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. 2014 Nov 26;14(4):309–314. doi: 10.1007/s40268-014-0067-3

Table 1.

Stability and recovery of fidaxomicin dispersed in water, applesauce, or Ensure^®

	Time (h)
	0	2	6	12	24
A. Water
Method 1
% Recovery, mean (SD) (n = 3)	95.3 (2.32)	nt	104.4 (3.07)	nt	100.6 (2.23)
% Impurity A^a	<LOQ	nt	0.19	nt	0.65
Method 2
% Recovery, mean (SD) (n = 6)	103.8 (1.28)	102.9 (1.57)	102.2 (1.49)	104.1 (1.13)	nt
% Impurity A^a	<LOQ	0.11	0.25	0.38	nt
B. Applesauce
Method 1
% Recovery, mean (SD) (n = 3)	105.0 (1.37)	nt	108.2 (4.29)	nt	104.6 (2.22)
% Impurity A^a	<LOQ	nt	<LOQ	nt	<LOQ
Method 2
% Recovery, mean (SD) (n = 6)	104.8 (1.20)	nt	104.5 (1.05)	101.7 (1.96)	104.6 (0.80)
% Impurity A^a	<LOQ	nt	<LOQ	<LOQ	<LOQ
C. Ensure^®
Method 1
% Recovery, mean (SD) (n = 3)	95.5 (3.41)	nt	99.1 (5.92)	nt	99.0 (3.87)
% Impurity A^a	<LOQ	nt	<LOQ	nt	0.08
Method 2
% Recovery, mean (SD) (n = 6)	105.6 (1.03)	nt	107.7 (1.35)	105.4 (1.48)	107.8 (1.71)
% Impurity A^a	<LOQ	nt	0.06	0.06	0.14

h hour, LOQ limit of quantification (0.05 %), nt not tested, SD standard deviation

^aLimit in drug product is not more than 0.2 %