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What are the 7 nitrosamine impurities? www.molkem.comban site
The seven commonly referenced nitrosamine impurities are NDMA, NDEA, NMPA, NDIPA, NIPEA/NEIPA, NDBA and NMBA. These impurities may form during the manufacturing or storage of APIs and finished pharmaceutical products. Proper nitrosamine analysis and sensitive nitrosamine detection help identify and measure them at very low levels.
Molkem provides professional nitrosamine testing, including method development, validation and confirmatory testing for APIs, drug products, excipients and intermediates. Its reliable nitrosamine analysis services support companies that require accurate nitrosamine analytical testing according to applicable regulatory requirements.
Conclusion: Testing for these seven nitrosamines should be based on product-specific risk assessment, suitable regulatory limits and a validated analytical method.
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