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Analysis of the influence of adsorbed moisture on DSC method for detecting drug purity
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Yi LIU1, Rui WU1, 2, Xian-hui GUO1, Jiong ZHU1, *, Hua CHEN1, *
Chinese Journal of Pharmaceutical Analysis | 2025, 45(5) : 915 - 920
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Chinese Journal of Pharmaceutical Analysis | 2025, 45(5): 915-920
• Standard Deliberation •
Analysis of the influence of adsorbed moisture on DSC method for detecting drug purity
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Yi LIU1, Rui WU1, 2, Xian-hui GUO1, Jiong ZHU1, *, Hua CHEN1, *
Affiliations
  • 1. National Institutes for Food and Drug Control, Beijing 102629, China
  • 2. School of Pharmacy, Yantai University, Yantai 264005, China
doi: 10.16155/j.0254-1793.2024-1249
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Objective: To investigate the effect of adsorbed moisture on drug purity determination by differential scanning calorimetry (DSC). Methods: The DSC analysis for drug purity was performed with a heating rate of 0.5℃ · min-1 under a nitrogen atmosphere (drying gas flow rate: 50 mL · min-1). The optimized method reduced by 10 ℃ than the conventional method and included an additional heating segment at 1 ℃ · min-1 for 10 min, while other parameters remained unchanged. Results: Without pre-drying, the conventional DSC method accurately determined the purity of imidazole, phenylephrine hydrochloride, and neostigmine methylsulfate samples with adsorbed moisture below 7%. After optimization, the method further eliminated moisture interference, allowing accurate analysis of samples with adsorbed moisture below 8%. Conclusion: Adsorbed moisture may affect DSC-based purity analysis. For general samples with a melting point above 80 ℃ and adsorbed moisture below 7%, pre-drying is unnecessary. The optimized method further reduces the impact of adsorbed moisture.

differential scanning calorimetry (DSC)  /  purity analysis  /  influence of adsorbed moisture  /  method optimization
Yi LIU, Rui WU, Xian-hui GUO, Jiong ZHU, Hua CHEN. Analysis of the influence of adsorbed moisture on DSC method for detecting drug purity[J]. Chinese Journal of Pharmaceutical Analysis, 2025 , 45 (5) : 915 -920 . DOI: 10.16155/j.0254-1793.2024-1249
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doi: 10.16155/j.0254-1793.2024-1249
  • Receive Date：2024-11-05
  • Online Date：2025-12-12
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  • Received：2024-11-05
Affiliations
    1. National Institutes for Food and Drug Control, Beijing 102629, China
    2. School of Pharmacy, Yantai University, Yantai 264005, China
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表12种不同金属材料的力学参数
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Family		 属数
Number of
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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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