Certified Solution Standards for Clinical Applications - Sponsored Whitepaper

Accuracy and reliability of clinical results and medical device performance is dependent on accuracy and reliability of the method of analysis, accuracy in the preparation of samples, and accuracy of the calibrators used. 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. 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.

Results are only as accurate as the reference! Accuracy depends on robustness of the analysis and quality of the reference

What makes a Good Reference Standard - One Suitable for Quantitative Applications?

• Thoroughly & accurately characterized components • Prepared using accurate, calibrated, and qualified pipettes, glassware & balances • Traceability of all components • High purity diluents and/or stabilizers, compatible with the compound(s) • Analyzed to verify accuracy & consistency • Uncertainty assessed and reported

Reference Standards Are Critical to the Quantitation of Drugs in a Clinical Setting