2019.10.03日13：55，分析员杨兵全在CAY-107-03上

On October 10, 2019, at 13:55, analyst Yang Bingquan injected the Milbemycin Concentrate 4037-A190906 on CAY-107-03 and found that the instrument status was displayed as a yellow light when the sequence was run to the needle standard solution. 2. Not connected, check the reason for not being ready and display "Not ready condition: No tray", that is, the injector has no sample tray. <br><br>This deviation is an abnormal accidental failure of the instrument's main board parameters. The sample tray cannot be identified and the sample injection is aborted. <br><br>1. The deviation is caused by the failure of the instrument due to instrument failure, which has nothing to do with the quality of the product itself. <br>2. The spectrum and data of the Milbemycin concentrated solution tested in this experiment are discarded and retained. Under the original conditions unchanged, the 4037-A190906 batch of Milbemycin Concentrated Sample Solution was re-tested, and the retest result was 299077.4 μg / ml, the primary yield and total extraction yield calculated from this test result are 78.8% and 62.4%, respectively, which meets the technological requirements of primary yield and 75% -85% and total extraction yield of 60 ~ 70%. <br><br>.Reservation of invalid maps. The 4037-A190906 batch of Milbemycin concentrated sample solution was retested and a test report was issued. <br>2. Cold start the CAY-107-03 liquid chromatograph sampler module. <br>3. Follow up the observation of CAY-107-03 liquid chromatograph for 3 months to see if there is a similar situation.

2019.10.03日13：55，分析员杨兵全在CAY-107-03上进样检测米尔贝霉素浓缩液4037-A190906时，发现序列运行至回针标准溶液时，仪器状态显示为黄灯、未结绪，查看未就绪原因显示“Not ready condition：No tray”即进样器无样品盘。 <br><br>此次偏差为仪器主板参数发生异常偶然故障，进样盘无法被识别导致进样中止。 <br><br>1.本次偏差为仪器故障导致进样中止，与产品本身质量无关。<br>2.此次实验检测的米尔贝霉素浓缩液图谱及数据作废保留，原有条件不变的情况下，重新对4037-A190906批米尔贝霉素浓缩液样品溶液进行检测，复测结果为299077.4 μg/ml，通过该检测结果计算出的一次上柱收率和提取总收率分别为78.8%和62.4%，符合一次上柱收率工艺要求75%~85%和提取总收率工艺要求60~70%。<br><br>.对错误图谱进行作废保留。对4037-A190906批米尔贝霉素浓缩液样品溶液进行复测，并出具检测报告。<br>2.对CAY-107-03液相色谱仪进样器模块进行冷启动。<br>3.对CAY-107-03液相色谱仪进行3个月的跟踪观察，看是否有类似情况发生。

2019.10.03 day Thirteen : Fifty-five , analyst Yang Bingquan CAY-107-03 Determination of milbemycin concentrate by upper injection 4037-A190906 It is found that when the sequence runs to the back injection standard solution, the status of the instrument is displayed as yellow light, open thread, and the reason for not ready is displayed“ Not ready condition : No tray ”That is, there is no sample disk in the injector.<br>This deviation is due to the accidental failure of the main board parameters of the instrument, and the injection disk can not be identified, resulting in the suspension of injection.<br>One This deviation is caused by the failure of the instrument, which has nothing to do with the quality of the product itself.<br>Two The atlas and data of milbemycin concentrate tested in this experiment are invalid and reserved. If the original conditions remain unchanged, re check 4037-A190906 A batch of milbemycin concentrate sample solution was tested, and the retest results were as follows two hundred and ninety-nine thousand and seventy-seven point four Mu g/ml The yield of the first column and the total yield of the extraction calculated by the test results are respectively 78.8% and 62.4% It meets the process requirements of primary column yield 75% ~ 85% And total yield process requirements Sixty ~ 70% 。<br>. Discard and retain the error map. Yes 4037-A190906 A batch of sample solution of milbemycin concentrate was retested and a test report was issued.<br>Two Yes CAY-107-03 The liquid chromatograph injector module is cold started.<br>Three Yes CAY-107-03 By liquid chromatograph Three Months of follow-up observation to see if there is a similar situation.<br>