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USP.....USP1225:ICHQ2(R1):FDASFDA()()1225:USP-NF1225:1226:FDAUSPANDA1224:()()1224USP—()——()—-------USPICH-------Example1.XXXAHPLCHPLCHPLCICHQ2B2.A(,,)ICH-------Example---(/)------QC/----()----Y=a+kxa---Y(n%)k---r2---SStotal=SSexplained+SSunexplainedr2=SSexplained/SStotal----X0.05%—2%X1mg/mLX0.002mg/mL(0.2%)r20.999Y20%----X--------R²=0.99940.999Y-355.49186320%=373--------/---0.5-2%n%FRSDn%FC----(RSD)---2.0%5---2.0%6---1.0—2.0%---5.0—15.0%USP1226:----------------()()()---QC---AB()---QC---AB/---------------()1.2.3.------------T-testF-testANOVA()f2()RSD---------1225---------------------NOYesYesYesYesNONO------------------------------------1.2.3.4.---------------------------------Summary12251226USP1224SummaryNO1225NO1224YesYes1226Thankyou for your attention!