Comparison of Injection Water Testing Items between the 2025 Edition and the 2020 Edition of the Chinese Pharmacopoeia

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Date: 2025-08-12Read: 7

Compared to the 2020 edition of the Chinese Pharmacopoeia, the 2025 edition has optimized and adjusted the testing items for injection water, streamlined some testing items related to conductivity indicators, relaxed the requirements for non-volatile matter testing, and added guidance on microbial monitoring. The specific comparison is as follows:

Test Item	2020 version of regulations	2025 version of regulations
trait	Colorless clear liquid, odorless	Colorless clear liquid
PH value	Need to be tested	Determine whether to detect based on the conductivity results. If the conductivity meets the requirements in the first step of the judgment method, there is no need to test it; If the first step is not qualified, and the second or third step is qualified and the pH is between 5.0-7.0, there is no need for testing. Otherwise, testing is required
ammonia	Need to be tested	According to the same pH value detection and judgment logic, when the conductivity is judged as qualified in the first step, the detection can be exempted
nitrate	Need to be tested	According to the same pH value detection and judgment logic, when the conductivity is judged as qualified in the first step, the detection can be exempted
nitrite	Need to be tested	According to the same pH value detection and judgment logic, when the conductivity is judged as qualified in the first step, the detection can be exempted
conductivity	Must comply with the relevant provisions of General Rule 0681	Consistent with the 2020 version, still tested according to General Rule 0681. If the first step of testing meets the requirements, multiple indicators can be exempted from testing
Total organic carbon (TOC)/easily oxidizable substances	Choose one of the two for testing	Maintain unchanged, choose one to test
non-volatile matter	Need to be tested	Adjust to be based on risk assessment and only detect when necessary
heavy metal	Need to be tested	Determine based on the conductivity test results. If the conductivity is judged to be compliant in the first step, or if it is not compliant in the first step but compliant in the second and third steps, no testing is required
bacterial endotoxin	Need to be tested	Maintain the requirement for testing
Microbial Limit	≤10CFU/100mL	The limit value remains unchanged, and a new clause has been added stating that "the test results of three consecutive batches shall not exceed the limit value by 50%"; For high-risk applications such as cell therapy and gene drugs, a new limit of ≤ 1CFU/100mL has been added

In addition, the 2025 edition of the Pharmacopoeia has added 9209 guidelines for microbial monitoring and control of pharmaceutical water, emphasizing dynamic monitoring of microorganisms and aligning quality control with international standards.

2025版 VS 2020版《中国药典》注射用水检测项目对比

The testing items for injection water in 2025 will be implemented in accordance with the provisions under the "Pharmaceutical Water" section of the Chinese Pharmacopoeia 2025 edition, which will be implemented on October 1st

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