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Impurity Qualification Studies For Pharmaceuticals
VIMTA offers the complete package to support qualification of impurity
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Good service and knowledge.
Application Area:
Confirmation of genotoxic impurities in pharmaceutical
They provide very good service for Ames tests.
Review Date: 8 Feb 2021 | Vimta Labs Ltd.
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
