Feasibility Study on Test Method Establishment for Histamine-like Substances in Pirarubicin / 中国药师

ABSTRACT

Objective:To establish the test method for histamine-like substances in pirarubicin. Methods:According to the meth-od described in the appendix of Chinese Pharmacopoeia (2010 edition), the test for histamine-like substances was carried out. Re-sultsThe test for histamine-like substances had no interference under the condition with pirarubicin concentration of 0. 01mg·ml-1 . The established test method for histamine-like substances in pirarubicin was applied in 10 samples, and the results were accordant with those of the test method for depressor substances. Conclusion:The test method for histamine-like substances in pirarubicin is feasible with the limit of 1 μg·mg-1 .