The presence of any component in a finished pharmaceutical product that is neither an active ingredient nor an excipient is considered an impurity. Such impurities may exhibit potentially toxic effects or negatively impact the safety and efficacy of the drug, making impurity qualification studies essential. These studies are critical for establishing the biological safety of individual impurities or an overall impurity profile at specified levels. When impurity levels reach or exceed qualification thresholds, the manufacturer must provide adequate toxicological justification to support product safety.
VIMTA offers a comprehensive package to support impurity qualification studies.
Our study design is based on product specifications to ensure that all required evaluations are included. All in vitro and in vivo studies are conducted in accordance with ICH guidelines under strict quality control. Our scientists are experienced in method development and validation, enabling them to address challenges associated with low detection levels and complex impurity matrices.
