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New Certified Snap-N-Spike® Solutions of Thyroid Hormones
ROUND ROCK, TEXAS – June 12, 2012 – Cerilliant introduces certified Snap-N-Spike® solutions of thyroid hormones T4, T3, and reverse T3 at concentrations of 100 µg/mL in 0.1 N ammonia in methanol for each solution standard. These Certified Spiking Solutions® are suitable for use as critical starting materials in preparation of calibrators, controls, or linearity standards for analytical testing including LC-MS/MS analysis of free and total thyroid hormone levels.
Analytical challenges in thyroid hormone testing range from standardization of free thyroid hormone testing methods to agreement in value assignment of the calibrator concentration. With the push towards developing LC-MS/MS LDTs, the need for highly accurate Certified Reference Materials has significantly increased. Accuracy in the concentration of thyroid hormone calibrators and controls, for example, are complicated by the presence of residual impurities of not only water, solvent and inorganic but also other thyroid hormones in the reference material. Any significant difference in purity of the thyroid hormone reference material or its impurity profile from lot-to-lot could increase variability and impact the test’s accuracy and reproducibility.
According to Dr. Isil Dilek, Cerilliant’s Quality Control Manager, “with thyroid hormones it is critical to use fully characterized compounds because some of the impurities present in each hormone are the other hormones of interest. We provide reference standards with the concentration adjusted for these impurities and note them on the COA for full transparency of the impurity profile. At Cerilliant we are very sensitive to the intended use of our Certified Spiking Solutions® and characterize them accordingly.”
Cerilliant Certified Spiking Solutions® are prepared and certified to the highest industry standards including ISO Guide 34 and ISO 17025. Comprehensive Certificates of Analysis (COAs) are provided for every Cerilliant certified reference standard and include all analytical data from full neat material characterization and solution standard verification to uncertainty and traceability information for a laboratory’s regulatory requirements. COAs for the thyroid hormone Certified Spiking Solutions® also identify T1, T2, T3, reverse T3 or T4 if present in the Certified Reference Material.
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