Our Services

Research and Development Support

Testing support for product research and development.

Impact Analytical provides analytical testing to support drug product and medical device research and development. Impact’s scientists have a combined 300+ years of experience in analytical chemistry. We have experience developing material specific assays and methods for use in research support that can subsequently be utilized for final product testing. Our dedicated R&D support teams partner directly with the client to provide chemical and material testing support that ensures timeline integrity. This approach allows the client to access our experience and regulatory knowledge directly, saving time and budget. 

Impact Analytical provides focused support for API development, assay and impurities methods development, container closure material selection, stability, drug or material compatibility, extractables, accelerated stability, and medical device material selection. This support can be leveraged from development through preclinical, phases I and II, and final product manufacture.  

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Services Stability Testing

Evaluation of product or material stability.

Impact Analytical is a leading provider of stability testing services and accelerated stability studies. Understanding the stability of a product or material against the effects of time, temperature and/or humidity is an important part of product development. While this is vital to the pharmaceutical industry, it is of equal importance to the consumer product, food and beverage industries. Impact Analytical has the testing facilities to safely conduct the desired stability or shelf-life study, as well as the corresponding analytical testing to evaluate the effects of the storage conditions. Examples of these effects include:

  • Material degradation

  • Pharmaceutical API stability

  • Consumer product active ingredient stability

  • Shelf life evaluation

  • Packaging integrity evaluation

  • Raw material and chemical stability

We perform stability studies and accelerated stability testing on many different products and materials for:

  • Cosmetic stability testing
  • Pharmaceutical stability testing
  • GMP and GLP stability testing
  • Medical device stability testing
  • Dietary supplements stability testing
  • Chemical stability testing

These studies can be conducted in the following environments:

  • 20-25oC, with 60% RH

  • 20-25oC, with no RH

  • 30oC, with 65% RH

  • 36oC, with no RH

  • 40oC, with 75% RH

  • 45oC, with no RH

  • 50oC, with 75% RH

  • 55oC, with no RH