Chromatographic suitability tailing factor

System suitability tests for chromatographic impurities procedures, such as precision, resolution factor, calibration standard, and tailing factor, should be considered as appropriate. In the presence of multiple peaks, a resolution factor between the two closest peaks should be proposed. For reliable quantitation, baseline resolution of the impurities will provide accurate measurement of the... 

Chromatographic system (see Chromatography, in the general procedure (621)) The liquid chromatography is equipped with a 280-nm detector and a 4.6 mm x 15-cm column that contains 5-/im packing L7. The flow-rate is about 0.8 ml/min. Chromatograph the System suitability solution, and record the peak responses as directed for Procedure the capacity factor, k , is not less than 6 the column efficiency is not less than 3000 theoretical plates the tailing factor is not more than 1.5 and the relative standard deviation (RSD) for replicate injections is not more than 1%. 

The suitability of the system is determined by chromatographing the Standard solution, and recording the peak responses as directed under Procedure. The tailing factor is not more than 2.0, and the relative standard deviation for replicate injections is not more than 4.0%. 

In addition to validation of the automation, full validation of the chromatographic procedure, as described in Chapter 12, should be conducted for late-phase methods. This should include specification of system suitability parameters to ensure that the performance obtained during method development and validation is maintained during routine use. The system suitability parameters may include specification of acceptable injection repeatability, criteria for resolution between critical pairs, maximum allowable tailing factors, and a means of verifying that the requisite sensitivity is obtained. As recommended by Vander Heyden et al., system suitability limits are best set following robustness tests. 

Validation of a chromatographic system is required by numerous quality assurance systems. For this purpose hardware, firmware, software and the analytical method used for analysis should be validated. Moreover, the chromatographic system needs to be tested against documented performance specifications for a given analytical method (system suitability test). Besides the prerequisites of a chromatographic separation, such as tailing factor, column... 

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