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 reside 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 targets.
• Techniques used are GC-MS/MS, HS-GC-MS, LCMS, ICPMS, HPLC, GC and IC.