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Phycochemical screening and standard parameter determination of Spirulina plantesis, Chlorella vulgaris, and Euchema spinosum, cultivated in Indonesia
Published in Ade Gafar Abdullah, Isma Widiaty, Cep Ubad Abdullah, Medical Technology and Environmental Health, 2020
I.T. Maulana, L. Mulqie, K.M. Yuliawati, Y. Sukarman, N.A. Suhara, N.A. Suhara, R. Safira
Determining the water content in the material was done by three methods, namely Karl Fischer titration, azeotropic distillation, and gravimetry. The gravimetric method was done by measuring the amount of compound that evaporates/disappeared after the material was heated within a certain period. Water content could be determined by the gravimetric method if it was certain that there were no other metabolite compounds that could evaporate at 105ºC beside water, such as essential oils and other compounds (Menkes 2009). If there were volatile compounds in the material, then the amount of water content could not be determined by the gravimetric methods but by the azeotropic distillation method.
Adulteration of Essential Oils
Published in K. Hüsnü Can Başer, Gerhard Buchbauer, Handbook of Essential Oils, 2020
Adding of water is very simple and cheap. This is not possible for all essential oils but is likely for those possessing compounds with high affinity of binding to water. Conifer varieties and citrus oils are examples. Siberian pine (Abies sibirica Ledeb.) was supplied in August at 25°C–30°C. Visually no water could be detected. In January the oil came from stock (−5°C) and the quantity of water could be esteemed to 8%. Is that adulteration or natural behavior? Rajeswara Rao et al. (2002) mentioned water contents up to 20%, but that level seems too high by following GMP. Responsible for this effect are monoterpenes, and like conifer oils, citrus oils contain higher quantities of these compounds. Citrus expression techniques use a lot of water to spray away the oil/wax emulsion. Centrifugation will separate water and waxes from essential oil. Unfortunately also aldehydes and alcohols contained in the water/wax phase are removed. Cotroneo et al. (1987) observed this effect by comparing oils from manual sponge method without water and the industrial technical methods. An easy method to detect higher value of water in citrus oil is the visible cloudiness and the deposit of waxes when cooled down to 10°C. A validated method to detect the water content in essential oils is the Karl Fischer titration (ISO, 11021, 1999).
Engineering Stable Spray-Dried Biologic Powder for Inhalation
Published in Anthony J. Hickey, Sandro R.P. da Rocha, Pharmaceutical Inhalation Aerosol Technology, 2019
Nicholas Carrigy, Reinhard Vehring
The analytical techniques described in the Particle Analysis section, in particular bioassays, should be performed at each time point in the stability tests. Performing different analytical measurements at the same time can be important for determining causes of instability. For example, if biologic inactivation is found to occur at a specific time point, moisture content measurement by Karl Fischer titration may indicate increased moisture content (which could be due to a leak in the packaging), solid state analysis may indicate crystallization has occurred (because of an increased moisture content), and scanning electron microscopy may indicate that the morphology of the dried particles has changed (through moisture-induced crystallization events).
Combination of a hot-melt subcoating and an enteric coating for moisture protection of hygroscopic Sennae fructus tablets
Published in Pharmaceutical Development and Technology, 2019
Kira-Isabel Zier, Wulf Schultze, Claudia S. Leopold
Aqueous spray-dried Sennae fructus extracts were obtained from roha arzneimittel (Bremen, Germany). The subcoating materials were medium chain triglyceride (MCT), purchased from Henry Lamotte Oils (Bremen, Germany), stearic acid (StA; Palmac 98-18) from Berg + Schmidt (Hamburg, Germany), Precirol® ATO 5 (Pr), and Compritol® 888 ATO (Cp) both from Gattefossé (Bad Krozingen, Germany). The outer enteric coating Eudragit® L 30D-55 (EuL55) was received from Evonik (Darmstadt, Germany) and talcum from CSC Jäklechemie (Hamburg, Germany). Triethyl citrate, sodium chloride, magnesium chloride, Combi Titrant 5, Combi Methanol for volumetric Karl-Fischer titration, and potassium carbonate were obtained from Merck (Darmstadt, Germany). Magnesium stearate was bought from Magnesia (Lüneburg, Germany). Fumed silica and microcrystalline cellulose were obtained from NRC (Hamburg, Germany). Sudan red 7B was purchased from Merck (Darmstadt, Germany). Methanol was bought from Honeywell (Erkrath, Germany), acetonitrile for HPLC from VWR International (Hannover, Germany), and anhydrous formic acid was purchased from Sigma-Aldrich (Schnelldorf, Germany). Sennoside B was obtained from Carl Roth (Karlsruhe, Germany).
Applying the methodology of Design of Experiments to stability studies: a Partial Least Squares approach for evaluation of drug stability
Published in Drug Development and Industrial Pharmacy, 2018
Nika Jordan, Jure Zakrajšek, Simona Bohanec, Robert Roškar, Iztok Grabnar
Design of Experiments (DoE) is an organized approach for setting up experiments in a way that the information required is obtained as efficiently and precisely as possible [9]. The use of DoE has increasingly been applied to pharmaceutical product development as a part of Quality by Design (QbD) approach. It has been applied to study the effects of various factors and their interactions in compatibility studies of drug substances and excipients as well as in analytical methods development, such as Karl Fischer titration and liquid chromatography assay determination [10–12]. Although QbD and DoE have both been promoted by the regulatory authorities and are increasingly used by the pharmaceutical industry [13–15], the application of this methodology as a possible tool for the evaluation of drug stability has not been described before.
Whole-body inhalation exposure to 2-ethyltoluene for two weeks produced nasal lesions in rats and mice
Published in Inhalation Toxicology, 2021
Madelyn C. Huang, Cynthia J. Willson, Sridhar Jaligama, Gregory L. Baker, Alan W. Singer, Yu Cao, Jessica Pierfelice, Esra Mutlu, Brian Burback, Guanhua Xie, David E. Malarkey, Barney Sparrow, Kristen Ryan, Matthew Stout, Georgia K. Roberts
Sarchem Laboratories, Inc (Farmingdale, NJ) provided us with 2-ET (CAS no. 611-14-3; Lot No. SL-0197). Characterization of the test material was performed by Battelle Columbus (Columbus, OH). Chemical identity was confirmed by Fourier Transform Infrared (FTIR) spectroscopy, proton and carbon-13 nuclear magnetic resonance (NMR) spectroscopy, elemental analysis, and mass spectrometry. Purity was determined by gas chromatography with flame ionization detection (GC-FID) and also in comparison to a purchased high purity standard (Sigma-Aldrich, St. Louis, MO). Water content by Karl Fischer titration was also performed.