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- Posts: 108
- Joined: Fri Sep 03, 2004 3:42 pm
- Location: South Africa
I am busy validating a residual solvents method. The method will be treated as a limit test. Therefore, the following method validation parameters will be done: Specificity and LOD as per USP <1225>.
This method will be required to be transfered to our QC laboratory. Since this method has been validated as a limit test, what would be required for an AMT?
I was thinking of only requesting the Receing Lab (QC) to confirm the LOD. Would an LOD satisfy AMT requirements?
Thanks in advance.
Michael