ICH Q1 a Stability Testing for New Dosage Form.

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. [ABSTRACT FROM AUTHOR]