Impurities Assessment & Risk Analysis

Through processing, packaging, and storage, there is the potential for pharmaceutical and healthcare products to contain a variety of impurities. These may include residual solvents, related substances, degradants, leachables, and contaminants. It is imperative that patient safety is not compromised as a result of these unwanted (but often unavoidable) constituents.

Ashuren Health Sciences assists clients in evaluating the potential health risks posed by consumer products, foods, supplements and natural products, biomaterials, biotechnology products and industrial or agricultural chemicals and workplace substances.

Our senior scientific staff have helped develop methods and strategies for risk assessment and management at national and international levels. Our methodology includes the following:

Conducting complex searches of published literature

      • Preparing comprehensive literature-based justifications
      • Evaluating safety concerns in the context of product use and providing in-depth risk assessments
      • Identifying relevant chemical surrogates (where no public literature exists for the
        chemical(s) in question)
      • Developing toxicology testing strategies and protocols

    Ashuren uses the above methodology to determine safe levels of excipients/inactive ingredients for use in toxicology studies, clinical trials, and final products, giving you assurance that your product is safe.