LC-MS/MS analysis has been part of the services of our GMP-certified laboratory in Itzehoe from day one. 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
- Biotechnology-derived medicinal products: assay, purity, molecular 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 result is assessed under the responsibility of our Head of Quality Control and, for batch release, also of a Qualified Person under § 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? Contact us via our contact form.
