Validation process of EDTA for infusion/ injection with ceftriaxone and sulbactam

Authors

  • Md. Semimul Akhtar Shri Ram Murti Smarak College of Engineering and Technology (Pharmacy), Bareilly-243202, (UP)
  • Akash Babu Shri Ram Murti Smarak College of Engineering and Technology (Pharmacy), Bareilly-243202, (UP)
  • Sudip Kumar Mandal Dr. B C Roy College of Pharmacy & AHS, Dr. Meghnad Saha Sarani, Bidhannagar, Durgapur, West Bengal- 713206

DOI:

https://doi.org/10.18231/j.joapr.2021.v9.i3.39-47

Keywords:

Validation, Process validation, Prospective Validation, Concurrent validation

Abstract

The validation of the manufacturing process to produce ceftriaxone/ sulbactam with EDTA1.5 g/ vial powder for solution for injection/ infusion. Ceftriaxone works by inhibiting the mucopeptide synthesis in the bacterial cell wall. The beta-lactam moiety of Ceftriaxone binds to carboxypeptidases, endopeptidases, and transpeptidases in the bacterial cytoplasmic membrane. These enzymes are involved in cell- wall synthesis and cell division. By binding to these enzymes, Ceftriaxone results in the formation of defective cell walls and cell death. Sulbactam is an irreversible inhibitor of beta-lactamase; it binds the enzyme and does not allow it to interact with the antibiotic. The validation confirms that each stage of the manufacturing process is in control and will consistently produce a product of acceptable quality, as defined by the specifications of product. It is planned that operating variables and control parameters of processes shall be studied and documented. The associated critical product attributes and characteristics shall also be studied. Process validation of ceftriaxone/ sulbactam 1.5g/ vial powder for solution for injection. Process for manufacture of ceftriaxone/ sulbactam 1.5g/ vials powder for solution for injection/ infusion is said to be in state of control. Hence this product can be manufactured by using this process without modifying any parameters

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References

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FDA. 2011. Process Validation: General Principles and Practices .U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Center for Veterinary Medicine (CVM), pp 1-22. 9

FDA. 2004. Guidance for Industry Sterile Drug Products Produced by Aseptic Processing Current Good Manufacturing Practice. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Center for Veterinary Medicine (CVM), pp 1-63.

Durairaj S, Annadurai T, Kumar PB, Kumar AS. Simultaneous estimation of ceftriaxone sodium and sulbactam sodium using multi component mode of analysis. International Journal of ChemTech Research, 2(4), 2177- 2181 (2010)

Published

2021-09-30

How to Cite

Akhtar, M. S., Babu, A., & Mandal, S. K. (2021). Validation process of EDTA for infusion/ injection with ceftriaxone and sulbactam. Journal of Applied Pharmaceutical Research, 9(3), 39-47. https://doi.org/10.18231/j.joapr.2021.v9.i3.39-47

Issue

Section

Articles