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Determination of process-related impurities in N-acetylglucosamine prepared by chemical and enzymatic methods: structural elucidation and quantification
- Determination of process-related impurities in N-acetylglucosamine prepared by chemical and enzymatic methods: structural elucidation and quantification
- Kim, Yi Soo; Lee, Sung Joong; Choi, Jin Young; Kim, Yun-Hi; Desta, Kebede Taye; Piao, Zhe; Choi, Su-Lim; Nam, Sang-Jip; Kang, Kyung-Yun; Abd El-Aty, A. M.; Shin, Yong Chul; Shin, Sung Chul
- Ewha Authors
- SCOPUS Author ID
- Issue Date
- Journal Title
- ARCHIVES OF PHARMACAL RESEARCH
- 0253-6269; 1976-3786
- vol. 39, no. 7, pp. 937 - 945
- beta-N-acetylglucosamine; Process-related impurity; Tandem mass spectrometry; Chitin; Nuclear magnetic resonance
- PHARMACEUTICAL SOC KOREA
- SCIE; SCOPUS; KCI
- beta-N-acetylglucosamine (beta-AG) is a monosaccharide distributed widely in living organisms with various pivotal roles. The presence of particulates and impurities can affect the safety and efficacy of a product for its intended duration of use. Thus, the current study was carried out to identify and quantify the potentially-harmful process related impurities; namely alpha-N,6-diacetylglucosamine (alpha-DAG) and alpha-N-acetylglucosamine (alpha-AG), derived from the chemical and enzymatic synthesis of beta-AG. The impurities were characterized using a high resolution mass spectrometry, a nuclear magnetic resonance spectroscopy, and liquid chromatography-tandem mass spectrometry (LC/MS/MS). The developed method showed a good linearity (R (2) a parts per thousand yen 0.998), satisfactory precision (a parts per thousand currency sign6.1 % relative standard deviation), intra- and inter-day accuracy (88.20-97.50 %), extraction recovery (89.30-110.50 %), matrix effect (89.70-105.20 %), and stability (92.70-101.60 %). The method was successfully applied to determine the level of alpha-DAG that was 3.04 and 0.07 % of the total beta-AG, following chemical and enzymatic methods, respectively. It can be concluded that the enzymatic rather than the chemical method is more efficient for the synthesis of beta-AG. Characterization of impurities heeds the signal for acquiring and evaluating data that establishes biological safety.
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