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Purpose <p>This study aimed to investigate the impact of moisture content on the assay of amoxycillin and potassium clavulanate dry oral suspension.</p> Methods <p>For this purpose, 35 samples of different brands and strengths of amoxycillin and potassium clavulanate dry oral suspension were collected from various high-humidity locations in India. All collected samples were subjected to moisture content test, while selected samples were subjected to amoxycillin and clavulanic acid assay; both were performed as specified in the corresponding Indian Pharmacopoeia (IP) 2022 monograph for amoxycillin and potassium clavulanate dry oral suspension.</p> Results <p>The moisture content of the samples ranged from 4.6% to 9.3% for amoxycillin 200&#xa0;mg/clavulanic acid 28.5&#xa0;mg per 5&#xa0;ml strength and from 6.3% to 10.5% for the amoxycillin 400&#xa0;mg/clavulanic acid 57&#xa0;mg per 5&#xa0;ml strength. Of the 35 samples analysed, 2 samples of amoxycillin 200&#xa0;mg strength failed the IP 2022 moisture limit (not more than 8.5%), with observed values of 9.3% and 9.1%. The amoxycillin content in the two failed samples was 74.52% and 73.36%, respectively, which is below IP 2022 limits (90.0%–120.0%). However, clavulanic acid content remained within acceptable IP 2022 limits (90.0%–125.0%).</p> Conclusion <p>These findings indicate that moisture may affect amoxycillin content, stability, and assay performance of amoxycillin and potassium clavulanate dry oral suspension, suggesting that moisture content could be a vital quality control parameter in its formulation and storage.</p>

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Impact of Excessive Moisture on Amoxycillin Content in Amoxycillin and Potassium Clavulanate Dry Oral Suspensions Marketed in High-Humidity Regions of India: A Pharmacopoeial Study

  • 期刊论文

  • 发表日期：

    2026年2月27日

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  • Pawan Kumar,
  • Pawan Kumar Saini,
  • Saurabh Sahoo,
  • Rajeev Singh Raghuvanshi,
  • Gaurav Pratap Singh Jadaun

摘要

Purpose

This study aimed to investigate the impact of moisture content on the assay of amoxycillin and potassium clavulanate dry oral suspension.

Methods

For this purpose, 35 samples of different brands and strengths of amoxycillin and potassium clavulanate dry oral suspension were collected from various high-humidity locations in India. All collected samples were subjected to moisture content test, while selected samples were subjected to amoxycillin and clavulanic acid assay; both were performed as specified in the corresponding Indian Pharmacopoeia (IP) 2022 monograph for amoxycillin and potassium clavulanate dry oral suspension.

Results

The moisture content of the samples ranged from 4.6% to 9.3% for amoxycillin 200 mg/clavulanic acid 28.5 mg per 5 ml strength and from 6.3% to 10.5% for the amoxycillin 400 mg/clavulanic acid 57 mg per 5 ml strength. Of the 35 samples analysed, 2 samples of amoxycillin 200 mg strength failed the IP 2022 moisture limit (not more than 8.5%), with observed values of 9.3% and 9.1%. The amoxycillin content in the two failed samples was 74.52% and 73.36%, respectively, which is below IP 2022 limits (90.0%–120.0%). However, clavulanic acid content remained within acceptable IP 2022 limits (90.0%–125.0%).

Conclusion

These findings indicate that moisture may affect amoxycillin content, stability, and assay performance of amoxycillin and potassium clavulanate dry oral suspension, suggesting that moisture content could be a vital quality control parameter in its formulation and storage.