Chi Sheng Chemical Corporation

Hsinchu, Taiwan

Chi Sheng Chemical Corporation

Hsinchu, Taiwan
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Wei L.-J.,China Medical University at Taichung | Wei L.-J.,Chi Sheng Chemical Corporation | Yu H.-Y.,National Taiwan University | Chang W.-B.,Chi Sheng Chemical Corporation | And 3 more authors.
Journal of Food and Drug Analysis | Year: 2013

Effects of glass and plastic containers on the physicochemical properties of propofol injectable emulsion consisting of medium-chain triglycerides (MCTs) and long-chain triglycerides (LCTs) after being diluted with 0.9% NaCl were evaluated. Propofol MCT/LCT reconstituted with normal saline to 2.0 mg/mL, 2.5 mg/mL, 3.0 mg/mL, 4.0 mg/mL, and 5.0 mg/mL were packaged into glass (type II soda-lime-silica), polyvinyl chloride (PVC) soft bag, and non-PVC soft bag (Cryovac®polyolefin soft bag container), and then stored at ambient temperature/humidity (25 ± 2 °C/50 ± 5% RH) for 3 days to test its stability. We found that the pH and osmolarity of propofol injectable emulsions were consistent among different formulations. All formulations packaged in glass and plastic containers were stable for 6 hours; the globule size distribution of these emulsions met the requirements described in Chapter 729 of the United States Pharmacopeia. However, propofol formulations of higher concentrations (3.0 mg/mL, 4.0 mg/mL, and 5.0 mg/mL) stored in plastic containers were found to have abnormal globule size distribution profiles compared with those stored in glass containers after 24 hours. We therefore recommend that the propofol MCT/LCT emulsions should be packaged into glass containers and used within 6 hours after reconstitution with diluents. © 2013, Food and Drug Administration, Taiwan. Published by Elsevier Taiwan LLC. All rights reserved.


Wei L.-J.,China Medical University at Taichung | Wei L.-J.,Chi Sheng Chemical Corporation | Chang W.-B.,Chi Sheng Chemical Corporation | Lin C.-H.,Chi Sheng Chemical Corporation | And 2 more authors.
Journal of Food and Drug Analysis | Year: 2013

The compatibility of propofol MCT/LCT with non-PVC soft bag was investigated in this study. Solutions of 2.0 and 2.5 mg/mL propofol MCT/LCT in 0.9% NaCl solution were filled into CRYOVAC® containers. The studied samples were grouped and stored at ambient temperature (25 ± 2°C) in the light, at ambient temperature in the dark, and at 2-8°C in the dark for 5 days. At indicated sampling time, propofol was assayed by high-performance liquid chromatography. For long-term study, propofol samples were analyzed at day 8 and at day 15. The results showed that all studied samples were stable for 5 days. Propofol contents decreased by 8-12% and 15-23% when stored in the non-PVC bag at ambient temperature in the light for 8 days and 15 days, respectively. Studied samples in non-PVC bag stored at ambient temperature in the dark showed 3-9% decrease when stored for 8 days, whereas 10-13% decrease for 15 days. Propofol concentration in non-PVC bag stored at 2-8°C in the dark showed approximately 2-8% decrease at both day 8 and day 15. In conclusion, the 2.0 and 2.5 mg/mL propofol MCT/LCT in 0.9% NaCl solution with CRYOVAC® container stored at all conditions were stable for 5 days. It is found that samples stored at ambient temperature were more labile as compared to those at 2-8°C; moreover, propofol sample was vulnerable to light exposure. In addition, DEHP additive was not detected in the CRYOVAC® soft bag container by HPLC with a quantitation limit at 5 ppm. Therefore, CRYOVAC® non-PVC soft bag is a suitable container system for propofol MCT/LCT emulsion.

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