The synthesis of drug substances involves the use of reactive chemicals, reagents, solvents, catalysts, and other processing aids. As a result of chemical synthesis or subsequent degradation, impurities resides in the drug substances and associated drug products.
Genotoxic impurities (mutagenic & carcinogenic) are DNA reactive substances that have a potential to directly cause DNA damage when present at low levels leading to mutations and therefore, potentially causing cancer.
Our genotoxic impurity study services include:
Genotoxic impurity testing according to ICH M7 (R1), USFDA, EMA and/or customer requirements for Identification cum quantification.
We develop, validate and analyze the genotoxic impurities by considering allowable maximum daily exposure target.
Techniques used are GC-MS/MS, HS-GC-MS, LCMS, ICPMS, HPLC, GC and IC.
We perform genotoxic impurity study testing on:
Active Pharmaceutical Ingredients (APIs) / Drug Substance
