LC-MS System

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The key parameters that are to be determined on the LC-HRMS instrument for in-process control and for release of the manufactured active substances and test preparations (Investigational Medicinal Products (IMPs) – medicinal products for clinical trials) are: unambiguous determination of identity by means of exact mass and isotope distribution; confirmation of the peptide sequence through MS/MS experiments; detection, identification, and quantification of in some cases isobaric by-products; and determination of the content of the target peptide. Due to the large number of potential analytes in the intermediate and final products, with potentially very fast elution (UHPLC), the instrument speed combined with high resolution is crucial. Quadrupole/Time-of-Flight (QTOF) instruments combine both aspects and therefore represent the most suitable mass detector for our purposes. The key parameters that are to be determined on the LC-HRMS instrument for in-process control and for release of the manufactured active substances and test preparations (Investigational Medicinal Products (IMPs) – medicinal products for clinical trials) are: unambiguous determination of identity by means of…

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