RRT mismatch in USP method
Posted: Tue Oct 18, 2011 4:57 pm
Hi,
I am following a USP monograph.
In this there are six impurities in RS analysis,two related. For rest of 4 only names are given.
The related impurity standards area available in USP, but for rest of the four impurities thay have provided RRT and responce factors.
As per SST, the RRT matches for two reference standards. But Iam not sure whether thay will match for the remaining four.
Is it needed to inject these impurities? Since they are not listed in USP, i have to buy them from outside.
Also plase let me know that during method validation, should I have to perform the specificity with these impurities?
I am following a USP monograph.
In this there are six impurities in RS analysis,two related. For rest of 4 only names are given.
The related impurity standards area available in USP, but for rest of the four impurities thay have provided RRT and responce factors.
As per SST, the RRT matches for two reference standards. But Iam not sure whether thay will match for the remaining four.
Is it needed to inject these impurities? Since they are not listed in USP, i have to buy them from outside.
Also plase let me know that during method validation, should I have to perform the specificity with these impurities?