Presentation Outline ICHP Annual Meeting September 13-15

Sample Preparation
• Intravenous acetaminophen supplied as 10 mg/mL,
100 mL bottle
• Doses in syringes (triplicate)
– 100 mg (10 mL in 10 mL syringe)
– 250 mg (25 mL in 30 mL syringe)
– 500 mg (50 mL in 60 mL syringe)
• Volumes in original opened bottle (triplicate)
– 250 mg (25 mL in bottle)
– 900 mg (90 mL in bottle)
Stability‐Indicating Assays
• Forced decomposition of intravenous
acetaminophen
– 3% hydrogen peroxide
– 1 N sodium hydroxide (pH 12)
– 1 N hydrochloric acid (pH 2)
• Procedure
– Heat to 90ºC for 2 hours
– Neutralized to pH 7
Results
y = 131692.3000x +
1067843.7000
R² = 0.9996
• Visually inspected for color change and
precipitate formation
• pH measured
Sample Analysis
• Microbiological testing not performed
Time
Results
Sample Acetaminophen Chromatogram
Degradation
Solution
3% hydrogen
peroxide
1 N hydrochloric
acid (pH 2)
1 N sodium
hydroxide (pH 12)
HPLC Peak Height
Results
Degradation Peaks
(minutes)
Acetaminophen peak
at 4.05 minutes
Stability-Indicating Capability of HPLC Assay
Acetaminophen peak: 4 minutes
p‐aminophenol peak: 7.35 minutes
Acetaminophen
Degradation (%)
246 2.46 5
2.70, 6.08, 7.35 8
2.64, 5.23, 7.35 25
8/29/2012
4