RE: RE: RE: Method validation requirement if we use only one solvent Contribution from Mohandoss T written on 2/6/2012 at 07:00
Original contribution: RE: RE: Method validation requirement if we use only one solvent written by vasks on 2/6/2012 at 00:44) Whether one solvent is used or many solvents are used in the manufacturing process, we need to perform the analytical method validation to prove that the method is reliable and accurate. If there is no chance of class I and class II solvents in the final API, then we can avoid testing the residual solvents and go by LOD limit as NMT 0.5% for the class 3 solvent/s.
Answering this Contribution:
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