Standard Deliberation

Analysis of the impact of storage temperature on the critical quality attributes of terlipressin for injection*

  • WANG Pei ,
  • LU Xin ,
  • MA Bing ,
  • DUAN Xi-yu ,
  • QIN Ting-ting ,
  • HAN Xiao-jie ,
  • BAI Hai-jiao
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  • Tianjin Institute of Drug Control, Tianjin 300070, China

Online published: 2025-10-13

Abstract

Objective: To clarify the differences between the “Room temperature” definitions in the European Pharmacopoeia and the Chinese Pharmacopoeia, to emphasize that storage temperature was closely related to the design of long-term stability studies and product labeling, and to investigate the effects of storage temperature variations on the critical quality attributes (CQAs) of terlipressin for injection, so as to raise awareness among generic drug manufacturers regarding this critical issue. Methods: Given the discrepancies in storage temperature recommendations across different manufacturers’ product inserts, the original drug’s long-term stability studies and storage conditions were traced. Validated methods for related substances and polymer content were employed to assess the impact of temperature differences on the product’s CQAs. Results: Samples stored at 30 ℃exhibited a significantly higher increase in related substances compared to those stored at 15 ℃. In one manufacturer’s product, polymer levels exceeded specification limits within just five months of storage at 30 ℃. The divergence among manufacturers stems from some companies misinterpreting the original drug’s labeling by directly translating without considering the differences between Chinese and European Pharmacopoeias. Conclusion: Storage temperature has a significant impact on the levels of related substances and polymer content in terlipressin for injection. To ensure product quality, the storage temperature in the labeling should be restricted to “not exceeding 25 ℃.”

Cite this article

WANG Pei , LU Xin , MA Bing , DUAN Xi-yu , QIN Ting-ting , HAN Xiao-jie , BAI Hai-jiao . Analysis of the impact of storage temperature on the critical quality attributes of terlipressin for injection*[J]. Chinese Journal of Pharmaceutical Analysis, 2025 , 45(5) : 907 -914 . DOI: 10.16155/j.0254-1793.2024-1064

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