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Butylated hydroxytoluene (BHT) is a synthetic antioxidant commonly used in biologic formulations to prevent oxidative degradation. It acts as a preservative, protecting biologic products from oxidation, which can affect the potency and stability of sensitive molecules. Its application is critical in maintaining the integrity of biologics, particularly those that are exposed to air or light during production and storage.

The United States Pharmacopeia (USP) provides quality standards for biologics to ensure their safety, efficacy, and quality throughout the manufacturing process. These standards assist manufacturers in adhering to regulatory requirements and help safeguard public health by reducing risks associated with biologics.

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