Ideal Mixing Model Comparison with the Yalkowsky and Bolton Approach

3 IDEAL MIXING MODEL COMPARISON WITH THE YALKOWSKY AND BOLTON APPROACH 

Another method for estimating the effect of particle size on content uniformity has been described by Yalkowsky and Bolton2 and more recently updated by Rohrs et al.4 The Yalkowsky and Bolton approach attempts to establish a particle size specification that would lead to a 99% chance of passing the USP Content Uniformity test. In this section, a comparison of their approach vs the ideal mixing model1 will be made. 

Dose Maximum Median Diameter Minimum Particle Diameter Maximum Particle Diameter 

TABLE 3.5 Predicted Potency Distributions Using the Ideal Mixing Model and the Maximum Volume Median Particle Diameters and Particle Distribution Minimum and Maximum Diameters from Table 3.4 and a Geometric Standard Deviation of 2 

Number of Units Out of 100,000 in the Given Potency Range for the Indicated Dose 

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