Polysorbate and Solubilizer

　4) Survival Rate

In addition to the data mentioned above regarding the safety features of highly pure Polysorbate80 that were identified through in vitro testing, we also wish to report the results of an acute toxicity test performed in vivo.
Conventional injection-grade Polysorbate80 and our highly pure Polysorbate80 were diluted to a certain concentration with saline. A selected dose of each was administered into the tail veins of mice and the survival rates of the animals were evaluated. In addition to the set of data regarding the safety features of highly pure Polysorbate80 in vitro, which we previously reported, highly pure Polysorbate80 also showed excellent safety features in vivo.
Dosage: The groups of mice that were given 0.75 mL or 1 mL of our highly pure Polysorbate80 showed a markedly higher rate of survival than mice given other grades of Polysorbate80.

In addition to the tests on safety features performed in vitro, which evaluate a limited range of properties, our highly pure Polysorbate80 showed an excellent level of safety in the tests performed in vivo; these measure a wider range of biological functions relating to the metabolic detoxification system.
Since people nowadays pay considerable attention to the safety aspects of pharmaceutical products and to the quality of life, we are benefiting society by providing our highly pure Polysorbate80 as a standard product worldwide.

Effect of concentration of Polysorbate 80 on Survival Rate in BALB/c mice. Polysorbate 80 is diluted by PBS and injected into mice with intravenous administration.