Feasibility Study of Test Method for Histamine-like Substances in Aclarubicin Hydrochloride / 中国药师

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-sultsThe 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 .