Table 4. Stability of DTG Under Various Conditions.

DTG in Plasma Matrix
3 F/T Cycles	Control Samples				Test Samples
	Low	Mid	High		Low	Mid	High
	15	450	9000	theoretical conc.	15	450	9000
	13.5	411.3	8201.5	mean	12.8	405.1	8070.6
	0.5	12.1	179.1	SD	0.2	2.5	229.0
	3.3	2.9	2.2	%CV	1.2	0.6	2.8
	-10.2	-8.6	-8.9	%dev	-14.4	-10.0	-10.3
				%diff*	-4.7	-1.5	-1.6
Long Term (15 months)	Control Samples				Test Samples
	Low	Mid	High		Low	Mid	High
	15	450	9000	theoretical conc.	15	450	9000
	14.9	453.9	9185.7	mean	14.3	428.2	8482.4
	0.7	13.5	101.1	SD	0.4	11.9	39.0
	4.4	3.0	1.1	%CV	2.7	2.8	0.5
	-0.7	0.9	2.1	%dev	-4.9	-4.8	-5.8
				%diff*	-4.3	-5.7	-7.7
	DTG in Injection Matrix
3 Days in Autosampler 15°C	Control Samples				Test Samples
	Low	Mid	High		Low	Mid	High
	15	450	9000	theoretical conc.	15	450	9000
	16.2	411.7	8262.1	mean	15.7	402.3	8027.2
	2.4	11.5	116.9	SD	2.5	8.4	131.7
				%diff*	-3.4	0.1	-0.4
	DTG Stock in DMSO
4°C for 13 months	Old Master Stock				New Master Stock
	2017641			mean area	2028447
	56465			SD	64842
	2.8			%CV	3.2
				%diff	0.5

^*%difference as compared control samples, determined by the following equation: (mean test – mean control)/[((mean test + mean control)/2)*100].