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Quality of Atropine sulfate injection and Norepinephrine bitartrate injection
  • 1.04.2019
  • 365
Quality of Atropine sulfate injection and Norepinephrine bitartrate injection
Owner / Producer Owner / Producer
Chanwit Budburee, Sumana Sirisoonthorn, Nonthawat Phusua, Paveena Charoensit, Patima Maneesatid
Year Year
2019
Pages
1
Details

Atropine sulfate injection and Norepinephrine bitartrate injection are drugs listed in the National List of Essential Medicines 2017 in the group of cardiovascular system drugs and antidotes. By intravenous administration, both of them were used for rescuing the patients in the case of cardiac arrest in intensive care unit (ICU). Therefore, their quality of them is important. Bureau of Drug and Narcotic perform the quality survey of Atropine sulfate injection in fiscal year 2017 and of Norepinephrine bitartrate injection in fiscal year 2018. The samples were collected from hospital and manufacturer via single window system. A total of 5 Atropine sulfate injection samples, classified into 1 registration 1 from manufacturer, a total of 13 norepinephrine bitartrate injection samples, classified into 4 registration from 4 importers, were evaluated for the content of active ingredient, pH determination, particulate matter, sterility test and bacterial endotoxins by using methods and specifications of the United States Pharmacopeia (USP39 and USP40 respectively). The analytical methods were verified for the suitability prior to sample testing. The results showed that all of samples are conformed to the requirement of all topics. It can be concluded that all of the samples surveyed are good quality.
Keywords: quality, Atropine sulfate injection, Norepinephrine bitartrate injection