Mass Spectrometry: Determination of Isotopic Purity by Accurate Mass LC/MS
Following the synthesis of isotopic labelled APIs at Almac, or stability testing, it is often necessary to accurately determine the isotopic enrichment of the compounds by mass spectrometry. This process is often complicated if the compound in question contains a variety of labelled atoms, including C, N and H, or where the isotopes resolution between the isotopes of labelled compounds and this has allowed more accurate extraction of these isotopes than ever before. With this high degree of mass accuracy, it is possible to accurately quantify the labelled composition of the compounds in question.
A case study for the determination of isotopic purity of a compound manufactured at Almac which contained two C atoms and two N atoms is presented.
Almac API, Chemical Development, Analytical & Solid State Services
Almac Sciences provides integrated services from development to commercial scale of advanced intermediates and Active Pharmaceutical Ingredients (API).
We provide a range of services for small molecules (including highly potent) and peptides. We have a proven track record of saving time and cost through the integration of our services and application of innovative biocatalysis and technology solutions.
We offer a full suite of analytical testing for a range of different product types including small molecules, peptides, biologics, conjugates, potent and controlled substances.
Our vast pool of scientific knowledge can help to overcome the analytical challenges that typically arise during drug development.