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Certified Solution Standards for Therapeutic Drug Monitoring Applications

Authors: Isil Dilek PhD, Kevin Gates, Rebecca Johnson, Sherri Pogue, Mitzi Rettinger, Uma Sreenivasan PhD
Presented at SAT, May 2009
Presented at MATT, April 2009

Highly pure, well-characterized, solution based standards or reagents are a good and efficient alternative to the use of neat materials in clinical, toxicology and therapeutic drug monitoring applications. The accuracy, stability, and consistency of these materials are critical to ensure accuracy of results in the analytical laboratory, in clinical applications and medical device performance.

Certified Solution Standards and Reagents offer a significant advantage over neat reference materials in terms of accuracy, consistency and stability. Long term stability of solution based materials is achievable when appropriate parameters are chosen in the design, preparation, packaging, and storage.

This poster presents the development and design of Certified Solution Standards and Reagents providing examples of pre-made solutions that exhibit multi-year stability. Factors critical to the selection of the analytes, diluents, storage and stability are discussed. These include: raw material handling, characterization and potency, certification and qualification of solutions, and homogeneity and stability of the solution. Certified Reference Standard Solutions and Reagents prepared in a diluent that promotes stability and packaged under argon in flame sealed ampoules can be stable for many years.

Multiple examples are presented. Also presented is a comparison of certified ampouled solutions vs. neat reference materials.

Certified Solution Standards and Reagents ensure accurate, consistent and reliable results in clinical and toxicology applications and medical device performance.

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