Cerilliant introduces Certified Spiking Solutions™ of the immunosuppressant drugs Sirolimus, Tacrolimus, and Cyclosporin A. These certified reference solutions are suitable for critical quantitative applications such as therapeutic drug monitoring assays.
The stable, quantitative solution format provides significant benefits to the clinical laboratory including increased efficiency of labor and materials and convenience of use. The Snap-N-Spike™ format allows laboratories to eliminate weighing operations of these hazardous substances, significantly reducing occupational exposure hazards related to handling of acutely toxic powders, and provides the ability to spike into their matrix of choice just before use.
Accurate preparation of a quantitative reference is highly critical for the monitoring of transplant and other patients on immunosuppressive therapy to ensure patients remain within the therapeutic range. Preparation of Cerilliant certified Snap-N-Spike™ solutions begins with full characterization of neat materials, including determination of chromatographic purity, residual solvent, residual water, and inorganic content to determine proper weighing adjustments which is critical to accuracy and lot-to-lot consistency.
Toxic materials are handled in isolation chambers and are gravimetrically prepared using precision balances which have been qualified to ensure minimal uncertainty; flame sealed under argon into ampoules for long term shelf life; and rigorously tested to ensure accuracy and shelf life through accelerated and real time studies. Cerilliant Snap-N-Spike™ reference solutions are supported by comprehensive Certificates of Analysis which provide all analytical data and uncertainty and traceability information to support regulatory requirements.
Mitzi Rettinger, Cerilliant Vice President, commented, “it is important to both clinical labs and their patients that their quantitative reference standards are completely accurate and qualified. Our Snap-N-Spike™ solutions are prepared and tested to the highest industry standards and are suitable for highly critical assays such as immunosuppressive therapy monitoring. In the coming year, we expect to launch additional new therapeutic and narrow therapeutic index (NTI) drugs to address this important market.”
Cerilliant offers a wide range of Certified Spiking SolutionsTM for use in clinical chemistry and clinical toxicology applications including Snap-N-SpikeTM solutions of therapeutic drugs, pain-management drugs, steroids and hormones, drugs-of-abuse, and ethanol (blood alcohol) including parent drugs, metabolites, and internal standards. Cerilliant is an ISO Guide 34, ISO/IEC 17025 accredited and ISO 9001:2008 certified company. Our quality system incorporates FDA’s GMP and GLP requirements.
Source: Cerilliant
