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- Posts: 3
- Joined: Thu Oct 24, 2019 8:51 pm
I'm wondering if anyone could shed some light on the titled subject.
Ill dive straight in.
Talking about pharma HPLC validation. In the company i work for we perform solution stability studies on the solutions for analysis.
In the validation protocol we state that a solution is stable for a defined length of time (for example 72 hours).
Once validated, methods are written stating "samples/ std solution zstable for 72 hour"
Personally i interpret this as all solutions must be prepared and injected with in this window. By doing this the accuracy and integrity of data is maintained.
It would not be ideal, for example, to make up solutions then inject them on the 71st hour.
A point to a paper or good reference would be appreciated also. Cheers