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- Posts: 95
- Joined: Fri Nov 30, 2012 5:18 pm
Accuracy should be assessed on samples (drug substance/drug product) spiked with
known amounts of impurities. (this is as per ICH Q3R1)
I just want to know how is this being made?
Am I right if what I'm going to do is to place a placebo and spiked it with API and Known impurity. Then calculating the percent recovery of each. Thanks.