Case Study

Contract Testing Lab Quickly Responds To Increased Customer Requests For Nitrosamine Services

Waters Nitrosamine analysis

Pharma & Tech has 27 staff members working across their two labs. To support their pharmaceutical customers, the organization offers QC testing for pharmaceutical production processes, for incoming raw materials, research, and development, as well as outgoing QC release testing for both active pharmaceutical ingredients (APIs) and finished products. The company is also a designated testing and inspection agency for Korea's Ministry of Food and Drug Safety.

When global reports began to surface about well-known drug products containing N-nitrosamine impurities, Pharma & Tech scientists knew they needed to respond promptly to address the needs of their customers.  N-nitrosodimethylamine (NDMA) and other nitrosamine impurities in pharmaceutical products has spurred action from regulatory agencies, and has placed pressure on the industry to improve their controls and processes.

Nitrosamines can be produced when a secondary amine is present with a nitrating source - such as a nitrite, nitrosyl, or nitrate. In addition to in-process production, contamination could occur from external sources such as water, solvents, packaging, and raw materials.

Because this testing is an essential element from government health agencies, it is important that the data generated meets all predicated quality regulations such as GMP, including regulations for electronic records and signatures. Read how a mass spectrometer solution accompanied with security software enabled Pharma & Tech to develop their nitrosamine impurity testing services in less than two months, as they responded to evolving global regulatory guidelines.

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