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. 2015 Dec 16;3(4):379–385. doi: 10.3390/pharmacy3040379

Table 2.

Stability of Batch Compounded Controlled Substances.

Conditions/Results Fentanyl Fentanyl Fentanyl Hydro-morphone Ketamine Midazolam Midazolam Morphine Morphine Pento-barbital
concentration 10 mcg/mL in NS 10 mcg/mL in D5W 50 mcg/mL 100 mcg/mL in NS 10 mg/mL 5 mg/mL 0.4 mg/mL in D5W 1 mg/mL in NS 1 mg/mL in D5W 50 mg/mL
mobile phase(buffer: ACN) 75:25 75:25 65:35 65:35 85:15 70:30 70:30 97.5:2.5 97.5:2.5 65:35
detection wavelength (nm) 210 210 210 254 210 254 254 210 210 210
injection volume (µL) 12.5 12.5 5 5 5 5 5 5 5 5
retention time (min) 5.46 5.46 1.89 2.62 3.55 2.58 2.58 3.88 3.88 4.17
Degradants a (min) 0.9 (a,b) 0.9 (a,b) 0.8 (a,b) 1.3 (a,b) 1.9 (a), 2.3 (a) 1.0 (b) 1.0 (b) 3.1 (a, b, p) 3.1 (a, b, p) ppt (a)
initial (concentration)b 10.6 ± 0.1
mcg/mL
10.0 ± 0.1
mcg/mL
48.3 ± 0.4
mcg/mL
98.6 ± 0.3
mcg/mL
10.1 ± 0.02
mg/mL
5.06 ± 0.06
mg/mL
0.397 ± 0.001
mg/mL
1.05 ± 0.004
mg/mL
1.02 ± 0.01
mg/mL
48.8 ± 0.8
mg/mL
week 7–8
% remaining b
104.0 ± 1.9
(day 50)
101.7 ± 3.9
(day 50)
102.7 ± 3.2
(day 50)
94.2 ± 1.6
(day 50)
102.2 ± 0.4
(day 50)
97.2 ± 1.9
(day 51)
98.5 ± 0.5
(day 51)
100.9 ± 0.2
(day 50)
100.8 ± 0.6
(day 50)
99.6 ± 2.0
(day 50)
day 100
% remaining b
101.7 ± 3.0 104.0 ± 3.3 98.3 ± 4.4 90.3 ± 0.7 100.5 ± 1.5 96.5 ± 2.6 96.4 ± 1.7 101.1 ± 0.3 100.9 ± 1.0 102.2 ± 2.2
Linearity 0.9992 0.9992 0.9999 0.9999 > 0.9999 0.9996 0.9996 0.9998 0.9998 0.9994
precision 0.33 0.33 0.87 0.17 0.29 0.36 0.50 0.10 0.10 0.97
intraday coefficient of variation 0.45 0.45 1.35 1.07 0.29 0.90 0.90 0.28 0.28 1.35
interday coefficient of variation 1.74 1.74 2.82 1.11 1.48 1.05 1.05 1.63 1.63 1.52

Notes: a a = acid, b = base, p = peroxide; b mean ± SD; Triplicate determinations of four samples.