Hello,
Continuing with this topic, this new draft monograph from the USP that indicates that a risk assessment for nitrosamines in water should be performed. To date, all risk assessments for APIs and pharmaceutical products include an assessment of nitrosamines in water and even the presence of nitrites. So, is the assessment currently performed in the risk assessment sufficient to meet USP requirements, or are additional measures required? What approach is to be taken regarding this new chapter?
Thank you!