Blend Uniformity and Content Uniformity (BUCU) Sampling Tables

Please note: The sampling tables have been thoroughly checked by an industry-wide panel, but may require additional validation to comply with regulatory commitments.

All tables listed below estimate a 95% chance of passing the USP UDU test <905>

Sampling Plan 1: One dosage unit tested at each location

Confidence Level Sample Size(s) File
90 10,20,30,40,50,60,70,80,90,100,125,150,175,200,500 S1_N_10-500_Cov.pdf
50 10,30 S1_N_10-30_Cov.pdf

Sampling Plan 2: Greater than one dosage unit tested at each location (equal number at each location)

Confidence Level # Locations #/Location File
90 20 3 S2_20x3_90CI95Cov.pdf
90 20 7 S2_20x7_90CI95Cov.pdf
90 40 3 S2_40x3_90CI95Cov.pdf

Excel Workbook: Blend & ASTM Final Dosage Units Calculations - updated April 2018

  1. User inputs data from Blend or the S2 plans from above
  2. Workbook provides overall summary statistics, data plot, variance component estimates, statistics used to look up ASTM Acceptance Limits, looks up ASTM Limits, and indicates whether or not sample meets Limits.