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Study on the harmonization of weight (filling) variation test of Chinese Pharmacopoeia with ICH Q4B Annex 6 with respect to the harmonization consideration and statistical simulation
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Ying GENG1, Rui DING2, Ning-yi WEI1, Qi-ming ZHANG1, Xin-yi XU3, Yue SHANG3, Ping LIAO4, Quan YANG5, Jia-nan LIU6, Ling MA2, *, Hua CHEN1, *
Chinese Journal of New Drugs | 2026, 35(9) : 903 - 910
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Chinese Journal of New Drugs | 2026, 35(9): 903-910
Study on the harmonization of weight (filling) variation test of Chinese Pharmacopoeia with ICH Q4B Annex 6 with respect to the harmonization consideration and statistical simulation
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Ying GENG1, Rui DING2, Ning-yi WEI1, Qi-ming ZHANG1, Xin-yi XU3, Yue SHANG3, Ping LIAO4, Quan YANG5, Jia-nan LIU6, Ling MA2, *, Hua CHEN1, *
Affiliations
  • 1National Institutes for Food and Drug Control, Beijing 102629, China
  • 2Ningxia Hui Autonomous Region Institute for Drug Control, Yinchuan 750004, China
  • 3Chinese Pharmacopoeia Commission, Beijing 100061, China
  • 4Shanghai Center of Drug Evaluation and Inspection, Shanghai 201210, China
  • 5China Novartis Institutes for Biomedical Research Co., Ltd., Shanghai 201203, China
  • 6National Health Commission of the People's Republic of China, Beijing 100044, China
Published: 2026-05-15 doi: 10.20251/j.cnki.1003-3734.2026.09.002
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Weight (filling) variation is an important critical quality attribute for pharmaceutical preparations, and is one of the critical aspects for the uniformity of dosage unit testing. In the ICH tripartite pharmacopoeias (USP, EP and JP), the harmonized general chapter on uniformity of dosage units (ICH Q4B Annex 6), utilizing a unified attribute and variable sampling plan. In General Requirements for Preparations of Chinese Pharmacopoeia, the Weight (Filling) Variation test has always used an attribute sampling plan, and there are differences with the Weight (Filling) Variation test in the ICH general chapter on uniformity of dosage units in terms of the preparation scope, sampling plan, and acceptance criteria. After the harmonization process with ICH Q4B, the newly added general chapter 〈0940 Uniformity of Dosage Units〉 was incorporated in Chinese Pharmacopoeia 2025 edition. In this paper, the harmonization consideration including the preparation scope, sampling plan and acceptance criteria was reviewed and interpreted in detail for Weight (Filling) Variation test described both in 〈General Requirements for Preparations〉 and in 〈0940 Uniformity of Dosage Units〉. The harmonization with ICH can further improve China's drug regulatory capacity and facilitate drug quality control to align with international standards.

Chinese Pharmacopoeia  /  weight(filling) variation test  /  ICH  /  international harmonization  /  uniformity of unit dose  /  statistics  /  data simulation
耿颖, 丁锐, 魏宁漪, 张启明, 徐昕怡, 尚悦, 廖萍, 杨泉, 刘嘉楠, 马玲, 陈华. 《中华人民共和国药典》重（装）量差异检查法与ICH Q4B附录6通则协调考虑及统计学数据模拟研究. 中国新药杂志, 2026 , 35 (9) : 903 -910 . DOI: 10.20251/j.cnki.1003-3734.2026.09.002
Ying GENG, Rui DING, Ning-yi WEI, Qi-ming ZHANG, Xin-yi XU, Yue SHANG, Ping LIAO, Quan YANG, Jia-nan LIU, Ling MA, Hua CHEN. Study on the harmonization of weight (filling) variation test of Chinese Pharmacopoeia with ICH Q4B Annex 6 with respect to the harmonization consideration and statistical simulation[J]. Chinese Journal of New Drugs, 2026 , 35 (9) : 903 -910 . DOI: 10.20251/j.cnki.1003-3734.2026.09.002
Appendix
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Year 2026 volume 35 Issue 9
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Article Info
doi: 10.20251/j.cnki.1003-3734.2026.09.002
  • Online Date：2026-10-26
  • Published：2026-05-15
Article Data
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History
  • Accepted：2025-10-28
Funding
Affiliations
    1National Institutes for Food and Drug Control, Beijing 102629, China
    2Ningxia Hui Autonomous Region Institute for Drug Control, Yinchuan 750004, China
    3Chinese Pharmacopoeia Commission, Beijing 100061, China
    4Shanghai Center of Drug Evaluation and Inspection, Shanghai 201210, China
    5China Novartis Institutes for Biomedical Research Co., Ltd., Shanghai 201203, China
    6National Health Commission of the People's Republic of China, Beijing 100044, China
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表12种不同金属材料的力学参数
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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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