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How do you check for nitrosamine impurities? www.molkem.comban site
Checking for nitrosamine impurities begins with a risk assessment of raw materials, solvents, manufacturing processes, equipment and packaging. If a possible formation or contamination risk is found, nitrosamine analysis is performed using sensitive techniques such as LC-MS or GC-MS. Proper nitrosamine detection confirms whether an impurity is present and measures it against the applicable regulatory limit.
Reliable nitrosamine testing requires a product-specific and validated analytical method. Molkem provides professional nitrosamine analysis services, including risk-evaluation support, method development, validation and confirmatory quantification. Its structured nitrosamine analytical testing supports APIs, finished drug products, excipients and intermediates.
Conclusion: Nitrosamine impurities are checked through risk evaluation, validated laboratory testing and comparison with applicable acceptable intake limits.
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