Detection of Bacterial Endotoxin in Recombinant Follicle-Stimulating Hormone β Injection Using Gel-Clot Method and Recombinant C-Factor Method

doi:10.19803/j.1672-8629.20240685

Abstract

Abstract: Objective To establish a method for detecting bacterial endotoxins in recombinant follicle-stimulating hormone β injection in order to ensure clinical safety. Methods As required by the pharmacopoeia, the detection limit of bacterial endotoxin for recombinant follicle stimulating hormone β injection was established. The methodology of bacterial endotoxin detection was studied by using the gel method and two recombinant C factor kits made at home and abroad respectively before the two detection methods were compared. Results Interference testing showed that after an 80-fold dilution, both the gel-clot method and the recombinant C-factor method met the specified criteria, with no interference detected. The endotoxin levels in three batches of the test samples were less than 0.25 EU·IU^-1. Results from the two recombinant C-factor kits were consistent with those obtained using the gel-clot method. Conclusion Both the gel-clot method and the recombinant C-factor method established in this study are applicable to the detection of bacterial endotoxins in recombinant follicle-stimulating hormone β injection.

Key words: Recombinant Follicle Hormone β Injection, Bacterial Endotoxin, Gel Method, Limulus Amebocyte Lysate, Test for Interference, Recombinant Factor C

CLC Number:

R927.1

CHEN Chen, ZHAO Xiaoyan, CAI Tong, PEI Yusheng. Detection of Bacterial Endotoxin in Recombinant Follicle-Stimulating Hormone β Injection Using Gel-Clot Method and Recombinant C-Factor Method[J]. Chinese Journal of Pharmacovigilance, 2025, 22(4): 372-376.

Add to citation manager EndNote|Ris|BibTeX

URL: https://zgywjj.magtechjournal.com/EN/10.19803/j.1672-8629.20240685

https://zgywjj.magtechjournal.com/EN/Y2025/V22/I4/372

References

[1] ZHANG CH, TAN XL, TENG X, et al.To Investigate the Effect of Recombinant Folliele Stimulating Hormone Beta and High Purity Urinary Follicle Stimulating Hormone on the Outcome of in vitro Fertilization Embryo Transfer[J]. Shanxi Medical Journal(山西医药杂志), 2018, 47(11): 1414-1433.
[2] ZHEN XL, SHI L, WANG B, et al.Methodological Research on the Detection of Bacterial Endotoxin in Shuanghuanglian Injection by Recombinant C Factor Method[J]. Lishizhen Medicine and Materia Medica Research(时珍国医国药), 2021, 32(9): 2165-2167.
[3] WANG WJ, JIANG SJ, HE HH, et al.Investigation on the Applicability of Bacterial Endotoxins Test Using Recombinant Factor C in Extract of Ginkgo Biloba Leaves Injection for Detection of Bacterial Endotoxin[J]. Drug Standards of China(中国药品标准), 2023, 24(6): 601-604.
[4] YANG YX, PEI YS, LIU T, et al.Current Situation and Reflection on Limulus Amebocyte Lysate and Recombinant Reagents for Testing[J]. 5 Chinese Journal of Pharmacovigilance(中国药物警戒), 2024, 21(8):6 847-851.
[5] Chinese Pharmacopoeia Commission.Pharmacopoeia of the People's Republic of China, Volume IV(中华人民共和国药典四部)[M]. Beijing: China Medical Science Press, 2020: 516-520.
[6] SUI X, YE XY, HUANG LY, et al.Suggestion on Application of Recombinant C Factor Bacterial Endotoxin Assay to Medical Devices[J]. China Medical Device Information(中国医疗器械信息), 2023, 29(7): 27-29, 39.
[7] PEI YS, CAI T, CHEN C, et al.Methodological Study on the Detection of Bacterial Endotoxin in Fosaprepitant Dimeglumine by Recombinant Factor C[J]. Chinese Journal of Modern Applied Pharmacy(中国现代应用药学), 2019, 36(1): 1-4.
[8] Chinese Pharmacopoeia Commission.Pharmacopoeia of the People's Republic of China, Volume IV(中华人民共和国药典四部)[M]. Beijing: China Medical Science Press, 2020: 178-181.
[9] CHENG B, SU W, WANG HY, WANG L.Determination of Bacterial Endotoxin by the Micro - Gel Method[J]. China Pharmaceutical Journal, 2024(15): 73-76.
[10] JIE XY, ZHONG JX, GUAN JY, et al.Urgent Study on the Conservation of Limulus Resources in China Based on the Demand for Limulus Reagents[J]. Chinese Fisheries Economics(中国渔业经济), 2021, 39(2): 109-116.
[11] MARIUS M, VACHER F, BONNEVAY T.Comparison of Limulus Amoebocyte Lysate and Recombinant Factor C Assays for Endotoxin Detection in Four Human Vaccines with Complex Matrices[J]. PDA Journal of Pharmaceutical Science and Technology, 2020, 74(4): 394.
[12] European Pharmacopoeia Commission.European Pharmacopoeia 9.0[S]. Strasbourg: European Directorate for the Quality of Medicines & HealthCare of the Council of Europe, 2016.
[13] PEI YS, CAI T, CHEN C, et al.Study on the Application of Supplementary Methods of Bacterial Endotoxin Test in Chinese Pharmacopoeia 2020 Edition[J]. Chinese Journal of Modern Applied Pharmacy(中国现代应用药学), 2022, 39(6): 822-826.
[14] QIN Y, SUN LX, WANG GW, et al.Methodological Study of Recombinant Factor C Method for Detection of Bacterial Endotoxins in Medical Devices[J]. Food and Drug(食品与药品), 2024, 26(4): 307-311.