Conducting Nitrosamine impurity testing and analysis on drug substance and drug product
Using mass spec analysis techniques to mitigate the risk of NDMA presence during the manufacture of medicines containing chemically synthesized active substances.
Nitrosamines are organic compounds that we are commonly exposed to. They exist in low levels in our water and foods, including meat, vegetables, and dairy products. They originate from chemical reactions and can form in drugs during manufacturing.
Nitrosamines are classified by the ICH M7(R1) Guideline as Class 1 impurities, “known mutagenic carcinogens”(1), and may increase the risk of cancer if people are exposed to them above acceptable levels over a significant time period.
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.