pharmaceutical impurity analysis solutions - Lcms-connect.com

Appendix: Agilent Solutions for Pharmaceutical Impurity AnalysisAgilent leads the industry with a wide range of instrumentation, LC and GC column choices, and software and informatics solutionsfor impurity analysis.InstrumentationCategory of Impurity Application Agilent InstrumentationOrganic impurities Impurity detection and rapid method scouting/development 1200 Infinity Series LC + Diode-array Detector SLDetection of impurities not easily separated by HPLC (e.g., 7100 CE Systemhighly polar compounds)Detection of chiral impurities1260 Infinity Analytical SFC SystemIsolation of impurities1260 Infinity Preparative-scale Purification SystemIdentification of impurity structure 600-IR series FTIR + 400-MR DD2 Magnetic Resonance System +1200 Infinity Series LC + 6100 Series Single Quadrupole or 6200 SeriesAccurate-Mass TOF or 6500 Series Accurate-Mass Q-TOF LC/MSSystems (for trace level genotoxic impurities)Quantitation of genotoxic impurities1200 Infinity Series LC + 6400 Series Triple Quadrupole LC/MS SystemsInorganic impurities Analysis of elemental impurities in pharmaceutical 700 Series ICP-OESingredients - basic requirements of USP that do notnecessitate the lowest detection limitsAnalysis of all 16 regulated elements at and below the 7700 Series ICP-MSregulated levels in the new USP method, even whenlarge sample dilutions are requiredSpeciation of certain regulated elements (As and Hg) 1200 Infinity Series LC + 7700 Series ICP-MSResidual solvents Analysis per USP procedures 7890A GC + 7967A Headspace samplerAnalysis involving unknown peaks/solvents7890A GC + 5975C GC/MS system + 7697A Headspace samplerColumns and SuppliesAgilent offers a comprehensive portfolio of GC and LC columns, and supplies for chromatography, spectrometry, and spectroscopy, allmeeting ISO 9001 standards to ensure maximum instrument performance and reproducible results.Agilent leads the LC industry with column choices that meet a wide range of analytical needs and support the pharmaceutical lifecyclewith maximum scalability across laboratory development settings, and around the world service and support. For example Poroshell120 columns can save signifi cant analysis time, and Rapid Resolution High Defi nition (RRHD) columns offer maximum fl exibility insolvent selection and fl ow rates. Agilent also has the broadest portfolio of GC columns available, including innovative options like ourultra inert GC columns.Agilent’s comprehensive portfolio of supplies including vials, syringes, gas management, fl ow meters, leak detectors, fi ttings, tools, andstandards, all engineered or selected by our instrument design teams, manufactured to our demanding specifi cations, and tested undera variety of conditions.Software and InformaticsAgilent’s industry leading software and informatics portfolio is continuously expanding to cover a broader range of analyticalworkstations, data and laboratory management solutions, and applications to satisfy the growing needs of the life sciencesand chemical industries. Agilent software solutions are integrated to address the complete life cycle of scientifi c data, includingexperimental design, data acquisition, knowledge management, and analysis in an open system architecture. The Agilent OpenLABSoftware Suite includes OpenLAB Chromatography Data System (CDS), OpenLAB Enterprise Content Manager (ECM), and OpenLabElectronic Lab Notebook (ELN).Laboratory Qualification and Testing SolutionsYou can count on Agilent to provide the system qualifi cation services or proof of calibration that you needto support your GLP/GMP or ISO/IEC 17025 quality initiatives. Agilent has been ranked #1 in compliancesince 1995. With the delivery of over 100,000 successful instrument qualifi cations and over a decade ofpractical experience in quality testing, you can trust Agilent to deliver confi dence in your analytical results.29