Table 1.

Concentration of Dexamethasone (from Tablets) in Oral Mix Suspension Vehicle During 91 Days of Storage in Glass Bottles, Plastic Bottles, and Plastic Syringes at 25°C and in Glass and Plastic Bottles at 4°C^*

Study Day	Mean Concentration ± SD (mg/mL) and Mean % Remaining
	Glass Bottles	Plastic Bottles	Plastic Syringes
25°C storage
0	0.992±0.009	0.992±0.009	0.992±0.009
7	0.983±0.015 (99.1)	0.984±0.008 (92.2)	0.981±0.010 (98.9)
14	0.990±0.012 (99.9)	0.988±0.009 (99.6)	0.992±0.006 (100.0)
28	0.979±0.018 (98.7)	0.982±0.028 (99.1)	0.968±0.046 (97.6)
49	0.960±0.007 (96.8)	0.981±0.010 (98.9)	0.972±0.005 (98.0)
70	0.974±0.018 (98.2)	0.981±0.015 (98.9)	0.946±0.009 (95.4)
91	0.961±0.016 (96.9)	0.942±0.009 (95.0)	0.963±0.030 (97.1)
% remaining on day 91 by linear regression†	97.1	96.4	96.4
Lower limit of 95% CI for % remaining‡	94.9	93.4	93.5
4°C storage			NA
0	0.992±0.009	0.992±0.009
7	1.000±0.013 (100.8)	0.994±0.016 (100.2)
14	0.985±0.011 (99.3)	0.992±0.006 (100.0)
28	0.983±0.008 (99.1)	0.998±0.007 (99.0)
49	0.977±0.010 (98.5)	0.982±0.035 (99.0)
70	0.971±0.022 (97.9)	0.976±0.008 (98.4)
91	0.965±0.012 (97.3)	0.973±0.029 (98.1)
% remaining on day 91 by linear regression†	97.0	97.9
Lower limit of 95% CI for % remaining‡	95.8	97.1

CI = confidence interval, NA = not applicable, SD = standard deviation.

^*Nominal concentration: 1.0 mg/mL. Mean values based on 2 samples analyzed in duplicate. Percent remaining is relative to measured concentration on day 0.

^†Calculated from concentration on day 91 as determined by linear regression and concentration observed at time 0, according to the following formula: (concentration at day 91 ÷ concentration at time 0) × 100.

^‡Calculated from lower limit of 95% CI of the slope of the curve relating concentration to time, determined by linear regression, according to the following formula: (lower limit of 95% CI of concentration at day 91 ÷ concentration at time 0) × 100.