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Drug Impurities Research

Genotoxic Impurities(GTIs) Research

One-stop solution for drug impurities research

1. Quantitative research service for genotoxic impurities (GTIs) and other trace-level impurities (including evaluation, control strategy establishment, method development, validation, sample test)

2. Structure elucidation service for unknown impurity in starting materials, drug substance and drug product (including structure identification, formation mechanism research, source tracing and process improvement)

3. Custom synthesis service for impurity standard.

Genotoxic impurities(GTIs) research 

(We can provide custom standard synthesis service for certain GTIs)

We have qualified instruments including HPLC, UPLC, GC, LC-MS, GC-MS and triple quadrupole MS(including several AB API-6500 plus LC-MS/MS, excellent for trace substance quantification), and professional researchers with cross background on organic chemistry and analytical chemistry, which enable us to dealing with the most complicated GTIs research.

Drug Impurities Research

Classification of GTIs

  • Sulfonates (benzene sulfonate, p-toluenesulfonate, methanesulfonate, camphorsulfonate, dimethyl sulfate et al.)

  • Alkyl halides (iodomethane, chloroethane, bromoethane, chloropropane, chloroacetic acid, dichloroacetic acid et al.)

  • Epoxides (ethylene oxide et al.)

  • Hydrazines (hydrazine hydrate, methylhydrazine et al.)

  • Anilines

  • Azides (sodium azide, alkyl azide et al. )

  • Acyl chlorides (sulfonyl chloride,butyryl chloride,ethyl chloroformate et al.)

  • Azo compounds (DEAD et al.)

  • Nitrocompounds and nitroso compounds (nitrobenzene, NDMA, NDEA, NEIPA, NDIPA, NDBA and NMBA et al.)

  • Others, like MBTS (dibenzothiazole disulfide), MBT (2-mercaptobenzothiazole), methylamine, acetamide, residual solvent et al.

Structure elucidation for Unknown impurities 

(We provide custom synthesis service for drug impurities)

  • We have single-quadrupole LC-MS, GC-MS and HRMS (like Thermo QE, tandem MS with quadrupole and orbitrap mass analyzers, which could provide very high resolution up to 140K), and researchers who focused on drug impurity research. We provide professional service to resolve unknown impurity related process/stability problem, and OOS or deviation investigation.

Drug Impurities Research

We can solve these problems

  • Structure elucidation for unknown impurities in starting material, intermediate and drug substance and find their possible formation pathway.

  • Identify the degradation impurities in drug product, confirm their degradation mechanism.

  • Custom synthesis/isolation service for drug impurities.

  • Source tracing, formation mechanism research, and finally control impurities’ content via QBD.

Drug Impurities Research