Comparison of Monographs of Indian Pharmacopeia with BP and USP Pharmacopeia’s

  • Jayaprakash Munirathnam Mr
  • Gowri Radhakrishnan
DOI https://doi.org/10.22270/ijdra.v11i1.572

Abstract

The objective of this study is to emphasis on the importance of the chromatographic testing methods updates to evaluate the quality of drug products and drug substances. Indian pharmacopeial monographs compared with United States pharmacopeia and British pharmacopoeia monographs for the critical testing parameters. The monographs of most commonly prescribed or sold Tablets like Paracetamol, Amoxycillin, Co-amoxiclav, Losartan potassium and its drug substances were selected for this comparative study. The comparison was made to the critical tests like assay and related substances for drug substances; assay, dissolution and related substances tests for drug Products. It has been observed that the Indian pharmacopoeia assay and dissolution tests are comparable with other pharmacopoeias, however related substances methods of analysis need to be updated as per current requirement. The comparative study suggests that Indian Pharmacopoeia need to strengthen testing procedure and specification limits to improve the quality of pharmaceutical products.

Keywords: Paracetamol, Amoxycillin, Co-amoxiclav, Losartan potassium, Monograph, USP, British Pharmacopoeia (BP), Indian Pharmacopoeia (IP)

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How to Cite
Munirathnam, J., and G. Radhakrishnan. “Comparison of Monographs of Indian Pharmacopeia With BP and USP Pharmacopeia’s”. International Journal of Drug Regulatory Affairs, Vol. 11, no. 1, Mar. 2023, pp. 6-14, doi:10.22270/ijdra.v11i1.572.
Issue
Vol 11 No 1 (2023): VOLUME 11, ISSUE 1, 2023
Section
Review
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