Strengthening Pharmaceutical Producers' Battle Against Nitrosamine Pollution by AZ Biopharm
In the pharmaceutical industry, the presence of nitrosamines continues to be a significant concern for manufacturers worldwide. AZ Biopharm, a Berlin-based contract lab specialising in challenging pharmaceutical analytics, is at the forefront of investigating nitrosatable substances and conducting stability tests under stress conditions.
AZ Biopharm's mission is to provide robust and economically feasible solutions to the nitrosamine issue. The company collaborates closely with clients to systematically analyse all active substances, set acceptable limit values according to ICH M7, and carry out routine monitoring in the production process.
The discovery of nitrosamines in certain blood pressure medications in 2018 triggered an ongoing investigation by international authorities, who now require all manufacturers to investigate their products for possible nitrosamine sources. This includes not just the end products, but also starting materials and the entire supply chain, from seemingly harmless excipients like glidants or tablet coatings, to the reaction that can occur during manufacturing, storage, or through certain excipients.
Nitrosamines typically form when nitrogen compounds react with nitrite. AZ Biopharm's range includes the quantification of classic nitrosamines like NDMA or NDEA. The company offers targeted support in evaluating and testing nitrosamine-related issues, and provides regulatory assurance by establishing methods, validating, and documenting them according to current regulatory standards, including ICH Q2(R2).
It's important to note that GBA Pharma GmbH, another Berlin-based company specialising in advanced pharmaceutical analytics and support in evaluating and testing nitrosamine-related issues, is certified for information security and provides analytics and services for the pharma and biotechnology sectors.
Manufacturers must stay vigilant, regularly reviewing processes and having the right partners by their side to manage the nitrosamine issue. AZ Biopharm offers flexible capacities to cover short-term investigations or special inquiries, ensuring that manufacturers can quickly and effectively address any nitrosamine-related concerns.
