Application of Abraham's solvation parameter model to extractables and leachables studies in pharmaceutical and medical device industries: A tutorial

Bibliographic Details
Title: Application of Abraham's solvation parameter model to extractables and leachables studies in pharmaceutical and medical device industries: A tutorial
Authors: Jianwei Li
Source: Journal of Chromatography Open, Vol 6, Iss , Pp 100158- (2024)
Publisher Information: Elsevier, 2024.
Publication Year: 2024
Collection: LCC:Analytical chemistry
Subject Terms: Abraham's solvation parameter model, Extractables, Leachables, Simulating solvent, Chemical characterization, Extraction, Analytical chemistry, QD71-142
More Details: The Abraham's solvation parameter model is an important tool to model and predict distribution properties of compounds in numerous partitioning systems in chemistry, environmental chemistry, medicine, and biology. The evaluation of the distribution properties in extractables and leachables (E&L) studies in pharmaceutical and medical device industries is another major application of this model. This tutorial is aimed at illustrating the applications of the model in E&L studies. Specific examples of the application illustrated in this tutorial include: (a) establishment of equivalent or similar solvents; (b) determination of polarity of solvents, biological tissues, and materials; (c) development of drug product simulating solvents; (d) understanding solvent extraction power for a material; (e) selection of solvent and standards in pretreatment of extraction samples; and (f) chromatography retention prediction for E&L.
Document Type: article
File Description: electronic resource
Language: English
ISSN: 2772-3917
Relation: http://www.sciencedirect.com/science/article/pii/S2772391724000458; https://doaj.org/toc/2772-3917
DOI: 10.1016/j.jcoa.2024.100158
Access URL: https://doaj.org/article/086d16eb3079435ead31054f513fbcea
Accession Number: edsdoj.086d16eb3079435ead31054f513fbcea
Database: Directory of Open Access Journals
More Details
ISSN:27723917
DOI:10.1016/j.jcoa.2024.100158
Published in:Journal of Chromatography Open
Language:English