摘要
目的考察碘化钾溶液在聚丙烯瓶中的稳定性。方法以性状、微生物限度及含量为指标,进行影响因数试验、加速试验和长期试验考察。结果在温度(40±2)℃、相对湿度(25±2)%的条件下放置2个月,在室温(25±2)℃、相对湿度(40±5)%的条件下放置9个月,样品的各项指标均符合质量标准。结论根据稳定性考察结果,碘化钾溶液在聚丙烯瓶中的有效期可暂订为9个月。
OBJECTIVE To study the stability of potassium iodide solution in polypropylene bottles.METHODS With traits,microbial limits,and content of indicators as inder impact factor test,accelerated testing and long-term test were processed.RESULTS At a temperature of(40 ± 2) ℃,relative humidity(25 ± 2) %condition for 2 months,at room temperature(25 ± 2) ℃,relative humidity(40 ± 5) % conditions of exposure of 9months,Indicators in samples were in line with quality standards.CONCLUSION According to the study on the stability of results,potassium iodide solution in polypropylene interim certificate may be issued for 9 months in polypropylene bottles.
出处
《海峡药学》
2015年第3期20-21,共2页
Strait Pharmaceutical Journal
关键词
碘化钾溶液
稳定性试验
加速试验
长期试验
Potassium iodide solution
Stability test
Accelerated test
Long-term test