Nitrosamine impurities have become an important concern for pharmaceutical manufacturers because they may form through several routes involving raw materials, manufacturing processes, recovered solvents, packaging or storage conditions. Testing is an important part of risk control, but sending a sample to a laboratory without a defined strategy may produce information that is incomplete or difficult to interpret. Before requesting Nitrosamine Impurities Analysis , manufacturers should review the product, process and analytical requirements carefully. Begin with a Product-Specific Risk Assessment Not every product presents the same nitrosamine risk. Manufacturers should examine the active ingredient, excipients, reagents, catalysts, solvents, process water and packaging system. The assessment should consider whether nitrosating agents and vulnerable amines may be present under conditions that allow nitrosamine formation. Recycled or recovered materials may require particular attention b...