Evaluation of the maximum beyond-use-date stability of regular human insulin extemporaneously prepared in 0.9% sodium chloride in a polyvinyl chloride bag

Figures & data

Figure 1 Sample label.

Table 1 Mean insulin concentrations of triplicate insulin samples in 0.9% sodium chloride stored at 2°C–8°C

Time (hour)	Bag 1*	Bag 2*	Bag 3*	Combined*	Considered stable**
0	0.92 (0.04)	0.91 (0.01)	0.93 (0.03)	0.92 (0.02)	Yes
6	0.88 (0.01)	0.89 (0.04)	0.91 (0.02)	0.89 (0.02)	Yes
24	0.83 (0.03)	0.86 (0.04)	0.87 (0.02)	0.85 (0.03)	Yes
48	0.84 (0.01)	0.82 (0.03)	0.87 (0.01)	0.84 (0.03)	Yes
72	0.78 (0.03)	0.83 (0.01)	0.84 (0.08)	0.82 (0.05)	Yes
144	0.85 (0.02)	0.84 (0.03)	0.90 (0.04)	0.87 (0.04)	Yes
168	0.79 (0.01)	0.82 (0.03)	0.77 (0.00)	0.79 (0.03)	No
192	0.87 (0.00)	0.86 (0.03)	0.91 (0.03)	0.88 (0.03)	Yes
216	0.82 (0.04)	0.89 (0.01)	0.95 (0.02)	0.89 (0.06)	Yes
240	0.81 (0.03)	0.86 (0.05)	0.86 (0.02)	0.84 (0.04)	Yes
312	0.82 (0.06)	0.90 (0.00)	0.91 (0.00)	0.88 (0.05)	Yes
336	0.91 (0.01)	0.90 (0.00)	0.92 (0.02)	0.91 (0.02)	Yes

Notes:

* Represents data presented as mean (standard deviation)

** time points were considered stable if the mean concentration of the samples exceeded 90% of the equilibrium concentration at 6 hours (shown in bold).

Figure 2 Mean concentration of insulin 100 units prepared in a total volume of 100 ml 0.9% sodium chloride stored at 2°C–8°C.

Notes: Data are expressed as mean ± standard deviation; *represents the 168-hour time point sample, which did not maintain the equilibrium concentration.