CAS number: 9005-65-6

CDE registration number: F20190001857（A）

FDA DMF: 35699

CEP: R0-CEP2020-419-Rev 00

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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