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Pharmaceutical Research
Study on Genotoxic Impurities
Genotoxic impurities, also known as genotoxic impurities, usually refer to substances that can cause DNA mutation, chromosome tear or DNA recombination. Based on the significant impact of impurities on the quality of drugs, any drug registration application has corresponding regulatory requirements for impurity analysis and control, with the purpose of ensuring the efficacy, quality and safety of drugs.
service content
Content detection of common known genotoxic impurities: sulfonic acid esters; Volatile nitrosamines; Solvent residues; Hydrazine; Epoxides; Sulfate alkyl ester; High boiling point; Halogenated hydrocarbons, etc; Identification of other unknown genotoxic impurities.
The identification of unknown components and impurities in drugs is carried out by using complete technical platforms such as gas quality, liquid quality, high resolution mass spectrometry and elemental analysis ICP-MS.
Structural analysis of unknown impurities;
Content detection of unknown impurities.