What is the Impact of the Excipient Manufacturer in the Nitrosamine World?

What is the impact of the excipient manufacturer in the nitrosamine world? During the presentation, the focus will be held on magnesium stearate. Magnesium stearate is used as an excipient in the pharmaceutical industry. For some years, the FDA and EMA have been looking at the nitrosamine content in pharmaceuticals. Based on the realization that some drugs have shown a too high content of nitrosamines, a guideline for the risk assessment of nitrosamines was established by the FDA, in which all ingredients should be assessed for the presence of nitrosamines. IPEC has also introduced a nitrosamine risk assessment questionnaire for excipient manufacturers.