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RECOMBINANT THERAPEUTIC MONONLONAL ANTIBODIES .DETERMINATION OF PRODUCT-RELATED IMPURITIES ACCORDING TO USP 129 AND CH.P 3127 |
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The measurement method is based on capillary gel electrophoresis(CGE) with direct UVdetection at the wavelength of 220(214) nm,Sample preparation procedure(denaturation with SDS under reducing or non-reducing conditions)and analysis conditions in accordance with USP129 or Ch.P3127.