Uncertainty Evaluation of the Potency Testing of Oxytocin Injection
10.6039/j.issn.1001-0408.2015.18.46
- VernacularTitle:缩宫素注射液效价测定的不确定度评定
- Author:
Haifang LI
;
Wenning GENG
;
Mingyu YAN
- Publication Type:Journal Article
- Keywords:
Oxytocin injection;
Potency;
Testing;
Uncertainty evaluation
- From:
China Pharmacy
2015;(18):2575-2577,2578
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To establish a method of the uncertainty evaluation of the potency testing of Oxytocin injection. METHODS:Mathematical model was established for potency testing of Oxytocin injection to analyze the influential factors of un-certainty. The uncertainty components were quantitatively analyzed and the uncertainty was calculated. RESULTS:The expanded un-certainty of the potency testing of Oxytocin injection was 0.20 u/ml and the potency was(9.29±0.20)u/ml,coverage factor K=2. CONCLUSIONS:The method is suitable for the uncertainty evaluation of potency testing of Oxytocin injection.
