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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.

Ramiril impurity
 

Phloroglucinol oxidation

Phloroglucinol is a polyphenol compound, it may me oxidized to Phlorotannins such as trifucol witch are thought to be marine-exclusive metabolites.

phloroglucinol impurity

Penconazole impurity

Penconazole is an conazole based fungicide. Here is an example of triazole, positional isomer of Penconazole.

penconazole impurity

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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.

niroso pendamethalin

Labelled N-Nitroso Nornicotine

Air curing, burning and acidic conditions of the stomach degradate nicotine, and thus further the process of N-Nitrosation. 

nitroso_Nor_Nicotine.

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Stable Isotopes - Abundances %

The key elements in organic chemistry are carbon (C), hydrogen (H), nitrogen (N), oxygen (O), phosphorus (P), sulfur (S), chlorine (Cl), and bromine (Br). These elements naturally occur as mixtures of isotopes, which significantly influence the isotope distribution. Isotopes are atom species of the same chemical element that differ in mass. They have varying numbers of neutrons, while the number of protons and electrons remains the same.

5-Hydroxy omeprazole standards

Omeprazole is primarily hydroxylated by CYP2C19 into 5-hydroxyomeprazole. 5-Hydroxy omeprazole retains the general structure of Omeprazole with an additional hydroxyl group on the pyridine ring, increasing its hydrophilicity. 5-Hydroxyomeprazole is an inactive metabolite, meaning it does not contribute to Omeprazole’s pharmacological effect of inhibiting stomach acid production. Its formation is a key step in Omeprazole clearance. 

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