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- Posts: 6
- Joined: Fri Sep 23, 2016 1:51 am
Best regards,
Maily
Discussions about HPLC, CE, TLC, SFC, and other "liquid phase" separation techniques.
HPLC chemist wrote:
Per ICH Q3 a related substance can be no more than 0.05% wt/wt of the API i the drug product. Assuming this peak is a treated like a related substance the tolerable peak area is a maximum of 0.05% of the peak area for the API assay peak.
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