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Development of the detection method for exogenous DNA of neomycin sulfate based on QbD concept
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Pei-pei ZAHNG, Shang-chen YAO, Jin LI, Xia ZHANG, Wen-bo ZOU, Ming-zhe XU, Yan WANG, Bao-ming NING
Chinese Journal of New Drugs | 2023, 32(9) : 947 - 954
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Chinese Journal of New Drugs | 2023, 32(9): 947-954
Development of the detection method for exogenous DNA of neomycin sulfate based on QbD concept
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Pei-pei ZAHNG, Shang-chen YAO, Jin LI, Xia ZHANG, Wen-bo ZOU, Ming-zhe XU, Yan WANG, Bao-ming NING
Affiliations
  • National Institutes for Food and Drug Control, Beijing 102629, China
Published: 2023-05-15
Outline
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Objective:

To establish a detection method for exogenous DNA in neomycin sulfate drugs based on the concept of analytical quality by design (AQbD).

Methods:

The MODDE Pro11 software was used to design the experiment, investigate the key influencing factors and optimize the parameters. Qubit® DNA detection kit based on fluorescence staining method was employed for the determination of exogenous DNA.

Results:

The universal detection method of exogenous DNA in neomycin sulfate was established. The key effect factors are solvent type, solvent concentration and sample concentration. When NaCl was used as solvent, the optimal analysis conditions were solvent concentration at 1.4 mol·L-1 and sample concentration at 1.8 mg·mL-1. The linear range of DNA standard was 20~100 ng·mL-1 (r=0.995 7, n=2). The accuracy was above 81.0%. The recoveries in ruggedness tests were 80%~120%.

Conclusion:

The established method is accurate, robust and universal. This study provides reference for the development of determination of exogenous DNA in aminoglycoside antibiotics.

neomycin  /  exogenous DNA  /  the binding of neomycin-DNA  /  fluorescence staining method  /  analytical quality by design concept
Pei-pei ZAHNG, Shang-chen YAO, Jin LI, Xia ZHANG, Wen-bo ZOU, Ming-zhe XU, Yan WANG, Bao-ming NING. Development of the detection method for exogenous DNA of neomycin sulfate based on QbD concept[J]. Chinese Journal of New Drugs, 2023 , 32 (9) : 947 -954 .
Year 2023 volume 32 Issue 9
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Article Info
  • Online Date:2026-03-05
  • Published:2023-05-15
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History
  • Accepted:2022-11-21
Funding
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    National Institutes for Food and Drug Control, Beijing 102629, 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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