DIPRIVAN

Strength 20ml：200mg
Character white, aqueous and isotonic emulsion
Active Pharmaceutical Ingredient Propofol（10mg/ml）
Complete table
Soybean oil （100mg/ml）
Egg lecithin （12mg/ml）
Additives Glycerol （22.5mg/ml）
Sodium hydroxide q.s
Water for injection add to 20ml
pH Value 6.0～8.5
Osmolarity mOsmol/kg No control
Free fatty acid mmol/L ≤1.8mg/ml
Peroxide value No control
Anisidine value No control
Lysophosphatidylcholine ≤0.20%（w/v）（2.0mg/ml）
Lysophosphatidylethanolamine No control
2,6-diisopropylphenylisopropylether ≤ 0.25%
3,3'-5,5'-tetraisopropyldiphenol ≤ 0.1%
Max. unknown impurity No control
Total impurities No control
Average Particle size μm <0.25
Particle size ≥2μm ≤ 5000 /ml

No particle>5μm No control
Assay of Propofol% 95.0%~105.0%
Glycerin mg/ml No control
Phosphorus mg/ml No control
≥10μm ≤3000 particles/ampule
Insoluble particle
≥25μm ≤300 particles/ampule
Visible foreign matter None
Bacterial endotoxins ＜0.33 EU/mg（equivalently 3.3EU/ml）
Sterility test Sterile
Storage condition Store between 4° to 25°C. Do not freeze.
Packing materials Ampoule
The general anesthesia induction and maintenance of
adults and children aged three years and older.