Quality evaluation of desmopressin tablets and injection

doi:10.19803/j.1672-8629.20230385

Abstract

Abstract: Objective To evaluate the quality of listed products of desmopressin tablets and its injection, and provide data for the revision of drug quality standards and for drug quality control and supervision. Methods Based on statutory inspection and exploratory research, 20 batches of desmopressin tablets and 16 batches of desmopressin injection were inspected before exploratory research was carried out, such as methodological research on related substances of tablets, dissolution analysis of tablets, stability of tablets and injections. Results The qualification rate of statutory inspection for 20 batches of desmopressin tablets and 16 batches of desmopressin injection was 100%. The exploratory research optimized the determination methods of related substances in tablets and the interference of the excipient povidone in detection was eliminated. The dissolution of tablets at home and abroad was investigated and the results showed that the dissolution behavior was similar. The stability of the tablets and injection was investigated, and the structure of impurities in the injection was confirmed, which were mainly 5-site deamidation desmopressin and optical isomer impurities. Conclusion The quality of desmopressin tablets and their injections is good, and there are still some problems with the quality standards, which need to be improved.

Key words: desmopressin, tablets, injection, quality evaluation, related substances, dissolution rate, stability

CLC Number:

R927.11

SUN Yue, HU Xinyue, LI Jing, ZHANG Wei, DING Xiaoli, ZHANG Hui, LIANG Chenggang. Quality evaluation of desmopressin tablets and injection[J]. Chinese Journal of Pharmacovigilance, 2024, 21(6): 632-637.

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https://www.zgywjj.com/EN/Y2024/V21/I6/632

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