Table 4.

Assay and Related Substances Results for Glycopyrrolate Pre- and Postnebulization Test Samples

			Postnebulized (n = 3, mean ± SD)
Glycopyrrolate strength	Drug assay/related substances	Prenebulized	Nebulizer 1	Nebulizer 2
25 μg/mL	Active (% nominal concentration)	98.70	98.64 ± 0.32	98.69 ± 0.15
	Known impurity 1 (%)	0.15	0.15 ± 0.01	0.14 ± 0.00
	Known impurity 2 (%)	0.28	0.29 ± 0.01	0.28 ± 0.00
	Largest unknown impurity (%)	0.36	0.33 ± 0.02	0.34 ± 0.02
	Total impurities (%)	0.78	0.77 ± 0.02	0.76 ± 0.01
50 μg/mL	Active (% nominal concentration)	98.70	98.31 ± 0.33	98.76 ± 0.78
	Known impurity 1 (%)	<0.10	<0.10	<0.10
	Known impurity 2 (%)	0.23	0.24 ± 0.00	0.24 ± 0.00
	Largest unknown impurity (%)	0.14	0.14 ± 0.01	0.14 ± 0.01
	Total impurities (%)	0.38	0.38 ± 0.01	0.38 ± 0.01

SD, standard deviation.