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How to develop the analytical target profile of analytical procedure
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Mei-ling YANG1, 2, Jia-min SUN1, Lu HAN1, 2, Ying GENG1, Ying DU1, Tai-jun HANG2, De-jiang TAN1
Chinese Journal of New Drugs | 2023, 32(22) : 2293 - 2299
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Chinese Journal of New Drugs | 2023, 32(22): 2293-2299
How to develop the analytical target profile of analytical procedure
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Mei-ling YANG1, 2, Jia-min SUN1, Lu HAN1, 2, Ying GENG1, Ying DU1, Tai-jun HANG2, De-jiang TAN1
Affiliations
  • 1NMPA Key Lab for Quality Research and Evaluation of Chemical Drug, National Institutes for Food and Drug Control, Beijing 102629, China
  • 2China Pharmaceutical University, Nanjing 210009, China
Published: 2023-11-30
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The analytical target profile (ATP) of analytical procedure is the key content in the development of analytical procedure and even the whole life cycle management, and the content had been explicitly proposed in the latest release of ICH Q14 and USP <1220 in 2022. The steps of establishing ATP were discussed in detail in this paper based on the latest research progress in the whole life cycle of analytical procedure at home and abroad, which included: ① Collect relevant prior knowledge. ② Determine the performance characteristics of the procedure to be reported according to the relevant critical quality attribute (CQA) to be detected. ③ Study and formulate the acceptance criteria of corresponding performance characteristics. ④ Construct the ATP of existed analytical procedure using retrospective research. ⑤ Optimize and update the primary ATP. It is expected that the paper could provide reference for methodological researchers at home and abroad and bring convenience to the development and evaluation for the whole life cycle of analytical procedure.

analytical target profile  /  life cycle of analytical procedure  /  validation of analytical procedure  /  verification of analytical procedure  /  analytical procedure development
Mei-ling YANG, Jia-min SUN, Lu HAN, Ying GENG, Ying DU, Tai-jun HANG, De-jiang TAN. How to develop the analytical target profile of analytical procedure[J]. Chinese Journal of New Drugs, 2023 , 32 (22) : 2293 -2299 .
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  • Online Date：2026-03-05
  • Published：2023-11-30
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  • Accepted：2023-05-06
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Affiliations
    1NMPA Key Lab for Quality Research and Evaluation of Chemical Drug, National Institutes for Food and Drug Control, Beijing 102629, China
    2China Pharmaceutical University, Nanjing 210009, China
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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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