Research on Element Impurity Migration in the Compatibility Test of Pantoprazole Sodium for Injection with Combination Packaging Materials and Container
OBJECTIVE To establish an experimental method using ICP-MS to study the compatibility between pantoprazole sodium for injection and neutral borosilicate glass injection bottle-coated stopper composite packaging materials.METHODS By conducting extraction experiments,simulated acceleration experiments,and migration experiments under long-term experimental conditions,the changes in elemental impurities of pantoprazole sodium for injection at different times were investigated.The simulated solution after erosion was analyzed to predict the tendency of detachment on the inner surface of boron tube bottles,and its migration amount was evaluated for safety.RESULTS The linear relationship of each element by ICP-MS method was good,and the correlation coefficient(r)was greater than 0.999 0.The quantitative limit was less than its corresponding limit of 10％.The average recovery rate was 97.5％-108.8％.In the extraction experiment,the elements with higher detected level in each sample were Si,B,and Al,but all were below the safety limits.The detected levels of other elements were relatively low,even below the detection limits.Under intermediate and long-term conditions of 6 and 12 months,the detection results of elemental impurities in various added components in the packaging materials were all lower than the AET values.CONCLUSION This method can effectively determine the content of various impurity elements in the sample and reveal their migration trends.The compatibility between the composite packaging components and pantoprazole sodium for injection is good,and the safety of the product meets the requirements.It provided a scientific basis for selecting boron tube bottle and film-covered stopper as the inner packaging material.
pantoprazole sodium for injectionneutral borosilicate glasslaminated plugcompatibilitymigration test
万方数据
维普
