With the introduction of the Drug Safety Plan (2011-2015), higher requirements have been put forward for comprehensively improving drug safety assurance capabilities and reducing drug safety risks. In drug safety research, impurity issues have always been a difficult and key point in domestic registration, and controlling impurities in drugs has become one of the key factors in controlling drug quality. Due to the wide range of sources of drug impurities, known impurities can be qualitatively and quantitatively analyzed using existing analytical methods, while unknown impurities become a challenge for analysis.

In order to enable drug analysts in Chongqing to effectively control drug impurities and gain a deeper understanding of the critical impact of safety on drugs.2018On February 2nd of the year,The Chongqing Drug Impurity Analysis and Research Academic Exchange Conference, hosted by the Drug Analysis Committee of the Chongqing Pharmaceutical Association and co organized by Shimadzu Enterprise Management (China) Co., Ltd., was grandly held,Experts from food systems, pharmaceutical research and development/pharmaceutical companies, universities, and research institutes participated in this exchange activity. The communication inside and outside the venue was frequent and lively, and guests had many practical and specific questions. With the careful answers of the attending experts and Shimadzu Analytical Testing Marketing Department teachers, they were all resolved properly. The guests also learned from each other, borrowed and learned from each other, and interacted actively and had a strong academic atmosphere on site.

At the beginning of the exchange meeting, Ms. Zhou Xiangmin, Chairman of the Drug Analysis Committee of Chongqing Pharmaceutical Association, delivered the opening speech. Dean Zhou succinctly described the importance of drug impurity analysis and emphasized the practical significance of this meeting.

Ms. Zhou Xiangmin, Chairman of the Drug Analysis Committee of Chongqing Pharmaceutical Association, delivered the opening speech

Subsequently, Wu Xiaojun from the Southwest Region of Shimadzu Corporation's Analytical Instruments Division delivered a speech. Wu reviewed the development history of Shimadzu and emphasized that as a provider of analytical instruments and solutions, Shimadzu has always adhered to the entrepreneurial purpose of "making contributions to society through science and technology" since its establishment in 1875, and upheld the business philosophy of "for the health of humanity and the earth", constantly exploring and innovating. Regarding the increasingly important significance of drug impurity research for drug development and application, which is of great concern to the pharmaceutical industry, Wu emphasized that Shimadzu has responded positively and provided comprehensive solutions for users to choose from. Afterwards, Wu, on behalf of all colleagues at Shimadzu, extended New Year's greetings to the attending experts and guests.

Speech by Wu Xiaojun, Southwest Region, Shimadzu Corporation

This conference adheres to the concept of "talking about practical knowledge and doing practical things". After the opening, it quickly entered the technical exchange section, and Chen Zhu, a member of the Drug Analysis Committee of the Chongqing Pharmaceutical Association and Director of the Chemistry Department of the Chongqing Institute for Drug Control, made a work report on "recent impurity research". Director Chen's work report mainly covers four aspects: related substances, genotoxic impurities, residual solvents, and elemental impurities. Director Chen's report is logically organized, with exceptionally clear organization from definition to research objectives and empirical evidence. Director Chen fully shared his experimental methods and results with the guests present, and received recognition from the attendees.

Director Chen Zhu from the Chemistry Department of Chongqing Institute for Drug ControlPublish a thematic report

undertakeDirector Chen Zhu's report,Shimadzu Analysis Center*Title:《Shimadzu Corporation's solution for liquid chromatography-mass spectrometry analysis of drug impurities》The theme report. Li elaborated on Shimadzu's two-dimensional impurity identification system Trap free 2D-LCMS, analysis method development system control software Method Guiding Solution, a new concept C2P purification system, and Shimadzu's Pittcon Gold Award winning Nexera UC online SFE-SFC-MS system. Overall, the report on chromatographic techniques for impurity analysis, starting from UHPLC and ghost peak removal technology, gradually expanded to Shimadzu's intelligent application system and software, and then expanded to Shimadzu's advantages in preparation and purification technology. It further elaborated on the forefront development of SFC technology and the principles and applications of Shimadzu triple quadrupole liquid mass quantification technology. The outline was stripped of the thread, and the product combinations were flexible and varied, providing many inspirations for the participants.

Shimadzu Analysis and Testing Center*Deliver a keynote speech

The second half of the meeting will be fully chaired by Dr. Li Min, Vice President and Scientist of Huahai Pharmaceutical Company, as a specially invited guest,Dr. Li is mainly engaged in drug analysis, research on drug degradation mechanisms, drug stability research, and solving various difficult and complicated problems that arise in drug production, as well as supporting new drug applicationsHe has published over 50 papers in the journal, and his monograph "Organic Chemistry of Drug Degradation" published by the British Chemical Society in 2012 has received high praise from domestic and foreign peers.The topic of Dr. Li's publication is "Strategies for Rapid and In Depth Study of Degradation Impurities and Degradation Mechanisms in Drug Quality Research: Using LC-MSⁿReport on Molecular Fingerprint Spectroscopy and Rational Strong Degradation Study for Rapid Analysis of Degradation Impurity Structure and Degradation Mechanism. Dr. Li first emphasized the importance of drug impurity analysis (such as the mandatory regulations in ICH), and pointed out that the degradation of impurities in drugs is crucial for drug screening or the stability and improvement of drug quality. Of course, degradation identification work is also challenging. Therefore, multi-stage liquid chromatography-mass spectrometry is the top choice for structural analysis of impurity degradation products due to its ultra fast and highly sensitive characteristics. Dr. Li subsequently shared 7 real and effective cases, indicating how to apply LC-MSⁿMolecular fingerprint spectroscopy and reasonable strong degradation methods can quickly analyze the structure of degraded impurities. Dr. Li's research direction is forward-looking, and his professionalism is beyond doubt. The guests and experts present here have taken careful notes and praised him.

Dr. Li Min, a scientist from Huahai Pharmaceutical Company, delivered a keynote speech

After Dr. Li's keynote speech, the main core part of this exchange meeting will come to an end. At this exchange meeting, we will discuss cutting-edge workers in drug impurity analysisDirector Chen Zhu started by providing comprehensive solutions in the field of drug impurity research to Shimadzu Enterprise Management (China) Co., Ltd., and then went on toExperts in solving various difficult and complicated problems during the drug production registration process have opened up the "tip of the iceberg" of drug impurity analysis for the attending guests. Although it is only a partial development, it is also an important beginning. In the future, Shimadzu is willing to cooperate with more industry experts and users in the field of drug analysis at multiple levels, fields, and dimensions.

Silhouette of Q&A session at the exchange meeting

At the end of the meeting, it was already evening on that day. Under the guidance of Minister Lv Dong of the Shimadzu Analytical and Testing Instrument Marketing Department, all Shimadzu colleagues once again expressed their sincere gratitude to the guests for their enthusiastic support and extended their best wishes for the Chinese New Year to everyone.

About Shimazu

Shimadzu Enterprise Management (China) Co., Ltd. is a local legal entity established in China with 100% investment from Shimadzu Manufacturing Co., Ltd. in 1999. It has 13 branches throughout China and its business scale continues to expand. It has analysis centers in Beijing, Shanghai, Guangzhou, Shenyang, and Chengdu, as well as a sales agent network covering 30 provinces across the country and over 60 technical service stations. It has established a complete system to provide excellent services to its customers. this companyWith the business philosophy of "for the health of humanity and the earth", we are always committed to providing users with better products and more satisfactory services, and contributing to the progress of Chinese society.