Impurity Profile
What Is an Impurity Profile? An impurity profile is a comprehensive characterization of identified and unidentified impurities in a drug substance or pharmaceutical product. According to ICH Q7, this profile should include qualitative or structural identification (like retention time), observed impurity ranges, and classification of impurities (e.g., organic, inorganic, solvent). Why Is Impurity Profiling Critical in Pharmaceuticals? Impurity profiling […]