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.