Evaluation of nitrosamines in drug products has become one of the top challenges for formulators in the pharmaceutical industry.
One of the potential risk factors to take into consideration during the drug product risk assessment are the excipients. Even if the risk of the presence of nitrosamines is very low, many excipients do contain traces of nitrites that can, under specific conditions, ultimately result in formation of nitrosamines within the drug product.
Different studies show that nitrite levels differ highly amongst excipients. The same studies also show that for the same excipient type major differences in nitrite levels exist between suppliers. Comparing excipient types and suppliers is key to de-risk production.