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Synthesis 2024; 56(23): 3660-3668
DOI: 10.1055/s-0040-1720141
paper

Synthesis, Isolation and Characterization of Nine Pharmacopeial Impurities Related to the Active Pharmaceutical Ingredient Olsalazine Sodium

Jagdish Chavan
a   API R&D Centre, Emcure Pharmaceuticals Limited, IT-BT Park, Phase II, M.I.D.C., Hinjewadi, Pune 411 057, Maharashtra, India
,
Sudhir Chaskar
a   API R&D Centre, Emcure Pharmaceuticals Limited, IT-BT Park, Phase II, M.I.D.C., Hinjewadi, Pune 411 057, Maharashtra, India
,
Hanmant Vedpathak
a   API R&D Centre, Emcure Pharmaceuticals Limited, IT-BT Park, Phase II, M.I.D.C., Hinjewadi, Pune 411 057, Maharashtra, India
,
Venkat Suryawanshi
b   Department of Chemistry, PG and Research Centre, Shri Chhatrapati Shivaji College, Omerga, Dharashiv 413 606, Maharashtra, India
,
Rakesh G. Thorat  ∗
a   API R&D Centre, Emcure Pharmaceuticals Limited, IT-BT Park, Phase II, M.I.D.C., Hinjewadi, Pune 411 057, Maharashtra, India
,
Ashok Chaudhari
a   API R&D Centre, Emcure Pharmaceuticals Limited, IT-BT Park, Phase II, M.I.D.C., Hinjewadi, Pune 411 057, Maharashtra, India
,
Chinmoy Pramanik
a   API R&D Centre, Emcure Pharmaceuticals Limited, IT-BT Park, Phase II, M.I.D.C., Hinjewadi, Pune 411 057, Maharashtra, India
,
Abhijit Roychowdhury
a   API R&D Centre, Emcure Pharmaceuticals Limited, IT-BT Park, Phase II, M.I.D.C., Hinjewadi, Pune 411 057, Maharashtra, India
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Abstract

Olsalazine sodium is an anti-inflammatory agent used to treat ulcerative colitis. Both British and European Pharmacopoeia list nine process-related impurities in their monographs. Quantification of the impurities in the final synthesized active pharmaceutical ingredient (API) is required to meet the quality standards set by the International Council for Harmonisation (ICH). Both literature reports and commercial vendors for these impurities are few and far between. The present report describes the synthesis, isolation, purification and characterization of these nine pharmacopeial impurities.

Key words

olsalazine sodium - impurities - British Pharmacopeia - ulcerative colitis - diazotization

Supporting Information

    Supporting information for this article is available online at https://doi.org/10.1055/s-0040-1720141.
  • Supporting Information


Publication History

Received: 22 July 2024

Accepted after revision: 19 September 2024

Article published online:
16 October 2024

© 2024. Thieme. All rights reserved

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