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General considerations on the forced degradation studies of chemical innovative drugs
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Ting-ting XU, Xiao-hua ZHANG*
Chinese Journal of Pharmaceutical Analysis | 2024, 44(12) : 2148 - 2153
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Chinese Journal of Pharmaceutical Analysis | 2024, 44(12): 2148-2153
Process Evaluation
General considerations on the forced degradation studies of chemical innovative drugs
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Ting-ting XU, Xiao-hua ZHANG*
Affiliations
  • Nanjing Chia-Tai Tianqing Pharmaceutical Company, Nanjing 210046, China
Published: 2024-12-31 doi: 10.16155/j.0254-1793.2024-0308
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Compared to chemical generic drugs, more attempts should be made for chemical innovative drugs in the identification of major degradation products, the exploration of stress testing conditions, and the mutagenicity study of degradation products due to their novel structures and unknown degradation pathways. At present, many literature reviews on the forced degradation studies of drugs have been published, but there are almost no specific discussions for innovative drugs. This article is intended to discuss the identification of major degradation products, the exploration of experiment conditions, and the mutagenicity of degradation products based on the related literatures and research experiences in order to provide some references for researchers.

chemical innovative drugs  /  forced degradation  /  general considerations  /  stress testing conditions  /  degradation products  /  mutagenicity
Ting-ting XU, Xiao-hua ZHANG. General considerations on the forced degradation studies of chemical innovative drugs[J]. Chinese Journal of Pharmaceutical Analysis, 2024 , 44 (12) : 2148 -2153 . DOI: 10.16155/j.0254-1793.2024-0308
Year 2024 volume 44 Issue 12
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doi: 10.16155/j.0254-1793.2024-0308
  • Receive Date:2024-05-10
  • Online Date:2026-03-13
  • Published:2024-12-31
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  • Received:2024-05-10
Affiliations
    Nanjing Chia-Tai Tianqing Pharmaceutical Company, Nanjing 210046, China
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表12种不同金属材料的力学参数

Family
属数
Number of
genus
种数
Number of
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占总种数比例
Percentage of
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种数
Number of
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占总种数比例
Percentage of total
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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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