PT  - JOURNAL ARTICLE
AU  - Allen C. Templeton
AU  - Jiri Placek
AU  - Hui Xu
AU  - Rajiv Mahajan
AU  - William A. Hunke
AU  - Robert A. Reed
TI  - Determination of the Moisture Content of Bromobutyl Rubber Stoppers as a Function of Processing: Implications for the Stability of Lyophilized Products
DP  - 2003 Mar 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 75--87
VI  - 57
IP  - 2
4099  - http://journal.pda.org/content/57/2/75.short
4100  - http://journal.pda.org/content/57/2/75.full
SO  - PDA J Pharm Sci Technol2003 Mar 01; 57
AB  - The purpose of the present study is to apply and contrast several analytical techniques to understand the change in moisture content of 20 mm diameter bromobutyl rubber stoppers as a function of typical stopper processing conditions. Three separate methods were examined and Karl-Fischer titration and techniques based on capacitance measurements at a thin-fi lm sensor were found to provide comparable results. Stopper moisture levels were examined in stoppers: (i) as received from the manufacturer, (ii) following steam sterilization, (iii) as a function of various drying cycles, and (iv) during simulated hold conditions prior to use. Finally, the transfer of moisture from stopper to an actual product is examined on storage and general agreement observed between stopper drying conditions and cake moisture levels.