cGMPs / QRM Process

Celsis Expands into Mass Spec and Ion Chromatography

Source: PharmaManufacturing.com

Mar 31, 2010

Chicago, Ill. – Celsis Analytical Services, a division of Celsis International, announced the company has expanded the analytical chemistry capabilities of its accredited cGMP labs to include Mass Spectrometry (LC-MS/MS) and Ion Chromatography, making it easier to analyze complex materials and compounds.

“With the availability of mass spectrometry and ion chromatography, Celsis has increased its commitment to provide cost-effective, outsourced CGMP-certified laboratory services,” said Marc Caira, director of business development, Celsis Analytical Services. “Now, suppliers and manufacturers in a wide variety of industries – including pharmaceutical, biotechnology and consumer goods – can address their specialized testing needs, while avoiding costly investments in additional lab space, personnel and equipment.”

LC-MS/MS Services

Referenced in several chapters of the US Pharmacopeia (USP), LC-MS/MS enables analysts to separate, quantify and identify elements in complex mixtures. The LC-MS/MS testing method works by using HPLC to first separate the compounds. The mass spectrometer (MS) filters the separation in order to detect and identify components. A second MS may be used to further refine identifications. Celsis has both the Sciex API 5000 tandem (triple) Quadrupole and the Micromass Quattro Ultima mass spectrometers.  In addition to USP testing, the mass spectrometry equipment can be used for raw material characterization, impurity identification, quality control programs and more.

Ion Chromatography Capabilities

The Dionex ICS-3000 ion chromatographic (IC) system has conductivity, amperometry and UV detectors. The system not only determines inorganic action, cations and organic acids but also uses amperometric detection for accurate analysis of traditionally difficult-to-analyze materials. These powerful IC techniques fill the void between liquid chromatography and gas chromatography analysis. Additional methods and benefits include: low level ion analysis with suppressed ion chromatography; conductivity detection for compounds such as sulphate, phosphate and fluoride; and integrated pulsed amperometry that overcomes problematic analysis of non-soluble products of an oxidation or reduction.

Visit www.celsis.com for more information.