Table 2.

Chemical Stability of Tacrolimus Formulation Prepared from Tablets^*

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)	0.490 ± 0.015 (100.0)	0.490 ± 0.015 (100.0)
7	0.491 ± 0.029 (100.2)	0.481 ± 0.050 (98.2)
14	0.471 ± 0.028 (96.2)	0.452 ± 0.013 (92.2)
30	0.478 ± 0.042 (97.5)	0.488 ± 0.039 (99.6)
45	0.537 ± 0.011 (109.5)	0.514 ± 0.012 (105.0)
60	0.535 ± 0.023 (109.2)	0.515 ± 0.012 (105.1)
75	0.528 ± 0.012 (107.7)	0.499 ± 0.005 (101.9)
90	0.509 ± 0.007 (103.9)	0.488 ± 0.020 (99.6)
Storage at 25°C, 60% RH
Initial (day 0)	0.490 ± 0.015 (100.0)	0.490 ± 0.015 (100.0)
7	0.510 ± 0.011 (104.1)	0.493 ± 0.012 (100.6)
14	0.496 ± 0.010 (101.2)	0.458 ± 0.015 (93.5)
30	0.512 ± 0.020 (104.4)	0.504 ± 0.018 (102.9)
45	0.521 ± 0.019 (106.4)	0.500 ± 0.005 (102.1)
60	0.548 ± 0.014 (111.8)	0.505 ± 0.018 (103.1)
75	0.511 ± 0.011 (104.3)	0.500 ± 0.011 (102.0)
90	0.502 ± 0.018 (102.5)	0.475 ± 0.011 (96.9)

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.