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Study on the cross-linking degree of PVPP by NMR technology and its powder compressibility
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Jue WANG1, 2, Li HU3, Mei-qin WU2, Rui YANG1, Hui-min SUN1, *, Jia-sheng TU2, *
Acta Pharmaceutica Sinica | 2022, 57(2) : 474 - 479
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Acta Pharmaceutica Sinica | 2022, 57(2): 474-479
Original Articles
Study on the cross-linking degree of PVPP by NMR technology and its powder compressibility
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Jue WANG1, 2, Li HU3, Mei-qin WU2, Rui YANG1, Hui-min SUN1, *, Jia-sheng TU2, *
Affiliations
  • 1. NMPA Key Laboratory for Quality Research and Evaluation of Pharmaceutical Excipients, National Institutes for Food and Drug Control, Beijing 100050, China
  • 2. NMPA Key Laboratory for Research and Evaluation of Pharmaceutical Preparations and Excipients, China Pharmaceutical University, Nanjing 210009, China
  • 3. Chengdu Suncadia Medicine Co., Ltd., Chengdu 610000, China
Published: 2022-02-12 doi: 10.16438/j.0513-4870.2021-0937
Outline
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In this paper, the low-field nuclear magnetic resonance technology CPMG (Carr-Purcell-Meiboom-Gill) echo method was used to determine the cross-linking degree and cross-linking density of crospovidone (PVPP) from different manufacturers. Based on the seven physical properties of PVPP, a fingerprint spectrum (radar chart) of twenty secondary quality indicators were obtained, and three compressibility evaluation indicators, index of the parameter (IP), index of parametric profile (IPP), index of good compression (IGC) were calculated by the fingerprint spectrum. It was found that the cross-linking degree and compressibility index IP of PVPP showed a strong correlation (r=0.816) by the correlation analysis, indicating that the cross-linking degree is one of the key quality attributes for evaluating the compressibility of PVPP.

crospovidone  /  crosslinking degree  /  crosslinking density  /  NMR  /  compressibility  /  physical fingerprint
Jue WANG, Li HU, Mei-qin WU, Rui YANG, Hui-min SUN, Jia-sheng TU. Study on the cross-linking degree of PVPP by NMR technology and its powder compressibility[J]. Acta Pharmaceutica Sinica, 2022 , 57 (2) : 474 -479 . DOI: 10.16438/j.0513-4870.2021-0937
Year 2022 volume 57 Issue 2
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Article Info
doi: 10.16438/j.0513-4870.2021-0937
  • Receive Date:2021-06-28
  • Online Date:2025-12-22
  • Published:2022-02-12
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History
  • Received:2021-06-28
  • Revised:2021-10-08
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Affiliations
    1. NMPA Key Laboratory for Quality Research and Evaluation of Pharmaceutical Excipients, National Institutes for Food and Drug Control, Beijing 100050, China
    2. NMPA Key Laboratory for Research and Evaluation of Pharmaceutical Preparations and Excipients, China Pharmaceutical University, Nanjing 210009, China
    3. Chengdu Suncadia Medicine Co., Ltd., Chengdu 610000, 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
species
占总种数比例
Percentage of
total species (%)

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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