원문정보
초록
영어
Human albumin solutions which are used in medical and surgical conditions are required national lot release regulatory before releasing into the market. Testing for the albumin content is the key component and the Kjeldahl method, which can be time-consuming processes and safety concerns regarding sulfuric acid use, is currently the official test method for albumin content in Ministry of Food and Drug Safety, Republic of Korea. In this study, we applied SoloVPE, a new UV-vis spectroscopic technology using a variable path length extension to quantify albumin content for quality control purposes regarding human albumin solution. With its validation, a strong correlation was shown between the Kjeldahl method and SoloVPE. Our findings can help improve the current testing methods for albumin content and provide better quality controls for human albumin solutions.
목차
I. Introduction
II. Materials and methods
1. Materials
2. Variable pathlength extension spectrophotometry (SoloVPE)
3. Semi-micro Kjeldahl
4. Data analysis
III. Results
1. Validation of SoloVPE
2. Comparison between the semi-micro Kjeldahl and SoloVPE methods
3. Application of the quality control test to therapeutic human albumin
IV. Discussion
Conflict of interest
Acknowledgements
References