Ethyl Oleate EP / USP - Oleic Acid Ethyl Ester
Ethyl Oleate EP (Ph.Eur) / USP Pharma Grade: Ph.Eur / USP quality for Pharmaceutical Applications
Ethyl Oleate EP/USP is a Pharma grade, widely recognized for its exceptional quality and compliance with the stringent standards of the European Pharmacopoeia (Ph.Eur / EP) and US Pharmacopoeia. This clear, colourless to pale yellow, oily liquid is an ethyl ester of oleic acid, produced through the reaction of ethanol and oleic acid. Its superior purity and consistent performance make it a preferred choice in the pharmaceutical industry for a variety of applications.
Key Features and Specifications
- Pharma Grade Compliance: Meets EP (Ph.Eur) and USP standards, ensuring safety and efficacy for pharmaceutical use.
- CAS Number: 111-62-6
- Molecular Formula: C20H38O2
- Molecular Weight: 310.51
- Specific Gravity: 0.866–0.874 at 20°C
- Refractive Index: 1.443–1.450
- Acid Value: ≤ 0.5
- Iodine Value: 75–90
- Saponification Value: 177–188
- Appearance: Clear, colorless to pale yellow liquid
- Solubility: Miscible with chloroform, ethanol, ether, fixed oils, and most organic solvents; practically insoluble in water.
Applications in Pharmaceuticals
Ultra Refined grade Ethyl Oleate EP (Ph.Eur)/USP is primarily used as:
- A vehicle for parenteral (intramuscular) drug formulations: Its low viscosity and rapid absorption make it ideal for injectable solutions.
- A solvent for lipophilic drugs: Especially suitable for steroids and other fat-soluble pharmaceuticals.
- A carrier in microemulsions and topical formulations: Enhances drug delivery and absorption.
Advantages
- Excellent Solvent Properties: Superior to many fixed oils due to lower viscosity and faster tissue absorption.
- Stable and Long Shelf Life: Resistant to oxidation when stored properly in well-closed, light-resistant containers; antioxidants may be added to extend shelf life.
Packaging and Storage
Ethyl Oleate EP (Ph.Eur)/USP is typically supplied in 20 kg or 180 kg drums, with custom packaging available upon request. For optimal stability, store in a cool, dry place, protected from light and air. Use of inert gas (e.g., nitrogen) in partially filled containers is recommended to prevent oxidation.
Why Choose Ethyl Oleate EP (Ph.Eur)/USP Pharma Grade?
- Regulatory Compliance: Fully conforms to EP/Ph.Eur and international pharmacopeial standards.
- Versatility: Suitable for a wide range of pharmaceutical formulations.
- Global Supply: Available in bulk and laboratory quantities, with worldwide shipping and technical support.