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Analysis and Comparison of Microbial Control Criteria Among Chinese Pharmacopeia, United States Pharmacopeia and European Pharmacopeia
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Jing WANG1, Yiling FAN2, Meicheng YANG3, *
Chinese Pharmaceutical Journal | 2025, 60(6) : 658 - 662
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Chinese Pharmaceutical Journal | 2025, 60(6): 658-662
Analysis and Comparison of Microbial Control Criteria Among Chinese Pharmacopeia, United States Pharmacopeia and European Pharmacopeia
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Jing WANG1, Yiling FAN2, Meicheng YANG3, *
Affiliations
  • 1 Shanghai Food and Drug Packaging Material Control Center, Shanghai 201203, China
  • 2 Shanghai Institute for Food and Drug Control, Shanghai 201203, China
  • 3 Shanghai Center for Drug Evaluation and Inspection, Shanghai 201203, China
Published: 2025-03-22 doi: 10.11669/cpj.2025.06.013
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OBJECTIVE To investigate the key factors and directions for construction of a standard system for microbial control of pharmaceutical excipients. METHODS The contents related to pharmaceutical excipient microbial control including general requirements and monographs of standards in Chinese Pharmacopeia, United States Pharmacopeia and European Pharmacopeia were extracted and analyzed in combination with the current industrial status. RESULTS The included pharmacopoeias exhibit considerable differences in the coverage of pharmaceutical excipients and requirement for microbial control and there is still a lack of scientific and systematic guiding standards. The industrial requirements are yet to be met in terms of testing methodology, standardization, and instruction. CONCLUSION Attention should be paid to the methodological research and risk management of microbial control of pharmaceutical excipients. Instructive standards for microbial control of pharmaceutical excipients should be developed based on comprehensive consideration of excipient features and intended use with formulation as a core, to improve the quality standard system of pharmaceutical excipients and ensure drug safety.

pharmaceutical excipient  /  microbial control  /  pharmacopeia standard  /  drug safety  /  associated evaluation and approval  /  risk management
Jing WANG, Yiling FAN, Meicheng YANG. Analysis and Comparison of Microbial Control Criteria Among Chinese Pharmacopeia, United States Pharmacopeia and European Pharmacopeia[J]. Chinese Pharmaceutical Journal, 2025 , 60 (6) : 658 -662 . DOI: 10.11669/cpj.2025.06.013
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Year 2025 volume 60 Issue 6
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Article Info
doi: 10.11669/cpj.2025.06.013
  • Receive Date：2024-09-12
  • Online Date：2025-11-07
  • Published：2025-03-22
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  • Received：2024-09-12
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Affiliations
    1 Shanghai Food and Drug Packaging Material Control Center, Shanghai 201203, China
    2 Shanghai Institute for Food and Drug Control, Shanghai 201203, China
    3 Shanghai Center for Drug Evaluation and Inspection, Shanghai 201203, China
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https://castjournals.cast.org.cn/joweb/zgyxzz/EN/10.11669/cpj.2025.06.013
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表12种不同金属材料的力学参数
科
Family		 属数
Number of
genus		 种数
Number of
species		 占总种数比例
Percentage of
total species (%)		 属
Genus		 种数
Number of
species		 占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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