Full
Outline
The disintegration test is a critical method and means for controlling the critical quality attributes of solid dosage forms. The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) harmonized the disintegration test methods of the United States Pharmacopeia (USP), European Pharmacopoeia (EP), and Japanese Pharmacopoeia (JP), resulting in the ICH Q4B Guideline Annex 5, which allows for mutual recognition within the ICH region. The 〈0921 Disintegration Test〉 in the 2025 edition of the Chinese Pharmacopoeia (ChP) has been harmonized with ICH Q4B Annex 5 (R1), achieving consistency with respect to apparatus and general procedure; acceptance criteria according to ICH and CHP are described in parallel; and the requirements for specific dosage forms as per the 2020 edition were retained. Additionally, the framework of 〈0921 Disintegration Test〉 has been revised to align with the ICH guideline, ensuring harmonization with international standards. This revision not only considers the historical inheritance of the Chinese Pharmacopoeia and the practical needs of China's pharmaceutical industry but also achieves international harmonization. This article provides a detailed comparison of the differences in apparatus and procedure between 〈0921 Disintegration Test〉 in the Chinese Pharmacopoeia and ICH Q4B Annex 5 (R1). Research on the harmonization of disintegration test methods across the ICH tripartite regions (EP, USP, JP) was carried out, including the comparison of disintegration test results, investigation of statistical data simulation for acceptance criteria, and the interpretation of the background, approach, and considerations behind the harmonization of 〈0921 Disintegration Test〉 with ICH. The aim is to enhance the understanding of the revisions to the 〈0921 Disintegration Test〉 in the 2025 edition and provide supportive reference for both the pharmaceutical industry and regulatory authorities.
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| 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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