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Adjustments to Core Indicators for Pharmaceutical Water in the 2025 Edition of the Chinese Pharmacopoeia

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    Purified Water


    Conductivity Exemption: If the conductivity test step 1 of the three-step method is passed, testing for pH, heavy metals, nitrates, nitrites, and ammonia is exempt. If the second or third step is passed, pH and heavy metal testing is exempt.


    Non-volatile Matter: Changed from mandatory to optional; testing is required when necessary.


    Other Indicators: Standards for total organic carbon, easily oxidizable substances, and conductivity remain unchanged.


    Water for Injection


    Conductivity Exemption: If the conductivity test step 1 of the three-step method is passed, testing for nitrates, nitrites, and ammonia is exempt.


    Non-volatile Matter: Also changed to optional; testing is required when necessary.


    Other Indicators: Standards for total organic carbon and bacterial endotoxins remain unchanged.


    Sterile Water for Injection


    Description Adjustment: The content remains largely unchanged; only the description method has been adjusted for clarity.


    Overall Impact


    The 2025 edition of the Chinese Pharmacopoeia reduces testing costs and workload for enterprises and improves testing efficiency by exempting certain testing items. At the same time, it strengthens microbial monitoring and the entire lifecycle management of water systems, which helps ensure drug quality and safety, promotes alignment with international standards, and enhances enterprises' competitiveness in expanding into international markets.


    Adjustments to Core Indicators for Pharmaceutical Water in the 2025 Edition of the Chinese Pharmacopoeia

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