114
Views
1
CrossRef citations to date
0
Altmetric
Antimicrobial Original Research Papers

Quality control and consistency evaluation of ceftriaxone sodium for injection

, , &
Pages 477-490 | Received 08 Oct 2022, Accepted 24 Nov 2022, Published online: 15 Dec 2022

References

  • National Medical Products Administration. 2016. Opinions on the consistency evaluation of quality and efficacy of generic drugs [EB/OL]. February 26. http://www.gov.cn/zhengce/content/2016-03/05/content_5049364.htm.
  • Pehourcq F, Jarry C. Determination of third generation rephalosporins by high performance liquid chromalography in connection with pharmacokinteic studies. J Chromatogr A. 1998;812(1–2):159–178.
  • Merck&Co., Inc. 1965.The Merck Index. 13th edition.
  • Chinese Pharmacopoeia 2015 edition Ceftriaxone sodium.
  • U.S. Pharmacopeia 43 edition Ceftriaxone sodium.
  • European Pharmacopoeia 11.0 edition Ceftriaxone sodium.
  • Chinese Pharmacopoeia 2015 edition Ceftriaxone sodium for injection.
  • U.S. Pharmacopeia 43 edition Ceftriaxone sodium for injection.
  • Lambert PA, Conway BR. Pharmaceutical quality of ceftriaxone generic drug products compared with rocephin. J Chemother. 2003;15(4):357–368.
  • Arnet I, Altermatt M, Roggo Y, et al. Pharmaceutical quality of eight generics of ceftriaxone preparation for injection in Eastern Asia. J Chemother. 2015;27(6):337–342.
  • Jia HTH. Comparative studies on the quality of ceftriaxone sodium for injection from two companies. Shanghai Med Pharmaceut J. 2013;34(13):45–49.
  • Xue J, Jia YH, Li J, et al. Subtype classification of ceftriaxone sodium and its influence on the quality of product. Yao Xue Bao. 2014;49(7):1034–1038.
  • Geng Y, Zhang JL, Yuan YZ. Quality assessment of domestic ceftriaxone sodium for injection. Central South Pharm. 2020;18(3):489–492.
  • Zhao Y, Hu CQ, Yao SC, et al. A strategy for population pharmaceutical quality assessment based on quality by design. J Pharm Anal. 2021;11(5):588–595.
  • Kwon KI, Bourne DW, Ho PC. Effect of caffeine on the plasma protein binding and the disposition of ceftriaxone. J Pharm Pharmacol. 1985;37(11):836–839.
  • Popick AC, Crouthamel WG, Bekersky I. Plasma protein binding of ceftriaxone. Xenobiotica. 1987;17(10):1139–1145.
  • Bourget P, Fernandez H, Quinquis V, et al. Pharmacokinetics and protein binding of ceftriaxone during pregnancy. Antimicrob Agents Chemother. 1993;37(1):54–59.
  • Tu L. Quality evaluation of domestic ceftriaxone sodium for injection. Nanjing: China Pharmaceutical University, 2002.
  • Zhang DS, Xue J, Wang D, et al. Critical quality attributes of cephalosporins for injection. Chinese J New Drug. 2016;25(22):2606–2613.
  • Zhao X, Hu CQ, Jin SH. The analysis of volatile substances of butyl rubber closures. Chinese J Pharmaceut Anal. 2006;26(3):315–318.
  • Zhao X, Hu CQ, Jin SH. Consideration and suggestion to estimate the compatibility between rubber closures and drugs. Chinese Pharmaceut Affair. 2007;21(10):810–812.
  • Zhao X, Jin SH, Hu CQ. The effect of rubber closures on the haze state of ceftriaxone sodium for injection. Drug Dev Ind Pharm. 2007;33(1):35–44.
  • Chong XM, Dong X, Yao SC, et al. Research on the relationship between cephalosporin structure, solution clarity, and rubber closure compatibility using volatile components profile of butyl rubber closures. Drug Dev Ind Pharm. 2019;45(1):159–167.
  • Lu L. Application of mixed-mode chromatographic column in quality analysis of antibiotics and study on degradation impurity of ceftriaxone. Beijing: National Institutes for Food and Drug Control, 2011.
  • Qu HT. Study on organic impurity in ceftriaxone sodium. Shenyang: Shenyang Pharmaceutical University, 2011.
  • Yu J, Yang LH, Hu CQ, et al. Degradation test of ceftriaxone sodium and structure identification of its degradation products. Central South Pharm. 2014;12(2):106–109.
  • Tian Y, Lu L, Chang Y, et al. Identification of a new isomer from a reversible isomerization of ceftriaxone in aqueous solution. J Pharm Biomed Anal. 2015;102:326–330.
  • Wang NN, Xu X, Liu J, et al. Determination of 2-mercaptobenzothiazole in ceftriaxone sodium by HPLC. Chinese J Antibiotic. 2022;47(06):581–584.
  • Han Y, Chen B, Liu Y, et al. Rediction and evaluation of the toxicity of impurities in cephalosporins. Chinese J New Drug. 2019;28(19):2353–2359.
  • Chinese Pharmacopoeia 2015 edition General chapter 0902 Clarity of solution.
  • Han Y, Q Qian J, Zhang JP, et al. Structure-toxicity relationship of cefoperazone and its impurities to developing zebrafish by transcriptome and Raman analysis. Toxicol Appl Pharmacol. 2017;327:39–51.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.