Technical
July / August 2015
Comparison of Two Relevant Statistical Approaches to Assess Content Uniformity
This article compares the performance of two statistical approaches (tolerance interval and ASTM E2709/E2810) to assess dosage unit uniformity. The potential impact that the approaches can have on the USP <905> monograph is also discussed
Figure 1
Process flow diagram for assessment of blend and content uniformity for process design and process qualifications batches
Figure 2
Process flow diagram for assessment of blend and content uniformity for continued process verification (Stage 3B) batches
Figures 3 and 4
OC curves for various sample sizes at a constant level of confidence (90 pecent) and probability of passing the USP UDU test (95 percent) for the ASTM E2709/E2810 and tolerance for interval approaches (Top), and OC curves for various levels of confidence and coverage for the ASTM E2709/E2810 and tolerance interval approaches (two-tiered 10 + 20 testing approach)
Figure 5
OC curves for sampling plans 20 x 3 and 40 x 3, varying confidence/probability (pass USP), true lot mean = 100 percent, and USP UDU vs. true lot standard deviation.