Genotoxic impurities (GI) are DNA reactive substances that can cause DNA damage when present at very low levels in a product. This may lead to mutations and it can cause cancer. Genotoxic Impurity analysis can identify and detect cancer-causing agents within your product. According to ICH, Genotoxic impurities are classified as organic, inorganic impurities and residual solvents.
We at Chromak Research perform all testing like identification and quantification of Genotoxic impurities by using standards according to ICH M7, EMA and USFDA. Chromak Research performs Genotoxic Impurity analysis by using instruments such as, HPLC, UV, LC-MS, GC-FID, GC- MS, and ICP-MS. We perform analysis on APIs, drug substances in pharma, tablets, emulsions, suspensions, creams and lotions. Our team assure you for your product safety and follow strict regulatory guidelines.