化药有关物质测定中关于较正因子的研究(国外英文资料).docVIP

化药有关物质测定中关于较正因子的研究(国外英文资料) The study of correction factor in the measurement of substances Medicine on the calculation method of material including main impurity reference substance method, add the correction factor of principal component self contrast method, principal component itself without correction factor comparison method, the peak area normalization method of impurities quantitative methods such as, widely applied at present is mainly the former three methods, which mainly USES the former two methods for specific impurities. ??????????? Correction factor measurement: in general, the calibration factor can be determined by the following methods: ????? (1) a single concentration point determination: the solution of the specific impurities in the preparation of the appropriate concentration and the main component of the control solution are measured separately, and the correction factor is obtained. ????? (2) concentration more determination: the preparation of high, medium and low three levels of the appropriate concentration of impurity reference substance solution and principal component reference substance solution (loq, standard limit), sample determined respectively, and RSD calculation, averaging, and get the correction factor. ????? (3) the standard curve method: precision weigh and impurity reference substance and the principal component reference substance, respectively, the preparation of the series solution (loq, standard limit), after sample, respectively, by the least square method to sample quantity of response value (peak area, etc.) of linear regression, two standard curve is obtained, the ratio of the two curve slope is the correction factor. ????? (4) absorption coefficient ratio method: contrast grade other reference materials, high, medium and low three levels of concentration determination of absorbance between 0.3 ~ 0.8, at least 5 different types of UV spectrophotometer, two parallel at the same time the preparation of Chinese herbs we