Stability of Propofol Medium Chain Triglyceride/Long Chain Triglyceride (MCT/LCT) in 0.9% NaCl Solution with CRYOVAC (R) Non-PVC Soft Bag Containers | Health & Environmental Research Online (HERO)

HERO ID

2519124

Reference Type

Journal Article

Title

Stability of Propofol Medium Chain Triglyceride/Long Chain Triglyceride (MCT/LCT) in 0.9% NaCl Solution with CRYOVAC (R) Non-PVC Soft Bag Containers

Author(s)

Wei, L; Chang, W; Lin, CH; Chen, YuC; Wu, J

Year

2013

Is Peer Reviewed?

Yes

Journal

Journal of Food and Drug Analysis
ISSN: 1021-9498

Volume

21

Issue

1

Page Numbers

87-92

Language

English

DOI

10.6227/jfda.2013210111

Web of Science Id

WOS:000319792300011

URL

https://www.scopus.com/inward/record.uri?eid=2-s2.0-84877845489&doi=10.6227%2fjfda.2013210111&partnerID=40&md5=80db39eb507959662c3dd1c62fa2ae33
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Abstract

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 (R) containers. The studied samples were grouped and stored at ambient temperature (25 +/- 2 degrees C) in the light, at ambient temperature in the dark, and at 2-8 degrees 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 degrees 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 (R) 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 degrees C; moreover, propofol sample was vulnerable to light exposure. In addition, DEHP additive was not detected in the CRYOVAC (R) soft bag container by HPLC with a quantitation limit at 5 ppm. Therefore, CRYOVAC (R) non-PVC soft bag is a suitable container system for propofol MCT/LCT emulsion.

Keywords

compatibility; propofol MCT/LCT; non-PVC soft bag containers