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

  • Jayaprakash Munirathnam Mr
  • Gowri Radhakrishnan

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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References

1. Mark Wiggins J, Joseph A. Albanese. A brief history of Pharmacopoeias: A Global Perspective, Pharm Tech, Regulatory sources; 2019 Sep 15.
2. USP. United States Pharmacopeia Celebrates 200 Years of Building Trust in Medicines, Supplements and Foods. [Internet]. USP.org; 2020 Jan [cited 2023 Jan 01]. Available from:
https://www.usp.org/news/usp-celebrates-200-years-of-building-trust-in-medicines-supplements-and-foods
3. British Pharmacopoeia (BP) [Internet]. pharmacopoeia. com; 2023 [cited 2023 Jan 01]. Available from:
https://www.pharmacopoeia.com/what-is-the-bp
4. Patel D. Indian Express. [Internet]. New Delhi: pharmacopoeia.com; 2018 Jul 10 [cited 2023 Jan 02]. Available from:
https://indianexpress.com/article/business/business-others/paracetamol-sales
5. Indian Pharmacopoeia. eighth ed. V-I. New Delhi: Ministry of Health and Family Welfare, Govt. of India; 2018.p. 2853-54, 2858, 1230-32, 2965-66, 1235-36, 2467-69.
6. The United States Pharmacopoeia. V-III. Acetaminophen. The United States Pharmacopoeial Convention, Rockville: USP; 2021. Doi.org/10.31003/USPNF_M150_04_01
7. British Pharmacopoeia. V-II, London: Ministry of Health and Family Welfare, Department of ISM & H, Govt. of India; 2020.p. 536-537.
8. The United States Pharmacopoeia. V-III. Rockville: The United States Pharmacopoeial Convention; 2021. GUID-32170AD6-FA98-4DC8-90E9-823EC5E59945_5_en-US
9. British Pharmacopoeia. V-III, London: Ministry of Health and Family Welfare, Department of ISM & H, Govt. of India; 2020.p. 1115-1116.
10. The United States Pharmacopoeia. V-III. Rockville: The United States Pharmacopoeial Convention; 2021. GUID-BE258FA7-AD04-4D79-B3D5-52E27CDC924B_6_en-US
11. British Pharmacopoeia. V-I. London: Ministry of Health and Family Welfare, Department of ISM & H, Govt. of India; 2020.p. 173-174.
12. The United States Pharmacopoeia. V-III. Rockville: The United States Pharmacopoeial Convention; 2021. GUID-A984DC58-903F-4577-B7E4-A108B988F1E0_3_en-US
13. British Pharmacopoeia. V-III. London: Ministry of Health and Family Welfare, Department of ISM & H, Govt. of India; 2020.p. 154-155.
14. The United States Pharmacopoeia. V-III. Rockville: The United States Pharmacopoeial Convention; 2021. GUID-984E0EB3-698B-4DF6-961B-62321C3840AA_1_en-US
15. British Pharmacopoeia. V-II. London: Ministry of Health and Family Welfare, Department of ISM & H, Govt. of India; 2020.p. 669-671.
16. The United States Pharmacopoeia. V-III. Rockville: The United States Pharmacopoeial Convention; 2021. GUID-26D67006-2847-43C4-AEE8-8610488016B6_5_en-US
17. British Pharmacopoeia. V-II. London: Ministry of Health and Family Welfare, Department of ISM & H, Govt. of India; 2020.p. 146 -147.
18. The United States Pharmacopoeia. V-III. Rockville: The United States Pharmacopoeial Convention; 2021. GUID-12B43E12-F04D-490E-90F8-8981D9F74685_1_en-US
19. British Pharmacopoeia. V-III, London: Ministry of Health and Family Welfare, Department of ISM & H, Govt. of India; 2020.p. 904905.
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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.