Table 2.

Percentage of Azacitidine Remaining^* with Storage at 4°C

	Type of Container; Initial Concentration; Mean % Remaining ± SD
	Vials		Syringes
Study Day	Nominal 25 mg/mL	Nominal 10 mg/mL	Nominal 25 mg/mL	Nominal 10 mg/mL
Initial concentration, observed (mg/mL)	27.79±0.29	11.42±0.08	28.83±0.15	11.68±0.07
1	93.55±0.55	92.27±0.2	91.82±0.91	91.03±0.38
3	76.74±0.24	73.57±0.49	72.46±1.57	71.90±1.02
4	71.37±0.57	67.33±0.85	67.06±2.04	64.56±0.37
Data analysis
Degradation rate (%/day)†	−7.407	−8.404	−8.523	−9.000
SD from regression (Sy.x)‡	1.180	1.178	1.623	0.853
Fastest degradation rate (% loss/day) with 95% confidence§	−9.012	−10.007	−10.732	−10.161
Shortest T-90 (h) with 95% confidence§¶	26.63	23.98	22.36	23.62

CI = confidence interval, SD = standard deviation.

^*Each value is based on duplicate determination of 3 samples. The percent remaining is based on designation of the initial measured concentration (day 0) as 100%.

^†The degradation rate was determined by linear regression of the percent remaining on each study day.

^‡The SD from the regression (Sy.x) provides an estimate of the SD about the line determined by linear regression, expressed as a percentage relative to the concentration. Expressed in this way, it is also an estimate of the between-day error of replicate analysis.

^§The fastest degradation rate was determined from the lower limit of the 95% CI of the slope (percent remaining versus study day) determined by linear regression.

^¶T-90 is the time for the concentration to decline by 10%, i.e., to 90% of the initial concentration.