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  1. Study on Genotoxic Impurities_Analytical Development and Quality Study_CMC Study_Service_Bostal Drug Delivery Co., Ltd. EN
    2. EN 中文
Study on Genotoxic Impurities_Analytical Development and Quality Study_CMC Study_Service_Bostal Drug Delivery Co., Ltd.

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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