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Cerilliant Introduces Snap-N-SpikeTM Reference Solutions of Immunosuppressant Drugs
ROUND ROCK, TEXAS – November 30, 2009 – Cerilliant introduces Certified Spiking
SolutionsTM of the
immunosuppressant drugs,
Sirolimus, Tacrolimus,
and Cyclosporin A.
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-SpikeTM
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-SpikeTM 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-SpikeTM 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 Solutions® 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.
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