Introduction - Good Cascade Impactor Practices, AIM and EDA for Orally Inhaled Products - page 8

Table 1.2 Relationsh ips between EDA metrics and determination methods

Metric determination method when fractionation measurements are obtained by
Full-resolution CI and assay of each
individual deposition sites

Full-resolution CI and assay of combined
selected deposition sites

AIM apparatus and assay of
combined selected deposition sites Metric

API mass
deposited on a
site

Actual mass measurement for each stage
deposition site selected for assay of API

Actual mass measurement of stage
deposition sites selected for combined assay
and/or individual assay of API

Actual mass measurement of
abbreviated impactor stage
deposition sites selected for
individual assay of API

Grouped stages Mathematical : direct sum of API mass for

selected non-sized and sized CI
measurements

Actual API mass measurement of stage
deposition sites selected for combined assay
for API

N/A

Fine particle
mass ( FPM )

Mathematical : direct sum of API mass on
deposition sites in CI where stage cutoff
sizes ( d 50 ) are below ca. 5 µm in aerody-
namic diameter (boundary diameter)

Actual API mass measurement of stage
deposition sites selected for combined assay
for API where cutoff sizes ( d 50 ) are below
ca. 5 µm in aerodynamic diameter

N/A

Large particle
mass ( LPM )

Mathematical : direct sum of API mass
measurements for deposition sites with d 50
values larger than boundary diameter

Actual API mass measurement for
deposition sites with d 50 values larger than
boundary diameter for combined assay

Actual API mass measurement of
abbreviated impactor deposition site
with d 50 values larger than boundary
diameter for assay

Small particle
mass ( SPM )

Mathematical : direct sum of API mass
measurements for deposition sites with d 50
values smaller than boundary diameter

Actual API mass measurement for
deposition sites with d 50 values smaller than
boundary diameter for combined assay

Actual API mass measurement of
abbreviated impactor deposition site
with d 50 values smaller than
boundary diameter for assay

Impactor- sized
mass ( ISM )

Mathematical : direct sum of API mass
measurements for deposition sites with d 50
values larger and smaller than boundary
diameter

Mathematical : direct sum of API mass
measurements from deposition sites larger
and smaller than boundary diameter

Direct sum of API
mass measurements of abbreviated
impactor deposition sites larger and
smaller than boundary diameter for
assay