At NINGBO INNO PHARMCHEM CO.,LTD., we prioritize safety and regulatory compliance in all our products, including Ethyl Oleate. Ethyl Oleate (CAS: 111-62-6) has a generally favorable safety profile, which has led to its approval and use in various regulated industries. Understanding the safety of Ethyl Oleate is crucial for formulators and end-users alike.

In the United States, Ethyl Oleate is regulated by the Food and Drug Administration (FDA) as a food additive, permitted for direct addition to food for human consumption under specific regulations (21 CFR 172.515). This classification signifies its recognized safety for use in food products, often as a flavoring agent or carrier. Its use in cosmetics is also widespread, where it is valued for its emollient and solvent properties, contributing to product texture and skin feel.

In the pharmaceutical sector, while Ethyl Oleate is used as a vehicle for intramuscular drug delivery and as a solvent for lipophilic drugs, it's important to note that it is not typically approved for direct injectable use by regulatory bodies like the FDA in all contexts. Compounding pharmacies may use it under specific protocols. However, its utility as an excipient and solvent in various dosage forms is well-established. The regulatory status can vary by region and specific application, necessitating careful adherence to guidelines.

Extensive studies have been conducted regarding the metabolism and safety of Ethyl Oleate, particularly concerning its potential role in ethanol metabolism. Research indicates that when ingested orally, it is rapidly degraded in the digestive tract, suggesting a safe profile for dietary intake. NINGBO INNO PHARMCHEM CO.,LTD. ensures that its Ethyl Oleate meets the purity standards required for these applications, providing reliable documentation to support regulatory compliance for clients worldwide. For precise details on regulatory approvals and safety data, consulting the relevant authorities and product documentation is always recommended.