AN EFFICIENT METHOD FOR THE DETERMINATION OF TRACE EXCIPIENT IMPURITIES IN BIOTHERAPEUTIC DRUG PRODUCTS CONTAINING POLYSORBATE Robert Birdsall, Brooke Koshel, Ximo Zhang, Scott Berger, Ying Qing Yu Waters Corporation, Milford, MA RESULTS INTRODUCTION Figure 2. Dynamic range and internal standard…
Key words
oleic, neat, mecn, sir, retention, tuv, acid, area, min, time, ppm, polysorbate, volume, experimental, yes