海峡药学
海峽藥學
해협약학
STRAIT PHARMACEUTICAL JOURNAL
2015年
3期
20-21
,共2页
碘化钾溶液%稳定性试验%加速试验%长期试验
碘化鉀溶液%穩定性試驗%加速試驗%長期試驗
전화갑용액%은정성시험%가속시험%장기시험
Potassium iodide solution%Stability test%Accelerated test%Long-term test
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。
目的:攷察碘化鉀溶液在聚丙烯瓶中的穩定性。方法以性狀、微生物限度及含量為指標,進行影響因數試驗、加速試驗和長期試驗攷察。結果在溫度(40±2)℃、相對濕度(25±2)%的條件下放置2箇月,在室溫(25±2)℃、相對濕度(40±5)%的條件下放置9箇月,樣品的各項指標均符閤質量標準。結論根據穩定性攷察結果,碘化鉀溶液在聚丙烯瓶中的有效期可暫訂為9箇月。
목적:고찰전화갑용액재취병희병중적은정성。방법이성상、미생물한도급함량위지표,진행영향인수시험、가속시험화장기시험고찰。결과재온도(40±2)℃、상대습도(25±2)%적조건하방치2개월,재실온(25±2)℃、상대습도(40±5)%적조건하방치9개월,양품적각항지표균부합질량표준。결론근거은정성고찰결과,전화갑용액재취병희병중적유효기가잠정위9개월。
OBJECTIVE To study the stability of potassium iodide solution in polypropylene bot-tles.METHODS With traits,microbial limits,and content of indicators as inder impact factor test ,accelerated tes-ting 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 9 months,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 poly-propylene bottles.