ROUND ROCK, TEXAS – December 9, 2013 – Cerilliant introduces new antifungal Certified Spiking Solutions® of fluconazole, itraconazole, voriconazole, posaconazole, 5-fluorocytosine and ketoconazole at a 2.0 mg/mL concentration.  These Certified Reference Materials (CRMs) are suitable as Snap-N-Spike® starting materials in preparation of calibrators, controls, or linearity standards for LC-MS/MS testing of antifungals in therapeutic drug monitoring (TDM) or other critical clinical and diagnostic testing applications.

 

The development of LC-MS/MS methods for TDM of antifungals has increased the need for highly accurate CRMs. Accuracy in concentration of the calibrator or control is dependent on proper certification of the reference material for chromatographic and other residual impurities including water, solvent, and inorganics. Insufficient characterization and/or use of low purity research grade materials in place of CRMs can potentially result in incorrect therapeutic reference ranges and negatively impact clinical outcomes.1 Lot-to-lot differences in purity of the reference material or its impurity profile can also impact the test’s accuracy and reproducibility if not properly accounted for.

 

Josh Cooper, PhD, Cerilliant’s supervisor for Analytical R&D states “calibrators for LC-MS/MS methods are critical to the accuracy of results and must be carefully evaluated. It is important to use fully characterized materials to properly adjust for any chromatographic or residual impurities present. At Cerilliant, we are very sensitive to the intended use of our Certified Spiking Solutions® and characterize our CRMs accordingly.”    

 

Cerilliant Certified Spiking Solutions® are prepared and certified to the highest industry standards including ISO Guide 34, ISO 17025, and ISO 13485. Cerilliant reference solutions are manufactured using a validated process that ensures the highest level of accuracy for critical quantitative applications from TDM, diagnostic testing and endocrinology, to toxicology, forensic testing, and clinical chemistry. Cerilliant offers a comprehensive listing of parent drug, metabolite, and internal standard Certified Spiking Solutions® for clinical applications such as immunosuppressants, vitamins including 25-hydroxyvitamin D, steroids and hormones, catecholamines, cardiac drugs, antidepressants, and pain management drugs.