Table 2.

Sample Size and Requirements for In Vitro Testing for Study 2

Test	No. of inhalers required	No. of pockets tested per inhaler
Microbiology	40	Sufficient inhalers/pockets opened to deliver 5 g of powder	Conducted and reported in line with the harmonized pharmacopeia-defined method for inhaled products (USP). Disks were removed from the used inhalers and externally wiped with an alcohol swab before removal of powder for microbiological assessment
Delivered dose uniformity/APSD	30	1	One pocket from each of 30 inhalers was tested for emitted dose and APSD (at 60 L/min)
Assay/degradation products	10	≤7	One pocket from each of 10 inhalers
Water content	4	≤7	Water content: samples taken from at least four inhalers
Analytical retest samples	15	Test dependent	Inhalers retained for laboratory investigations of aberrant results. Sample size based on retest requirement of any individual test from assay/degradation products/water content

The same inhaler could be used for more than one test type.

APSD, aerodynamic particle size distribution; USP, United States Pharmacopeia.