Dear Nitrosamine assessors,
Does any of you observed level of NDSRIs follow different growth patterns with respect to age in the same drug product?
For example, after analyzing let’s say 30 or 40 stability batches of a drug product, few batches shows linear trend across the shelf-life while few other shows non-linear and some batches does not follow any trend [Note: Test method for NDSRIs is validated].
Anyone observed such scenario in any or your drug product? If so, I will be happy to connect with you to discuss further.
Thanks in advance