Nitrosamine excipient risk refers to the potential formation or presence of nitrosamine molecules, including tertiary nitrosamine species and volatile nitroso compounds, within pharmaceutical excipients.
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.
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 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.
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 drug contaminants, also called nitrosamine drug impurities, are chemicals known as nitrosamine carcinogenic-risk impurities because they may cause cancer.
Nitrosamine compounds are a critical quality concern because many are potentially carcinogenic and can be harmful even at very low levels, making their control essential in pharmaceuticals
Embryo-fetal toxicity refers to harmful effects on a developing embryo or fetus due to exposure to certain substances, such as medications, chemicals, or environmental factors.