The Pharmacopeia of the People′s Republic of China 2025 Edition (referred to as the Chinese Pharmacopoeia 2025, ChP 2025) has been promulgated and implemented. The general idea, compilation principles, and drug standard system of ChP 2025 were analyzed in this article. The sources of drug varieties, changes in general notices, and the core content of revisions were introduced in detail. To facilitate readers′ accurate understanding and effective implementation of this edition of the Pharmacopoeia, the content that may give rise to doubts during the implementation process was further interpreted herein. It was pointed out that the new development concept of “innovation, coordination, green, openness, and sharing” has been fully implemented in ChP 2025 (Volume Ⅱ). In terms of coordination with international standards, the primary responsibility of marketing license holders in the control of residual solvents and elemental impurities was clarified in ChP 2025 (Volume Ⅱ), and the application of risk management concepts and methods for scientific evaluation was encouraged. Additionally, the great significance of the implementation of the “Measures for the Administration of Drug Standards” was emphasized in this article, which has been identified as an important basis for the Pharmacopoeia Committee to continuously improve the standardization and revision requirements for national chemical drug standards.

As a key component of pharmaceutical preparations, the quality control of pharmaceutical excipients is crucial to the safety and efficacy of drugs. The Chinese Pharmacopoeia, as the core of the national drug standard system, sets strict requirements for the quality control of excipients. In recent years, with the rapid development of analytical technologies, an increasing number of advanced analytical techniques have been applied to pharmaceutical excipients. These technologies can accurately determine the composition, purity, and impurities of pharmaceutical excipients, evaluate their safety and functionality, and provide a scientific basis for the quality control of pharmaceutical excipients. In Chinese Pharmacopoeia 2025, the quality control of pharmaceutical excipients not only retains classic spectroscopic and chromatographic methods but also introduces new analytical approaches, thereby improving the precision and systematicness of pharmaceutical excipient quality control. This article provides a comprehensive overview of the application progress of quality control methods for pharmaceutical excipients in Chinese Pharmacopoeia 2025, aiming to offer technical references for pharmaceutical research and development, production, and supervision, and to promote the high-quality development of the pharmaceutical excipient and pharmaceutical industries.

Chinese Pharmacopoeia 2025 has been officially promulgated and put into enforcement from 1^st October 2025. The Chinese Pharmacopoeia, as the core of the national drug standard system, has always played an important role in improving drug quality, ensuring drug safety, and serving drug supervision. The residue of heavy metals and harmful elements in traditional Chinese medicine(TCM) is an important issue of public and industry concern. The heavy metal and harmful element standards formulated in Chinese Pharmacopoeia 2025 have broken through the inclusion mode of heavy metal standards in previous editions, and have significantly increased the number of standards compared with previous editions. This article provides introduction to the drafting and review process of heavy metals and harmful element standards in the previous and new editions of the Chinese Pharmacopoeia. This article also proposes prospects for future research on relevant standards and the development of the TCM industry, to enhance the public and TCM industry understand the relevant standards and promoting the implementation of Chinese Pharmacopoeia 2025.

OBJECTIVE To interpret and analyze 9625 guidelines on metallic materials and containers for pharmaceutical packaging Systems in the Chinese Pharmacopeia (ChP) 2025 Edition, provide a reference for accurate understanding and implementation of the ChP. METHODS The overview of metallic pharmaceutical packaging materials, the background, core framework, and key technical indicators of standard development and future prospects for advancing standardization and international alignment were introduced. RESULTS Guided by the principles of scientificity, operability, and sustainable development, and based on the guiding ideology, objectives, and key tasks outlined in the ChP 2025 edition, the development of the 9625 for pharmaceutical packaging, along with the supporting methodological standards, was completed under the guidance of the Pharmaceutical Packaging Materials Committee of the Chinese Pharmacopoeia Commission. This was achieved through extensive industry research and consultation. CONCLUSION As of now, foreign pharmacopoeias have not officially included standards for metallic pharmaceutical packaging materials . ChP 2025 edition has officially included standards for metallic pharmaceutical packaging materials for the first time, marking a significant milestone. The 9625 clarifies the critical quality attributes and quality control requirements for metallic materials and containers and provides essential support for quality control. Furthermore, it plays a pivotal role in driving the adoption of advanced testing technologies and enhancing the global influence of the ChP, fostering greater harmonization with international regulatory frameworks.

The standards of pharmaceutical excipients are an important part of the Chinese Pharmacopoeia. The pharmaceutical excipient standard system is more perfect, and the content is more abundant in the 2025 edition of Chinese Pharmacopoeia. This article focuses on the overall information of the system, major changes, and the main characteristics of pharmaceutical excipient standards in the 2025 edition of Chinese Pharmacopoeia, which can contribute to accurately understand the standards of pharmaceutical excipients in the 2025 edition of Chinese Pharmacopoeia.