Genotoxic Impurity Studies

Genotoxic Impurity Studies


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 study services:

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.

The genotoxic impurity study testing performed on:

Active Pharmaceutical Ingredients (APIs) / Drug Substance

Drug Products (Tablets, Capsules, Injectables, Syrups, Suspensions & Emulsion, etc.,)

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