RT Journal Article
SR Electronic
T1 Comprehensive Determination of Extractables from Five Different Brands of Stoppers Used for Injectable Products
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 527
OP 536
VO 63
IS 6
A1 Corredor, Claudia C.
A1 Haby, Thomas A.
A1 Young, Joel D.
A1 Shah, Pankaj A.
A1 Varia, Sailesh A.
YR 2009
UL http://journal.pda.org/content/63/6/527.abstract
AB Five commonly used stopper formulations were tested for extractables using three different vehicles (pH 3 citrate buffer with 20% w/v sulfobutylether-β-cyclodextrin, pH 8 phosphate buffer and 50/50 v/v polyoxyethylated castor oil/dehydrated alcohol). The stoppers, made from butyl and halobutyl rubbers, coated and uncoated with proprietary films, were stored in contact with each vehicle for up to 6 months at 40 °C/75% relative humidity (RH) or for up to 24 months at 25 °C/60% RH. Samples were analyzed for the presence of extractables using inductively coupled plasma-atomic emission spectroscopy, ion chromatography, high-performance liquid chromatography, and gas chromatography. Extractables were observed at greater than 10 ppm for only one of the five stoppers that were tested. Based on these results, a standardized protocol for stopper extractable testing was developed. This protocol has been used to satisfy stopper extractable testing regulatory requirements for a number of different new injectable products.© PDA, Inc. 2009