Research ArticleRESEARCH
Comprehensive Determination of Extractables from Five Different Brands of Stoppers Used for Injectable Products
Claudia C. Corredor, Thomas A. Haby, Joel D. Young, Pankaj A. Shah and Sailesh A. Varia
PDA Journal of Pharmaceutical Science and Technology November 2009, 63 (6) 527-536;
Claudia C. Corredor
Thomas A. Haby
Joel D. Young
Pankaj A. Shah

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In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 63, Issue 6
November/December 2009
Comprehensive Determination of Extractables from Five Different Brands of Stoppers Used for Injectable Products
Claudia C. Corredor, Thomas A. Haby, Joel D. Young, Pankaj A. Shah, Sailesh A. Varia
PDA Journal of Pharmaceutical Science and Technology Nov 2009, 63 (6) 527-536;
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