The original formula of fat emulsion injection uses soybean oil as the oil phase and egg yolk lecithin as the emulsifier to achieve good stability and safety.
With the development of fat emulsion injection, the oil phase has more choices such as olive oil, MCT, fish oil and other oils with different properties. In addition, drug loaded emulsions for therapeutic use have also been developed. Thus the product stability faces great challenge.
The use of a single emulsifier cannot satisfy quality requirements in some cases. Therefore, it is necessary to add oleic acid or sodium oleate as an auxiliary emulsifier when egg yolk lecithin alone cannot achieve good emulsification effects.
Sodium oleate is obtained by neutralizing oleic acid in ethanol with sodium hydroxide or sodium carbonate. It is white to light yellow solid at room temperature.
NMPA CDE registration no.: F20190001608（A）
USFDA DMF no.: /
Product Name | Sodium Oleate（for injection) |
Chemical Name | / |
CAS No. | 143-19-1 |
NMPA CDE registration no. | F20190001608（A） |
USFDA DMF No. | / |
Quality grade | Injection |
Quality standards | Manufacturer's standard |
Molecular Formula | C18H33NaO2 |
Applications and examples | Fat emulsion co-emulsifier |
Product code | O04005 |
Package sizes | 100g |
Storage condition | Store at room temperature, keep dry and cool |
As an anionic surfactant, sodium oleate is more toxic and corrosive than oleic acid;
Topical use may cause slight irritation and burning sensation to the skin and mucous membrane;
Animal experiments show that sodium oleate has strong gastrointestinal corrosive effects and obvious reproductive toxicity. Eye irritation can cause relatively severe corneal damage.
The solubility of sodium oleate in water increases and can be dissolved in 10 times the amount of water, foaming to a viscous liquid. Due to it's partial hydrolysis into insoluble acidic soap and sodium hydroxide, the solution becomes strongly alkaline and milky.
Sodium oleate is soluble in about 20 times the amount of ethanol, almost insoluble in diethyl ether, petroleum ether and other organic solvents.
If you have any questions, please don't hesitate to contact us. We're always here to help with Pharmaceutical Excipients for your business. We can provide products ranging from grams to tons. AVT is able to produce and even register the product in US FDA according to your special needs.
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