Impurities and Degradation products
Drug Impurities - Oxidation Cyclisation, Rearrangement and more: Manufacturers are responsible for controlling their processes and preventing the presence of undesirable impurities. They are also in charge to identify unacceptable impurities and develop methods for the measurement of amounts of impurities in drug substance and drug products. Organic impurities can arise during the manufacturing process and/or storage of the new drug substance.
Ramipril Impurity
Ramipril EP Impurity D is an impurity standard of Ramipril. Intramolecular cyclization produced the diketopiperazine derivative.
Phloroglucinol oxidation
Phloroglucinol is a polyphenol compound, it may me oxidized to Phlorotannins such as trifucol witch are thought to be marine-exclusive metabolites.
Penconazole impurity
Penconazole is an conazole based fungicide. Here is an example of triazole, positional isomer of Penconazole.
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Drug Impurities - N-Nitroso formation: N-Nitroso (NOC) compounds have been studied extensively. They are of biological interest and many of their uses for the treatment of cardiovascular and central nervous system diseases, and diseases related to immunity and physiological disorders. While the body has mechanisms to detoxify some of these metabolites, the balance between activation and detoxification determines the risk associated with nitrosamine exposure. Nirosamine impurities can arise during the manufacturing process and/or storage of the new drug substance.
N-Nitroso Pendimethalin
Pendimethalin is used as a pesticide, its manufacture generally results in crude product with a N-nitroso-pendimethalin as impurity.
Labelled N-Nitroso Nornicotine
Air curing, burning and acidic conditions of the stomach degradate nicotine, and thus further the process of N-Nitrosation.
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