When inspector Wang Wenbin perfected the inspection record of tegacyclin content and related substances items detected by Shimadzu 35 Chen instrument on February 28, 2019, he found that the theoretical number of main peak of separation under the content item was 2089, which was not in conformity with the requirement of SOP ≥ 3000, other system adaptability requirements were in conformity with the SOP, and the inspection atlas and pressure were consistent with the historical data, without abnormality.
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