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what should be the precision during technology transfer?

Answer Posted / aruna k

for assay 1.0%
For Impurities or residual solvents
If its less than 0.10% the difference should be +or- 0.02 %
If its less than 0.50% the difference should be +or- 0.10 %
If its less than 1.0% the difference should be +or- 0.2%
For assay +or- 1.0%

Is This Answer Correct ?    4 Yes 1 No



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