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
- User inputs data from Blend or the S2 plans from above
- 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.