此次偏差为人员对SOP执行不到位和设备原因。需要对该台仪器的四元比例阀

This deviation is due to personnel's inadequate implementation of SOP and equipment reasons. The quaternary proportional valve of this instrument needs to be cleaned with isopropanol and re-calibrated. And check all the HPLC cleaning conditions of the analytical technology department. If it is not cleaned with isopropanol, it needs to be cleaned with isopropanol. Check that the gradient ratio deviation of this calibration is not very large, the maximum is -6.64%, indicating that the internal leakage of the A pump is not very serious. The internal leakage of the pump A has no effect on the isocratic experiment, and does not have a great influence on the gradient experiment results. Through the investigation of the latest 3 gradient experiments, the system adaptability meets the requirements, the retention time is stable, and it is compared with the history of other instruments. In comparison, they are basically the same. Therefore, the comprehensive evaluation has no effect on the results of the products tested by this instrument. . <br>For further details, please refer to: D-TZ-API-EG-21001-R.

This deviation is due to the improper implementation of SOP by personnel and equipment. It is necessary to use isopropanol to clean the four way proportional valve of the instrument and then calibrate it again. And check and analyze all HPLC cleaning conditions of Technology Department. If it is not cleaned with isopropanol, it needs to be cleaned with isopropanol. Check that the calibration gradient proportion deviation is not very large, the maximum is - 6.64%, indicating that the internal leakage of pump a is not very serious. The internal leakage of pump a has no influence on the gradient experiment, but has little influence on the gradient experiment results. Through the investigation of the last three gradient experiments, the adaptability of the system meets the requirements, the retention time is stable, and it is basically consistent with the detection history of other instruments. Therefore, comprehensive evaluation has no effect on the results of products tested by this instrument..<br>See d-tz-api-eg-21001-r for details.<br>

This deviation is due to the inadequate implementation of SOP by personnel and equipment. The quaternary proportional valve of this instrument needs to be cleaned with isopropyl alcohol and then rechecked. And check and analyze all HPLC cleaning conditions of technical department. If it is not cleaned with isopropanol, it needs to be cleaned with isopropanol. Check that the gradient proportion deviation of this calibration is not very large, and the maximum deviation is -6.64%, indicating that the internal leakage of pump A is not very serious. A, the equivalence experiment of pump internal leakage has no influence, but it has little influence on the gradient experiment results. Through the investigation of the last three gradient experiments, the system adaptability meets the requirements, and the retention time is stable, which is basically consistent with the history of other instruments. Therefore, comprehensive evaluation has no influence on the results of products tested by this instrument. .See D-TZ-API-EG-21001-R for details.