Quality Revolution Under New Pharmacopoeia Regulations: 2025 Chinese Pharmacopoeia Quality Control and Testing Standards Interpretation Seminar Successfully Concluded in Suzhou

On May 9, byVCBeat in collaboration with Beijing Chengfeng Jihai Co., Ltd.Hosted by,WATERS TECHNOLOGIES(SHANGHAI)LIMITEDSupporting the hosting of “New Technologies, New Standards, New Methods: Interpretation of Quality Control and Testing Standards in the 2025 Edition of the Pharmacopoeia“The Suzhou Stop of the Training Series Was Successfully Held at the Suzhou International Expo Center. The event gathered authoritative experts from both domestic and international fields of pharmaceutical R&D analysis and production testing, providing in-depth interpretations of the additions and revisions related to traditional Chinese medicine and biologics in the new edition of the Chinese Pharmacopoeia, as well as demonstrating the practical applications of new standards, methods, and technologies for relevant testing and analytical instruments.”

The training program was meticulously planned and divided into two major thematic sessions: the morning session focused on traditional Chinese medicine, and the afternoon session on biologics. Shao Kai, Senior Pre-sales Technical Engineer at Waters China, andKe Lingna served as the host for both major segments.

Zhan Beidou, National Sales Director for Pharmaceuticals at Waters ChinaDelivering the opening remarks for this training event, he extended his sincere welcome and heartfelt gratitude to the experts and industry peers attending the Suzhou Pharmacopoeia training. He emphasized that China’s pharmaceutical industry has always been a vital and strategically significant core market in Waters’ global business layout. Against the complex backdrop of the current US-China tariff war, Waters is actively adjusting its market strategy. By optimizing resource allocation, expanding localized services, and providing customized solutions, Waters is fully committed to ensuring that Chinese pharmaceutical enterprises can access a more competitive pricing structure, more stable technical support, and a more efficient service experience when selecting Waters’ instruments and solutions. This approach aims to help clients reduce costs, increase efficiency, and maximize commercial benefits by enhancing their competitiveness.

Zhan Beidou, National Sales Director for Pharmaceuticals at Waters China

During the Traditional Chinese Medicine segment of this event,Hu Haobin, Deputy Director of the Department of Traditional Chinese Medicine, Jiangsu Institute for Food and Drug ControlHe first delivered a keynote presentation titled “A Brief Analysis of Traditional Chinese Medicine Standards and Changes in the 2025 Edition of the Pharmacopoeia.” Drawing on perspectives such as the TCM standard system, general notices of the Pharmacopoeia and changes to TCM provisions in the 2025 edition, revisions to TCM monographs, updates to general chapters and related TCM changes, modifications to technical guidelines, and key inspection considerations under the new Pharmacopoeia, he provided an in-depth analysis of the general notices and the classification and structure of TCM standards. He compared differences between the old and new editions, covering aspects such as processing specifications for decoction pieces, revisions to monograph content, updates to general chapters, and key points for testing.

Hu Haobin, Deputy Director of the Traditional Chinese Medicine Division, Jiangsu Institute for Food and Drug Control

Song Yuling, Pre-Sales Manager, Pharmaceuticals, Waters ChinaDelivered a keynote presentation on “Application of New Technologies in Traditional Chinese Medicine (TCM) Research and Solutions for TCM Safety.” She provided a comprehensive analysis of the application of new technologies in TCM quality research, focusing on three key areas: the use of novel liquid chromatography techniques for TCM quality analysis, the application of advanced mass spectrometry technologies for in-depth characterization of TCM, and insights into the plant growth regulator guidelines outlined in the Chinese Pharmacopoeia (2025 Edition). Her presentation aims to facilitate the modernization and internationalization of TCM research.

Waters China Pre-Sales Manager, Song Yuling

Shi Shangmei, Former Director of the Department of Traditional Chinese Medicine at the Chinese Pharmacopoeia CommissionPresentation titled “Application of Hyphenated Mass Spectrometry Techniques in the Safety Control of Traditional Chinese Medicine.” She stated that, owing to its high sensitivity and high resolution, hyphenated mass spectrometry plays a pivotal role in the quality control of traditional Chinese medicine safety, with applications including multi-residue analysis of pesticide residues, detection of mycotoxins, and speciation analysis of harmful elements.Valence State Analysisand other aspects.

Shi Shangmei, Former Director of the Department of Traditional Chinese Medicine at the Chinese Pharmacopoeia Commission

During the Biologics Module of this training,Liu Haijing, Chief Expert at Shaanxi Institute for Food and Drug ControlShe delivered a presentation titled “Updates and Revisions to the Chinese Pharmacopoeia 2025 Edition (Volume III) and Key Points in Quality Control of Biological Products.” She provided an in-depth analysis of the primary objectives and requirements for the compilation of the 2025 edition, the overall revisions and amendments to Volume III, an overview of major changes, the application of new technologies and methodologies, key points in quality control of biological products, as well as the development opportunities and prospects for biological products.

Liu Haijing, Chief Expert at the Shaanxi Provincial Institute for Food and Drug Control

Shao Kai, Senior Pre-sales Technical Engineer at Waters ChinaDelivered a keynote presentation titled “Advances in New Technologies for Quality Analysis of Biochemical Drugs.” He discussed ADCs, peptides,AOC, taking nucleic acid-based drugs and other pharmaceutical categories as examples, an analysis was conducted on the quality attribute standards and requirements related to pharmacopoeial biotherapeutic analysis,Waters’ updated biopharmaceutical solutions provide effective strategies for addressing new pharmacopoeial standards and emerging technologies.

Shao Kai, Senior Pre-sales Technical Engineer at Waters China

Li Zhanjun, Former Director of the Biochemistry Laboratory and Chief Pharmacist at the National Institutes for Food and Drug ControlA thematic presentation was delivered on “Revised and Added Standards for Recombinant Hormones and Their Bioassays in the 2025 Edition of the Chinese Pharmacopoeia (ChP).” She provided a detailed introduction to recombinant hormones and the revisions and additions included in the 2025 edition, focusing on growth hormone–related products and gonadotropins.Follicle-Stimulating Hormone、A comparative analysis of the changes in bioassay methods for insulin and hypoglycemic agents in the 2025 edition of the Pharmacopoeia.

Li Zhanjun, Former Chief Pharmacist of the Biochemistry Division at the National Institutes for Food and Drug Control

Waters China Consumables Department Senior Application Specialist Wang XinlingShe delivered a presentation titled “Accelerating Efficiency and Prioritizing Quality: Selection of Chromatographic Separation Methods to Expedite Quality Analysis of Biopharmaceuticals.” She highlighted the advantages of several chromatography columns, including Premier SEC and Bioresolve SEC, such as high separation efficiency, durability, and stability. She noted that Waters also provides comprehensive workflows and solutions ranging from peptide mapping to N-glycan analysis, including the PeptideWorks Trypsin Protein Digestion Kit and RapiFluor-MS reagents, to enhance analytical accuracy and throughput, thereby accelerating efficiency in quality control and research and development of biopharmaceuticals.

Waters China Consumables Department Senior Application Specialist Wang Xinling

The successful conclusion of this event was made possible by the dedicated efforts of numerous behind-the-scenes mentors and the strong support and assistance from sponsoring enterprises. Hereby, we extend our sincerest gratitude to the following key leaders, mentors, and companies:

Ms. Zhang Mei, Former Director of the Jiangsu Institute for Drug Control

President of Suzhou Pharmaceutical Association, Mr. Gu Bingren

Mr. Yang Zhiqiang, Secretary-General of the Suzhou Pharmaceutical Association

Mr. Yu Baozhu, Former Editor-in-Chief of Chinese Drug Standards Magazine, Chinese Pharmacopoeia Commission

WATERS TECHNOLOGIES(SHANGHAI)LIMITED

In 2025, VCBeat has successfully held two stops of “New Standards, New Methods, and New Technologies—Training on the Interpretation of Quality Control and Testing Standards in the 2025 Edition of the Pharmacopoeia”event, the third stop in Guangzhou has officially launched and is scheduled toJune 10-11, atGuangzhou Bio IslandWe look forward to meeting you. Interested enterprises and industry professionals are welcome to scan the QR code below to register, or add Teacher Ying on WeChat for inquiries about event details and content.

Scan the QR Code to Register

Tel: 13439390341 (WeChat ID same as phone number)

E-Mail：ying.ej@vcbeat.net