[Application Note] Introducing the validation of analytical methods for TOC in cleaning validation.
The TOC method for cleaning validation is an important technique for evaluating the cleanliness of equipment. The TOC method is recognized as a way to assess the carbon content in samples and is used to evaluate the cleanliness of equipment. In accordance with ICH Q2B guidance, examples of the evaluation of various parameters related to the validation of analytical methods using TOC will be introduced.
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- Accuracy/Reproducibility Accuracy is an indicator that evaluates how close the measured values of the analyte are to the true value. Reproducibility indicates whether the values obtained from analyzing the sample multiple times are consistent, measured as relative standard deviation (RSD). - Linearity/Recovery The linearity test verifies that the measured values have a linear relationship with the concentration of the analyte. Recovery assesses how much of the total organic carbon (TOC) can be recovered from the analyte. - Robustness Robustness is an indicator of the ability to obtain normal results even with slight variations in parameters during method development. - Limit of Detection (LOD)/Limit of Quantification (LOQ) LOD is a value used to evaluate whether the measured values are due to instrument noise or the presence of a compound. LOQ is a value used to assess meaningful data versus meaningless data. The cleaning validation using this new TOC method is expected to significantly improve quality and efficiency. For more details, please refer to the application note.
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Cleaning validation of pharmaceuticals
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Since our establishment in 1967, we have been dedicated to the development and dissemination of water quality measurement devices that anyone can use quickly, easily, and with high precision. In today's world, where the effective use of water, a limited resource, is required alongside environmental conservation, we aim to be a total solution provider that responds to all water environments by utilizing our water quality measurement devices, technology, and services. Furthermore, leveraging the latest technology and years of know-how, we are committed to delivering user-friendly and reliable water quality measurement devices more affordably, quickly, and widely.