李雪,杨德忠,罗卓雅,洪建文,林生文
LI Xue,YANG Dezhong,LUO Zhuoya,HONG Jianwen,LIN Shengwen

• 1:广东省食品药品检验所

摘要(Abstract)：

目的考察确定《中国药典》中二甲酚橙指示液的有效期。方法通过对二甲酚橙指示液含量、灵敏度试验及对模型药物的滴定结果 3个指标来考察确定其使用有效期。结果经考察二甲酚橙指示液在5℃条件下有效期为6个月,在20、25℃条件下有效期为2~3个月,在40℃条件下有效期为1个月。结论通过二甲酚橙指示液含量、灵敏度试验及对滴定结果的影响的研究并综合其他实验室的相关规定,确定常温(10~30℃)下有效期为2个月。
OBJECTIVE To investigate the expiry date of Xylenol orange indicator solution in Chinese Pharmacopeia.METHODS The expiry date of Xylenol orange indicator solution were analyzed through the assay of Xylenol orange indicator solution by HPLC,the sensitivity test and the result of model drug's assay. RESULTS The expiry date of Xylenol orange indicator solution was 6 months under the condition of 5 ℃,2-3 months under the condition of 20 ℃,25 ℃,and 1 month under the condition of 40 ℃.CONCLUSION Through the stability test,the sensitivity test,the result of model drug's assay and the data of other laboratories,the expiry date of Xylenol orange indicator solution is 2 months under 10-30 ℃.

关键词(KeyWords)： 二甲酚橙指示液;有效期;灵敏度试验
Xylenol orange indicator solution;expiry date;sensitivity test

Abstract:

Keywords:

基金项目(Foundation): 中青年发展研究基金(2013WQI)

作者(Author): 李雪,杨德忠,罗卓雅,洪建文,林生文
LI Xue,YANG Dezhong,LUO Zhuoya,HONG Jianwen,LIN Shengwen

参考文献(References)：

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