How to Reduce the Sample Size for Test Performance

This topic has 1 reply, 2 voices, and was last updated 1 year, 4 months ago by Robert Butler.

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February 24, 2019 at 7:35 am #236677

Mateos1
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Hi,
I wanna reduce the sample size of a Quality test performance.
Per USP USP40–NF35 Page 6298 Tensile strength test require not fewer than 10 units of data to conclude an objective analysis. Based on this, ten (10) units represent enough data that allow for objective analysis.
Why ten (10) units it is enough to release a production lot?
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February 24, 2019 at 9:51 am #236678

Robert Butler
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In order to get an answer to your question you will have to read the detailed description of the derivation of the requirements for that particular USP protocol. Somewhere in the description will be statements concerning minimum detectable differences and power along with other things and it will be these assumptions/requirements that result in the minimum requirement of 10 samples.
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