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Comparison of Purified Water Testing Items between the 2025 Edition and the 2020 Edition of the Chinese Pharmacopoeia
Date: 2025-08-11Read: 8
The following is a summary table of the comparison and core changes between the purified water testing items in the 2025 edition of the Chinese Pharmacopoeia and the 2020 edition:
Comparison of Purified Water Testing Items between the 2025 Edition and the 2020 Edition of the Chinese Pharmacopoeia
| Test Item | 2020 version requirements | 2025 version requirements | core changes |
|---|---|---|---|
| trait | Colorless clear liquid; Odorless | Colorless and clear liquid (remove the description of "odorless") | Simplified textual description |
| conductivity | Not used as a substitute indicator |
Replace 5 chemical tests： Qualified can exempt nitrate, nitrite, ammonia, heavy metals, and acidity/alkalinity According to General Rule 0681 three-step test | Major changesIntegrating traditional testing and aligning with international standards |
| Total Organic Carbon (TOC) | ≤ 0.50 mg/L (General Rule 0682), choose between easily oxidizable substances | Continue with the same limit values and optional rules | TOC is still recommended as a priority due to its high efficiency and accuracy |
| Microbial Limit | Total aerobic bacteria count ≤ 100 CFU/mL (sample ≥ 1ml, cultured in R2A medium for 5 days) |
Dynamic management upgrade： The sampling volume needs to meet the trend monitoring requirements Mandatory setting of alert/correction limits (such as 50/80 CFU/mL) | Strengthen risk controlEnterprises need to establish personalized limits |
| non-volatile matter | Residual residue ≤ 1mg (100ml sample) | Formally deletedChange to options based on risk assessment | The necessity is reduced under modern water treatment technology |
| nitrate | Chemical detection (such as diphenylamine sulfuric acid test solution) | ⤵️ Qualified conductivity can be exempted | Integrated into conductivity |
| Nitrite/ammonia/heavy metals/acidity/alkalinity | Independent chemical testing | ⤵️ Qualified conductivity can be exempted | Integrated into conductivity |
| oxidizable substance | Choose between TOC and potassium permanganate titration method | The rule of choosing between retention and TOC | Not adjusted, but TOC is gradually becoming mainstream |
Key Change Analysis
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Simplify testing items
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The total number is from9 items → 7 itemsIntegrate 5 chemical tests for conductivity and remove non-volatile substances.
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Enterprise benefitsReduce duplicate testing and lower labor costs by 30% ✅。
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Three step method for conductivity
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Alternative LogicEnsure the reliability of ion concentration monitoring through temperature compensation, removal of CO ₂, and other steps (General Rule 0681).
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Compliance selectionEnterprises are free to adopt conductivity integration schemes or traditional chemical methods.
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Microbial limit upgrade
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Clear requirements for formulationWarning limit (≤ 50 CFU/mL)andCorrection limit (≤ 80 CFU/mL)Exceeding the limit requires initiating a deviation investigation.
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The 2025 edition of the Pharmacopoeia of the People's Republic of China has been promulgated by the National Medical Products Administration and the National Health Commission in Announcement No. 29 of 2025, and will be officially implemented from October 1, 2025. This edition of the pharmacopoeia has made regulations and adjustments to multiple drug related standards, including purified water testing, with the aim of further improving the level of drug quality control and ensuring the safety and effectiveness of public medication. After October 1st, production and inspection activities related to purified water testing must be carried out in accordance with the items and standards specified in the new version of the pharmacopoeia.