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您好，我想咨詢(xún)下，氣相方法學(xué)驗(yàn)證以及液相方法學(xué)驗(yàn)證線性與范圍... 已有4人參與
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9樓2016-01-03 13:17:03
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感謝參與，應(yīng)助指數(shù) +1
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Determination of Linearity and Range—Linearity should be established across the range of the analytical procedure. It should be established initially by visual examination of a plot of signals as a function of analyte concentration of content. If there appears to be a linear relationship, test results should be established by appropriate statistical methods (e.g., by calculation of a regression line by the method of least squares). Data from the regression line itself may be helpful to provide mathematical estimates of the degree of linearity. The correlation coefficient, y-intercept, slope of the regression line, and residual sum of squares should be submitted. The range of the procedure is validated by verifying that the analytical procedure provides acceptable precision, accuracy, and linearity when applied to samples containing analyte at the extremes of the range as well as within the range. ICH recommends that, for the establishment of linearity, a minimum of five concentrations normally be used. It is also recommended that the following minimum specified ranges should be considered: Assay of a Drug Substance (or a finished product): from 80% to 120% of the test concentration. Determination of an Impurity: from 50% to 120% of the acceptance criterion. For Content Uniformity: a minimum of 70% to 130% of the test concentration, unless a wider or more appropriate range based on the nature of the dosage form (e.g., metered-dose inhalers) is justified. For Dissolution Testing: ±20% over the specified range (e.g., if the acceptance criteria for a controlled-release product cover a region from 30%, after 1 hour, and up to 90%, after 24 hours, the validated range would be 10% to 110% of the label claim). The traditional definition of linearity, i.e., the establishment of a linear or mathematical relationship between sample concentration and response, is not applicable to particle size analysis. For particle size analysis, a concentration range is defined (instrument- and particle size-dependent) such that the measured particle size distribution is not affected by changes in concentration within the defined concentration range. Concentrations below the defined concentration range may introduce an error due to poor signal-to-noise ratio, and concentrations exceeding the defined concentration range may introduce an error due to multiple scattering. |
2樓2016-01-03 12:54:10
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4樓2016-01-03 12:56:52
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【答案】應(yīng)助回帖
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3. RANGE The specified range is normally derived from linearity studies and depends on the intended application of the procedure. It is established by confirming that the analytical procedure provides an acceptable degree of linearity, accuracy and precision when applied to samples containing amounts of analyte within or at the extremes of the specified range of the analytical procedure. The following minimum specified ranges should be considered: - for the assay of a drug substance or a finished (drug) product: normally from 80 to 120 percent of the test concentration; - for content uniformity, covering a minimum of 70 to 130 percent of the test concentration, unless a wider more appropriate range, based on the nature of the dosage form (e.g., metered dose inhalers), is justified; - for dissolution testing: +/-20 % over the specified range; e.g., if the specifications for a controlled released product cover a region from 20%, after 1 hour, up to 90%, after 24 hours, the validated range would be 0-110% of the label claim for the determination of an impurity: from the reporting level of an impurity1 to 120% of the specification; - for impurities known to be unusually potent or to produce toxic or unexpected pharmacological effects, the detection/quantitation limit should be commensurate with the level at which the impurities must be controlled; Note: for validation of impurity test procedures carried out during development, it may be necessary to consider the range around a suggested (probable) limit. - if assay and purity are performed together as one test and only a 100% standard is used, linearity should cover the range from the reporting level of the impurities1 to 120% of the assay specification. |
5樓2016-01-03 12:58:30
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