含量测定方法的评价（国外英文资料）.docVIP

含量测定方法的评价（国外英文资料） Analytical performance parameters (Analytical performance parameters) Any method of analysis, based on the objects and requirements it USES, should have corresponding performance indicators. Analysis of performance evaluation indicators include: usually used precision, accuracy, detection limit, quantitative limit, selectivity, linearity and range, repeatability and durability, etc.; The effectiveness of the measurement method can be used as the test basis for the new measurement method. A, precision. The degree to which a set of measurements of the same homogeneous sample is measured by the method. The closer they are, the more sophisticated they are. In drug analysis, standard deviation (SD or S) is commonly used. Relative standard deviation (relative standard) Deviation, RSD), also called the coefficient of variation, CV. In the analysis of biological samples, RSD is used to represent the precision and can be subdivided into the precision of the batch (or day) and the precision of the batch (or daytime). Within the batch precision (within - run precision) : the precision of the same measurement. Usually use high, medium and low concentration of three kinds of 7 to 10 copies of the same samples according to the concentration of each sample analysis method proposed by the operation, after a startup, one by one. Calculate the SD and RSD values for each concentration sample. The precision of the batch is also considered as the in-day precision. The RSD should strive for 5%, but not more than 10%. Between-run precision: the precision of the different measurements. The same sample is usually used in high, medium and low concentrations. Each concentration is made up of 7-10 parts and refrigerated in the refrigerator. From the day of the preparation of the sample, a measurement is taken to calculate the SD and RSD values for each concentration sample. Batch precision can also be seen as day to day precision. The RSD should be contained within 15%. Accu