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Autor:
Gregory L. Erexson, Kim Li, Brad Stanard, Melisa Masuda-Herrera, Susanne Glowienke, Thomas Broschard, Amanda Giddings, Geraldine Whelan, Lee M. Nagao, Uma S. Bruen, Maureen T. Cruz, David G. Dolan, Cheryl L. M. Stults, Patricia Parris, Courtney M. Callis, Elizabeth A. Martin, Ornella Binazon, Joel P. Bercu
Publikováno v:
Regulatory toxicology and pharmacology : RTP. 118
Leachables from pharmaceutical container closure systems are a subset of impurities that present in drug products and may pose a risk to patients or compromise product quality. Extractable studies can identify potential leachables, and extractables a