RT Journal Article
SR Electronic
T1 Generation of the Extractables Profile for an Elastomeric Material and Investigation of the Accumulation Behavior of Targeted Leachables Including Bis(2,2,6,6-tetramethyl-4-piperidyl) Sebacate (Tinuvin 770) and a Related Substance
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 101
OP 112
VO 64
IS 2
A1 James Story
A1 Martha Gill
A1 Norman Liu
A1 Yousheng Hua
A1 Dennis Jenke
YR 2010
UL http://journal.pda.org/content/64/2/101.abstract
AB The organic extractables profile of a synthetic polyisoprene material being considered for use as a closure on a bag-type packaging system has been delineated. The predominant organic extractables associated with the test material were bis(2,2,6,6-tetramethyl-4-piperidyl) sebacate (Tinuvin 770), several Tinuvin-related substances, fatty acids, and antioxidant-related compounds. Based on their potential product safety impact, Tinuvin and one of its related substances were chosen as target leachables. In order to establish the accumulation behavior of these target leachables under conditions that simulate the desired application, monobags (100-mL fill volume) and multichambered bags (1000-mL fill volume) were constructed with injection sites made from the test material, filled with water, and subjected to accelerated aging including multiple sterilization cycles and long-term storage at 40 °C. Even under the worse-case contact conditions, the accumulation levels of the target leachables were much less than their total available pool in the injection sites.© PDA, Inc. 2010