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Genotoxic impurities are compounds that directly or indirectly damage cellular DNA, produce genetic mutations or mutagenesis in vivo, and have carcinogenic potential or propensity. It is characterized by damage to human genetic material at very low concentrations, leading to genetic mutations and possibly tumorigenesis. Genotoxic impurities commonly found in the pharmaceutical industry include:
Alkyl Halides and Esters
β-lactam Related Impurities
Fig. 1. Structures of common sulfonate salts1
Because genotoxic impurities are highly toxic and threaten the public's medication safety, they need to be risk assessed and controlled. Alfa Chemistry is an expert in the analytical chemistry industry, providing solutions for the development and analysis of chemical methods for the detection of trace amounts of genetic impurities for the complex pharmaceutical industry. We design custom-compliant inspection methods according to your needs and provide you with an evaluation report. If you have any questions about genotoxic impurities analysis, please feel free to contact us.
Alfa Chemistry's technology for impurities analysis include but not limited to:
Inductively-Coupled Plasma Mass Spectrometry (ICP-MS)