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, dissolution, 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 Phthalate Testing

Qualitative and Quantitative Analysis of Phthalate Compounds

Phthalate materials are routinely added to polymeric materials to serve as plasticizers, thereby improving the mechanical properties of the material. Plasticizers are used in all applications of polymeric materials in all industries, and often times in significant concentrations. Given their high solubility in polymer materials, plasticizers are often transferred through contact from material to material. Unwanted plasticizers (often phthalates) can become contaminants in other polymers or products. Impact Analytical has years of experience analyzing for phthalates in polymeric systems, as well as in final products. Our team of experts has developed in-house methods designed specifically for phthalates. 

Examples of projects we routinely execute involving phthalates include:

  • Identification and quantitation of Phthalates in polymeric materials

  • Quantitationof phthalate contaminants from packaging
  • Investigation of Pthatlate leachables from drug product container closure system (CCS)
  • Characterization of drug product for phthalate leachables

Impact Analytical has polymer- and phthalate-specific methods developed. 

Phthalates we have experience with:include: