医院制剂生产中纯化水的制备与质量控制

摘要

目的 对医院制剂生产中所用的纯化水进行质量监测,确保生产用水质量合格.方法 在不同取样点进行取样,按2010年版收载的纯化水检测项目进行检测.结果 纯化水样品的各项化学指标及微生物限度指标均符合规定.结论 所生产的纯化水质量合格,可应用于医院制剂的生产.%Objective To monitor the quality of purified water used in hospital preparations in order to ensure the eligible quality of production water. Methods The samples were collected from different sampling points and detected according to the detection item of purified water stipulated in the Chinese Pharmacopoeia (Vol. I, edition 2010). Results The various chemical indexes and microbial limit test all accorded with the standard. Conclusion The produced purified water is the quality conformance and fits for the production of the hospital preparations.