The 2025 edition of the Chinese Pharmacopoeia, which will officially come into effect on October 1, 2025, has comprehensively updated the standard system for pharmaceutical water use,Breakthroughs have been achieved mainly in three aspects: process, inspection, and microbial controlIt not only draws on foreign concepts and experiences, but also adapts to the development needs of the domestic pharmaceutical industry.

　　The new version of the pharmacopoeia has adjusted the classification of pharmaceutical waterMove purified water and injection water from Pharmacopoeia Part 2 (Chemicals) to Part 4 (Excipients), further clarifyingThe auxiliary properties of purified water and injection water.The sterilization injection water is still retained in the second part, highlighting its dual properties as an excipient and drug.

　Breakthrough 1: Allow non distillation processes to prepare injection water

The biggest change in the 2025 edition of the Chinese Pharmacopoeia is that General Rule 0261 has revised the definition of water for injection,Injection water is purified water obtained by distillation, or prepared through a purification process equivalent to distillation.

From the above table, it can be seen that in the futurePreparation of injection water by membrane method becomes possibleThe revised Chinese Pharmacopoeia has further improved its alignment with the European, American, and Japanese Pharmacopoeias, allowing for the preparation of injection water through distillation or non distillation methods. In the pharmaceutical industry, membrane separation technology has been widely recognized as a mature purification method. It not only ensures the safety and stability of water quality, but also improves the utilization rate of raw water, saves energy and reduces emissions, which is in line with the business philosophy of green environmental protection, cost reduction and efficiency improvement, and sustainable development of pharmaceutical enterprises.

This breakthrough provides pharmaceutical companies with more and more flexible options for pure water preparation, marking a new era in pharmaceutical water production!

Lefeng's Super Genie and high flow Genie pure water systems use pre filtration, RO membrane EDI、 Advanced purification technologies such as ultraviolet lamps and ion exchange, combined with intelligent whole process monitoring systems and IoT technology, can meet the requirements of pharmacopoeia for the reliability and stability of pure water systems. We can provide various pure water production flow rates (30-600 L/h), different types of pure water (EDI pure water, RO pure water, CLRW pure water), to supply water to single or multiple laboratories of pharmaceutical companies, and are highly favored by many users in the biopharmaceutical field such as antibodies, vaccines, and nucleic acids.

Purification Technology and Flow Path Diagram of Super Genie Pure Water System

　Breakthrough 2: Simplify inspection items, conductivity can replace multiple tests

Another important change in the 2025 Pharmacopoeia is the "reversal" of conductivity, which has become the core judgment indicator. The conductivity meets the regulations, and purified water can no longer undergo pH, heavy metal, nitrate, nitrite, and ammonia checks; Injection water can be exempted from pH, nitrite, and ammonia tests.The inspection items for purified water and injection water should reduce duplicate testing, with conductivity, TOC (total organic carbon), and microbiological testing as the core quality control indicators.

The new version of the pharmacopoeia has streamlined the testing items for purified water and injection water, cancelled or revised some traditional chemical testing items, and relied more on advanced testing methods to ensure water quality. This can not only improve inspection efficiency, but also reduce the burden on enterprises.The stability of conductivity has become the core indicator for measuring the stability of pure water systems. The pure water system needs to have stable operating capability to ensure that the conductivity continuously meets high standard requirements.

Breakthrough 3: Microbial control upgrade, full lifecycle risk management

Microbial contamination is one of the important challenges faced by pharmaceutical water.The 2025 edition of the Pharmacopoeia has added the "Guidelines for Microbial Monitoring and Control of Pharmaceutical Water 9209"This provides detailed operational guidelines for standardizing microbial monitoring in enterprises. Enterprises are required to develop a comprehensive microbial monitoring strategy for the entire system and lifecycle, combined with rapid microbial detection methods for rapid and real-time monitoring of microorganisms, in order to promptly identify potential microbial risks.

Overall, the 2025 Pharmacopoeia places greater emphasis on risk management and process control throughout the entire drug production cycle.The requirements for the stability of pure water systems are more systematic, scientific, and riskyIt is no longer limited to endpoint detection, but requires enterprises to establish a full lifecycle management system from design, operation to monitoring. Strict certification of raw materials, real-time monitoring of the entire pipeline, and a highly stable standardized pure water system are key factors for enterprises to continuously and stably provide high-quality pure water and fully meet new management requirements.

Overall Water Supply Plan for Lefeng Pure Water System