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Advances in research on mass spectrometry based chiral amino acid analysis for quality control of racemic peptide impurities
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Jie-hong LIN1, 2, Hong WANG2, Hong SHAO2, Gang CHEN2, *, Mei LIN2, *
Acta Pharmaceutica Sinica | 2019, 54(11) : 1958 - 1964
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Acta Pharmaceutica Sinica | 2019, 54(11): 1958-1964
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Advances in research on mass spectrometry based chiral amino acid analysis for quality control of racemic peptide impurities
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Jie-hong LIN1, 2, Hong WANG2, Hong SHAO2, Gang CHEN2, *, Mei LIN2, *
Affiliations
  • 1. Shanghai Institute of Pharmaceutical Industry, China State Institute of Pharmaceutical Industry, Shanghai 201203, China
  • 2. Shanghai Institute for Food and Drug Control, Shanghai 201203, China
Published: 2019-11-12 doi: 10.16438/j.0513-4870.2019-0335
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Chiral amino acid analysis is a sensitive, efficient and economical method for controlling racemic peptide impurities, especially for synthetic polypeptide drugs with complex composition of amino acids. Unexpected amino acid enantiomers in racemic peptides can be measured by chiral amino acid analysis coupled with mass spectrometry. The position of amino acid isomerization in the peptide segment can be accurately mapped by mass spectrometry, which lays a solid foundation for screening of racemic peptide impurities and rapid identification or quantification of trace racemic peptide impurities. Combination of the two techniques is vital for quality control of the synthetic polypeptide drugs and for research of polypeptide drugs based on chemical synthesis. The strategies of peptide hydrolysis have been summarized in this review. The latest chiral amino acid analysis based on mass spectrometry is briefly reviewed. Based on our knowledge, we have pointed to the direction of research and control of racemic peptide impurities in synthetic polypeptide drugs.

synthetic polypeptide drug  /  racemic peptide impurity  /  peptides hydrolysis  /  chiral amino acids analysis  /  mass spectrometry
Jie-hong LIN, Hong WANG, Hong SHAO, Gang CHEN, Mei LIN. Advances in research on mass spectrometry based chiral amino acid analysis for quality control of racemic peptide impurities[J]. Acta Pharmaceutica Sinica, 2019 , 54 (11) : 1958 -1964 . DOI: 10.16438/j.0513-4870.2019-0335
Year 2019 volume 54 Issue 11
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Article Info
doi: 10.16438/j.0513-4870.2019-0335
  • Receive Date:2019-04-28
  • Online Date:2026-01-26
  • Published:2019-11-12
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  • Received:2019-04-28
  • Revised:2019-07-01
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    1. Shanghai Institute of Pharmaceutical Industry, China State Institute of Pharmaceutical Industry, Shanghai 201203, China
    2. Shanghai Institute for Food and Drug Control, Shanghai 201203, 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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