Study on Analytical Method of Leachable Substances of Allogeneic Products.
10.3969/j.issn.1671-7104.2023.03.021
- Author:
Zhuoying CHEN
1
;
Ziqi LIU
1
;
Lijing HAO
2
;
Bufang FU
1
Author Information
1. National Institutes for Food and Drug Control, Beijing, 102629.
2. South China University of Technology, Guangzhou, 510006.
- Publication Type:Journal Article
- Keywords:
allogeneic products;
detection techniques;
leachable substance;
organic solvents residual
- MeSH:
Humans;
Hematopoietic Stem Cell Transplantation;
Drug Packaging
- From:
Chinese Journal of Medical Instrumentation
2023;47(3):332-336
- CountryChina
- Language:Chinese
-
Abstract:
Products made from allogeneic tissue are largely used in clinical treatment due to its wide source compared with autologous tissue, causing less secondary trauma of patients and the good biocompatibility. Various organic solvents and other substances introduced in the production process of allogeneic products will leach down into the human through clinical treatment, thus bringing varying degrees of harm to patients. Therefore, it is very necessary to detect and control the leachables in such products. Based on the classification and summary of leachable substances existing in the allogeneic products, the preparation of extract and the establishment of the detection techniques for known and unknown leachable are briefly introduced in this study, in order to provide research method for the study of leachable substances of allogeneic products.
