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Development of an Ion Chromatography Method for the Determination of Organic Impurities in Ferumoxytol

1, 1, 2, 3, 4, 4, 5, 1

  1. 1Department of Chemistry, Acharya Nagarjuna University, Nagarjuna Nagar, Andhra Pradesh, INDIA.
  2. 2Department of Physics, Sri Vasavi Engineering College, Pedatadepalli, Tadepalligudem, Andhra Pradesh, INDIA .
  3. 3Department of Chemistry, College of Science, King Saud University, Riyadh, SAUDI ARABIA.
  4. 4Department of Chemistry, Aditya University, Surampalem, Andhra Pradesh, INDIA .
  5. 5Division of Chemistry and Biotechnology, Dongguk University, Dongdaero, Gyeongjusi, Gyeongjusi, SOUTH KOREA.

CORRESPONDENCE

Prof. Rudraraju Ramesh Raju

Department of Chemistry, Acharya Nagarjuna University, Nagarjuna Nagar-522510, Andhra Pradesh, INDIA.

rrraju1@gmail.com

Received: 16-11-2024; Revised: 24-01-2025; Accepted: 02-04-2025.

Volume 59, Issue 3s (Supplement) · pp. s1110-s1116 · 2025 · DOI: 10.5530/ijper.20251319

ABSTRACT

Aim: To the development of an ion chromatography method for the determination of organic impurities in Ferumoxytol.Materials and Methods: A new ion chromatographic method was employed for the precise and suitable quantification of organic impurities in Ferumoxytol drug. Specifically, LOD, LOQ, Linearity, and Accuracy evaluations were conducted to thoroughly validate each of these areas.Results: All the studied carbohydrate impurities showed linear ranges within 0.0005 to 0.0030 mg/mL with the correlation coefficients higher than 0.9991. The limits of detection were all less than 0.0002 mg/mL. The limits of quantification were all less than 0.0006 mg/mL. The RSDs of the method were less than 3%.Conclusion: This method showed a lot of promise for precise impurity testing in Ferumoxytol drug substance, improving pharmaceutical quality assurance and making sure that patients are protected.

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    Deepala, N. S. R., Pedapalli, S., Jagadeesh, K., Islam, M. S., Gadipelli, P., Dahlous, K. A., Alam, M., & Raju, R. R. (2025). Development of an Ion Chromatography Method for the Determination of Organic Impurities in Ferumoxytol. Indian Journal of Pharmaceutical Education and Research, 59(3s), s1110-s1116. https://doi.org/10.5530/ijper.20251319

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    © 2025 Author(s)

    This is an open access article distributed under the terms of the Creative Commons Attribution 4.0 License, which permits unrestricted use, distribution and reproduction in any medium, provided the original author and source are credited. CC BY 4.0