Table 1.

Chemical Stability of Tacrolimus Formulation Prepared from Bulk Powder^*

Study Day	Mean Concentration ± SD (mg/mL) and Mean % Remaining†
	Packaged in Amber Glass Bottles	Packaged in Amber Plastic Syringes
Storage at 5°C, ambient RH
Initial (day 0)	0.489 ± 0.012 (100.0)	0.489 ± 0.012 (100.0)
7	0.521 ± 0.015 (106.6)	0.515 ± 0.011 (105.3)
14	0.500 ± 0.017 (102.4)	0.503 ± 0.004 (102.9)
30	0.485 ± 0.008 (99.2)	0.489 ± 0.007 (100.1)
45	0.510 ± 0.008 (104.2)	0.516 ± 0.020 (105.5)
60	0.533 ± 0.010 (108.9)	0.518 ± 0.014 (106.0)
75	0.505 ± 0.004 (103.2)	0.504 ± 0.011 (103.0)
90	0.494 ± 0.005 (101.1)	0.484 ± 0.007 (99.0)
Storage at 25°C, 60% RH
Initial (day 0)	0.489 ± 0.012 (100.0)	0.489 ± 0.012 (100.0)
7	0.512 ± 0.007 (104.7)	0.518 ± 0.007 (105.9)
14	0.518 ± 0.022 (105.9)	0.496 ± 0.028 (101.4)
30	0.494 ± 0.014 (101.1)	0.498 ± 0.005 (101.8)
45	0.511 ± 0.011 (104.6)	0.511 ± 0.010 (104.6)
60	0.533 ± 0.016 (109.0)	0.513 ± 0.010 (105.0)
75	0.492 ± 0.014 (100.6)	0.494 ± 0.008 (101.0)
90	0.488 ± 0.010 (99.8)	0.469 ± 0.008 (95.9)

RH = relative humidity, SD = standard deviation.

^*Nominal concentration: 0.50 mg/mL.

^†Mean concentrations are based on 3 separate samples; the percentage remaining is relative to the initial concentration measured on day 0.