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Polysorbate 80（For Injection）

Excipients for Injection

Polysorbate 80 is a hydrophilic nonionic surfactant. It is utilized as a surfactant in soaps and cosmetics and also as a lubricant in eye drops. In food or pharmaceutical products, it can act as an emulsifier. Polysorbate 80 is an excipient that is used to stabilize aqueous formulations of medications for parenteral administration or vaccinations. A solubilizing agent acts as a surfactant and increases the solubility of one agent in another. A substance that would not normally dissolve in a particular solution is able to dissolve with the use of a solubilizing agent. It is also known as an emulsifier, which helps ingredients mix together and prevent separation, and water-containing small amounts of salts, and is included in several vaccines

Product Description

CAS number: 9005-65-6

Pharmacopoeia specification compliance: USP/EP/JP/ChP

Storage: In an airtight container, protected from light.

Properties and Benefits

l Comply with the specifications of current EP, USP and JP.

l Using high-purity raw materials derived from plants, product can withstand terminal sterilization, and the product has good batch-to-batch repeatability.

l Lower acid value, peroxide value and water content compared with non-injectable grade.

l Bacterial endotoxins and micro-organisms or sterility are strictly controlled, meet the requirements of parenteral dosage forms.

 

Applications

l Nonionic surfactant, solubilizer, wetting agent, plasticizer. It also can be used as oil-in-water emulsifier.

 

Safety Evaluation

l Compared with non-injectable polysorbate 80, polysorbate 80 (For Injection) did not show hemolysis and erythrocyte aggregation at the final concentration of 0.5mg/mL in the test system.

l Polysorbate 80 (For Injection) simulated the highest clinical concentration, and after injection into the ear vein of New Zealand rabbits, no obvious pathological changes appeared, which proves that the product is not irritating to blood vessels.

l Compared with non-injectable polysorbate 80, in the guinea pig active allergy test, the polysorbate 80 (For Injection) administration group had no abnormal reaction symptoms, and no toxicological significance change of hematology, coagulation, blood biochemical and other indicators.

l The maximum tolerated dose (MTD) of polysorbate 80 (For Injection) was significantly higher than that of non-injectable polysorbate 80.

l The above research conclusions come from a safety evaluation center with GLP qualification.

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