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1.
Identification,control strategies,and analytical approaches for the determination of potential genotoxic impurities in pharmaceuticals: A comprehensive review 下载免费PDF全文
Ambavaram Vijaya Bhaskar Reddy Jafariah Jaafar Khalid Umar Zaiton Abdul Majid Azmi Bin Aris Juhaizah Talib Gajulapalle Madhavi 《Journal of separation science》2015,38(5):764-779
Potential genotoxic impurities in pharmaceuticals at trace levels are of increasing concern to both pharmaceutical industries and regulatory agencies due to their possibility for human carcinogenesis. Molecular functional groups that render starting materials and synthetic intermediates as reactive building blocks for small molecules may also be responsible for their genotoxicity. Determination of these genotoxic impurities at trace levels requires highly sensitive and selective analytical methodologies, which poses tremendous challenges on analytical communities in pharmaceutical research and development. Experimental guidance for the analytical determination of some important classes of genotoxic impurities is still unavailable in the literature. Therefore, the present review explores the structural alerts of commonly encountered potential genotoxic impurities, draft guidance of various regulatory authorities in order to control the level of impurities in drug substances and to assess their toxicity. This review also describes the analytical considerations for the determination of potential genotoxic impurities at trace levels and finally few case studies are also discussed for the determination of some important classes of potential genotoxic impurities. It is the authors’ intention to provide a complete strategy that helps analytical scientists for the analysis of such potential genotoxic impurities in pharmaceuticals. 相似文献
2.
Muhammad Saad Khan Cornelius Borecho Bavoh Khor Siak Foo Azmi Mohd Shariff Zamzila Kassim Nurzatil Aqmar Bt Othman Bhajan Lal Iqbal Ahmed Mohammad Azizur Rahman Sina Rezaei Gomari 《Molecules (Basel, Switzerland)》2021,26(2)
This study evaluates the kinetic hydrate inhibition (KHI) performance of four quaternary ammonium hydroxides (QAH) on mixed CH4 + CO2 hydrate systems. The studied QAHs are; tetraethylammonium hydroxide (TEAOH), tetrabutylammonium hydroxide (TBAOH), tetramethylammonium hydroxide (TMAOH), and tetrapropylammonium hydroxide (TPrAOH). The test was performed in a high-pressure hydrate reactor at temperatures of 274.0 K and 277.0 K, and a concentration of 1 wt.% using the isochoric cooling method. The kinetics results suggest that all the QAHs potentially delayed mixed CH4 + CO2 hydrates formation due to their steric hindrance abilities. The presence of QAHs reduced hydrate formation risk than the conventional hydrate inhibitor, PVP, at higher subcooling conditions. The findings indicate that increasing QAHs alkyl chain lengths increase their kinetic hydrate inhibition efficacies due to better surface adsorption abilities. QAHs with longer chain lengths have lesser amounts of solute particles to prevent hydrate formation. The outcomes of this study contribute significantly to current efforts to control gas hydrate formation in offshore petroleum pipelines. 相似文献
3.
Kok Tong Wong Hasnah Osman Thaigarajan Parumasivam Unang Supratman Mohammad Tasyriq Che Omar Mohamad Nurul Azmi 《Molecules (Basel, Switzerland)》2021,26(7)
A total of fourteen pyrazoline derivatives were synthesized through cyclo-condensation reactions by chalcone derivatives with different types of semicarbazide. These compounds were characterized by IR, 1D-NMR (1H, 13C and Distortionless Enhancement by Polarization Transfer - DEPT-135) and 2D-NMR (COSY, HSQC and HMBC) as well as mass spectroscopy analysis (HRMS). The synthesized compounds were tested for their antituberculosis activity against Mycobacterium tuberculosis H37Ra in vitro. Based on this activity, compound 4a showed the most potent inhibitory activity, with a minimum inhibitory concentration (MIC) value of 17 μM. In addition, six other synthesized compounds, 5a and 5c–5g, exhibited moderate activity, with MIC ranges between 60 μM to 140 μM. Compound 4a showed good bactericidal activity with a minimum bactericidal concentration (MBC) value of 34 μM against Mycobacterium tuberculosis H37Ra. Molecular docking studies for compound 4a on alpha-sterol demethylase was done to understand and explore ligand–receptor interactions, and to hypothesize potential refinements for the compound. 相似文献
4.
This study has presented a performance investigation of an advanced tracked prime mover for the operation of agricultural goods and other operations on peat terrain. The maximum and continuous traction torque of the prime mover has been developed by designing an advanced controller for controlling the intelligent system. The prime mover’s mobility is studied with ultrasonic displacement sensor, torque transducer, National Instrument cRIO-9004 Compact-RIO Real-time Controller Unit (RCU), a National Instrument TPC 2106T Touch Panel Control (TPC), a Trimble AG132 GPS antenna and receiver unit, and a Dlink DIR-655 router. The fuzzy logic controller (FLC) has been equipped with the prime mover hydraulic system to increase the traction torque of the hydraulic motor when the prime mover’s sinkage is more than or equal to 70 mm. The prime mover’s design demonstrates good potential in traversing peat terrain as the measured tractive effort was found to be 48% of the vehicle’s gross weight while the recommended tractive effort is in the range of 30–36% of the vehicle’s gross weight. 相似文献
5.
The purification and characterization of intracellular tyrosine phenol lyase from Citrobacter freundii has been carried out. The enzyme was purified 35-fold to homogeneity by ammonium sulphate precipitation and hydrophobic interaction chromatography. Its subunit molecular weight was found to be 52 kDa on sodium dodecyl sulphate polyacrylamide gel electrophoresis. The purified tyrosine phenol lyase showed maximum activity in borate buffer (0.05 M at pH 8.5) at 45 °C after 20 min of incubation. The K m and V max values of purified enzyme were found to be 0.446 mm and 0.342 mM/min/mg. This enzyme exhibits t 1/2 of 10, 52 and 130 min at 55, 45 and 35 °C, respectively. The N-terminal amino acid sequence was determined as MET-ASN-TYR-PRO-ALA-GLU-PRO-PHE-ARG-ILE-TRP-TRP-VAL-GLY. 相似文献
6.
A validated spectrophotometric method has been developed for the determination of uranyl ion in soil samples. The method is based on the complexation reaction between uranyl ion and rifampicin in methanol‐water medium at room temperature. The method is followed spectrophotometrically by measuring the absorbance at 375 nm. Under the optimized experimental conditions, Beer's law is obeyed in the concentration range of 1.35–20.25 μg mL‐1 with apparent molar absorptivity and Sandell's sensitivity of 8.0 × 103 L mol‐1cm‐1 and 0.042 μg/cm2/0.001 absorbance unit, respectively. The interference of a large number of anions and cations has been investigated and the optimized conditions developed have been utilized for the determination of uranium(VI) in soil samples. The three sigma detection limit (n = 9) for uranyl ion was found to be 0.20 μg mL‐1. The proposed method was successfully applied to the determination of uranyl ion in soil samples. 相似文献
7.
Akbas Yusuf Azmi Yusan Sabriye 《Journal of Radioanalytical and Nuclear Chemistry》2020,323(2):763-772
Journal of Radioanalytical and Nuclear Chemistry - In this study, low-cost olive pomace, which is a waste of olive mill, was chemically modified using different acids, characterized, and utilized... 相似文献
8.
Azmi Mohamed Argo Khoirul Anas Suriani Abu Bakar Azira Abd. Aziz Masanobu Sagisaka Paul Brown Julian Eastoe Azlan Kamari Norhayati Hashim Illyas Md Isa 《Colloid and polymer science》2014,292(11):3013-3023
The performance of single-, double- and triple-chain anionic sulphosuccinate surfactants for dispersing multiwall carbon nanotubes (MWNCTs) in natural rubber latex (NR-latex) was studied using a range of techniques, including field emission scanning electron microscopy (FESEM), transmission electron microscopy (TEM), thermogravimetric analysis (TGA) and Raman spectroscopy. The conductivities of the nanocomposites were also investigated using four-point probe measurements. Here, MWCNTs were efficiently dispersed in NR-latex with the aid of hyperbranched tri-chain sulphosuccinate anionic surfactants, specifically sodium 1,4-bis(neopentyloxy)-3-(neopentyloxycarbonyl)-1,4-dioxobutane-2-sulphonate (TC14). This paper highlights that TC14 performs much better than that of the commercially available surfactant sodium dodecyl sulphate (SDS), demonstrating how careful consideration of surfactant architecture leads to improved dispersibility of MWCNTs in NR-latex. The results should be of significant interest for improving nanowiring applications suitable for aerospace-based technology. 相似文献
9.
M. Mohsin Khan W. Bari M. D. Azmi Vipin Gaur A. R. Khan M. Zafar M. Irfan 《Indian Journal of Physics》2011,85(1):195-199
An analysis to disentangle information about the occurrence of dynamical fluctuations in multiparticle production in high
energy nucleus-nucleus collisions has been carried out in terms of fractal moments and entropy for the experimental and simulated
data using FRITIOF, UrQMD and HIJING generators. Although there is a possibility to thermodynamically interpret the final
state of multiparticle production by calculating the values of specific heat, c, using G
q
- and F
q
-moments. However, both these moments give markedly different values of c. The constancy observed in the values of specific heats calculated from either G
q
- or F
q
-moments is in accord with the predictions of constant specific heat approximation. Variations of multifractal and factorial
moments and various other parameters calculated from these moments predict the presence of non-statistical fluctuations in
high energy nuclear collisions. 相似文献
10.
Reza Zamiri B. Z. Azmi Mahmoud Goodarz Naseri Hossein Abbastabar Ahangar Majid Darroudi Forough Kalaei Nazarpour 《Applied Physics A: Materials Science & Processing》2011,105(1):255-259
We report fabrication of silver nanoparticles (Ag NPs) by laser ablation technique in different concentrations of aqueous
chitosan solution. The ablation process of silver plate was carried out by using a nanosecond Q-switched Nd:YAG pulsed laser
and the characterization of Ag NPs was done by Transmission electron microscopy, UV-Vis spectroscopy, and X-ray diffraction.
UV-visible plasmon absorption spectra revealed that the formation efficiency as well as the stability of nanoparticles was
increased by addition of chitosan. On the other hand, the size decrement of nanoparticles was more remarkable in the higher
chitosan concentration. 相似文献