Spreadsheet for USP <905> Content Uniformity Calculation

At first glance, the acceptance criteria for the content uniformity calculation in USP chapter <905> seem somewhat daunting. These criteria are different from the old criteria which were based on performing a simple arithmetic mean and standard deviation calculation. Once one examines how the criteria are determined, it actually makes sense. If the mean deviates more than 1.5% from the target label claim of the product, this is seen as a significant change and the criteria for the permitted deviation of the individual units (using the standard deviation) become tighter. Ten (10) units are still analyzed in the initial testing and used for comparison with acceptance criteria. If outside of the acceptance criteria, an additional 20 units are tested and the calculations repeated.

I have gone through these calculations and acceptance criteria and created an spreadsheet for the general case. A view of this spreadsheet is shown below. If you email me, I will gladly sent this to you in Excel format. If you have online access to the USP-NF, sign on at hhttp://www.uspnf.com/ and go to general chapter <905> Uniformity of Dosage Units. There is a good article in Pharm Tech on the probability of passing CU. http://pharmtech.findpharma.com/pharmtech/data/articlestandard//pharmtech/382004/122726/article.pdf
The equations are also included for plugging into Excel. I've done the work for you.






































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