Cerilliant introduces eight new Snap-N-Spike® | Snap-N-Shoot® certified reference solutions of vitamins B and E for use in preparation of matrix based controls and calibrators for clinical applications or in dietary supplement analytical testing methods. Vitamin B certified solutions include thiamine HCl (B1), nicotinamide (B3), nicotinic acid (B3), pyridoxine HCl (B6), and cyanocobalamin (B12) each at a concentration of 1.0 mg/mL in methanol along with (-)-riboflavin (B2) at a 100 μg/mL concentration. Vitamin E reference solutions of α- and γ-tocopherol are prepared in methanol at a concentration of 1.0 mg/mL. Certified solutions of vitamin A including retinol, retinyl palmitate, and retinyl acetate will be available early summer 2012.
Cerilliant’s latest vitamin products complement their current offering of Vitamin D certified reference solutions for 25-Hydroxyvitamin D2 and D3; 1α,25-Dihydroxyvitamin D2 and D3; and a D6-labeled internal standard of 25-Hydroxyvitamin D3 all offered at concentrations suitable for dilution to the desired concentration in a matrix of choice.
Handling and preparation of reference solutions of vitamins present significant challenges to the laboratory due to their sensitivity to air, light, and solution pH. Cerilliant’s validated process includes manufacturing controls for sensitive compounds such as raw material handling and solution preparation under inert conditions and flame-sealing of ampoules under argon to minimize degradation and promote long-term shelf life. “The vitamins were a first of a class of compounds that proved very challenging to handle not only from a neat material standpoint, but also once it was in solution.” comments Habib Karimi, Manufacturing Manager, Standards and Packaging. “Oxygen, light, solution pH and temperature were some of the variables that needed to be controlled in a precise manner throughout the process. At Cerilliant, we have the capability to control these variables by utilizing specialized equipment enabling us to provide our customers with a consistent and reliable product while maintaining the highest of quality levels.”
Rigorous testing, from concentration certification to accelerated and real-time studies, ensures solution accuracy and shelf life not only for long-term storage but also for short-term transport from Cerilliant to the end user as well as normal lab use. Cerilliant Snap-N-Spike® | Snap-N-Shoot® certified solution standards are supported by a comprehensive Certificate of Analysis (COA) which provides all analytical data from full neat material characterization and solution standard verification to uncertainty and traceability information to meet laboratory regulatory requirements. Cerilliant certified reference solutions are prepared and certified to the highest industry standards including ISO Guide 34 and ISO 17025.
Cerilliant offers a wide selection of Certified Spiking Solutions® for use in clinical toxicology, endocrinology, therapeutic drug monitoring, and dietary supplement testing such as certified reference standards of catecholamines, steroids and hormones, immunosuppressants, natural products, and phytochemical solution mixes.
Cerilliant Corporation, located in Round Rock, Texas, is a global leader in providing certified
reference standards for critical applications. The company has been providing certified reference materials for over 30 years. Cerilliant offers approximately 3,000 catalog products and a full range of custom products and services that address the stringent and complex requirements of the pharmaceutical, clinical diagnostic, clinical/forensic toxicology, natural products, and environmental industries. Cerilliant sustains a modern, robust quality system which incorporates cGMP, GLP, and ISO requirements. We are accredited to ISO Guide 34 and ISO/IEC 17025 and certified to ISO13485 and ISO 9001. Our quality system incorporates GMP and GLP requirements.
Cerilliant Corporation is a subsidiary of Sigma-Aldrich®. For more information about Cerilliant, please visit www.cerilliant.com.