含量测定方法学考察(国外英文资料).docVIP

含量测定方法学考察(国外英文资料)Content determination methodology and acceptable standardsAccuracy???Index: the index is mainly reflected by the recovery.Methods: validation general requirements of mixture concentration is 80%, 100% and 80% respectively each three solution (9 samples), and the contents were determined to measured values compared with the theoretical value, calculate recovery rate. ?????The acceptable standard is that the average recovery rate of each concentration should be between 98.0% and 102.0%, and the relative standard deviation (RSD) of the 9 recovery data should not be greater than 2.0%. ????Linear???Metric: linearity is generally expressed in the form of linear regression equations.Methods: in order to determine the area of the main peak and calculate the corresponding content, the water supply of 6 different concentrations was prepared in the range of 80% to 120%. In the case of X, the peak area is the vertical coordinate (Y), and the linear regression analysis is performed. ?????Acceptable standard as follows: the correlation coefficient (R) shall not be less than 0.998 the tropic of cancer, the Y axial intercept should be within the response value of 100% and 2%, relative standard deviation of the response factor should be no greater than 2.0%. ?????Precision???1) repeatability???Methods: compound greatly 6 copies of the same concentration of the solution, by an analysis of the personnel in the test is carried out under the same conditions as possible, the relative standard deviation of 6 copies of the test liquid content should be not greater than 2.0%. ?????2) intermediate precision???Methods: compound 6 copies of the same concentration of the test solution, respectively by two analysts use different instruments and reagents for testing, the relative standard deviation of the 12 content data should be no greater than 2.0%. ?????Special properties???Acceptable standards: no interference should be allowed in the blank, the main component should be comp