The synthesis of drug substances involves the use of reactive substances, components, diluents, catalytic agent, and other processing aids. As a result of chemical synthesis or succeeding degradation, impurities reside in the drug substances and accompanying drug products.
Genotoxic impurities (mutagenic & carcinogenic) are DNA reactive substances that have a potential to nonstop cause DNA damage when present at low levels leading to mutations and therefore, theoretically causing cancer.
Genotoxic impurity testing according to ICH M7 (R1), and USFDA /or customer requirements for Identification cum quantification.
Umed develop, validate and analyze the genotoxic impurities by considering allowable maximum daily exposure target
Techniques used are HPLC,GC,GC-MS/MS, HS-GC-MS, LCMS and ICPMS.
Active Pharmaceutical Ingredients (APIs) / Drug Substance
Drug Products (Tablets, Capsules, Injectables, Syrups, Suspensions & Emulsion, etc.,)