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Analysis on the factors affecting the whiteness about pharmaceutical excipient talc
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Hui-juan WANG1, 2, 3, Rui YANG1, 2, Xiao-feng WANG1, 2, Xin-yue XIAO1, 2, Jing-bo SUN3
Chinese Journal of New Drugs | 2023, 32(1) : 65 - 71
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Chinese Journal of New Drugs | 2023, 32(1): 65-71
Analysis on the factors affecting the whiteness about pharmaceutical excipient talc
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Hui-juan WANG1, 2, 3, Rui YANG1, 2, Xiao-feng WANG1, 2, Xin-yue XIAO1, 2, Jing-bo SUN3
Affiliations
  • 1NMPA Key Laboratory for Quality Research and Evaluation of Pharmaceutical Excipients, Beijing 100050, China
  • 2National Institutes for Food and Drug Control, Beijing 100050, China
  • 3Pharmaceutical College of Beihua University, Jilin 132013, China
Published: 2023-01-15
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Objective: To study the factors affecting the whiteness of talc and the relationship between them. Methods: The content of metal elements, particle size and particle size distribution, which affect the whiteness of talc, were measured, and the main factors were speculated by principal component analysis (PCA). The linear regression model was established by SPSS. Results: Using PCA analysis, it is speculated that the main factors are the content of impurity metal calcium and particle size D90. The established linear regression model is: Whiteness=96.457+42.770×Calcium% -0.422×D90, with R2 of 0.944 and Adjusted R2 of 0.934 (P<0.05). The model was successfully constructed. Conclusion: The whiteness of pharmaceutical excipient talc is affected by its impurity metal calcium content and particle size D90. The established whiteness correlation regression model provides a theoretical basis for whiteness as a visual quantity to control the particle size and impurity metal calcium content in talc production process and preparation. This study also provides a new idea for the study of the characteristics and quality attributes of pharmaceutical excipient talc.

pharmaceutical excipients  /  talc  /  whiteness  /  principal component analysis  /  particle size  /  metal elements  /  linear regression
Hui-juan WANG, Rui YANG, Xiao-feng WANG, Xin-yue XIAO, Jing-bo SUN. Analysis on the factors affecting the whiteness about pharmaceutical excipient talc[J]. Chinese Journal of New Drugs, 2023 , 32 (1) : 65 -71 .
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Year 2023 volume 32 Issue 1
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  • Online Date：2026-03-06
  • Published：2023-01-15
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  • Accepted：2022-06-19
Affiliations
    1NMPA Key Laboratory for Quality Research and Evaluation of Pharmaceutical Excipients, Beijing 100050, China
    2National Institutes for Food and Drug Control, Beijing 100050, China
    3Pharmaceutical College of Beihua University, Jilin 132013, China
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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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