泼尼松龙残留分析方法的研究

The research residual analysis of prednisone

目的为确认泼尼松龙残留分析方法的准确、可靠,拟对该分析方法的专属性、线性、回收率(擦拭取样法)、溶液的稳定性、精密度(重复性试验、中间精密度试验)进行验证,以确保在本实验室验证条件下,氢化泼尼松注射液生产设备、设施清洁验证中泼尼松龙残留分析方法准确,可靠。

Object： To confirm the prednisone dragon residue analysis method is accurate and reliable,and probes into the analysis method of specificity,linear,recovery（ wipe sampling method）,the stability of the solution,precision,repeatability test,intermediate precision test verification,to ensure that under the condition of the laboratory test,hydrogenated prednisone injection production equipment and facilities in the cleaning validation prednisone dragon residue analysis method is accurate,and reliable.