The United States Food and Drug Administration (FDA) classifies SB as Generally Recognized as Safe (GRAS) for use in foods, with a maximum limit of 0.1% by weight . SB is commonly employed as a preservative in pharmaceuticals and medications. However, the precise concentration limitations of SB can differ based on the exact formulation and kind of medication. The FDA's guidance primarily focuses on ensuring the safety of the formulation for its intended use, despite the criticism that this assessment has overlooked many studies in related cases . The World Health Organization (WHO), in collaboration with the FAO (Food and Agriculture Organization), sets standards for food additives, including SB. According to the latest recommendation in the ninety-second meeting, the acceptable daily intake (ADI) for SB was established to be up to 20 mg/kg of body weight . Although this ADI has a wide application, it can also serve as a useful tool for assessing medication safety. The European Medicines Agency (EMA) provides guidelines for excipients like SB in pharmaceuticals. In the EU, SB is permitted as a preservative in various pharmaceutical formulations. The concentration of SB in medicines should comply with safety evaluations, which generally align with the maximum limit of therefore recommends a maximum dose of 5 mg.kg -1 per day in products, similar to food standards. However, this limit is not exclusively applicable to pediatric populations .