Performance Characterization of EDA and Its Potential to Improve Decision Making in Product Batch Release - Good Cascade Impactor Practices, AIM and EDA for Orally Inhaled Products - page 202

Comparison of ideal APSD vs. Limiting Quality Cases

variable
norm
lower
upper

20

15

10

5

0

0 1 2 3 4 5 6 7 8 9

Aerodynamic diameter ( m m)

Fig. 8.26 Individual API mass API-per-stage values derived from target and limiting cumulative
APSDs for OIP product w9j601 whose cumulative mass-weighted APSD is shown in Fig. 8.25

Fig. 8.27 Expected ideal behavior of CI stage groups as a function of shifting the MMAD value of
the target APSD for OIP product w9j601 . The horizontal lines represent one-sided limits that were
established for the groupings related to the upper and lower tail of the APSD (groups 2 and 4) and
the two-sided limit for the central grouping (group 3)