RT Journal Article
SR Electronic
T1 Determination of the Moisture Content of Bromobutyl Rubber Stoppers as a Function of Processing: Implications for the Stability of Lyophilized Products
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 75
OP 87
VO 57
IS 2
A1 Templeton, Allen C.
A1 Placek, Jiri
A1 Xu, Hui
A1 Mahajan, Rajiv
A1 Hunke, William A.
A1 Reed, Robert A.
YR 2003
UL http://journal.pda.org/content/57/2/75.abstract
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.