本次偏差主要属于方法的原因，与产品本身质量无关。3046011N210

This deviation is mainly due to the method and has nothing to do with the quality of the product itself. The peak area of ​​the main peak of the 3046011N210106-02 batch of cyclization reaction solution is too small to determine the content of TCG1 in the sample solution. However, when processing the spectrum, analyst Hu Qinxiang immediately recognized that the peak area was too small, and notified the IPC supervisor to report the deviation in time. The preliminary analysis was that the reason for the deviation was uneven pipetting by the analyst during the preparation process. Due to the special intermediates, the samples cannot be stored for a long time, and the results cannot be waited until the deviation investigation is over. Therefore, the samples shall be retested on the original samples, the retest results are qualified, and the original maps and data shall be discarded and retained, and a report will be issued based on the retest results. Investigating the abnormal events and deviations in the laboratory in the past, Hu Qinxiang has a relatively low error rate in his work since he started work, and he has been more careful. In the past three months, there has been no occurrence of similar deviations. In addition, the analyst has tested 7 batches of loop closure reactions in the past. It can be regarded as relatively close and has no effect on the historical test results. Because the cause of this deviation has nothing to do with the quality of the product itself, it does not affect the subsequent quality inspection of intermediates. See: D-TZ-API-IP-21001-R for details.

This deviation is mainly due to the method, and has nothing to do with the quality of the product itself. The main peak area of 3046011n210106-02 batch cyclization reaction solution was too small to determine the content of tcg1 in the sample solution. However, when processing the chromatogram, the analyst Hu Qinxiang immediately identified that the peak area was too small, and promptly informed the IPC supervisor to report the deviation. The preliminary analysis showed that the reason for the deviation was the uneven liquid transfer during the preparation process. Due to the special intermediates, the samples can not be stored for a long time, and the results can not be obtained after the deviation investigation. Therefore, the original samples are retested, and the retest results are qualified. The original chromatogram and data are invalid and reserved, and the retest results are reported. After checking the abnormal events and deviations of the laboratory in the past, Hu Qinxiang had a low overall error rate and was careful in his work since he took up his post, and there was no similar situation with the deviation in the past three months. In addition, the analyst had tested a total of 7 batches of cyclization reaction solution in history, which could be regarded as relatively close and had no impact on the historical test results. The reason for this deviation has nothing to do with the quality of the product itself, so it does not affect the subsequent quality testing of intermediates. See d-tz-api-ip-21001-r for details.<br>

This deviation is mainly due to the method and has nothing to do with the quality of the product itself. The main peak area of cyclization reaction solution in batch 3046011N210106-02 is too small to judge the content of TCG1 in sample solution. However, when processing the atlas, analyst Hu Qinxiang immediately recognized that the peak area was too small, and timely notified IPC supervisor to report the deviation. The preliminary analysis of the deviation was due to the uneven liquid removal during the preparation process of the analyst. Because the intermediate is special, the sample cannot be stored for a long time, and the results cannot be obtained after the deviation investigation is finished. Therefore, the sample is retested as it is, and the retest results are qualified, while the original atlas and data are invalid and retained, and a report is issued based on the retest results. Investigating the abnormal events and deviations in the laboratory in the past, Hu Qinxiang has a low overall error rate since taking up his post, and has been careful in his work. In the past three months, there have been no cases similar to deviations. In addition, the analyst has tested 7 batches of cyclization reaction solutions in history, which can be regarded as relatively close and has no influence on the historical test results. The reason of this deviation has nothing to do with the quality of the product itself, so it does not affect the subsequent intermediate quality inspection. See D-TZ-API-IP-21001-R for details.