To perform the content- uniformity test, test 10 dosage units. USP– NF calculation General Chapter < 905> Uniformity of Dosage Units. sheet It includes current chapter revision status information about the upcoming revision, background information, , statistical basis, testing requirements calculation frequently asked questions. 905 U nifo rm it calculation y o f D o s a ge calculation uod U nit s USP 27 page 2396 usp page 1587 usp uod of PF 28( 5) [ Sept. Figure 2: Distribution of “ probability of meeting Uniformity usp of Dosage Units ( UDU) ” results. The United States Pharmacopeia is the coordinating pharmacopeia in the efforts toward international harmonization of uod the specifications provided in this general test chapter. Let S i calculation be the criteria usp of passing sheet stage i i = 1 2. Pharmacopoeia and the U.Usp uod calculation sheet. The parts of the. 33) the minimum 90% probability results with 95% coverage ( Figure 2 n = 30) is equivalent to the minimum 100% conforming rate ( sheet calculation Figure 1 ). in usp which W is the weight of drug substance equivalent to 1 average dosage unit obtained by the Assay procedure P is the weight of drug substance equivalent to 1 average dosage unit uod obtained by the special procedure. Process benchmarking.
xls I created this spreadsheet based on the USP certificate for prednisone tablets. All that you need to do is change the limits in the calculations when the lots change. USP 35 Physical Tests / 〈 905〉 Uniformity of Dosage Units421 Solid Dosage Forms Calculation of Acceptance Value Assay 10 units individually using an appropriate analyticalCalculate the acceptance value by the formula: method. Calculate the acceptance value ( see Table 2). Liquid or Semi- Solid Dosage Forms in which the terms are as defined in Table 2.
usp uod calculation sheet
The calculations for the Uniformity of Dosage test by the Weight variation procedure use the average of the individual weights in the formula for calculating the estimated contents of the units tested. 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.