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I have the following situation:

A bulk drug has a purity specification of 98.5% to 101.0%. The precision for the bulk drug assay is σ = 0.92%.

How do I calculate the the probability of obtaining a failing result for those cases where the sample is in fact 100% pure? By failing result I mean a result that falls out of specification.

Thanks

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# ALFA ERROR, how do I calculate probability?

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