Impurity Qualification Studies For Pharmaceuticals

VIMTA offers the complete package to support qualification of impurity

Vimta Labs Ltd.

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Description

Vimta Labs objective is to design the studies that are necessary for your product in the most efficient and cost effective way. All in vitro and in vivo studies are performed as per ICH guidance document under strict quality control.

Their comprehensive package is designed based on product specification, and includes:

  • Bacterial reverse mutation assay (Ames test)
  • In vitro mammalian chromosomal aberration test
  • 14 to 28 day systemic toxicity studies in rodents (rats / mice)
  • 14 to 28 day systemic toxicity studies in non-rodents
  • 90 day systemic toxicity studies in rodents (rats / mice)
  • 90 day systemic toxicity studies in non-rodents
  • Standalone TK studies

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