Feb 18

Quantitation of low level impurities using LC-MS/MS in GMP analysis

LC-MS/MS has been the technique of choice for trace organic analysis in most areas of analytical chemistry for over a decade and is now slowly but steadily becoming so in GMP pharmaceutical analysis. LC-MS/MS offers unrivalled sensitivity and selectivity as well as speed of analysis. The technique is able to routinely quantify down to the parts per trillion level in complex APIs or final product drug formulations making it ideally suited to the quantitative analysis of impurities with low safety thresholds such as genotoxins and leachable species derived from container systems and drug delivery devices. Development and analysis times are greatly improved as a result of the mass analyser’s selectivity which can remove the need for complete chromatographic separation and thus dramatically reduce runtimes, cost and analyst time.


Quantitation of low level impurities webinar


Quantitative LC-MS/MS analysis

LGC has a long history of analytical excellence and expertise in quantitative LC-MS/MS analysis. Within CMC Analytical Services, our LC-MS/MS experts develop and validate quick, sensitive and reliable methods and the technique is routinely applied to the GMP analysis of genotoxins, leachables, degradants and cleaning agents as well as proteins and peptides for purposes of drug development, stability testing and batch release.


Quantitation of low level impurities using LC-MS/MS in GMP analysis

Dr Ellen Vringer-Stokvis, Sector Manager within CMC Analytical Services at LGC  will be hosting a webinar on  “Quantitation of low level impurities using LC-MS/MS in GMP analysis. During the webinar Ellen will cover the following:


  • Briefly touch on theory of LC-MS/MS, and subsequently discuss the strengths and challenges of the technique.
  • Case studies of impurity methods will be presented including a mini-focus on the notoriously difficult quantitation of peptides and proteins from natural extracts.
  • Provide an opportunity for Q&A.


Date: Thursday 25 February 2016

Time: 2:30 – 3:15 pm GMT


To find out more and to register, please visit: Quantitation of low level impurities using LC-MS/MS in GMP analysis webinar



Register for the LGC webinar on Quantitation of low level impurities



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