Publications by authors named "Jochen Norwig"

Article Synopsis
  • In 2018, the presence of high levels of NDMA, a known carcinogen, in valsartan led to major recalls and regulatory actions to protect patient safety due to its contamination during drug synthesis.
  • The complexity of N-nitrosamines, which vary in size and polarity, demands advanced analytical methods, primarily using gas and liquid chromatography linked to mass spectrometry for detection.
  • This study introduces a sensitive LC-MS/MS method for detecting 13 different N-nitrosamines, validated according to regulatory guidelines, showcasing its potential for identifying contamination in pharmaceuticals.
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Herbal drugs and extracts, like all pharmaceutical starting materials used in the manufacture of medicinal products, must have an appropriate pharmaceutical quality. Corresponding quality standards are described in the individual monographs of the pharmacopoeia according to § 55 of the German Drug Law. This includes information on ingredients and active substance content, among other things.

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The widespread occurrence of heparin contaminated with oversulfated chrondroitin sulfate (OSCS) in 2008 initiated a comprehensive revision process of the Pharmacopoeial heparin monographs and stimulated research in analytical techniques for the quality control of heparin. Here, a set of 177 heparin samples from the market in 2008 as well as pure heparin sodium spiked with defined amounts of OSCS and DS were used to evaluate established and novel methods for the quality control of heparin. Besides (1)H nuclear magnetic resonance spectroscopy (NMR), the assessment included two further spectroscopic methods, i.

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In 2008, some 900 cases of adverse events associated with the use of heparin were reported to the Food and Drug Administration of USA and the Federal Institute of Drugs and Medical Devices in Germany. 238 patients died from heparin in the USA. In March 2008, oversulfated chondroitin sulfate (OSCS) was identified to be responsible for these cases.

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The electrolytically induced precipitation of zinc oxide from zinc nitrate solution on gold surfaces in the presence of water-soluble polymers was examined for reaction times between 0.5 and 600 seconds. Regardless of the additive, polycrystalline films of zinc oxide have formed after 30 seconds, but polymeric additives dramatically change the morphology of the ZnO films.

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