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- Posts: 399
- Joined: Wed Jul 18, 2012 6:45 am
- Location: Germany
Assume you know that a substance is stable in stock solution and under controlled and defined storage conditions for a certain amount of time. This is tested and confirmed fulfilling all regulatory needs. Is it then reasonable to prepare a stock solution that expires later than the reference standard's expiry date?
In my opinion: Yes, because the expiry date from the CoA tells me that the quality of the reference standard is given until this date. So I can expect the solution of guaranteed quality to be stable for the known amount of time.
Looking forward to arguments supporting or proving wrong my argumentation. Or maybe there is official guidance to this question?
Best regards
Jörg