Limit for API having two NDSRI

Thank you for asking, @sarushail. First, I want you to read our previous discussion.

After discussion, FDA published new guidance for NDSRIs. It includes the following parts.

If more than one nitrosamine impurity (NDSRI(s) and/or small molecule nitrosamine(s)) is identified and the total level of nitrosamines exceeds the recommended AI limit for the most potent nitrosamine in the drug product based on the maximum daily dose, the manufacturer or applicant should contact the Agency. FDA also recognizes that if the recommended AI limits for the individual nitrosamines vary greatly, basing the total nitrosamine limit on the most potent individual nitrosamine limit might not be practical. In such cases, FDA encourages manufacturers to contact the Agency if proposing a nitrosamine limit other than the recommended AI of the most potent nitrosamine impurity detected.

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