The 2025 Edition of the Chinese Pharmacopoeia is Officially Released!
Time:2025-02-21
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Recently, the Pharmacopoeia of China (2025 Edition) was officially released. As the core of the national drug standard system, the new edition of the Pharmacopoeia realizes a number of breakthroughs in the inclusion of varieties, technical requirements and regulatory standards. The new Pharmacopoeia, as the core of the national drug standard system, has realized a number of breakthroughs in the inclusion of varieties, technical requirements and regulatory standards. In terms of drug impurity controls, new requirements have been put forward for their use and control, which provide a more scientific basis for drug R&D, production and quality control.
In the safety and quality control of chemical drugs, key concerns and general technical requirements have been put forward for six major aspects related to safety: identification, related substances, residual solvents, impurities, microbial contamination and other quality requirements. Some chemical varieties have increased the detection of genotoxic impurities and the determination of biodistribution of radiopharmaceuticals. For genotoxic impurities, nitrosamines and other high-risk substances, or recommend the use of high-sensitivity detection methods. In addition, new methods and new technologies have been added to the new method and new technology conversion of elemental impurity limits and determination guidelines.
These updates have an important impact on the research of new pharmaceutical preparations and promote the quality improvement of the whole industry.
The scientific, safety and international harmonization of the 2025 edition of the Chinese Pharmacopoeia will build a solid line of defense for public drug safety and provide a core driving force for the high-quality development of the pharmaceutical industry. The National Pharmacopoeia Committee suggests that relevant units can purchase the genuine Pharmacopoeia through officially authorized channels and pay attention to the follow-up training and policy interpretation.
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