HPLC设备的确认(中英)QualificationofHPLCEquipment解读.pdf,PA/PH/OMCL (11) 04 - OMCL Guideline on qualification of HPLC equipment (Annex 1) OMCL Network of the Council of Europe QUALITY MANAGEMENT DOCUMENT 欧洲委员会 OMCL 网络 质量管理文件 PA/PH/OMCL (11)
Standard_EQP_UHPLC Document Released: July 2010 Enterprise Edition Compliance Services Equipment Qualification Plan (EQP) Agilent Enterprise Edition Compliance Services Qualification of UHPLC Systems Agilent 1290 Infinity UHPLC Series and Selected Non-Agilent UHPLC Models REVIEW DOCUMENT NAME: Standard_EQP...
Determination of aggregate in each positive and negative control mAb preparation was performed by HPLC (TSK gel G3000 SWXL column, TOSOH BIOSCIENCE; 0.2 M sodium phosphate/0.1 M sodium sulphate buffer, pH6; 0.5 ml/min flow rate) and percentage of monomer reported in Table 1. 2.2. Participants...
– to be identified unambiguously within seconds whereas laboratory-based identification is limited by the inefficiency of traditional techniques such as titration or HPLC. In addition, FT-NIR spectroscopy is non-destructive, so the sample that is analyzed can be put into process as opposed to ...