Impurity Qualification Studies

The presence of any component in the finished product which is neither an active ingredient nor an excipient is basically considered to be an impurity. These impurities may exhibit potentially toxic effects or adversely impact the safety and efficacy of the drug, thus making it necessary to perform impurity qualification studies. The qualification studies are important for establishing the biological safety of an individual impurity or a given impurity profile at the levels specified. In case the level of impurity reaches or exceeds the level of qualification, it becomes essential for the manufacturer to justify the toxicity of the product.

VIMTA offers complete package to support impurity qualification studies.

Our comprehensive package is designed based on the product specification to ensure that all studies necessary for the product are included in it. All in vitro and in vivo studies are performed in accordance with ICH guidelines under strict quality control. Our scientists are highly skilled at method development and validation, thus helping overcome the challenges of low detection levels. Our offerings include

  • Classic Genetic Toxicity Studies
  • Repeated Dose (28 and 90 days) Toxicity Studies
  • Special Toxicity Studies (Comet Assay, Pig A Gene Mutation)