Formulation and Interpretation of Determination Method of Water in Rubber Closures

VernacularTitle:橡胶密封件水分测定方法制订与解析
Author: Yan JIANG ¹ ; Xiaolan WANG ; Xialan FENG ; Xiaochun ZHANG ; Wanling LAN ; Lei CHEN
Author Information

1. 四川省药品检验研究院(四川省医疗器械检测中心),成都 611731
Keywords: Rubber closures; Water; Oven-drying method; Karl Fischer drying furnace-Coulometric titration method
From: Herald of Medicine 2024;43(11):1765-1768
CountryChina
Language:Chinese
Abstract: Objective To establish methods for detection of water in rubber closures as one of the Chinese Pharmacopoeia series of standards for pharmaceutical packaging material.Methods The formulation process of determination of water in rubber closures was explained,the key contents of the standard were analyzed,and the determination results of water content by oven-drying method and Karl Fischer drying furnace-coulometric titration method were compared.Results The determination results of water content in multiple batches of rubber stopper samples by over-drying method were generally higher than that by Karl Fischer drying oven-Coulometric titration method.The latter method is highly specific and accurate,and can better reflect the true water content of rubber closures.Conclusion Two methods for determining water content in rubber closures have been developed.Enterprises can choose the appropriate method based on the intended use of their products and daily testing needs.