Open access · Peer reviewed · No APCs
Original ArticleInternational Journal of Pharmaceutical InvestigationVol. 14 | Issue 3 | 2024 | pp. 881–887Open access
ICH Q1 a Stability Testing for New Dosage Form
- 1,
- 2*,
- 3,
- 4,
- 5
- 1 Department of Pharmaceutical Quality Assurance, NITTE (Deemed to be University), NGSM Institute of Pharmaceutical Science, Deralakatte, Mangalore, Karnataka, INDIA.
- 2 Department of Pharmaceutics, NITTE (Deemed to be University), NGSM Institute of Pharmaceutical Science, Deralakatte, Mangalore, Karnataka, INDIA.
- 3 Department of Pharmaceutics, Vivekananda College of Pharmacy, Dr. Rajkumar Road, Rajajinagar 2nd Stage, Bangalore, Karnataka, INDIA.
- 4 Department of Pharmaceutics, KLE College of Pharmacy (A Constituent Unit of KLE Academy of Higher Education and Research, Belagavi), Hubballi, Karnataka, INDIA.
- 5 Department of Pharmaceutical Chemistry, NITTE (Deemed to be University), NGSM Institute of Pharmaceutical Science, Deralakatte, Mangalore, Karnataka, INDIA.
Published in International Journal of Pharmaceutical Investigation
Correspondence: Prashant Nayak
Department of Pharmaceutics, NITTE (Deemed to be University), NGSM Institute of Pharmaceutical Science, Deralakatte, Mangalore, Karnataka, INDIA.
Email: prashantn2001@nitte.edu.in
Copyright: © 2024 Manuscript Technomedia. This is an open access article.
- Published:
- Jun 30, 2024
- Received:
- Mar 17, 2024
- Accepted:
- Apr 29, 2024
- DOI:
- 10.5530/ijpi.14.3.98
How to cite
Subhramanya, A. B. K., Nayak, P., Ramalingappa, H., Hemanna, H. K., & Shetty, P. (2024). ICH Q1 a Stability Testing for New Dosage Form. International Journal of Pharmaceutical Investigation, 14(3), 881–887. https://doi.org/10.5530/ijpi.14.3.98
Abstract
Background
This study presents a comprehensive study on applying the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Q1A R2 guideline for conducting stability tests on new drug substances and products.
Materials and Methods
This study focused on the stability of multivitamin syrup under specific storage conditions, following ICH guidelines. The syrup was subjected to various tests, including pH measurement, weight per mL determination, microbial limit testing and assay analysis. Along with OOS, OOT and root cause analysis.
Results
Showed that the syrup maintained its yellow color, met pH specifications and had the appropriate weight per mL. Microbial limit tests revealed no presence of harmful bacteria and assay analysis confirmed the purity and quantity of the components in the syrup. A survey on tablet preparations also demonstrated stability and quality.
Conclusion
Overall, the stability studies indicated that the multivitamin syrup met all specifications and was considered stable. These findings contribute to ensuring the safety and effectiveness of the product throughout its shelf life.
Keywords
Subject
Article metadata
| Title | ICH Q1 a Stability Testing for New Dosage Form |
|---|---|
| Authors | Adhithyanarayana Bhat Kodangodlu Subhramanya; Prashant Nayak; Harshitha Ramalingappa; Harish Kachcharavi Hemanna; Prerana Shetty |
| Affiliations | Department of Pharmaceutical Quality Assurance, NITTE (Deemed to be University), NGSM Institute of Pharmaceutical Science, Deralakatte, Mangalore, Karnataka, INDIA.; Department of Pharmaceutics, NITTE (Deemed to be University), NGSM Institute of Pharmaceutical Science, Deralakatte, Mangalore, Karnataka, INDIA.; Department of Pharmaceutics, Vivekananda College of Pharmacy, Dr. Rajkumar Road, Rajajinagar 2nd Stage, Bangalore, Karnataka, INDIA.; Department of Pharmaceutics, KLE College of Pharmacy (A Constituent Unit of KLE Academy of Higher Education and Research, Belagavi), Hubballi, Karnataka, INDIA.; Department of Pharmaceutical Chemistry, NITTE (Deemed to be University), NGSM Institute of Pharmaceutical Science, Deralakatte, Mangalore, Karnataka, INDIA. |
| Corresponding author | prashantn2001@nitte.edu.in |
| Journal | International Journal of Pharmaceutical Investigation |
| Volume / Issue | Vol. 14, Issue 3 (2024) |
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