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REVIEW

A comparative analysis of pharmacopeial quality standards for antibiotics with respect to bacterial endotoxin limits

Roshni Rajpali1† ,  Anil Kumar Teotia1† ,  Prasad Thota1* ,  Disha Khanna2 ,  Vishwajeet Samaniya3 ,  Piyush Kumar1 ,  Manoj Kumar Pandey1 ,  Ajay Lagashetti1 ,  Vivekanandan Kalaiselvan1 ,  Rajeev Raghuvanshi1
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1 Microbiology Divisionn Pharmacopoeia Commission, Ministry of Health and Family Welfare, Government of India, Ghaziabad, Uttar Pradesh 201002, India
2 Department of Biotechnology and Microbiology, School of Science, Noida International University, Greater Noida, Uttar Pradesh 203201, India
3 Department of Bioscience, Institute Management Studies, Ghaziabad, Uttar Pradesh 201015, India
JBM, e99010087 https://doi.org/10.14440/jbm.0127
Submitted: 9 May 2025 | Revised: 12 September 2025 | Accepted: 9 October 2025 | Published: 25 November 2025
© 2025 by the Author(s). This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution 4.0 International License ( https://creativecommons.org/licenses/by/4.0/ )
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Abstract

Background: The bacterial endotoxin test (BET) is an important quality control measure for active pharmaceutical ingredients (APIs), injections, and antibiotics used in parenteral preparations. This test confirms that products do not contain hazardous amounts of endotoxins released from the outer membrane of Gram-negative bacteria upon cell lysis. The detection and quantification of endotoxins are crucial for patient safety, as they can cause severe pyrogenic reactions. A pharmacopeia is a book of drug standards that ensures the quality, safety, and efficacy of pharmaceutical products. Objective: This study aims to assess the differences and correlations among the Indian Pharmacopeia (IP), British Pharmacopeia (BP), Japanese Pharmacopeia (JP), European Pharmacopeia (Ph. Eur.), United States Pharmacopeia (USP), and International Pharmacopeia (Ph. Int.) regarding injection preparation specifications, antibiotic and API specifications, and acceptance criteria for bacterial endotoxins. BET guidelines are provided by these pharmacopeial organizations, including the BP, JP, IP, Ph. Eur., Ph. Int., and USP. The permissible endotoxin limits vary depending on the route of administration. It was found that bacterial endotoxin limits for antibiotic injections and APIs are specified in the IP, BP, JP, Ph. Eur., USP, and Ph. Int. The findings suggest that the similarities and variations in bacterial endotoxin limits and their acceptance criteria, as outlined in these pharmacopeias, should be harmonized to promote regulatory consistency and patient safety. Conclusion: The comparative data obtained from this study will be useful for developing strategies to harmonize pharmacopeial standards concerning antibiotic preparation requirements, including bacterial endotoxin limit specifications.

Keywords
Bacterial endotoxin limits
Antibiotics
Pharmacopeia
Harmonization
Safety
Funding
None.
Conflict of interest
The authors declare they have no competing interests.
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Journal of Biological Methods, Electronic ISSN: 2326-9901 Print ISSN: TBA, Published by POL Scientific
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