LC-MS/MS analytics has been part of the services of our GMP-certified laboratory in Itzehoe from the start. As we are often asked about it, here is a short overview of what you can use it for.
- Trace analysis with a triple quadrupole system, for example for nitrosamines in the sub-nanogram range, as the basis for a robust nitrosamine risk assessment
- Biotechnological medicinal products: assay, purity, mass determination and degradation products of proteins, peptides, oligonucleotides and mRNA by HPLC-MS/MS
- Assay, related substances and identity as part of release testing and EU retesting
Every assessment is made under the responsibility of the head of quality control and, for batch release, additionally under the responsibility of a Qualified Person under Section 14 of the German Medicinal Products Act (AMG).
You can find all tests offered by our laboratory under Analytical Services. Do you have a specific sample or question? Write to us via our contact form.
