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Study on Genotoxic Impurities
We can provide professional genotoxic impurity assessment, analytical method development, validation, transfer and sample analysis. The laboratory is equipped with multiple triple quadrupole liquid chromatograph-mass spectrometers and has completed the development and validation of analytical methods for a wide range of genotoxic impurities in a variety of matrices covering starting materials, intermediates, raw materials and drug products, applicable to different regulatory requirements such as ICH, USP, EP and CHP.
Genotoxic impurities that have been successfully detected:
Category | Representative Substances | Test Method |
Sulfonate esters (alkyl, aryl) | Methyl methanesulfonate, ethyl methanesulfonate, methyl benzenesulfonate, ethyl benzenesulfonate, methyl p-toluenesulfonate, ethyl p-toluenesulfonate, etc. | GC-MS/MS, GC-MS, LC-MS/MS |
Nitrosamines | NDMA, NDEA, NDIPA, NEIPA, NDPA, NMPA, NDBA, etc. | LC-MS/MS, GC-MS/MS |
NMBA etc. | NMBA | LC-MS/MS |
Solvent residues | Triphenylmethyl chloride, etc. | LC-MS, LC-MS/MS |
Epoxides | Ethylene oxide, etc. | GC-MS |
Halogenated hydrocarbons | Chloromethane, chloroethane, iodomethane, iodoethane, etc. | GC-MS/MS, GC-MS |