Quality evaluation of insulin glargine injections

doi:10.19803/j.1672-8629.20230460

Abstract

Abstract: Objective To evaluate the quality of and problems with insulin glargine injections, and study the validity and rationality of drug specifications so as to provide reference for evaluation and supervision of safety. Methods Insulin glargine injections were sampled and evaluated nationwide. The related substances and contents of the samples were tested using the stipulated standard method. The stability of injections and the increase of related substances of injections in usewere tested via exploratory research, and the structures of main related substances were confirmed by LC-MS/MS. According to the results, the limits of related substances specified in enterprise standards and the current Chinese pharmacopoeia standard were evaluated. Results The qualified rate of 48 batches of insulin glargine injections was 100%. Exploratory research showed that the number or contents of related substances in some of the insulin glargine injections were higher, and the contents of maximum related substances in some of the injections were at risk of exceeding the limit of enterprise standards. Conclusion The overall quality of insulin glargine injections is good. Related enterprises should formulate rational and precise limits of related substances in line with the Chinese pharmacopoeia by investigating the increase of relevant substances on the shelf or in use (especially near-effect products).

Key words: insulin glargine, injection, sampling inspection, quality evaluation, related substance, in-use period, stability study, standard, limit of related substances

CLC Number:

R977.15

DING Xiaoli, HU Xinyue, WANG Xuelei, SUN Yue, LI Jing, ZHANG Hui, Liang Chenggang, WANG Yan. Quality evaluation of insulin glargine injections[J]. Chinese Journal of Pharmacovigilance, 2024, 21(6): 644-650.

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URL: https://www.zgywjj.com/EN/10.19803/j.1672-8629.20230460

https://www.zgywjj.com/EN/Y2024/V21/I6/644

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