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- Posts: 129
- Joined: Tue Dec 04, 2007 12:55 pm
- Location: China
I have a question in term of reporting unknown impurity in drug product as obtained via HPLC.
Let me say the specification for any single unknown impurity is NMT 0.05%, the area percentage of an unknown impurity is 0.00236%. In my opinion, there are several options to report the result: 1). 0.00%, 2). < 0.01%. Or I can set the minimum area threshold in my CDS (Ezchrome) higher to disregard this peak.
Which option would you choose? Any justification or regulatory reference?
Thanks in advance,
Terry