<![CDATA[Reference standards are comparative materials used to ensure the accuracy of pharmaceutical product testing. However, the use of reference standards represents a substantial cost component in laboratory operations. At the Quality Control Laboratory of PT XYZ, the analysis of Clopidogrel products requires a reference standard cost of IDR 58,734,000.00 for a single testing procedure. This study aimed to analyze the effects of storage temperature and storage duration on the stability of Clopidogrel reference standard solutions, evaluate their compliance with the established acceptance tolerance limits, and determine the potential cost efficiency that could be achieved. An experimental method was employed using a Design of Experiment (DOE) approach combined with Analysis of Variance (ANOVA). The investigated factors included storage temperature, consisting of room temperature (25 ± 2°C) and refrigerated temperature (4–6°C), as well as storage duration at weeks 0, 2, 4, 6, and 8. The response variable was the chromatographic peak area obtained using High Performance Liquid Chromatography (HPLC). Stability was evaluated based on an acceptance tolerance limit of ±5% relative to the initial peak area. The results demonstrated that storage temperature, storage duration, and the interaction between these two factors had a statistically significant effect on solution stability (p < 0.05). Based on the tolerance limit evaluation, storage under refrigerated conditions exhibited superior stability compared with room temperature and remained within the acceptance criteria throughout the storage period. The proposed storage condition enables more efficient utilization of the reference standard solution, reducing the reference standard cost from IDR 58,734,000.00 to IDR 23,493,600.00 per analysis. This approach results in a cost saving of IDR 35,240,400.00, corresponding to an overall cost efficiency of 60%.]]>
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