs was calculated and assessed in accordance with the standards of the United States Environmental Protection Agency (US EPA). Case I in the toxicity assessment analysed the cancer risk to consumers of Malaysian blood cockle. Case II assessed the risk of cancer from exposure to PAHs from multiple pathways. The average cancer risk of case I and case II were found to be classifiable as unsafe according to the US EPA standard. The cancer risk due to c-PAHs acquired by the ingestion of blood cockle was (8.82 +/- 0.54) x 10-6 to (2.67 +/- 0.06) x 10(-2), higher than the US EPA risk management criterion. The non-cancer risks associated with multiple pathways in Kuala Gula, Kuala Juru and Kuala Perlis were higher than the U.S. EPA safe level, but the non-cancer risk for eating blood cockle was below the level of U.S. EPA concern.
    Matched MeSH terms: Quality Control
  17. Maqbool M, Ali A, Alderson PG, Zahid N, Siddiqui Y
    J Agric Food Chem, 2011 May 25;59(10):5474-82.
    PMID: 21476593 DOI: 10.1021/jf200623m
    The composite effects of gum arabic (GA) (5, 10, 15, and 20%) and chitosan (CH) (1.0%) on the biochemical and physiological characteristics of banana fruits stored at 13 ± 1 °C and 80 ± 3% relative humidity (RH) for 28 days and afterward for 5 days at simulated marketing conditions (25 °C, 60% RH) were investigated. Significant (P ≤ 0.05) differences were observed for the entire GA plus CH treatments as compared to the control. However, the results showed that after 33 days of storage, the weight loss and soluble solids concentration of fruits treated with 10% GA plus 1.0% CH composite coating were 24 and 54% lower, whereas fruit firmness, total carbohydrates, and reducing sugars were 31, 59, and 40% higher than the control, respectively. Furthermore, the composite edible coating of 10% GA plus 1.0% CH delayed color development and reduced the rate of respiration and ethylene evolution during storage as compared to the control. Similarly, sensory evaluation results also proved the effectiveness of 10% GA plus 1.0% CH composite coating by maintaining the overall quality of banana fruits. Consequently, the results of scanning electron microscopy also confirmed that the fruits coated with 10% GA plus 1.0% CH composite edible coating had very fewer cracks and showed a smooth surface. These findings suggest that 10% GA plus 1.0% CH as an edible composite coating can be used commercially for extending the storage life of banana fruits for up to 33 days.
    Matched MeSH terms: Quality Control
  18. Mod Ali N
    Radiat Prot Dosimetry, 2011 Mar;144(1-4):90-4.
    PMID: 21147789 DOI: 10.1093/rpd/ncq454
    As a laboratory certified to ISO 9001:2008 and accredited to ISO/IEC 17025, the Secondary Standard Dosimetry Laboratory (SSDL)-Nuclear Malaysia has incorporated an overall comprehensive system for technical and quality management in promoting a reliable individual monitoring service (IMS). Faster identification and resolution of issues regarding dosemeter preparation and issuing of reports, personnel enhancement, improved customer satisfaction and overall efficiency of laboratory activities are all results of the implementation of an effective quality system. Review of these measures and responses to observed trends provide continuous improvement of the system. By having these mechanisms, reliability of the IMS can be assured in the promotion of safe behaviour at all levels of the workforce utilising ionising radiation facilities. Upgradation of in the reporting program through a web-based e-SSDL marks a major improvement in Nuclear Malaysia's IMS reliability on the whole. The system is a vital step in providing a user friendly and effective occupational exposure evaluation program in the country. It provides a higher level of confidence in the results generated for occupational dose monitoring of the IMS, thus, enhances the status of the radiation protection framework of the country.
    Matched MeSH terms: Quality Control
  19. Taylor PW, Arnet I, Fischer A, Simpson IN
    Obes Facts, 2010 Aug;3(4):231-7.
    PMID: 20823686 DOI: 10.1159/000319450
    OBJECTIVE: To compare the pharmaceutical quality of Xenical (chemically produced orlistat) with nine generic products, each produced by fermentation processes.

    METHODS: Xenical 120 mg capsules (Roche, Basel, Switzerland) were used as reference material. Generic products were from India, Malaysia, Argentina, Philippines, Uruguay, and Taiwan. Colour, melting temperature, crystalline form, particle size, capsule fill mass, active pharmaceutical ingredient content, amount of impurities, and dissolution were compared. Standard physical and chemical laboratory tests were those developed by Roche for Xenical.

    RESULTS: All nine generic products failed the Xenical specifications in four or more tests, and two generic products failed in seven tests. A failure common to all generic products was the amount of impurities present, mostly due to different by-products, including side-chain homologues not present in Xenical. Some impurities were unidentified. Two generic products tested failed the dissolution test, one product formed a capsule-shaped agglomerate on storage and resulted in poor (=15%) dissolution. Six generic products were powder formulations.

    CONCLUSIONS: All tested generic orlistat products were pharmaceutically inferior to Xenical. The high levels of impurities in generic orlistat products are a major safety and tolerability concern.

    Matched MeSH terms: Quality Control
  20. Yodhnu S, Sirikatitham A, Wattanapiromsakul C
    J Chromatogr Sci, 2009 Mar;47(3):185-9.
    PMID: 19298703
    Mangosteen, Garcinia mangostana L., is known as the "Queen of fruits" and can be cultivated in the tropical rainforest such as Malaysia, Indonesia, and Thailand. Compounds isolated from the fruit peel of mangosteen contain abundant xanthones (especially alpha-mangostin). It has been used as traditional medicine such as anti-inflammatory and antibacterial and is popularly applied to cosmetic and pharmaceutical products. However, there is little information for quality and quantity determination of alpha-mangostin in mangosteen. Thus, the aim of this study was to set up a validated and stability-indicated isocratic reverse-phase high-performance liquid chromatographic (HPLC) method for quality control and quantity determination of a-mangostin from mangosteen peel extract. The assay was fully validated and shown to be linear (r(2) > 0.999), sensitive (LOD = 0.02 microg/mL and LOQ = 0.08 microg/mL), accurate (intra-day was between 98.1-100.8%, inter-day was between 90.0-101.3%), precise (intra-day variation < or = 1.8%, inter-day variation < or = 4.3%), specific, and with good recovery. Total analysis was approximately 8 min. The finalized method is also a stability-indicating assay. The present method should be useful for analytical research and for routine quality control analysis of alpha-mangostin in mangosteen peel extract and products of mangosteen.
    Matched MeSH terms: Quality Control
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