Nitrosamine impurities are highly potent, carcinogenic substances that can form when nitrosating agents react with amines during production, storage, or degradation.
Nitrosamine toxicants are highly hazardous chemicals formed from reactions between nitrites and amines, commonly found in processed foods, tobacco smoke, and contaminated drugs, and they are dangerous because they damage DNA and increase the risk of cancer even at very low exposure levels.
Nitrosamine drug contaminants, also called nitrosamine drug impurities, are chemicals known as nitrosamine carcinogenic-risk impurities because they may cause cancer.
The nitrosamine supply chain involves the sourcing, manufacturing, handling, and distribution of nitrosatable substances and related impurities, categorized under nitrosamine quality terminology and nitrosamine reference category terms, for use in pharmaceuticals, research, and analytical testing.
Nitrosamine regulatory impurities are potential human carcinogens and carcinogenic agents that may appear as nitrosamine signal impurities during pharmaceutical manufacturing, storage, or product degradation due to nitrosamine deviation-trigger substances and related reactions, including pathways involving nitroxylamide intermediates.
Nitroso-group impurities, often encountered as nitrosamine residual impurities, are characterized by the presence of a nitroso (–N=O) functional group and may form unintentionally during synthesis, processing, or storage of pharmaceutical and chemical products.
Nitrosamine trace impurities belong to a defined nitrosamine chemical grouping within the broader nitrosamine impurity family and can arise as nitrosamine impurity formation products during pharmaceutical manufacturing, processing, or storage.
Nitrosamine excipient risk refers to the potential formation or presence of nitrosamine molecules, including tertiary nitrosamine species and volatile nitroso compounds, within pharmaceutical excipients.