Feasibility Study of Test Method for Histamine-like Substances in Aclarubicin Hydrochloride
- VernacularTitle:盐酸阿柔比星组胺类物质检查法的可行性研究
- Author:
Liang XU
;
Jingwen XIAN
;
Runhua CHEN
;
Meirong QIN
;
Xiaowei WANG
;
Ping WANG
- Publication Type:Journal Article
- Keywords:
Aclarubicin hydrochloride;
Histamine-like substances;
Test
- From:
China Pharmacist
2015;(11):1885-1887,1898
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To establish a test method for histamine-like substances in aclarubicin hydrochloride. Methods:According to the method in the appendix of Chinese Pharmacopoeia ( edition 2010 ) , the test of histamine-like substances was carried out. Re-sults:The test of histamine-like substances was not interfered by aclarubicin hydrochloride with the concentration below 0. 01 mg· ml-1 . Histamine-like substances in 4 batches of samples were determined by the established method, and the results were consistent with those of the test method for depressor substances. Conclusion: The test method for histamine-like substances is feasible with the limit of 1 μg·mg-1 .
