The Experts below are selected from a list of 3486 Experts worldwide ranked by ideXlab platform
Yasser Nashedsamuel - One of the best experts on this subject based on the ideXlab platform.
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an evaluation of the glass vial Hydrolytic Resistance method
Pda Journal of Pharmaceutical Science and Technology, 2019Co-Authors: Christopher James Sloey, Camille Gleason, Michael Akers, Yasser Nashedsamuel, Joseph PhillipsAbstract:The European Pharmacopeia (Ph. Eur.) Hydrolytic Resistance method for glass vials is routinely used to screen pharmaceutical glass vial supply. Due to reliance on this method to reduce the risk of glass vial delamination in pharmaceutical drug products, it is important that the sources of method variability be understood and controlled. Several potential sources of variability in the Ph. Eur. alkalinity method have been studied for 3cc glass vials. Method parameters including vial rinsing, fill volume determination, vial covering, autoclave cycle execution, sample hold times, and titration procedure were evaluated in this study. The results of this study indicate the method parameters which require stringent control in order to achieve acceptable method precision and robustness.
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development of conductivity method as an alternative to titration for Hydrolytic Resistance testing used for evaluation of glass vials used in pharmaceutical industry
Pda Journal of Pharmaceutical Science and Technology, 2016Co-Authors: Kiyoshi Fujimori, Joseph Phillips, Yasser NashedsamuelAbstract:The European Pharmacopeia (Ph. Eur.) surface test to analyze the Hydrolytic Resistance is a common industrial method to understand and ensure the quality of produced glass vials. Hydrolytic Resistance is evaluated by calculating the alkalinity of water extract from autoclaved vials by titration. As an alternative to this titration technique, a conductivity technique was assessed, which directly measures the ions in the water extract. A conductivity meter with 12 mm diameter electrode was calibrated with 100 μS/cm conductivity standard and carryover minimized by rinsing the probe in a water beaker per analysis. Limit of quantification at 1 μS/cm was determined as having a signal to noise ratio of 3 compared with the water blank. The conductivity method was selective for glass composing elements (boron, sodium, aluminum, silicon, potassium, and calcium) within the vial extract. Accuracies of spiked conductivity standard within the range of 1 to 100 μS/cm were ± 7% and had linearity with coefficient of determination (R2) of ≥ 0.9999. Intraday precision had RSD (n=5) of ≤ 6% for spiked conductivity standard within the range of 1 to 100 μS/cm. Interday precision had RSD (n=4) of ≤ 6% for ten vials from three glass vial lots. Conductivity of water extracts from nine sets of seven lots of glass vials had a precise linear relationship [R2 = 0.9876, RSD = 1% (n=9)] with titration volumes of the same lots. Conductivity results in μS/cm could be converted to titration values in mL by conversion factor of 0.0275. The simplicity, sample stability, and individual vial analysis of the conductivity technique were advantageous than the current titration technique.
Joseph Phillips - One of the best experts on this subject based on the ideXlab platform.
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an evaluation of the glass vial Hydrolytic Resistance method
Pda Journal of Pharmaceutical Science and Technology, 2019Co-Authors: Christopher James Sloey, Camille Gleason, Michael Akers, Yasser Nashedsamuel, Joseph PhillipsAbstract:The European Pharmacopeia (Ph. Eur.) Hydrolytic Resistance method for glass vials is routinely used to screen pharmaceutical glass vial supply. Due to reliance on this method to reduce the risk of glass vial delamination in pharmaceutical drug products, it is important that the sources of method variability be understood and controlled. Several potential sources of variability in the Ph. Eur. alkalinity method have been studied for 3cc glass vials. Method parameters including vial rinsing, fill volume determination, vial covering, autoclave cycle execution, sample hold times, and titration procedure were evaluated in this study. The results of this study indicate the method parameters which require stringent control in order to achieve acceptable method precision and robustness.
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development of conductivity method as an alternative to titration for Hydrolytic Resistance testing used for evaluation of glass vials used in pharmaceutical industry
Pda Journal of Pharmaceutical Science and Technology, 2016Co-Authors: Kiyoshi Fujimori, Joseph Phillips, Yasser NashedsamuelAbstract:The European Pharmacopeia (Ph. Eur.) surface test to analyze the Hydrolytic Resistance is a common industrial method to understand and ensure the quality of produced glass vials. Hydrolytic Resistance is evaluated by calculating the alkalinity of water extract from autoclaved vials by titration. As an alternative to this titration technique, a conductivity technique was assessed, which directly measures the ions in the water extract. A conductivity meter with 12 mm diameter electrode was calibrated with 100 μS/cm conductivity standard and carryover minimized by rinsing the probe in a water beaker per analysis. Limit of quantification at 1 μS/cm was determined as having a signal to noise ratio of 3 compared with the water blank. The conductivity method was selective for glass composing elements (boron, sodium, aluminum, silicon, potassium, and calcium) within the vial extract. Accuracies of spiked conductivity standard within the range of 1 to 100 μS/cm were ± 7% and had linearity with coefficient of determination (R2) of ≥ 0.9999. Intraday precision had RSD (n=5) of ≤ 6% for spiked conductivity standard within the range of 1 to 100 μS/cm. Interday precision had RSD (n=4) of ≤ 6% for ten vials from three glass vial lots. Conductivity of water extracts from nine sets of seven lots of glass vials had a precise linear relationship [R2 = 0.9876, RSD = 1% (n=9)] with titration volumes of the same lots. Conductivity results in μS/cm could be converted to titration values in mL by conversion factor of 0.0275. The simplicity, sample stability, and individual vial analysis of the conductivity technique were advantageous than the current titration technique.
Paul R Raj - One of the best experts on this subject based on the ideXlab platform.
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selective enrichment of n 3 polyunsaturated fatty acids with c18 c20 acyl chain length from sardine oil using pseudomonas fluorescens mtcc 2421 lipase
Food Chemistry, 2009Co-Authors: Kajal Chakraborty, Paul R RajAbstract:An extracellular lipase purified from Pseudomonas fluorescens MTCC 2421 was used to enrich sardine oil triglycerides with eicosapentaenoic acid (20:5 n−3) and linolenic acid (18:3 n−3) to 35.28% and 8.25%, respectively, after 6 h of hydrolysis. The corresponding n−6 fatty acids (18:2 n−6 and 20:4 n−6) exhibit a reduction (54.93% and 50%, respectively). Structure–bioactivity relationship analyses revealed that the lower hydrophobic (log P values) constants of 18:3 n−3 and 20:5 n−3 (5.65 and 5.85, respectively) result in their higher Hydrolytic Resistance towards lipase, leading to their enrichment in the triglyceride fraction after lipase-catalysed hydrolysis. Lipase-catalysed hydrolysis of sardine oil for 6 h followed by urea fractionation at 4 °C with methanol provided free fatty acids containing 42.50% 20:5 n−3 and 10.31% 18:3 n−3, respectively. Argentation neutral alumina column chromatography, using n-hexane/ethylacetate (2:1, v/v) resulted in 20:5 n−3 of high purity (83.62%), while 18:3 n−3 was found to be eluted with n-hexane/dichloromethane (4:1, v/v) as eluting solvent with a final purity of 75.31%.
M Aparicio - One of the best experts on this subject based on the ideXlab platform.
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Hydrolytic Resistance of k2o pbo sio2 glasses in aqueous and high humidity environments
Journal of the American Ceramic Society, 2020Co-Authors: Teresa Palomar, Jadra Mosa, M AparicioAbstract:The authors acknowledge E. Peiteado, R. Navidad and S. Serena (ICV-CSIC, Spain) for their help during the tests, and the anonymous reviewers for their comments and suggestions that contributed to improve the final version of this paper. This work has been funded by Fundacion General CSIC (ComFuturo Programme).
Leandro M. De Carvalho - One of the best experts on this subject based on the ideXlab platform.
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Critical evaluation of the standard Hydrolytic Resistance test for glasses used for containers for blood and parenteral formulations
PDA journal of pharmaceutical science and technology, 2004Co-Authors: Dennis Bohrer, Paulo Cícero Do Nascimento, Emilene M. Becker, Fabiana Bortoluzzi, Fernanda Depoi, Leandro M. De CarvalhoAbstract:As prescribed by pharmacopoeias, containers should meet certain condition of stability to be used for pharmaceutical products. Glass containers are classified according to their Resistance to chemical attack, a test executed by heating the glass in contact with water for 30 min at 121 degrees C. The USP powdered glass test for glass containers was applied to different kinds of glasses used as containers for parenteral formulations. In this experiment not only the released alkalinity was measured but also the release of glass constituents: silicate, borate, sodium, and aluminum, and also the release of some impurities as copper and lead. The USP powdered glass test was also carried out with glass ampoules, clear and amber, in the presence of solution of some inorganic salts, NaCl, KCl, CaCl2, MgCl2, NaHCO3, NaH2PO4, KH2PO4, and sodium gluconate, citric acid and glucose. The results showed that even when releasing very low alkalinity, glasses also released their constituents, in concentration ranges from 8.8 to 33 mg/l for silicate, 0.9 to 6.9 mg/l for borate, 3 to 37 for mg/l for sodium and 0.5 to 2.4 mg/l for aluminum. More expressive results were found, however, for the tests done with solutions instead of pure water. The tests showed that, for most of the solutions, while the measured alkalinity was very low, high levels of the other constituents were found. Basic solutions of bicarbonate and gluconate presented the higher levels of all investigated constituents, confirming the ability of basic solutions to attack and dissolve the glass network. Glucose and citric acid interacted with the glass surface, selectively extracting aluminum, copper, and lead. Whereas silicate, borate and sodium found in these solutions were at levels similar to those found with pure water, the aluminum level was almost 20 times higher. This specific action of citrate and glucose could be related to their metal-complexing ability. The results indicate that even so-called "chemical-resistant glasses," as measured by the Hydrolytic Resistance test, react with many substances when packaged in contact with them. The Hydrolytic Resistance test, when used as the sole measure of potential drug-container compatibility, is not reliable.
